Trial Outcomes & Findings for Dose Ranging of GSK2336805 in Combination Therapy (NCT NCT01648140)

NCT ID: NCT01648140

Last Updated: 2017-06-02

Results Overview

eRVR is defined as plasma HCV ribonucleic acid (RNA) \<lower limit of quantification (LLOQ) and target not detected at Weeks 4 and 12. Participants who discontinued prior to Week 12 assessments or had missing HCV RNA values at Weeks 4 and 12 were treated as non-responders.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

286 participants

Primary outcome timeframe

Week 4 and Week 12

Results posted on

2017-06-02

Participant Flow

This study was conducted across 29 centers in 6 countries (United States, Puerto Rico, Germany, Belgium, France, and Bulgaria) from 15 August 2012 to 16 July 2014.

Participants with treatment-naïve(TN) chronic genotype1(G1) hepatitis C virus (HCV) infection were randomly allocated on 2:2:1 basis to 2 dose levels of GSK2336805 or telaprevir. In a nonrandomized single-arm cohort, participants with TN genotype4(G4) chronic HCV infection were enrolled in parallel at dose level of 60 milligrams (mg) of GSK2336805.

Participant milestones

Participant milestones
Measure
GSK2336805 40 mg, G1 HCV
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (Pegylated Interferon Alfa-2a \[PEG\] + Ribavirin \[RIBA\]) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the extended rapid virologic response (eRVR) achievement. PEG dose was 180 micrograms (µg) once weekly subcutaneous (SC) injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kilogram \[kg\]) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, G1 HCV
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, G1 HCV
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, G4 HCV
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Overall Study
STARTED
41
40
17
13
Overall Study
COMPLETED
29
28
9
11
Overall Study
NOT COMPLETED
12
12
8
2

Reasons for withdrawal

Reasons for withdrawal
Measure
GSK2336805 40 mg, G1 HCV
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (Pegylated Interferon Alfa-2a \[PEG\] + Ribavirin \[RIBA\]) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the extended rapid virologic response (eRVR) achievement. PEG dose was 180 micrograms (µg) once weekly subcutaneous (SC) injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kilogram \[kg\]) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, G1 HCV
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, G1 HCV
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, G4 HCV
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Overall Study
Physician Decision
1
0
0
0
Overall Study
Lack of Efficacy
4
7
1
0
Overall Study
Adverse Event
3
1
2
0
Overall Study
Withdrawal by Subject
2
3
3
2
Overall Study
Lost to Follow-up
2
1
2
0

Baseline Characteristics

Dose Ranging of GSK2336805 in Combination Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Total
n=111 Participants
Total of all reporting groups
Age, Continuous
43.7 Years
STANDARD_DEVIATION 13.23 • n=5 Participants
40.8 Years
STANDARD_DEVIATION 9.87 • n=7 Participants
39.4 Years
STANDARD_DEVIATION 12.02 • n=5 Participants
45.3 Years
STANDARD_DEVIATION 11.46 • n=4 Participants
42.2 Years
STANDARD_DEVIATION 11.73 • n=21 Participants
Sex: Female, Male
Female
13 Participants
n=5 Participants
16 Participants
n=7 Participants
6 Participants
n=5 Participants
3 Participants
n=4 Participants
38 Participants
n=21 Participants
Sex: Female, Male
Male
28 Participants
n=5 Participants
24 Participants
n=7 Participants
11 Participants
n=5 Participants
10 Participants
n=4 Participants
73 Participants
n=21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Black or African American
6 Participants
n=5 Participants
6 Participants
n=7 Participants
2 Participants
n=5 Participants
3 Participants
n=4 Participants
17 Participants
n=21 Participants
Race (NIH/OMB)
White
34 Participants
n=5 Participants
33 Participants
n=7 Participants
15 Participants
n=5 Participants
9 Participants
n=4 Participants
91 Participants
n=21 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
2 Participants
n=21 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants

PRIMARY outcome

Timeframe: Week 4 and Week 12

Population: Intent-To-Treat (ITT) Population: comprised of all participants who met the study criteria and were randomly assigned to treatment in the study with documented evidence of having received at least 1 dose of randomized treatment and at least 1 post Baseline HCV RNA measurement.

eRVR is defined as plasma HCV ribonucleic acid (RNA) \<lower limit of quantification (LLOQ) and target not detected at Weeks 4 and 12. Participants who discontinued prior to Week 12 assessments or had missing HCV RNA values at Weeks 4 and 12 were treated as non-responders.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Number of Participants Achieving eRVR
23 Participants
21 Participants
9 Participants
9 Participants

PRIMARY outcome

Timeframe: From the start of study treatment up to Week 12

Population: Safety Population: comprised of all participants who received at least 1 dose of study medication (GSK2336805 or telaprevir).

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) up to Week 12
Any AE
39 Participants
37 Participants
17 Participants
13 Participants
Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) up to Week 12
Any SAE
0 Participants
2 Participants
3 Participants
1 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) up to 12-week treatment period

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Blood pressure measurements were taken to observe vital signs and included SBP and DBP at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and Post-treatment (PT) Follow Up (FU) Weeks 4, 12 and 24. Change from Baseline in SBP and DBP is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12
SBP; Week1; n=41, 39, 15, 13
0.9 Millimeters of mercury (mmHg)
Standard Deviation 12.99
-3 Millimeters of mercury (mmHg)
Standard Deviation 11.24
-4.5 Millimeters of mercury (mmHg)
Standard Deviation 12.67
-2.6 Millimeters of mercury (mmHg)
Standard Deviation 11.84
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12
DBP; Day2; n=41, 40, 17, 13
-1.2 Millimeters of mercury (mmHg)
Standard Deviation 6.63
-1 Millimeters of mercury (mmHg)
Standard Deviation 7.03
-3 Millimeters of mercury (mmHg)
Standard Deviation 9.03
-1.5 Millimeters of mercury (mmHg)
Standard Deviation 10.45
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12
DBP; Week1; n=41, 39, 15, 13
-0.4 Millimeters of mercury (mmHg)
Standard Deviation 7.98
-2.2 Millimeters of mercury (mmHg)
Standard Deviation 9.13
1 Millimeters of mercury (mmHg)
Standard Deviation 10.54
-1 Millimeters of mercury (mmHg)
Standard Deviation 7.99
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12
DBP; Week2; n=41, 39, 14, 13
-0.4 Millimeters of mercury (mmHg)
Standard Deviation 10.41
-1.7 Millimeters of mercury (mmHg)
Standard Deviation 9.52
-0.3 Millimeters of mercury (mmHg)
Standard Deviation 8.8
-2.8 Millimeters of mercury (mmHg)
Standard Deviation 11.09
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12
DBP; Week4; n=41, 39, 14, 13
-1.2 Millimeters of mercury (mmHg)
Standard Deviation 7.73
-4.4 Millimeters of mercury (mmHg)
Standard Deviation 9.78
-3.9 Millimeters of mercury (mmHg)
Standard Deviation 9.74
0.8 Millimeters of mercury (mmHg)
Standard Deviation 9.92
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12
DBP; Week6; n=41, 39, 13, 13
-1.2 Millimeters of mercury (mmHg)
Standard Deviation 7.65
-4.8 Millimeters of mercury (mmHg)
Standard Deviation 9.86
-5.9 Millimeters of mercury (mmHg)
Standard Deviation 7.82
-1.6 Millimeters of mercury (mmHg)
Standard Deviation 10.1
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12
DBP; Week8; n=41, 39, 13, 13
-2.1 Millimeters of mercury (mmHg)
Standard Deviation 10
-2.9 Millimeters of mercury (mmHg)
Standard Deviation 9.11
-4.4 Millimeters of mercury (mmHg)
Standard Deviation 7.63
-2.4 Millimeters of mercury (mmHg)
Standard Deviation 9.02
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12
DBP; Week12; n=38, 35, 12, 13
0.3 Millimeters of mercury (mmHg)
Standard Deviation 8.48
-4.4 Millimeters of mercury (mmHg)
Standard Deviation 10.24
-3.5 Millimeters of mercury (mmHg)
Standard Deviation 9.2
-1 Millimeters of mercury (mmHg)
Standard Deviation 9.11
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12
SBP; Day2; n=41, 40, 17, 13
-1.4 Millimeters of mercury (mmHg)
Standard Deviation 10.1
-0.8 Millimeters of mercury (mmHg)
Standard Deviation 12.85
-3.3 Millimeters of mercury (mmHg)
Standard Deviation 10.46
-1.3 Millimeters of mercury (mmHg)
Standard Deviation 13.95
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12
SBP; Week2; n=41, 39, 14, 13
-2 Millimeters of mercury (mmHg)
Standard Deviation 10.57
-0.7 Millimeters of mercury (mmHg)
Standard Deviation 11.67
-4.1 Millimeters of mercury (mmHg)
Standard Deviation 12.67
-4.2 Millimeters of mercury (mmHg)
Standard Deviation 17.35
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12
SBP; Week4; n=41, 39, 14, 13
-3.6 Millimeters of mercury (mmHg)
Standard Deviation 11.56
-4.2 Millimeters of mercury (mmHg)
Standard Deviation 16.2
-3.8 Millimeters of mercury (mmHg)
Standard Deviation 9.73
-5.2 Millimeters of mercury (mmHg)
Standard Deviation 15.3
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12
SBP; Week6; n=41, 39, 13, 13
-0.4 Millimeters of mercury (mmHg)
Standard Deviation 14.47
-3.8 Millimeters of mercury (mmHg)
Standard Deviation 13.28
-5.9 Millimeters of mercury (mmHg)
Standard Deviation 11.39
0.2 Millimeters of mercury (mmHg)
Standard Deviation 14.47
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12
SBP; Week8; n=41, 39, 13, 13
-3.7 Millimeters of mercury (mmHg)
Standard Deviation 12.15
-1.5 Millimeters of mercury (mmHg)
Standard Deviation 12.64
-2.9 Millimeters of mercury (mmHg)
Standard Deviation 10.36
-4.2 Millimeters of mercury (mmHg)
Standard Deviation 12.95
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12
SBP; Week12; n=38, 35, 12, 13
-1.9 Millimeters of mercury (mmHg)
Standard Deviation 13.65
-1.4 Millimeters of mercury (mmHg)
Standard Deviation 11.72
-5.2 Millimeters of mercury (mmHg)
Standard Deviation 5.81
-2.6 Millimeters of mercury (mmHg)
Standard Deviation 19.16

PRIMARY outcome

Timeframe: Baseline (Week 0) and Day 2, Weeks 1, 2, 4, 6, 8, and 12

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4, 12 and 24. Change from Baseline in heart rate is summarized for each post-Baseline assessment upto Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12
Heart Rate; Day2; n=41, 40, 17, 13
6.5 Beats per minute
Standard Deviation 8.65
5.4 Beats per minute
Standard Deviation 9.96
9.3 Beats per minute
Standard Deviation 11.74
3.8 Beats per minute
Standard Deviation 5.79
Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12
Heart Rate; Week1; n=41, 39, 15, 13
1.5 Beats per minute
Standard Deviation 8.33
3.1 Beats per minute
Standard Deviation 8.75
8.1 Beats per minute
Standard Deviation 6.32
7.7 Beats per minute
Standard Deviation 10.11
Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12
Heart Rate; Week2; n=41, 39, 14, 13
3.8 Beats per minute
Standard Deviation 9.02
4.2 Beats per minute
Standard Deviation 12.14
8.7 Beats per minute
Standard Deviation 8.17
7.8 Beats per minute
Standard Deviation 8.6
Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12
Heart Rate; Week4; n=41, 39, 14, 13
6.8 Beats per minute
Standard Deviation 9.42
4.2 Beats per minute
Standard Deviation 11.78
10.7 Beats per minute
Standard Deviation 11.39
5.5 Beats per minute
Standard Deviation 8.35
Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12
Heart Rate; Week6; n=41, 39, 13, 13
8 Beats per minute
Standard Deviation 10.15
5 Beats per minute
Standard Deviation 10.98
13.8 Beats per minute
Standard Deviation 9.75
10.2 Beats per minute
Standard Deviation 8.2
Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12
Heart Rate; Week8; n=41, 39, 13, 13
4.7 Beats per minute
Standard Deviation 9.91
6.8 Beats per minute
Standard Deviation 12.42
14.2 Beats per minute
Standard Deviation 10.36
12.8 Beats per minute
Standard Deviation 12.27
Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12
Heart Rate; Week12; n=38, 35, 12, 13
7 Beats per minute
Standard Deviation 9.2
5.3 Beats per minute
Standard Deviation 12.1
11 Beats per minute
Standard Deviation 8.02
8.4 Beats per minute
Standard Deviation 9.47

PRIMARY outcome

Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils, platelet count and white blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Monocytes; Week12; n=37, 36, 12, 12
-0.185 Giga cells per liter
Standard Deviation 0.1715
-0.183 Giga cells per liter
Standard Deviation 0.1438
-0.219 Giga cells per liter
Standard Deviation 0.1493
-0.133 Giga cells per liter
Standard Deviation 0.2048
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Total Neutrophils; Week8; n=38, 39, 13, 13
-2.706 Giga cells per liter
Standard Deviation 1.7553
-2.168 Giga cells per liter
Standard Deviation 1.6902
-1.222 Giga cells per liter
Standard Deviation 1.3481
-1.613 Giga cells per liter
Standard Deviation 0.6882
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Eosinophils; Week2; n=40, 38, 14, 10
-0.08 Giga cells per liter
Standard Deviation 0.1004
-0.111 Giga cells per liter
Standard Deviation 0.0912
-0.059 Giga cells per liter
Standard Deviation 0.104
-0.114 Giga cells per liter
Standard Deviation 0.1247
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Eosinophils; Week4; n=41, 38, 14, 13
-0.105 Giga cells per liter
Standard Deviation 0.0872
-0.132 Giga cells per liter
Standard Deviation 0.1057
-0.079 Giga cells per liter
Standard Deviation 0.1089
-0.108 Giga cells per liter
Standard Deviation 0.0923
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Eosinophils; Week6; n=41, 37, 12, 12
-0.117 Giga cells per liter
Standard Deviation 0.0929
-0.134 Giga cells per liter
Standard Deviation 0.1182
-0.113 Giga cells per liter
Standard Deviation 0.0607
-0.109 Giga cells per liter
Standard Deviation 0.1208
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Eosinophils; Week8; n=38, 39, 13, 13
-0.121 Giga cells per liter
Standard Deviation 0.0897
-0.134 Giga cells per liter
Standard Deviation 0.1061
-0.13 Giga cells per liter
Standard Deviation 0.0965
-0.104 Giga cells per liter
Standard Deviation 0.0916
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Eosinophils; Week12; n=37, 36, 12, 12
-0.118 Giga cells per liter
Standard Deviation 0.0916
-0.112 Giga cells per liter
Standard Deviation 0.1594
-0.106 Giga cells per liter
Standard Deviation 0.1152
-0.102 Giga cells per liter
Standard Deviation 0.1428
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Lymphocytes; Week1; n=38, 38, 14, 11
-0.319 Giga cells per liter
Standard Deviation 0.5006
-0.282 Giga cells per liter
Standard Deviation 0.5698
-0.608 Giga cells per liter
Standard Deviation 0.5466
-0.371 Giga cells per liter
Standard Deviation 0.4332
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Lymphocytes; Week2; n=40, 38, 14, 10
-0.448 Giga cells per liter
Standard Deviation 0.5385
-0.603 Giga cells per liter
Standard Deviation 0.5921
-0.675 Giga cells per liter
Standard Deviation 0.5639
-0.553 Giga cells per liter
Standard Deviation 0.4346
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Lymphocytes; Week4; n=41, 38, 14, 13
-0.787 Giga cells per liter
Standard Deviation 0.5055
-0.854 Giga cells per liter
Standard Deviation 0.5114
-0.989 Giga cells per liter
Standard Deviation 0.5293
-0.773 Giga cells per liter
Standard Deviation 0.4104
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Lymphocytes; Week6; n=41, 37, 12, 12
-0.963 Giga cells per liter
Standard Deviation 0.5313
-1.043 Giga cells per liter
Standard Deviation 0.5928
-1.334 Giga cells per liter
Standard Deviation 0.4906
-0.93 Giga cells per liter
Standard Deviation 0.4955
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Lymphocytes; Week8; n=38, 39, 13, 13
-0.953 Giga cells per liter
Standard Deviation 0.4624
-1.061 Giga cells per liter
Standard Deviation 0.6021
-1.256 Giga cells per liter
Standard Deviation 0.3509
-0.964 Giga cells per liter
Standard Deviation 0.5098
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Lymphocytes; Week12; n=37, 36, 12, 12
-1.118 Giga cells per liter
Standard Deviation 0.5139
-1.074 Giga cells per liter
Standard Deviation 0.5883
-1.438 Giga cells per liter
Standard Deviation 0.4773
-1.048 Giga cells per liter
Standard Deviation 0.6612
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Monocytes; Week1; n=38, 38, 14, 11
-0.103 Giga cells per liter
Standard Deviation 0.1418
-0.056 Giga cells per liter
Standard Deviation 0.145
0.034 Giga cells per liter
Standard Deviation 0.1502
-0.025 Giga cells per liter
Standard Deviation 0.0808
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Monocytes; Week2; n=40, 38, 14, 10
-0.122 Giga cells per liter
Standard Deviation 0.227
-0.061 Giga cells per liter
Standard Deviation 0.1785
-0.091 Giga cells per liter
Standard Deviation 0.1562
-0.034 Giga cells per liter
Standard Deviation 0.1687
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Monocytes; Week4; n=41, 38, 14, 13
-0.151 Giga cells per liter
Standard Deviation 0.1771
-0.129 Giga cells per liter
Standard Deviation 0.158
-0.126 Giga cells per liter
Standard Deviation 0.1471
-0.055 Giga cells per liter
Standard Deviation 0.2103
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Monocytes; Week6; n=41, 37, 12, 12
-0.182 Giga cells per liter
Standard Deviation 0.1664
-0.171 Giga cells per liter
Standard Deviation 0.1326
-0.245 Giga cells per liter
Standard Deviation 0.1786
-0.135 Giga cells per liter
Standard Deviation 0.1088
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Monocytes; Week8; n=38, 39, 13, 13
-0.229 Giga cells per liter
Standard Deviation 0.167
-0.165 Giga cells per liter
Standard Deviation 0.1779
-0.185 Giga cells per liter
Standard Deviation 0.1344
-0.124 Giga cells per liter
Standard Deviation 0.2164
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Total Neutrophils; Week1; n=38, 38, 14, 11
-2.338 Giga cells per liter
Standard Deviation 1.4959
-1.871 Giga cells per liter
Standard Deviation 1.5089
-1.158 Giga cells per liter
Standard Deviation 1.2688
-1.378 Giga cells per liter
Standard Deviation 0.598
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Total Neutrophils; Week 2; n=40, 38, 14, 10
-2.114 Giga cells per liter
Standard Deviation 1.9189
-2.121 Giga cells per liter
Standard Deviation 1.6445
-1.186 Giga cells per liter
Standard Deviation 1.3343
-1.468 Giga cells per liter
Standard Deviation 0.584
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Total Neutrophils; Week4; n=41, 38, 14, 13
-2.487 Giga cells per liter
Standard Deviation 1.9145
-2.333 Giga cells per liter
Standard Deviation 1.5497
-1.412 Giga cells per liter
Standard Deviation 1.5704
-1.603 Giga cells per liter
Standard Deviation 0.5953
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Total Neutrophils; Week6; n=41, 37, 12, 12
-2.51 Giga cells per liter
Standard Deviation 1.8144
-2.247 Giga cells per liter
Standard Deviation 1.5132
-1.413 Giga cells per liter
Standard Deviation 1.4303
-1.683 Giga cells per liter
Standard Deviation 0.661
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Total Neutrophils; Week12; n=37, 36, 12, 12
-2.894 Giga cells per liter
Standard Deviation 1.8124
-2.188 Giga cells per liter
Standard Deviation 1.7297
-1.649 Giga cells per liter
Standard Deviation 0.8749
-1.483 Giga cells per liter
Standard Deviation 0.5873
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Platelet Count; Week1; n=38, 39, 14, 11
-58.5 Giga cells per liter
Standard Deviation 36.23
-51.4 Giga cells per liter
Standard Deviation 36.42
-59.5 Giga cells per liter
Standard Deviation 36.29
-33.1 Giga cells per liter
Standard Deviation 33.32
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Platelet Count; Week2; n=41, 38, 14, 11
-58 Giga cells per liter
Standard Deviation 43.92
-57.8 Giga cells per liter
Standard Deviation 44.02
-41.4 Giga cells per liter
Standard Deviation 37.44
-34.4 Giga cells per liter
Standard Deviation 41.74
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Platelet Count; Week4; n=41, 38, 14, 13
-54.4 Giga cells per liter
Standard Deviation 49.18
-55.9 Giga cells per liter
Standard Deviation 47.19
-56.2 Giga cells per liter
Standard Deviation 50.99
-33.8 Giga cells per liter
Standard Deviation 61.79
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Platelet Count; Week6; n=41, 38, 12, 13
-66.8 Giga cells per liter
Standard Deviation 50.43
-71.9 Giga cells per liter
Standard Deviation 38.6
-71.3 Giga cells per liter
Standard Deviation 47.07
-46 Giga cells per liter
Standard Deviation 46.05
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Platelet Count; Week12; n=38, 34, 12, 12
-73.4 Giga cells per liter
Standard Deviation 45.3
-85.3 Giga cells per liter
Standard Deviation 40.42
-58.8 Giga cells per liter
Standard Deviation 58.77
-53 Giga cells per liter
Standard Deviation 39.49
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Platelet Count; Week8; n=39, 39, 13, 13
-74.9 Giga cells per liter
Standard Deviation 42.31
-75.7 Giga cells per liter
Standard Deviation 45.82
-60.1 Giga cells per liter
Standard Deviation 43.26
-52.6 Giga cells per liter
Standard Deviation 43.54
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
White Blood Cell count; Week12; n=37, 36, 12, 12
-4.33 Giga cells per liter
Standard Deviation 2.149
-3.58 Giga cells per liter
Standard Deviation 1.934
-3.42 Giga cells per liter
Standard Deviation 1.104
-2.77 Giga cells per liter
Standard Deviation 0.963
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
White Blood Cell count; Week1; n=38, 38, 14, 11
-2.83 Giga cells per liter
Standard Deviation 1.705
-2.3 Giga cells per liter
Standard Deviation 1.872
-1.81 Giga cells per liter
Standard Deviation 1.516
-1.87 Giga cells per liter
Standard Deviation 0.508
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
White Blood Cell count; Week2; n=40, 38, 14, 10
-2.77 Giga cells per liter
Standard Deviation 2.178
-2.92 Giga cells per liter
Standard Deviation 1.81
-2.01 Giga cells per liter
Standard Deviation 1.869
-2.17 Giga cells per liter
Standard Deviation 0.886
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
White Blood Cell count; Week4; n=41, 38, 14, 13
-3.55 Giga cells per liter
Standard Deviation 2.183
-3.47 Giga cells per liter
Standard Deviation 1.712
-2.61 Giga cells per liter
Standard Deviation 2.055
-2.55 Giga cells per liter
Standard Deviation 0.919
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
White Blood Cell count; Week6; n=41, 37, 12, 12
-3.78 Giga cells per liter
Standard Deviation 2.051
-3.62 Giga cells per liter
Standard Deviation 1.682
-3.09 Giga cells per liter
Standard Deviation 1.69
-2.85 Giga cells per liter
Standard Deviation 0.923
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
White Blood Cell count; Week8; n=38, 39, 13, 13
-4.03 Giga cells per liter
Standard Deviation 2.028
-3.55 Giga cells per liter
Standard Deviation 1.896
-2.8 Giga cells per liter
Standard Deviation 1.477
-2.8 Giga cells per liter
Standard Deviation 1.04
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Basophils; Week1; n=38, 38, 14, 11
-0.011 Giga cells per liter
Standard Deviation 0.0191
-0.011 Giga cells per liter
Standard Deviation 0.0193
-0.012 Giga cells per liter
Standard Deviation 0.0105
-0.013 Giga cells per liter
Standard Deviation 0.0119
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Basophils; Week2; n=40, 38, 14, 10
-0.014 Giga cells per liter
Standard Deviation 0.0175
-0.01 Giga cells per liter
Standard Deviation 0.0192
-0.009 Giga cells per liter
Standard Deviation 0.0107
-0.009 Giga cells per liter
Standard Deviation 0.0179
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Basophils; Week4; n=41, 38, 14, 13
-0.017 Giga cells per liter
Standard Deviation 0.0184
-0.012 Giga cells per liter
Standard Deviation 0.0187
-0.01 Giga cells per liter
Standard Deviation 0.0118
-0.015 Giga cells per liter
Standard Deviation 0.0113
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Basophils; Week6; n=41, 37, 12, 12
-0.015 Giga cells per liter
Standard Deviation 0.021
-0.013 Giga cells per liter
Standard Deviation 0.0205
-0.013 Giga cells per liter
Standard Deviation 0.0114
-0.013 Giga cells per liter
Standard Deviation 0.0106
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Basophils; Week8; n=38, 39, 13, 13
-0.019 Giga cells per liter
Standard Deviation 0.0155
-0.016 Giga cells per liter
Standard Deviation 0.018
-0.009 Giga cells per liter
Standard Deviation 0.0132
-0.012 Giga cells per liter
Standard Deviation 0.0142
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Basophils; Week12; n=37, 36, 12, 12
-0.018 Giga cells per liter
Standard Deviation 0.0184
-0.013 Giga cells per liter
Standard Deviation 0.0187
-0.011 Giga cells per liter
Standard Deviation 0.0124
-0.012 Giga cells per liter
Standard Deviation 0.0153
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Eosinophils; Week1; n=38, 38, 14, 11
-0.051 Giga cells per liter
Standard Deviation 0.0874
-0.075 Giga cells per liter
Standard Deviation 0.106
-0.059 Giga cells per liter
Standard Deviation 0.0578
-0.085 Giga cells per liter
Standard Deviation 0.1052

PRIMARY outcome

Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12
Red Blood Cell count; Week2; n=41, 38, 14, 12
-0.48 Trillion cells per liter
Standard Deviation 0.376
-0.44 Trillion cells per liter
Standard Deviation 0.508
-0.57 Trillion cells per liter
Standard Deviation 0.312
-0.28 Trillion cells per liter
Standard Deviation 0.361
Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12
Red Blood Cell count; Week1; n=38, 39, 14, 12
-0.15 Trillion cells per liter
Standard Deviation 0.226
-0.04 Trillion cells per liter
Standard Deviation 0.279
-0.18 Trillion cells per liter
Standard Deviation 0.212
-0.13 Trillion cells per liter
Standard Deviation 0.303
Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12
Red Blood Cell count; Week4; n=41, 38, 14, 13
-0.88 Trillion cells per liter
Standard Deviation 0.507
-0.64 Trillion cells per liter
Standard Deviation 0.623
-1.03 Trillion cells per liter
Standard Deviation 0.441
-0.72 Trillion cells per liter
Standard Deviation 0.559
Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12
Red Blood Cell count; Week6; n=41, 38, 12, 13
-0.97 Trillion cells per liter
Standard Deviation 0.504
-0.78 Trillion cells per liter
Standard Deviation 0.563
-1.28 Trillion cells per liter
Standard Deviation 0.49
-0.86 Trillion cells per liter
Standard Deviation 0.52
Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12
Red Blood Cell count; Week8; n=39, 39, 13, 13
-1.01 Trillion cells per liter
Standard Deviation 0.506
-0.82 Trillion cells per liter
Standard Deviation 0.534
-1.45 Trillion cells per liter
Standard Deviation 0.357
-0.85 Trillion cells per liter
Standard Deviation 0.412
Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12
Red Blood Cell count; Week12; n=38, 36, 12, 12
-1.08 Trillion cells per liter
Standard Deviation 0.48
-0.79 Trillion cells per liter
Standard Deviation 0.56
-1.61 Trillion cells per liter
Standard Deviation 0.464
-0.92 Trillion cells per liter
Standard Deviation 0.459

PRIMARY outcome

Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Blood samples were collected for the measurement of hemoglobin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12
Hemoglobin; Week1; n=38, 39, 14, 12
-5.2 Grams per liter
Standard Deviation 6.98
-2.3 Grams per liter
Standard Deviation 9.38
-6.6 Grams per liter
Standard Deviation 5.83
-5.3 Grams per liter
Standard Deviation 8.85
Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12
Hemoglobin; Week2; n=41, 38, 14, 12
-16.7 Grams per liter
Standard Deviation 12.54
-14.9 Grams per liter
Standard Deviation 16.21
-20.5 Grams per liter
Standard Deviation 10.66
-9.9 Grams per liter
Standard Deviation 11.5
Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12
Hemoglobin; Week4; n=41, 38, 14, 13
-28.6 Grams per liter
Standard Deviation 15.38
-22.1 Grams per liter
Standard Deviation 18.98
-34.4 Grams per liter
Standard Deviation 13.55
-22.5 Grams per liter
Standard Deviation 14.89
Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12
Hemoglobin; Week6; n=41, 38, 12, 13
-30.1 Grams per liter
Standard Deviation 14.54
-24.7 Grams per liter
Standard Deviation 16
-40.8 Grams per liter
Standard Deviation 14.11
-25.2 Grams per liter
Standard Deviation 12.28
Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12
Hemoglobin; Week8; n=39, 39, 13, 13
-30.5 Grams per liter
Standard Deviation 13.29
-25.5 Grams per liter
Standard Deviation 14.22
-44.9 Grams per liter
Standard Deviation 11.73
-25.2 Grams per liter
Standard Deviation 8.66
Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12
Hemoglobin; Week12; n=38, 36, 12, 12
-33 Grams per liter
Standard Deviation 12.88
-24.1 Grams per liter
Standard Deviation 13.41
-47.4 Grams per liter
Standard Deviation 14.12
-27.6 Grams per liter
Standard Deviation 12.05

PRIMARY outcome

Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population

Blood samples were collected for the measurement of hematocrit at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12
Hematocrit; Week1; n=38, 39, 14, 12
-0.0196 Ratio
Standard Deviation 0.02345
-0.0069 Ratio
Standard Deviation 0.02751
-0.0201 Ratio
Standard Deviation 0.01921
-0.0166 Ratio
Standard Deviation 0.0298
Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12
Hematocrit; Week2; n=41, 38, 14, 12
-0.0539 Ratio
Standard Deviation 0.03653
-0.0465 Ratio
Standard Deviation 0.04738
-0.0609 Ratio
Standard Deviation 0.03007
-0.0335 Ratio
Standard Deviation 0.03625
Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12
Hematocrit; Week4; n=41, 38, 14, 13
-0.0848 Ratio
Standard Deviation 0.04576
-0.0621 Ratio
Standard Deviation 0.05468
-0.0999 Ratio
Standard Deviation 0.03967
-0.0668 Ratio
Standard Deviation 0.04445
Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12
Hematocrit; Week6; n=41, 38, 12, 13
-0.0859 Ratio
Standard Deviation 0.0411
-0.0685 Ratio
Standard Deviation 0.04487
-0.1203 Ratio
Standard Deviation 0.04463
-0.074 Ratio
Standard Deviation 0.03316
Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12
Hematocrit; Week8; n=39, 39, 13, 13
-0.0838 Ratio
Standard Deviation 0.03955
-0.0663 Ratio
Standard Deviation 0.04144
-0.1235 Ratio
Standard Deviation 0.03288
-0.07 Ratio
Standard Deviation 0.02758
Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12
Hematocrit; Week12; n=38, 36, 12, 12
-0.0843 Ratio
Standard Deviation 0.04038
-0.0589 Ratio
Standard Deviation 0.03648
-0.1318 Ratio
Standard Deviation 0.03847
-0.0688 Ratio
Standard Deviation 0.03298

PRIMARY outcome

Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Blood samples were collected for the measurement of mean corpuscle volume at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12
Mean corpuscle volume; Week8; n=39, 39, 13, 13
3.8 Femtoliters
Standard Deviation 5.39
3 Femtoliters
Standard Deviation 5.2
3.1 Femtoliters
Standard Deviation 2.78
2.2 Femtoliters
Standard Deviation 3.75
Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12
Mean corpuscle volume; Week1; n=38, 39, 14, 12
-1.1 Femtoliters
Standard Deviation 1.21
-0.8 Femtoliters
Standard Deviation 1.37
-0.4 Femtoliters
Standard Deviation 1.15
-0.7 Femtoliters
Standard Deviation 1.37
Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12
Mean corpuscle volume; Week2; n=41, 38, 14, 12
-2 Femtoliters
Standard Deviation 1.84
-1.4 Femtoliters
Standard Deviation 1.59
-1.4 Femtoliters
Standard Deviation 1.09
-1.5 Femtoliters
Standard Deviation 1.45
Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12
Mean corpuscle volume; Week4; n=41, 38, 14, 13
0.3 Femtoliters
Standard Deviation 3.33
0.2 Femtoliters
Standard Deviation 3.4
-0.8 Femtoliters
Standard Deviation 1.58
-0.2 Femtoliters
Standard Deviation 2.94
Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12
Mean corpuscle volume; Week6; n=41, 38, 12, 13
2.3 Femtoliters
Standard Deviation 4.76
1.8 Femtoliters
Standard Deviation 4.67
-0.2 Femtoliters
Standard Deviation 2.37
1.4 Femtoliters
Standard Deviation 4.63
Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12
Mean corpuscle volume; Week12; n=38, 34, 12, 12
5.7 Femtoliters
Standard Deviation 6
4.2 Femtoliters
Standard Deviation 6.3
5.3 Femtoliters
Standard Deviation 4.14
3.8 Femtoliters
Standard Deviation 4.28

PRIMARY outcome

Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Blood samples were collected for the measurement of albumin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12
Albumin; Week1; n=40, 39, 15, 13
-0.6 Grams per liter
Standard Deviation 2.67
-0.3 Grams per liter
Standard Deviation 2.46
-1.1 Grams per liter
Standard Deviation 1.6
-1 Grams per liter
Standard Deviation 1.87
Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12
Albumin; Week2; n=41, 38, 14, 13
-1.3 Grams per liter
Standard Deviation 2.98
-1.5 Grams per liter
Standard Deviation 2.68
-2 Grams per liter
Standard Deviation 2.6
-0.2 Grams per liter
Standard Deviation 2.39
Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12
Albumin; Week4; n=41, 39, 14, 13
-1.9 Grams per liter
Standard Deviation 2.48
-1.5 Grams per liter
Standard Deviation 2.52
-3 Grams per liter
Standard Deviation 3.21
-1.2 Grams per liter
Standard Deviation 1.46
Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12
Albumin; Week6; n=41, 38, 13, 13
-2.2 Grams per liter
Standard Deviation 2.65
-1.5 Grams per liter
Standard Deviation 2.27
-3.5 Grams per liter
Standard Deviation 3.36
-2.1 Grams per liter
Standard Deviation 2.22
Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12
Albumin; Week8; n=40, 39, 13, 13
-2.6 Grams per liter
Standard Deviation 2.99
-1.7 Grams per liter
Standard Deviation 2
-3.7 Grams per liter
Standard Deviation 4.71
-1.5 Grams per liter
Standard Deviation 1.94
Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12
Albumin; Week12; n=37, 35, 12, 13
-2.1 Grams per liter
Standard Deviation 3.03
-1.3 Grams per liter
Standard Deviation 2.84
-3.3 Grams per liter
Standard Deviation 3.02
-1.6 Grams per liter
Standard Deviation 2.1

PRIMARY outcome

Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Blood samples were collected for the measurement of ALP, ALT, AST, CK and GGT at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4 Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
GGT; Week12; n=37, 35, 12, 13
-29.7 International units per liter
Standard Deviation 80.2
-20.7 International units per liter
Standard Deviation 73.43
-33.6 International units per liter
Standard Deviation 49.61
-30 International units per liter
Standard Deviation 53.44
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
ALP; Week1; n=40, 39, 15, 13
0 International units per liter
Standard Deviation 7.73
1.5 International units per liter
Standard Deviation 10.21
3.9 International units per liter
Standard Deviation 19.36
-0.2 International units per liter
Standard Deviation 17.45
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
ALP; Week2; n=41, 38, 14, 13
4.6 International units per liter
Standard Deviation 9.26
3.8 International units per liter
Standard Deviation 16.22
9.4 International units per liter
Standard Deviation 21.15
3.8 International units per liter
Standard Deviation 12.43
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
ALP; Week4; n=41, 39, 14, 13
8.6 International units per liter
Standard Deviation 11.12
7.1 International units per liter
Standard Deviation 13.76
11.7 International units per liter
Standard Deviation 26.61
7.2 International units per liter
Standard Deviation 15.3
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
ALP; Week6; n=41, 38, 13, 13
9.1 International units per liter
Standard Deviation 13.73
7.2 International units per liter
Standard Deviation 17.1
16.6 International units per liter
Standard Deviation 31.03
6.6 International units per liter
Standard Deviation 16.38
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
ALP; Week8; n=40, 39, 13, 13
6.9 International units per liter
Standard Deviation 15.59
6.5 International units per liter
Standard Deviation 15.91
15.5 International units per liter
Standard Deviation 25.83
5.6 International units per liter
Standard Deviation 14.72
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
ALP; Week12; n=37, 35, 12, 13
6.7 International units per liter
Standard Deviation 15.56
6.4 International units per liter
Standard Deviation 20.78
11.7 International units per liter
Standard Deviation 25.09
7.3 International units per liter
Standard Deviation 18.33
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
ALT; Week1; n=40, 39, 15, 13
-26.8 International units per liter
Standard Deviation 31.64
-24.4 International units per liter
Standard Deviation 32.39
-30.7 International units per liter
Standard Deviation 30.1
-25.6 International units per liter
Standard Deviation 20.74
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
ALT; Week2; n=41, 38, 14, 13
-28.2 International units per liter
Standard Deviation 40.33
-24.9 International units per liter
Standard Deviation 47.49
-35.4 International units per liter
Standard Deviation 36.38
-26.8 International units per liter
Standard Deviation 24.25
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
ALT; Week4; n=41, 39, 14, 13
-32.5 International units per liter
Standard Deviation 44.5
-25.3 International units per liter
Standard Deviation 50.87
-40.4 International units per liter
Standard Deviation 38.73
-33 International units per liter
Standard Deviation 28.79
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
ALT; Week6; n=41, 38, 13, 13
-36 International units per liter
Standard Deviation 49.77
-30.3 International units per liter
Standard Deviation 50.74
-40.8 International units per liter
Standard Deviation 41.51
-38.4 International units per liter
Standard Deviation 29.11
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
ALT; Week8; n=40, 39, 13, 13
-36.8 International units per liter
Standard Deviation 55.75
-25.4 International units per liter
Standard Deviation 55.92
-39.9 International units per liter
Standard Deviation 40.27
-39.5 International units per liter
Standard Deviation 29.92
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
ALT; Week12; n=37, 35, 12, 13
-38.9 International units per liter
Standard Deviation 59.7
-23.5 International units per liter
Standard Deviation 59.69
-43.7 International units per liter
Standard Deviation 40.45
-36.8 International units per liter
Standard Deviation 24.75
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
AST; Week1; n=40, 39, 15, 13
-12.3 International units per liter
Standard Deviation 16.28
-15.2 International units per liter
Standard Deviation 21.55
-18.1 International units per liter
Standard Deviation 21.77
-13.9 International units per liter
Standard Deviation 10.52
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
AST; Week2; n=41, 38, 14, 13
-10 International units per liter
Standard Deviation 20.84
-11.6 International units per liter
Standard Deviation 26.3
-18.4 International units per liter
Standard Deviation 23.52
-10.2 International units per liter
Standard Deviation 12.56
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
AST; Week4; n=41, 39, 14, 13
-12.8 International units per liter
Standard Deviation 21.45
-10.6 International units per liter
Standard Deviation 27.4
-20.9 International units per liter
Standard Deviation 25.86
-15.8 International units per liter
Standard Deviation 11.92
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
AST; Week6; n=41, 38, 13, 13
-13.8 International units per liter
Standard Deviation 21.56
-13.8 International units per liter
Standard Deviation 25.01
-21.6 International units per liter
Standard Deviation 28.43
-19.5 International units per liter
Standard Deviation 12.99
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
AST; Week8; n=40, 39, 13, 13
-13.1 International units per liter
Standard Deviation 26.01
-7.6 International units per liter
Standard Deviation 38.38
-21.8 International units per liter
Standard Deviation 26.38
-18.6 International units per liter
Standard Deviation 12.38
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
AST; Week12; n=37, 35, 12, 13
-14.4 International units per liter
Standard Deviation 25.58
-6.5 International units per liter
Standard Deviation 36.17
-25.7 International units per liter
Standard Deviation 27.32
-17.3 International units per liter
Standard Deviation 12.68
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
CK; Week1; n=40, 39, 15, 13
18.2 International units per liter
Standard Deviation 82.13
-10.9 International units per liter
Standard Deviation 103.31
-3.3 International units per liter
Standard Deviation 32.1
-43.5 International units per liter
Standard Deviation 82.73
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
CK; Week2; n=41, 38, 14, 13
-0.7 International units per liter
Standard Deviation 53.87
-22.6 International units per liter
Standard Deviation 77.26
-9.6 International units per liter
Standard Deviation 36.26
-28.5 International units per liter
Standard Deviation 54.43
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
CK; Week4; n=41, 39, 14, 13
4.5 International units per liter
Standard Deviation 141.46
-32.1 International units per liter
Standard Deviation 59.61
-14.4 International units per liter
Standard Deviation 22.06
-47.7 International units per liter
Standard Deviation 59.52
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
CK; Week6; n=41, 38, 13, 13
-26 International units per liter
Standard Deviation 63.11
56.1 International units per liter
Standard Deviation 566.79
-21.5 International units per liter
Standard Deviation 48.49
-64.5 International units per liter
Standard Deviation 110.82
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
CK; Week8; n=40, 39, 13, 13
-21.3 International units per liter
Standard Deviation 95.03
-33.2 International units per liter
Standard Deviation 65.96
-30.3 International units per liter
Standard Deviation 51.17
-66.8 International units per liter
Standard Deviation 107.3
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
CK; Week12; n=37, 35, 12, 13
-36.3 International units per liter
Standard Deviation 75.56
-33.9 International units per liter
Standard Deviation 47.72
-20.9 International units per liter
Standard Deviation 59.82
-48.5 International units per liter
Standard Deviation 61.63
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
GGT; Week1; n=40, 39, 15, 13
-3.7 International units per liter
Standard Deviation 20.79
-2 International units per liter
Standard Deviation 16.83
-10.3 International units per liter
Standard Deviation 19.38
-6.4 International units per liter
Standard Deviation 23.77
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
GGT; Week2; n=41, 38, 14, 13
-11.7 International units per liter
Standard Deviation 33.78
-17.1 International units per liter
Standard Deviation 45.23
-19.9 International units per liter
Standard Deviation 29.59
-7.2 International units per liter
Standard Deviation 29.11
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
GGT; Week4; n=41, 39, 14, 13
-24.5 International units per liter
Standard Deviation 52.93
-25.5 International units per liter
Standard Deviation 59.64
-27.7 International units per liter
Standard Deviation 36.64
-16.2 International units per liter
Standard Deviation 36.59
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
GGT; Week6; n=41, 38, 13, 13
-28.1 International units per liter
Standard Deviation 67.33
-30.5 International units per liter
Standard Deviation 72.27
-30.5 International units per liter
Standard Deviation 44.3
-23.8 International units per liter
Standard Deviation 39.91
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
GGT; Week8; n=40, 39, 13, 13
-32.1 International units per liter
Standard Deviation 70.41
-27.2 International units per liter
Standard Deviation 80.33
-30.5 International units per liter
Standard Deviation 45.05
-28.5 International units per liter
Standard Deviation 45.5

PRIMARY outcome

Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Blood samples were collected for the measurement of direct bilirubin, total bilirubin and creatinine at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12
Creatinine; Week4; n=41, 39, 14, 13
-3.4 Micromoles per liter
Standard Deviation 5.894
-1.33 Micromoles per liter
Standard Deviation 6.403
5.35 Micromoles per liter
Standard Deviation 10.16
-3.57 Micromoles per liter
Standard Deviation 9.599
Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12
Total Bilirubin; Week1; n=40, 39, 15, 13
6.9 Micromoles per liter
Standard Deviation 8.74
6.7 Micromoles per liter
Standard Deviation 8.93
8.1 Micromoles per liter
Standard Deviation 11.81
4.2 Micromoles per liter
Standard Deviation 8.36
Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12
Total Bilirubin; Week2; n=41, 38, 14, 13
5.8 Micromoles per liter
Standard Deviation 6.62
5.5 Micromoles per liter
Standard Deviation 6.84
5.6 Micromoles per liter
Standard Deviation 9.8
6.5 Micromoles per liter
Standard Deviation 9.34
Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12
Total Bilirubin; Week4; n=41, 39, 14, 13
2.2 Micromoles per liter
Standard Deviation 5.03
2.9 Micromoles per liter
Standard Deviation 3.52
0.7 Micromoles per liter
Standard Deviation 8.94
2.5 Micromoles per liter
Standard Deviation 5.97
Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12
Total Bilirubin; Week6; n=41, 38, 13, 13
1.5 Micromoles per liter
Standard Deviation 4.14
2.7 Micromoles per liter
Standard Deviation 3.97
-0.5 Micromoles per liter
Standard Deviation 9.09
2.1 Micromoles per liter
Standard Deviation 6.87
Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12
Total Bilirubin; Week8; n=40, 39, 13, 13
1.4 Micromoles per liter
Standard Deviation 4.63
2.3 Micromoles per liter
Standard Deviation 4.93
-0.3 Micromoles per liter
Standard Deviation 9.83
1.8 Micromoles per liter
Standard Deviation 6.39
Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12
Total Bilirubin; Week12; n=37, 35, 12, 13
0.4 Micromoles per liter
Standard Deviation 4.46
1.4 Micromoles per liter
Standard Deviation 5.61
-2.8 Micromoles per liter
Standard Deviation 10.04
1.2 Micromoles per liter
Standard Deviation 5.31
Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12
Direct Bilirubin; Week1; n=1, 1, 1, 1
0 Micromoles per liter
Standard Deviation NA
A value of NA indicates not applicable
2 Micromoles per liter
Standard Deviation NA
too few participants or number of participants were analyzed at the indicated test/time point.
-8 Micromoles per liter
Standard Deviation NA
too few participants or number of participants were analyzed at the indicated test/time point.
-1 Micromoles per liter
Standard Deviation NA
too few participants or number of participants were analyzed at the indicated test/time point.
Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12
Direct Bilirubin; Week2; n=1, 1, 1, 1
0 Micromoles per liter
Standard Deviation NA
too few participants or number of participants were analyzed at the indicated test/time point.
0 Micromoles per liter
Standard Deviation NA
too few participants or number of participants were analyzed at the indicated test/time point.
-14 Micromoles per liter
Standard Deviation NA
too few participants or number of participants were analyzed at the indicated test/time point.
1 Micromoles per liter
Standard Deviation NA
too few participants or number of participants were analyzed at the indicated test/time point.
Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12
Direct Bilirubin; Week4; n=1, 1, 0, 0
0 Micromoles per liter
Standard Deviation NA
too few participants or number of participants were analyzed at the indicated test/time point.
2 Micromoles per liter
Standard Deviation NA
too few participants or number of participants were analyzed at the indicated test/time point.
NA Micromoles per liter
Standard Deviation NA
too few participants or number of participants were analyzed at the indicated test/time point.
NA Micromoles per liter
Standard Deviation NA
too few participants or number of participants were analyzed at the indicated test/time point.
Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12
Direct Bilirubin; Week6; n=1, 1, 0, 0
0 Micromoles per liter
Standard Deviation NA
too few participants or number of participants were analyzed at the indicated test/time point.
0 Micromoles per liter
Standard Deviation NA
too few participants or number of participants were analyzed at the indicated test/time point.
NA Micromoles per liter
Standard Deviation NA
too few participants or number of participants were analyzed at the indicated test/time point.
NA Micromoles per liter
Standard Deviation NA
too few participants or number of participants were analyzed at the indicated test/time point.
Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12
Creatinine; Week1; n=40, 39, 15, 13
-1.41 Micromoles per liter
Standard Deviation 5.983
0.23 Micromoles per liter
Standard Deviation 5.446
5.12 Micromoles per liter
Standard Deviation 7.883
-3.85 Micromoles per liter
Standard Deviation 5.868
Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12
Creatinine; Week2; n=41, 38, 14, 13
-2.47 Micromoles per liter
Standard Deviation 7.966
-2.78 Micromoles per liter
Standard Deviation 5.725
4.13 Micromoles per liter
Standard Deviation 6.518
-1.17 Micromoles per liter
Standard Deviation 7.692
Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12
Creatinine; Week6; n=41, 38, 13, 13
-2.15 Micromoles per liter
Standard Deviation 6.18
-0.34 Micromoles per liter
Standard Deviation 7.667
7.1 Micromoles per liter
Standard Deviation 7.905
-2.05 Micromoles per liter
Standard Deviation 9.365
Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12
Creatinine; Week8; n=40, 39, 13, 13
-1.88 Micromoles per liter
Standard Deviation 5.724
-0.51 Micromoles per liter
Standard Deviation 5.425
9.43 Micromoles per liter
Standard Deviation 10.839
-0.08 Micromoles per liter
Standard Deviation 10.23
Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12
Creatinine; Week12; n=38, 35, 12, 13
-1.49 Micromoles per liter
Standard Deviation 8.411
-1.99 Micromoles per liter
Standard Deviation 8.704
6.85 Micromoles per liter
Standard Deviation 10.363
-2.41 Micromoles per liter
Standard Deviation 12.239

PRIMARY outcome

Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Glucose; Week4; n=41, 39, 14, 13
-0.03 Millimoles per liter
Standard Deviation 1.162
0.02 Millimoles per liter
Standard Deviation 1.054
-0.11 Millimoles per liter
Standard Deviation 0.601
-0.48 Millimoles per liter
Standard Deviation 0.832
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Glucose; Week6; n=41, 38, 13, 13
-0.15 Millimoles per liter
Standard Deviation 1.315
-0.18 Millimoles per liter
Standard Deviation 1.154
0.18 Millimoles per liter
Standard Deviation 0.772
-0.55 Millimoles per liter
Standard Deviation 0.755
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Glucose; Week12; n=38, 35, 12, 13
-0.3 Millimoles per liter
Standard Deviation 1.877
-0.39 Millimoles per liter
Standard Deviation 1.047
-0.23 Millimoles per liter
Standard Deviation 0.757
-0.45 Millimoles per liter
Standard Deviation 1.063
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Potassium; Week1; n=40, 39, 15, 13
-0.02 Millimoles per liter
Standard Deviation 0.392
-0.06 Millimoles per liter
Standard Deviation 0.339
-0.11 Millimoles per liter
Standard Deviation 0.376
-0.02 Millimoles per liter
Standard Deviation 0.313
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Urea/BUN; Week1; n=40, 39, 15, 13
0.24 Millimoles per liter
Standard Deviation 0.996
0.04 Millimoles per liter
Standard Deviation 1.002
0.19 Millimoles per liter
Standard Deviation 1.287
-0.01 Millimoles per liter
Standard Deviation 1.188
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Chloride; Week1; n=40, 39, 15, 13
0.5 Millimoles per liter
Standard Deviation 2.1
-0.4 Millimoles per liter
Standard Deviation 2.03
0.6 Millimoles per liter
Standard Deviation 2.61
-0.2 Millimoles per liter
Standard Deviation 1.95
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Chloride; Week2; n=41, 38, 14, 13
0.7 Millimoles per liter
Standard Deviation 2.37
0.1 Millimoles per liter
Standard Deviation 1.9
0.5 Millimoles per liter
Standard Deviation 1.61
-0.7 Millimoles per liter
Standard Deviation 2.21
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Chloride; Week4; n=41, 39, 14, 13
1.7 Millimoles per liter
Standard Deviation 2.31
1 Millimoles per liter
Standard Deviation 2.46
1.6 Millimoles per liter
Standard Deviation 2.21
0.1 Millimoles per liter
Standard Deviation 2.5
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Chloride; Week6; n=41, 38, 13, 13
1.6 Millimoles per liter
Standard Deviation 2.62
0.8 Millimoles per liter
Standard Deviation 2.57
0.8 Millimoles per liter
Standard Deviation 2.73
-0.1 Millimoles per liter
Standard Deviation 1.38
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Chloride; Week8; n=40, 39, 13, 13
2 Millimoles per liter
Standard Deviation 3.49
0.7 Millimoles per liter
Standard Deviation 2.36
2.2 Millimoles per liter
Standard Deviation 3
-0.8 Millimoles per liter
Standard Deviation 2.77
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Chloride; Week12; n=37, 35, 12, 13
1.5 Millimoles per liter
Standard Deviation 2.36
0.1 Millimoles per liter
Standard Deviation 3.35
1.9 Millimoles per liter
Standard Deviation 2.61
1.2 Millimoles per liter
Standard Deviation 2.95
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Bicarbonate; Week1; n=40, 39, 15, 13
0 Millimoles per liter
Standard Deviation 3.05
-0.9 Millimoles per liter
Standard Deviation 2.57
-1.2 Millimoles per liter
Standard Deviation 2.54
-0.7 Millimoles per liter
Standard Deviation 2.56
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Bicarbonate; Week2; n=41, 38, 14, 13
-0.3 Millimoles per liter
Standard Deviation 2.2
-0.8 Millimoles per liter
Standard Deviation 3.1
-1.5 Millimoles per liter
Standard Deviation 2.98
-0.2 Millimoles per liter
Standard Deviation 3.65
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Bicarbonate; Week4; n=41, 39, 14, 13
-0.9 Millimoles per liter
Standard Deviation 1.91
-0.8 Millimoles per liter
Standard Deviation 2.55
-1.4 Millimoles per liter
Standard Deviation 1.86
-0.5 Millimoles per liter
Standard Deviation 2.67
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Bicarbonate; Week6; n=41, 38, 13, 13
-0.4 Millimoles per liter
Standard Deviation 2
-0.7 Millimoles per liter
Standard Deviation 2.23
-1.5 Millimoles per liter
Standard Deviation 2.18
0.6 Millimoles per liter
Standard Deviation 2.6
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Bicarbonate; Week8; n=40, 39, 13, 13
-0.7 Millimoles per liter
Standard Deviation 2.41
-0.8 Millimoles per liter
Standard Deviation 2.35
-1.2 Millimoles per liter
Standard Deviation 2.19
0 Millimoles per liter
Standard Deviation 2.2
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Bicarbonate; Week12; n=37, 35, 12, 13
-0.6 Millimoles per liter
Standard Deviation 2.42
-0.9 Millimoles per liter
Standard Deviation 2.37
-1.1 Millimoles per liter
Standard Deviation 2.23
-0.5 Millimoles per liter
Standard Deviation 2.76
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Glucose; Week1; n=40, 39, 15, 13
-0.37 Millimoles per liter
Standard Deviation 1.485
-0.34 Millimoles per liter
Standard Deviation 0.761
-0.03 Millimoles per liter
Standard Deviation 0.616
0.36 Millimoles per liter
Standard Deviation 1.619
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Glucose; Week2; n=41, 38, 14, 13
-0.22 Millimoles per liter
Standard Deviation 1.467
-0.17 Millimoles per liter
Standard Deviation 0.791
0.11 Millimoles per liter
Standard Deviation 0.52
0.13 Millimoles per liter
Standard Deviation 1.765
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Glucose; Week8; n=40, 39, 13, 13
-0.05 Millimoles per liter
Standard Deviation 1.165
-0.06 Millimoles per liter
Standard Deviation 0.835
0.04 Millimoles per liter
Standard Deviation 0.675
-0.36 Millimoles per liter
Standard Deviation 1.191
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Potassium; Week2; n=41, 38, 14, 13
-0.1 Millimoles per liter
Standard Deviation 0.428
-0.12 Millimoles per liter
Standard Deviation 0.453
-0.39 Millimoles per liter
Standard Deviation 0.417
-0.02 Millimoles per liter
Standard Deviation 0.316
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Potassium; Week4; n=41, 39, 14, 13
-0.16 Millimoles per liter
Standard Deviation 0.411
-0.11 Millimoles per liter
Standard Deviation 0.455
-0.34 Millimoles per liter
Standard Deviation 0.497
-0.05 Millimoles per liter
Standard Deviation 0.499
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Potassium; Week6; n=41, 38, 13, 13
-0.15 Millimoles per liter
Standard Deviation 0.483
-0.16 Millimoles per liter
Standard Deviation 0.387
-0.45 Millimoles per liter
Standard Deviation 0.355
-0.21 Millimoles per liter
Standard Deviation 0.38
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Potassium; Week8; n=40, 39, 13, 13
-0.11 Millimoles per liter
Standard Deviation 0.49
-0.19 Millimoles per liter
Standard Deviation 0.42
-0.51 Millimoles per liter
Standard Deviation 0.348
-0.14 Millimoles per liter
Standard Deviation 0.348
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Potassium; Week12; n=37, 35, 12, 13
-0.15 Millimoles per liter
Standard Deviation 0.394
-0.21 Millimoles per liter
Standard Deviation 0.362
-0.38 Millimoles per liter
Standard Deviation 0.447
-0.1 Millimoles per liter
Standard Deviation 0.428
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Sodium; Week1; n=40, 39, 15, 13
-0.4 Millimoles per liter
Standard Deviation 1.85
-0.8 Millimoles per liter
Standard Deviation 1.76
-0.2 Millimoles per liter
Standard Deviation 2.46
-0.8 Millimoles per liter
Standard Deviation 2.08
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Sodium; Week2; n=41, 38, 14, 13
-0.1 Millimoles per liter
Standard Deviation 2.15
-0.6 Millimoles per liter
Standard Deviation 1.81
0 Millimoles per liter
Standard Deviation 1.8
-1.3 Millimoles per liter
Standard Deviation 2.25
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Sodium; Week4; n=41, 39, 14, 13
0.1 Millimoles per liter
Standard Deviation 2.16
-0.1 Millimoles per liter
Standard Deviation 2.2
0.4 Millimoles per liter
Standard Deviation 1.78
-0.8 Millimoles per liter
Standard Deviation 1.95
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Sodium; Week6; n=41, 38, 13, 13
0.2 Millimoles per liter
Standard Deviation 2.39
-0.3 Millimoles per liter
Standard Deviation 2.39
0.2 Millimoles per liter
Standard Deviation 2.91
0 Millimoles per liter
Standard Deviation 2
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Sodium; Week8; n=40, 39, 13, 13
0.3 Millimoles per liter
Standard Deviation 3.28
-0.6 Millimoles per liter
Standard Deviation 2.24
1.1 Millimoles per liter
Standard Deviation 2.18
-0.6 Millimoles per liter
Standard Deviation 2.22
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Sodium; Week12; n=37, 35, 12, 13
0.1 Millimoles per liter
Standard Deviation 1.91
-0.3 Millimoles per liter
Standard Deviation 2.36
0.8 Millimoles per liter
Standard Deviation 2.66
0.5 Millimoles per liter
Standard Deviation 2.18
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Inorganic Phosphorus; Week1; n=40, 39, 15, 13
-0.13 Millimoles per liter
Standard Deviation 0.1599
-0.086 Millimoles per liter
Standard Deviation 0.1415
-0.122 Millimoles per liter
Standard Deviation 0.1353
-0.087 Millimoles per liter
Standard Deviation 0.1489
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Inorganic Phosphorus; Week2; n=41,38,14,13
-0.141 Millimoles per liter
Standard Deviation 0.181
-0.108 Millimoles per liter
Standard Deviation 0.1754
-0.081 Millimoles per liter
Standard Deviation 0.1194
-0.105 Millimoles per liter
Standard Deviation 0.1159
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Inorganic Phosphorus; Week4; n=41,39,14,13
-0.151 Millimoles per liter
Standard Deviation 0.1666
-0.125 Millimoles per liter
Standard Deviation 0.1421
-0.077 Millimoles per liter
Standard Deviation 0.1669
-0.078 Millimoles per liter
Standard Deviation 0.1871
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Inorganic Phosphorus; Week6; n=41,38,13,13
-0.171 Millimoles per liter
Standard Deviation 0.1939
-0.181 Millimoles per liter
Standard Deviation 0.1823
-0.121 Millimoles per liter
Standard Deviation 0.1549
-0.159 Millimoles per liter
Standard Deviation 0.121
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Inorganic Phosphorus; Week8; n=40,39,13,13
-0.169 Millimoles per liter
Standard Deviation 0.2025
-0.23 Millimoles per liter
Standard Deviation 0.1937
-0.112 Millimoles per liter
Standard Deviation 0.1563
-0.14 Millimoles per liter
Standard Deviation 0.167
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Inorganic Phosphorus; Week12; n=37,35,12,13
-0.172 Millimoles per liter
Standard Deviation 0.1708
-0.168 Millimoles per liter
Standard Deviation 0.2047
-0.117 Millimoles per liter
Standard Deviation 0.1123
-0.136 Millimoles per liter
Standard Deviation 0.1943
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Urea/BUN; Week2; n=41, 38, 14, 13
0.2 Millimoles per liter
Standard Deviation 1.012
-0.13 Millimoles per liter
Standard Deviation 1.05
0.08 Millimoles per liter
Standard Deviation 1.309
-0.12 Millimoles per liter
Standard Deviation 1.244
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Urea/BUN; Week4; n=41, 39, 14, 13
0.03 Millimoles per liter
Standard Deviation 1.145
-0.4 Millimoles per liter
Standard Deviation 1.047
0.11 Millimoles per liter
Standard Deviation 1.436
-0.88 Millimoles per liter
Standard Deviation 1.137
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Urea/BUN; Week6; n=41, 38, 13, 13
-0.04 Millimoles per liter
Standard Deviation 1.09
-0.29 Millimoles per liter
Standard Deviation 1.13
-0.39 Millimoles per liter
Standard Deviation 0.883
-1.02 Millimoles per liter
Standard Deviation 0.667
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Urea/BUN; Week8; n=40, 39, 13, 13
-0.16 Millimoles per liter
Standard Deviation 1.088
-0.46 Millimoles per liter
Standard Deviation 1.337
-0.07 Millimoles per liter
Standard Deviation 1.206
-0.85 Millimoles per liter
Standard Deviation 1.067
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Urea/BUN; Week12; n=37, 35, 12, 13
-0.08 Millimoles per liter
Standard Deviation 1.164
-0.31 Millimoles per liter
Standard Deviation 1.276
-0.11 Millimoles per liter
Standard Deviation 1.272
-0.64 Millimoles per liter
Standard Deviation 1.81

PRIMARY outcome

Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Blood samples were collected for the measurement of Creatinine Clearance at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. It is estimated by Cockcroft-Gault Equation. Change from Baseline in the Creatinine Clearance values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12
Creatinine Clearance; Week1; n=40, 39, 15, 13
1.5 Milliliter per minute (mL/min)
Standard Deviation 9.79
-2.1 Milliliter per minute (mL/min)
Standard Deviation 19.51
-9.5 Milliliter per minute (mL/min)
Standard Deviation 10.09
5.7 Milliliter per minute (mL/min)
Standard Deviation 10.18
Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12
Creatinine Clearance; Week2; n=41, 38,14,13
3.3 Milliliter per minute (mL/min)
Standard Deviation 13.48
4.7 Milliliter per minute (mL/min)
Standard Deviation 11.33
-9 Milliliter per minute (mL/min)
Standard Deviation 12.55
-1.8 Milliliter per minute (mL/min)
Standard Deviation 15.27
Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12
Creatinine Clearance; Week4; n=41, 39,14,13
5 Milliliter per minute (mL/min)
Standard Deviation 12.45
1.9 Milliliter per minute (mL/min)
Standard Deviation 14.72
-9.1 Milliliter per minute (mL/min)
Standard Deviation 13.42
4.5 Milliliter per minute (mL/min)
Standard Deviation 16.19
Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12
Creatinine Clearance; Week6; n=41, 38,13,13
2.7 Milliliter per minute (mL/min)
Standard Deviation 11.93
-0.7 Milliliter per minute (mL/min)
Standard Deviation 16.25
-19.1 Milliliter per minute (mL/min)
Standard Deviation 20.54
1.5 Milliliter per minute (mL/min)
Standard Deviation 13.12
Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12
Creatinine Clearance; Week8; n=40, 39,13,13
1.9 Milliliter per minute (mL/min)
Standard Deviation 10.49
3.4 Milliliter per minute (mL/min)
Standard Deviation 19.94
-17.8 Milliliter per minute (mL/min)
Standard Deviation 16.1
-3 Milliliter per minute (mL/min)
Standard Deviation 14.54
Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12
Creatinine Clearance; Week12; n=38,35,12,13
-0.2 Milliliter per minute (mL/min)
Standard Deviation 15.06
2.2 Milliliter per minute (mL/min)
Standard Deviation 17.27
-14.3 Milliliter per minute (mL/min)
Standard Deviation 16.99
1.2 Milliliter per minute (mL/min)
Standard Deviation 20.49

PRIMARY outcome

Timeframe: Baseline (Week 0), Weeks 2 and 12

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Urine samples were collected for urinalysis at Baseline, Weeks 2, 12, 18, 24, 48 and PT FU Weeks 4. Number of participants with shift from Baseline in urinalysis to normal (NL), abnormal (ANL) and missing (MIS) data up to Week 12 are summarized. Urine bilirubin (UBIL), urine glucose (UGLU), urine ketones (UKET), urine leukocyte esterase test (ULET) for detecting WBC, urine nitrite (UNIT), urine occult blood (UOB) were performed with dipstick method. Urine microscopy (UM) is performed to detect bacteria (BAC), red blood cells (RBC) and white blood cells (WBC). Other urinalysis parameter included urine pH (UpH) and urine specific gravity (USG). Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Week 12, ULET, BL MIS to PBL MIS,n=37,34,12,13
37 Participants
34 Participants
12 Participants
13 Participants
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Week 12, UMBT, BL MIS to PBL MIS,n=1,1,0,0
1 Participants
1 Participants
0 Participants
0 Participants
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Week 12, UMRBC, BL MIS to PBL MIS,n=4,5,2,2
4 Participants
5 Participants
2 Participants
2 Participants
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Week 12, UNIT, BL MIS to PBL MIS,n=37,34,12,13
37 Participants
34 Participants
12 Participants
13 Participants
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Week 12, UOB, BL MIS to PBL MIS,n=37,34,12,13
37 Participants
34 Participants
12 Participants
13 Participants
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Week 2, UPH, BL NL to PBL NL, n=1, 0,0,0
1 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Week 12, UPH, BL NL to PBL NL, n=37,34,12,13
36 Participants
34 Participants
12 Participants
13 Participants
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Week 2, USG, BL NL to PBL NL, n=1, 0,0,0
1 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Week 12, USG, BL NL to PBL NL, n=37,34,12,13
37 Participants
34 Participants
12 Participants
12 Participants
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Week 2, UBIL, BL MIS to PBL MIS, n=1,0,0,0
1 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Week 12, UBIL, BL MIS to PBL MIS,n=37,34,12,13
37 Participants
34 Participants
12 Participants
13 Participants
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Week 2, UGLU, BL MIS to PBL MIS, n=1,0,0,0
1 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Week 12, UGLU, BL MIS to PBL MIS,n=37,34,12,13
37 Participants
34 Participants
12 Participants
13 Participants
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Week 2, UKET, BL MIS to PBL MIS, n=1,0,0,0
1 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Week 12, UKET, BL MIS to PBL MIS,n=37,34,12,13
37 Participants
34 Participants
12 Participants
13 Participants
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Week 2, ULET, BL MIS to PBL MIS, n=1,0,0,0
1 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Week 12, UMWBC, BL MIS to PBL MIS, n=4,5,2,2
4 Participants
5 Participants
2 Participants
2 Participants
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Week 2, UNIT, BL MIS to PBL MIS, n=1,0,0,0
1 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Week 2, UOB, BL MIS to PBL MIS, n=1,0,0,0
1 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Week 12, UPH, BL NL to PBL ANL, n=37,34,12,13
1 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Week 12, USG, BL NL to PBL ANL,n=37,34,12,13
0 Participants
0 Participants
0 Participants
1 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) and Weeks 1 and 12

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

The ECG parameter heart rate was measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Electrocardiographic (ECG) Heart Rate Values at the Indicated Time Points up to Week 12
Week 1, n=41, 40, 15, 12
3.3 Beats per minute
Standard Deviation 8.28
0.8 Beats per minute
Standard Deviation 8.49
4.1 Beats per minute
Standard Deviation 9.52
4.8 Beats per minute
Standard Deviation 10.62
Mean Change From Baseline in Electrocardiographic (ECG) Heart Rate Values at the Indicated Time Points up to Week 12
Week 12, n=38, 35, 12, 13
8.3 Beats per minute
Standard Deviation 8.37
5.1 Beats per minute
Standard Deviation 10.86
9.3 Beats per minute
Standard Deviation 10.15
8.5 Beats per minute
Standard Deviation 8

PRIMARY outcome

Timeframe: Baseline (Week 0) and Weeks 1 and 12

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

The ECG parameters including PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF were measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG parameters are summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12
QTcF interval, Week 12,n=38,35,12,13
3.3516 Milliseconds
Standard Deviation 26.34546
-3.1442 Milliseconds
Standard Deviation 17.38368
1.6147 Milliseconds
Standard Deviation 18.38188
10.7637 Milliseconds
Standard Deviation 17.07259
Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12
PR interval, Week 1, n=41, 40, 15, 12
0.5 Milliseconds
Standard Deviation 19.43
1.2 Milliseconds
Standard Deviation 13.57
2.7 Milliseconds
Standard Deviation 7.27
-1.6 Milliseconds
Standard Deviation 20.92
Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12
PR interval, Week 12, n=38, 35, 12, 13
2.9 Milliseconds
Standard Deviation 13.36
3.2 Milliseconds
Standard Deviation 12.07
5.5 Milliseconds
Standard Deviation 8.73
0.2 Milliseconds
Standard Deviation 14.68
Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12
QRS duration, Week 1, n=41, 40, 15,12
-6.6 Milliseconds
Standard Deviation 50.28
0.4 Milliseconds
Standard Deviation 7.69
2.9 Milliseconds
Standard Deviation 6.61
0.4 Milliseconds
Standard Deviation 4.03
Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12
QRS duration, Week 12, n=38, 35, 12,13
-8.2 Milliseconds
Standard Deviation 51.69
-1.8 Milliseconds
Standard Deviation 6.44
0.4 Milliseconds
Standard Deviation 7.54
-2 Milliseconds
Standard Deviation 4.4
Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12
Uncorrected QT Interval, Week 1, n=41,40,15,12
-2.3 Milliseconds
Standard Deviation 27.29
-2.6 Milliseconds
Standard Deviation 22.29
-2.1 Milliseconds
Standard Deviation 22.39
5.9 Milliseconds
Standard Deviation 25.68
Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12
Uncorrected QT interval, Week 12,n=38,35,12,13
-11.8 Milliseconds
Standard Deviation 31.28
-12 Milliseconds
Standard Deviation 25.22
-17 Milliseconds
Standard Deviation 18.01
-4.6 Milliseconds
Standard Deviation 23.36
Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12
QTcB interval, Week 1, n=41,40,15,12
7.7087 Milliseconds
Standard Deviation 25.63001
0.2491 Milliseconds
Standard Deviation 22.90285
9.8112 Milliseconds
Standard Deviation 20.6771
19.8879 Milliseconds
Standard Deviation 40.13504
Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12
QTcB interval, Week 12,n=38,35,12,13
11.5512 Milliseconds
Standard Deviation 26.5644
1.7615 Milliseconds
Standard Deviation 20.3859
11.2801 Milliseconds
Standard Deviation 25.54652
18.9943 Milliseconds
Standard Deviation 16.76576
Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12
QTcF interval, Week 1, n=41,40,15,12
4.1995 Milliseconds
Standard Deviation 23.18239
-0.7151 Milliseconds
Standard Deviation 19.69091
5.7676 Milliseconds
Standard Deviation 17.06472
14.9187 Milliseconds
Standard Deviation 32.2737

SECONDARY outcome

Timeframe: From Week 12 up to PT Week 24 FU

Population: Safety Population

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Number of Participants With Any AEs and Any SAEs After Week 12
Any AE
21 Participants
22 Participants
8 Participants
9 Participants
Number of Participants With Any AEs and Any SAEs After Week 12
Any SAE
2 Participants
1 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: From the start of the treatment up to PT FU Week 24

Population: ITT Population

Blood samples for the determination of HCV RNA levels were collected at Screening and Baseline, every study visit during the Treatment Period, and at PT FU Weeks 4, 12, and 24. vRVR is defined as plasma HCV RNA \<LLOQ and target not detected 2 weeks after initiation of therapy. RVR is defined as plasma HCV RNA \<LLOQ and target not detected 4 weeks after initiation of therapy. cEVR is defined as plasma HCV RNA \<LLOQ and target not detected 12 weeks after initiation of therapy. SVR12 is defined as plasma HCV RNA \<LLOQ and target not detected 12 weeks after completion of all therapy. SVR24 is defined as plasma HCV RNA \<LLOQ and target not detected 24 weeks after completion of all therapy. SVR24 with RGT are participants who achieved both SVR24 and eRVR.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT)
cEVR
33 Participants
30 Participants
11 Participants
13 Participants
Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT)
vRVR
8 Participants
12 Participants
8 Participants
6 Participants
Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT)
RVR
23 Participants
23 Participants
10 Participants
9 Participants
Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT)
SVR12
30 Participants
26 Participants
10 Participants
0 Participants
Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT)
SVR24
27 Participants
25 Participants
10 Participants
0 Participants
Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT)
SVR24 with RGT
17 Participants
17 Participants
9 Participants
0 Participants

SECONDARY outcome

Timeframe: Day 1, Day 2, Week 4, and Week 12

Population: PK Population included all participants who received GSK2336805 and underwent plasma PK sampling (intensive or sparse) during the study. Only participants for whom plasma PK samples were obtained were assessed (represented by n=X, X in category titles).

Plasma pharmacokinetic (PK) samples were collected for all participants on Day 1 (0 hour \[h\]-1h, 1h-4h, 4h-8h, 8h-20h), Day 2 (Predose \[20-28h\]), Week 4 (Predose \[20-28h\], 0h-1h, 1h-4h, 4h-8h, 8h-20h, 20h-28h) and Week 12 (Predose \[20-28h\]). PK Population is comprised of all participants who received GSK2336805 and underwent plasma PK sampling (intensive or sparse) during the study.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=53 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12
Week 4 (1h-4h), n=46, 52
392.78 nanograms per milliliter (ng/mL)
Standard Deviation 275.504
591.07 nanograms per milliliter (ng/mL)
Standard Deviation 402.442
Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12
Day 1 (0h-1h), n=1, 3
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
A value of NA indicates not applicable
604 nanograms per milliliter (ng/mL)
Standard Deviation 392.763
Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12
Day 1 (1h-4h), n=35, 42
290.39 nanograms per milliliter (ng/mL)
Standard Deviation 241.05
445.18 nanograms per milliliter (ng/mL)
Standard Deviation 314.624
Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12
Day 1 (4h-8h), n=0, 3
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of NA indicates not applicable for the mean and the standard deviation).
221.33 nanograms per milliliter (ng/mL)
Standard Deviation 191.996
Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12
Day 1 (8h-20h), n=0, 1
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of NA indicates not applicable for the mean and the standard deviation).
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of NA indicates not applicable for the mean and the standard deviation).
Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12
Day 2 Predose (20-28h), n=36, 43
53.79 nanograms per milliliter (ng/mL)
Standard Deviation 52.629
123.89 nanograms per milliliter (ng/mL)
Standard Deviation 257.575
Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12
Week 4 Predose (20-28h), n=33, 42
81.18 nanograms per milliliter (ng/mL)
Standard Deviation 153.462
146.85 nanograms per milliliter (ng/mL)
Standard Deviation 243.331
Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12
Week 4 (0h-1h), n=2, 6
198.4 nanograms per milliliter (ng/mL)
Standard Deviation 242.679
553 nanograms per milliliter (ng/mL)
Standard Deviation 536.451
Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12
Week 4 (4h-8h), n=22, 19
215.55 nanograms per milliliter (ng/mL)
Standard Deviation 127.737
411.68 nanograms per milliliter (ng/mL)
Standard Deviation 251.604
Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12
Week 4 (8h-20h), n=1, 2
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of NA indicates not applicable for the mean and the standard deviation).
192.5 nanograms per milliliter (ng/mL)
Standard Deviation 94.045
Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12
Week 4 (20h-28h), n=11, 10
51.24 nanograms per milliliter (ng/mL)
Standard Deviation 57.261
66.29 nanograms per milliliter (ng/mL)
Standard Deviation 53.604
Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12
Week 12 (Predose [20-28h]), n=26, 35
45.99 nanograms per milliliter (ng/mL)
Standard Deviation 42.034
142.59 nanograms per milliliter (ng/mL)
Standard Deviation 178.252

SECONDARY outcome

Timeframe: Week 4 (24 h post dose)

Population: Intensive PK Summary Population: Intensive PK Summary Population comprised of participants with evaluable GSK2336805 PK parameters at Week 4. Only participants available at the indicated time point were assessed (represented by n=X, X in category titles).

Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours post-dose.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=11 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=10 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Maximum Plasma Concentration (Cmax) and Concentration at the End of the Dosing Interval (Ctau) of GSK2336805 at Week 4
Cmax, n=11, 10
335.35 ng/mL
Geometric Coefficient of Variation 69.4
618.75 ng/mL
Geometric Coefficient of Variation 46.1
Maximum Plasma Concentration (Cmax) and Concentration at the End of the Dosing Interval (Ctau) of GSK2336805 at Week 4
Ctau, n=11, 10
31.37 ng/mL
Geometric Coefficient of Variation 135.9
49.31 ng/mL
Geometric Coefficient of Variation 97.6

SECONDARY outcome

Timeframe: Week 4 (24 h post dose)

Population: Intensive PK Summary Population

Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours postdose.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=11 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=10 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Time of Maximal Plasma Concentration (Tmax) of GSK2336805 at Week 4
2 hour
Interval 1.0 to 4.0
2 hour
Interval 1.0 to 7.0

SECONDARY outcome

Timeframe: Week 4 (24 h post dose)

Population: Intensive PK Summary Population

Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=11 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=10 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) at Week 4
2733.34 hour*nanogram per milliliter(hr*ng/mL)
Geometric Coefficient of Variation 82
4948.23 hour*nanogram per milliliter(hr*ng/mL)
Geometric Coefficient of Variation 66.3

SECONDARY outcome

Timeframe: Week 4 (24 h post dose)

Population: Intensive PK Summary Population

Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. CL/F was calculated as dose divided by AUC(0-tau).

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=11 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=10 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Apparent Clearance (CL/F) at Week 4
14.63 Liter per hour (L/hr)
Geometric Coefficient of Variation 82
12.13 Liter per hour (L/hr)
Geometric Coefficient of Variation 66.3

SECONDARY outcome

Timeframe: Week 4 (24 h post dose)

Population: Intensive PK Summary Population

Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. Vz/F was calculated as dose divided by (AUC\[0-tau\] lambda z) where lambda z is the terminal phase rate constant.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=11 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=10 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Apparent Volume of Distribution (Vz/F) at Week 4
172.81 Liter per hour (L/hr)
Geometric Coefficient of Variation 76.6
125.09 Liter per hour (L/hr)
Geometric Coefficient of Variation 67.9

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT Week 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils platelet count and white blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Eosinophils; Week24; n=34, 32, 12, 11
-0.128 Giga cells per liter
Standard Deviation 0.101
-0.131 Giga cells per liter
Standard Deviation 0.1103
-0.118 Giga cells per liter
Standard Deviation 0.0612
-0.041 Giga cells per liter
Standard Deviation 0.1003
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Eosinophils; Week30; n=13, 10, 2, 2
-0.124 Giga cells per liter
Standard Deviation 0.0982
-0.116 Giga cells per liter
Standard Deviation 0.1117
-0.13 Giga cells per liter
Standard Deviation 0.0849
-0.04 Giga cells per liter
Standard Deviation 0.0141
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Eosinophils; Week48; n=8, 6, 1, 2
-0.071 Giga cells per liter
Standard Deviation 0.0889
-0.11 Giga cells per liter
Standard Deviation 0.1223
0.13 Giga cells per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-0.05 Giga cells per liter
Standard Deviation 0.0141
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Eosinophils; PT Week4; n=32, 34, 11,11
-0.069 Giga cells per liter
Standard Deviation 0.0925
-0.085 Giga cells per liter
Standard Deviation 0.1208
-0.07 Giga cells per liter
Standard Deviation 0.0694
-0.018 Giga cells per liter
Standard Deviation 0.0808
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Lymphocytes; Week18; n=37, 33, 13,12
-1.081 Giga cells per liter
Standard Deviation 0.5533
-1.157 Giga cells per liter
Standard Deviation 0.5373
-0.999 Giga cells per liter
Standard Deviation 0.4672
-0.973 Giga cells per liter
Standard Deviation 0.5328
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Lymphocytes; Week24; n=34, 32, 12,11
-1.181 Giga cells per liter
Standard Deviation 0.4795
-1.092 Giga cells per liter
Standard Deviation 0.5598
-1.405 Giga cells per liter
Standard Deviation 0.5912
-1.057 Giga cells per liter
Standard Deviation 0.4832
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Lymphocytes; Week36; n=12, 7, 1, 2
-1.267 Giga cells per liter
Standard Deviation 0.6828
-1.286 Giga cells per liter
Standard Deviation 0.8983
-1.97 Giga cells per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-1.92 Giga cells per liter
Standard Deviation 0.4808
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Lymphocytes; Week48; n=7, 6, 1, 2
-0.779 Giga cells per liter
Standard Deviation 1.0639
-1.4 Giga cells per liter
Standard Deviation 1.0384
0.09 Giga cells per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-2.2 Giga cells per liter
Standard Deviation 0.0424
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Lymphocytes; PT Week4; n=32, 34, 11,11
-0.681 Giga cells per liter
Standard Deviation 0.4594
-0.7 Giga cells per liter
Standard Deviation 0.6163
-0.756 Giga cells per liter
Standard Deviation 0.5874
-0.737 Giga cells per liter
Standard Deviation 0.5666
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Monocytes; Week18; n=37, 33, 13, 12
-0.186 Giga cells per liter
Standard Deviation 0.1588
-0.141 Giga cells per liter
Standard Deviation 0.1339
-0.088 Giga cells per liter
Standard Deviation 0.1663
-0.143 Giga cells per liter
Standard Deviation 0.1776
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Monocytes; Week24; n=34, 32, 12, 11
-0.206 Giga cells per liter
Standard Deviation 0.1692
-0.156 Giga cells per liter
Standard Deviation 0.1574
-0.151 Giga cells per liter
Standard Deviation 0.1474
-0.121 Giga cells per liter
Standard Deviation 0.1902
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Monocytes; Week30; n=13, 10, 2, 2
-0.151 Giga cells per liter
Standard Deviation 0.1655
-0.135 Giga cells per liter
Standard Deviation 0.091
-0.4 Giga cells per liter
Standard Deviation 0.3111
-0.06 Giga cells per liter
Standard Deviation 0.0141
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Monocytes; Week36; n=12, 7, 1, 2
-0.255 Giga cells per liter
Standard Deviation 0.1474
-0.18 Giga cells per liter
Standard Deviation 0.0987
-0.2 Giga cells per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
0.015 Giga cells per liter
Standard Deviation 0.1061
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Monocytes; Week42; n=10, 6, 2, 2
-0.184 Giga cells per liter
Standard Deviation 0.234
-0.093 Giga cells per liter
Standard Deviation 0.1743
-0.025 Giga cells per liter
Standard Deviation 0.2192
-0.01 Giga cells per liter
Standard Deviation 0.099
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Monocytes; Week48; n=7, 6, 1, 2
-0.066 Giga cells per liter
Standard Deviation 0.1744
-0.147 Giga cells per liter
Standard Deviation 0.088
0.02 Giga cells per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-0.085 Giga cells per liter
Standard Deviation 0.1909
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Total Neutrophils; Week18; n=37, 33,13,12
-2.702 Giga cells per liter
Standard Deviation 1.9136
-2.378 Giga cells per liter
Standard Deviation 1.6735
-1.652 Giga cells per liter
Standard Deviation 0.852
-1.463 Giga cells per liter
Standard Deviation 0.7174
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Total Neutrophils; Week24; n=34, 32,12,11
-2.527 Giga cells per liter
Standard Deviation 1.9492
-2.187 Giga cells per liter
Standard Deviation 1.7758
-1.308 Giga cells per liter
Standard Deviation 0.7148
-1.3 Giga cells per liter
Standard Deviation 0.9956
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Total Neutrophils; Week30; n=13, 10,2,2
-2.402 Giga cells per liter
Standard Deviation 1.7954
-2.252 Giga cells per liter
Standard Deviation 2.3658
-2.24 Giga cells per liter
Standard Deviation 1.2869
-2.085 Giga cells per liter
Standard Deviation 0.1909
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Total Neutrophils; Week42; n=10, 6, 2,2
-2.23 Giga cells per liter
Standard Deviation 2.0311
-3.085 Giga cells per liter
Standard Deviation 2.7313
-0.565 Giga cells per liter
Standard Deviation 0.7849
-1.815 Giga cells per liter
Standard Deviation 0.4455
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Platelet Count; Week30; n=13, 10, 1, 2
-70 Giga cells per liter
Standard Deviation 60.5
-71.9 Giga cells per liter
Standard Deviation 59.35
-112 Giga cells per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-36.5 Giga cells per liter
Standard Deviation 47.38
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Platelet Count; Week48; n=9, 6, 1, 2
-37.7 Giga cells per liter
Standard Deviation 66.18
-68.8 Giga cells per liter
Standard Deviation 65.74
33 Giga cells per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-14 Giga cells per liter
Standard Deviation 22.63
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Platelet Count; PT Week4; n=32, 34,11,11
-20.4 Giga cells per liter
Standard Deviation 44.37
-28.9 Giga cells per liter
Standard Deviation 45.92
-12.4 Giga cells per liter
Standard Deviation 34.3
-12.9 Giga cells per liter
Standard Deviation 42.3
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
White Blood Cell count; Week18; n=37,33,13,12
-4.1 Giga cells per liter
Standard Deviation 2.258
-3.81 Giga cells per liter
Standard Deviation 1.884
-2.84 Giga cells per liter
Standard Deviation 0.961
-2.65 Giga cells per liter
Standard Deviation 0.923
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
White Blood Cell count ; Week24; n=34,32,12,11
-4.06 Giga cells per liter
Standard Deviation 2.251
-3.58 Giga cells per liter
Standard Deviation 1.977
-3 Giga cells per liter
Standard Deviation 1.047
-2.52 Giga cells per liter
Standard Deviation 1.272
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Total Neutrophils; PT Week4; n=32, 34,11,11
-1.158 Giga cells per liter
Standard Deviation 1.8855
-0.808 Giga cells per liter
Standard Deviation 1.6104
-0.744 Giga cells per liter
Standard Deviation 1.1276
-0.671 Giga cells per liter
Standard Deviation 0.8001
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Platelet Count; Week18; n=38, 34, 13,12
-73.7 Giga cells per liter
Standard Deviation 43.93
-87.5 Giga cells per liter
Standard Deviation 38.4
-55.7 Giga cells per liter
Standard Deviation 56.96
-52.1 Giga cells per liter
Standard Deviation 39.87
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Platelet Count; Week24; n=35, 33, 12,11
-67.5 Giga cells per liter
Standard Deviation 43.22
-78.8 Giga cells per liter
Standard Deviation 44.15
-60.3 Giga cells per liter
Standard Deviation 56.5
-51.9 Giga cells per liter
Standard Deviation 44.19
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Platelet Count; Week36; n=12, 7, 1, 2
-64.1 Giga cells per liter
Standard Deviation 41.52
-75.7 Giga cells per liter
Standard Deviation 65.89
-115 Giga cells per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-34 Giga cells per liter
Standard Deviation 52.33
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Platelet Count; Week42; n=10, 6, 2, 2
-56.1 Giga cells per liter
Standard Deviation 53.01
-67.3 Giga cells per liter
Standard Deviation 62.09
-112 Giga cells per liter
Standard Deviation 0
-22 Giga cells per liter
Standard Deviation 52.33
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
White Blood Cell count ; Week30; n=13,10,2,2
-3.92 Giga cells per liter
Standard Deviation 2.258
-3.59 Giga cells per liter
Standard Deviation 3.051
-4.7 Giga cells per liter
Standard Deviation 1.838
-4.05 Giga cells per liter
Standard Deviation 0.495
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
White Blood Cell count ; Week36; n=12,7,1,2
-4.13 Giga cells per liter
Standard Deviation 2.188
-4.39 Giga cells per liter
Standard Deviation 3.168
-3.9 Giga cells per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-3.55 Giga cells per liter
Standard Deviation 0.919
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
White Blood Cell count ; Week42; n=10,6,2,2
-3.67 Giga cells per liter
Standard Deviation 2.807
-4.52 Giga cells per liter
Standard Deviation 3.68
-1.75 Giga cells per liter
Standard Deviation 2.051
-3.8 Giga cells per liter
Standard Deviation 0.707
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
White Blood Cell count; Week48; n=7,6,1,2
-2.09 Giga cells per liter
Standard Deviation 3.304
-4.17 Giga cells per liter
Standard Deviation 4.172
0.2 Giga cells per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-3.8 Giga cells per liter
Standard Deviation 0.141
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
White Blood Cell count; PT Week4;n=32,34,11,11
-1.97 Giga cells per liter
Standard Deviation 1.938
-1.64 Giga cells per liter
Standard Deviation 1.907
-1.54 Giga cells per liter
Standard Deviation 1.638
-1.45 Giga cells per liter
Standard Deviation 0.884
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Basophils; Week18; n=37, 33, 13, 12
-0.019 Giga cells per liter
Standard Deviation 0.0178
-0.01 Giga cells per liter
Standard Deviation 0.0194
-0.014 Giga cells per liter
Standard Deviation 0.0112
-0.012 Giga cells per liter
Standard Deviation 0.0119
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Basophils; Week24; n=34, 32, 12, 11
-0.018 Giga cells per liter
Standard Deviation 0.0177
-0.01 Giga cells per liter
Standard Deviation 0.0166
-0.013 Giga cells per liter
Standard Deviation 0.0129
-0.013 Giga cells per liter
Standard Deviation 0.011
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Basophils; Week30; n=13, 10, 2, 2
-0.018 Giga cells per liter
Standard Deviation 0.0142
-0.012 Giga cells per liter
Standard Deviation 0.0148
-0.02 Giga cells per liter
Standard Deviation 0
-0.02 Giga cells per liter
Standard Deviation 0
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Basophils; Week36; n=12, 7, 1, 2
-0.02 Giga cells per liter
Standard Deviation 0.0165
-0.006 Giga cells per liter
Standard Deviation 0.019
-0.02 Giga cells per liter
Standard Deviation NA
A value of NA indicates not applicable
-0.01 Giga cells per liter
Standard Deviation 0.0141
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Basophils; Week42; n=10, 6, 2, 2
-0.015 Giga cells per liter
Standard Deviation 0.0242
-0.005 Giga cells per liter
Standard Deviation 0.0187
0 Giga cells per liter
Standard Deviation 0.0424
-0.015 Giga cells per liter
Standard Deviation 0.0071
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Basophils; Week48; n=7, 6, 1, 2
-0.007 Giga cells per liter
Standard Deviation 0.0214
-0.007 Giga cells per liter
Standard Deviation 0.0197
0.02 Giga cells per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
0.005 Giga cells per liter
Standard Deviation 0.0071
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Basophils; PT Week4; n=32, 34, 11, 11
-0.007 Giga cells per liter
Standard Deviation 0.0162
-0.003 Giga cells per liter
Standard Deviation 0.0189
-0.001 Giga cells per liter
Standard Deviation 0.0181
-0.003 Giga cells per liter
Standard Deviation 0.0119
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Eosinophils; Week18; n=37, 33, 13, 12
-0.119 Giga cells per liter
Standard Deviation 0.1006
-0.127 Giga cells per liter
Standard Deviation 0.1207
-0.087 Giga cells per liter
Standard Deviation 0.0507
-0.068 Giga cells per liter
Standard Deviation 0.0746
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Eosinophils; Week36; n=12, 7, 1, 2
-0.081 Giga cells per liter
Standard Deviation 0.1459
-0.123 Giga cells per liter
Standard Deviation 0.1003
-0.06 Giga cells per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-0.05 Giga cells per liter
Standard Deviation 0.0141
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Eosinophils; Week42; n=10, 6, 2, 2
-0.105 Giga cells per liter
Standard Deviation 0.074
-0.1 Giga cells per liter
Standard Deviation 0.12
-0.02 Giga cells per liter
Standard Deviation 0.0424
-0.04 Giga cells per liter
Standard Deviation 0
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Lymphocytes; Week30; n=13, 10, 2, 2
-1.225 Giga cells per liter
Standard Deviation 0.7588
-1.085 Giga cells per liter
Standard Deviation 0.798
-1.905 Giga cells per liter
Standard Deviation 0.1768
-1.845 Giga cells per liter
Standard Deviation 0.2899
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Lymphocytes; Week42; n=10, 6, 2, 2
-1.135 Giga cells per liter
Standard Deviation 0.8657
-1.22 Giga cells per liter
Standard Deviation 0.9909
-1.125 Giga cells per liter
Standard Deviation 1.0253
-1.93 Giga cells per liter
Standard Deviation 0.1414
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Total Neutrophils; Week36; n=12, 7, 1,2
-2.503 Giga cells per liter
Standard Deviation 1.6709
-2.777 Giga cells per liter
Standard Deviation 2.4215
-1.61 Giga cells per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-1.63 Giga cells per liter
Standard Deviation 0.297
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Monocytes; PT Week4; n=32, 34, 11,11
-0.047 Giga cells per liter
Standard Deviation 0.1773
-0.031 Giga cells per liter
Standard Deviation 0.165
0.032 Giga cells per liter
Standard Deviation 0.1543
-0.053 Giga cells per liter
Standard Deviation 0.1536
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Total Neutrophils; Week48; n=7, 6, 1, 2
-1.129 Giga cells per liter
Standard Deviation 2.2597
-2.488 Giga cells per liter
Standard Deviation 3.397
0.02 Giga cells per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-1.445 Giga cells per liter
Standard Deviation 0.4596

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12
Red Blood Cell count; Week 18; n=38, 34, 13, 12
-1.13 Trillion cells per liter
Standard Deviation 0.494
-0.88 Trillion cells per liter
Standard Deviation 0.591
-1.19 Trillion cells per liter
Standard Deviation 0.638
-0.99 Trillion cells per liter
Standard Deviation 0.498
Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12
Red Blood Cell count; Week 24; n=35, 33, 12, 11
-1.13 Trillion cells per liter
Standard Deviation 0.482
-0.94 Trillion cells per liter
Standard Deviation 0.513
-1.19 Trillion cells per liter
Standard Deviation 0.552
-1.14 Trillion cells per liter
Standard Deviation 0.528
Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12
Red Blood Cell count; Week 30; n=13,10,2,2
-1.05 Trillion cells per liter
Standard Deviation 0.511
-0.75 Trillion cells per liter
Standard Deviation 0.809
-1.45 Trillion cells per liter
Standard Deviation 0.071
-1.45 Trillion cells per liter
Standard Deviation 0.354
Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12
Red Blood Cell count; Week 36; n=12,7,1,2
-0.88 Trillion cells per liter
Standard Deviation 0.67
-1.06 Trillion cells per liter
Standard Deviation 0.761
-1 Trillion cells per liter
Standard Deviation NA
The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of NA indicates not applicable for the mean and the standard deviation).
-1.3 Trillion cells per liter
Standard Deviation 0.283
Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12
Red Blood Cell count; Week 42; n=10,6,2,2
-0.91 Trillion cells per liter
Standard Deviation 0.674
-1.17 Trillion cells per liter
Standard Deviation 0.769
-0.55 Trillion cells per liter
Standard Deviation 0.636
-1.45 Trillion cells per liter
Standard Deviation 0.354
Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12
Red Blood Cell count; Week 48; n=9, 6,1,2
-0.83 Trillion cells per liter
Standard Deviation 0.791
-1.03 Trillion cells per liter
Standard Deviation 0.794
-0.4 Trillion cells per liter
Standard Deviation NA
The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of NA indicates not applicable for the mean and the standard deviation).
-1.5 Trillion cells per liter
Standard Deviation 0.566
Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12
Red Blood Cell count; PT Week 4; n=32,34,11,11
-0.57 Trillion cells per liter
Standard Deviation 0.435
-0.37 Trillion cells per liter
Standard Deviation 0.353
-0.66 Trillion cells per liter
Standard Deviation 0.437
-0.65 Trillion cells per liter
Standard Deviation 0.474

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Population: Safety population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Blood samples were collected for the measurement of hemoglobin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12
Hemoglobin; Week 18; n=38, 34, 13, 12
-33.6 Grams per liter
Standard Deviation 12.34
-26.7 Grams per liter
Standard Deviation 14.65
-35 Grams per liter
Standard Deviation 16.38
-29 Grams per liter
Standard Deviation 10.61
Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12
Hemoglobin; Week 24; n=35, 33, 12,11
-33.4 Grams per liter
Standard Deviation 12.16
-28 Grams per liter
Standard Deviation 12.44
-35.6 Grams per liter
Standard Deviation 13.48
-32.3 Grams per liter
Standard Deviation 14.98
Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12
Hemoglobin; Week 30; n=13, 10, 2, 2
-30.2 Grams per liter
Standard Deviation 16.13
-21 Grams per liter
Standard Deviation 20.02
-40 Grams per liter
Standard Deviation 12.73
-40 Grams per liter
Standard Deviation 1.41
Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12
Hemoglobin; Week 36; n=12, 7, 1, 2
-26.7 Grams per liter
Standard Deviation 18.86
-30 Grams per liter
Standard Deviation 16.37
-37 Grams per liter
Standard Deviation NA
The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of NA indicates not applicable for the mean and the standard deviation).
-35 Grams per liter
Standard Deviation 1.41
Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12
Hemoglobin; Week 42; n=10, 6, 2, 2
-27.1 Grams per liter
Standard Deviation 18.51
-31.7 Grams per liter
Standard Deviation 19.82
-25 Grams per liter
Standard Deviation 22.63
-40 Grams per liter
Standard Deviation 1.41
Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12
Hemoglobin; Week 48; n=9, 6, 1, 2
-25.9 Grams per liter
Standard Deviation 21.47
-29.3 Grams per liter
Standard Deviation 20.33
-18 Grams per liter
Standard Deviation NA
The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of NA indicates not applicable for the mean and the standard deviation).
-41 Grams per liter
Standard Deviation 8.49
Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12
Hemoglobin; PT Week 4; n=32, 34, 11,11
-16.5 Grams per liter
Standard Deviation 11.43
-11.7 Grams per liter
Standard Deviation 9.57
-21.4 Grams per liter
Standard Deviation 8.59
-16.8 Grams per liter
Standard Deviation 11.99

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Blood samples were collected for the measurement of hematocrit at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12
Hematocrit; Week 18; n=38, 34, 13, 12
-0.083 Ratio
Standard Deviation 0.03831
-0.0622 Ratio
Standard Deviation 0.04289
-0.0776 Ratio
Standard Deviation 0.04313
-0.0699 Ratio
Standard Deviation 0.02801
Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12
Hematocrit; Week 24; n=35, 33, 12, 11
-0.0782 Ratio
Standard Deviation 0.04021
-0.0635 Ratio
Standard Deviation 0.03499
-0.0808 Ratio
Standard Deviation 0.03543
-0.0823 Ratio
Standard Deviation 0.03968
Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12
Hematocrit; PT Week 4; n=32, 34, 11,11
-0.0293 Ratio
Standard Deviation 0.03575
-0.0135 Ratio
Standard Deviation 0.03178
-0.0362 Ratio
Standard Deviation 0.02907
-0.0354 Ratio
Standard Deviation 0.0358
Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12
Hematocrit; Week 30; n=13, 10, 2, 2
-0.0713 Ratio
Standard Deviation 0.0486
-0.0397 Ratio
Standard Deviation 0.05793
-0.0955 Ratio
Standard Deviation 0.03323
-0.1125 Ratio
Standard Deviation 0.00636
Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12
Hematocrit; Week 36; n=12, 7, 1, 2
-0.0567 Ratio
Standard Deviation 0.05031
-0.069 Ratio
Standard Deviation 0.04724
-0.087 Ratio
Standard Deviation NA
The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of NA indicates not applicable).
-0.0895 Ratio
Standard Deviation 0.00354
Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12
Hematocrit; Week 42; n=10, 6, 2, 2
-0.0623 Ratio
Standard Deviation 0.05449
-0.0802 Ratio
Standard Deviation 0.0562
-0.0535 Ratio
Standard Deviation 0.07
-0.111 Ratio
Standard Deviation 0.00566
Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12
Hematocrit; Week 48; n=9, 6, 1, 2
-0.0624 Ratio
Standard Deviation 0.06203
-0.0753 Ratio
Standard Deviation 0.05285
-0.047 Ratio
Standard Deviation NA
The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of NA indicates not applicable).
-0.1095 Ratio
Standard Deviation 0.03041

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Blood samples were collected for the measurement of mean corpuscle volume at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12
Mean Corpuscle Volume ; Week 18;n=38,34,13,12
7.5 Femtoliters
Standard Deviation 6.37
6.2 Femtoliters
Standard Deviation 8.19
8.5 Femtoliters
Standard Deviation 5.78
5.3 Femtoliters
Standard Deviation 5.28
Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12
Mean Corpuscle Volume ; Week 30; n=13,10,2,2
7.8 Femtoliters
Standard Deviation 7.24
9.5 Femtoliters
Standard Deviation 12.02
11.5 Femtoliters
Standard Deviation 7.78
3 Femtoliters
Standard Deviation 2.83
Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12
Mean Corpuscle Volume ; Week 36; n=12,7,1,2
8.1 Femtoliters
Standard Deviation 5.92
11.4 Femtoliters
Standard Deviation 13.6
2 Femtoliters
Standard Deviation NA
The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of NA indicates not applicable for the mean and the standard deviation).
5.5 Femtoliters
Standard Deviation 2.12
Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12
Mean Corpuscle Volume ; Week 42;n=10,6,2,2
6.9 Femtoliters
Standard Deviation 5.7
10.7 Femtoliters
Standard Deviation 14.47
1 Femtoliters
Standard Deviation 2.83
4 Femtoliters
Standard Deviation 2.83
Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12
Mean Corpuscle Volume ; Week 48;n=9,6,1,2
5.2 Femtoliters
Standard Deviation 5.76
9 Femtoliters
Standard Deviation 14.04
-1 Femtoliters
Standard Deviation NA
The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of NA indicates not applicable for the mean and the standard deviation).
5 Femtoliters
Standard Deviation 1.41
Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12
Mean Corpuscle Volume; PT Week 4; n=32,34,11,11
6.1 Femtoliters
Standard Deviation 5.56
5.1 Femtoliters
Standard Deviation 4.86
5.8 Femtoliters
Standard Deviation 3.79
5.3 Femtoliters
Standard Deviation 5.1
Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12
Mean Corpuscle Volume ; Week 24;n=35,33,12,11
8.5 Femtoliters
Standard Deviation 6.14
7.5 Femtoliters
Standard Deviation 8.89
7.6 Femtoliters
Standard Deviation 5.9
5.8 Femtoliters
Standard Deviation 5.08

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Blood samples were collected for the measurement of albumin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12
Albumin; Week 30; n=13, 10, 3, 2
-1.8 Grams per liter
Standard Deviation 2.09
-0.7 Grams per liter
Standard Deviation 4.22
-3 Grams per liter
Standard Deviation 2.65
-4.5 Grams per liter
Standard Deviation 0.71
Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12
Albumin; Week 36; n=10, 7, 2, 2
-1.7 Grams per liter
Standard Deviation 3.92
-1.1 Grams per liter
Standard Deviation 2.85
2 Grams per liter
Standard Deviation 1.41
-2 Grams per liter
Standard Deviation 0
Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12
Albumin; Week 18; n=38, 34, 13, 12
-2.3 Grams per liter
Standard Deviation 2.78
-1.4 Grams per liter
Standard Deviation 2.65
-1.8 Grams per liter
Standard Deviation 2.86
-1 Grams per liter
Standard Deviation 2.89
Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12
Albumin; Week 24; n=35, 33, 12, 11
-2.1 Grams per liter
Standard Deviation 3.08
-1.6 Grams per liter
Standard Deviation 2.82
-2.3 Grams per liter
Standard Deviation 2.81
-1.1 Grams per liter
Standard Deviation 2.81
Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12
Albumin; Week 42; n=9, 6, 1, 2
-1.3 Grams per liter
Standard Deviation 2.5
-1.3 Grams per liter
Standard Deviation 1.63
-1 Grams per liter
Standard Deviation NA
The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of NA indicates not applicable for the mean and the standard deviation).
-3 Grams per liter
Standard Deviation 0
Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12
Albumin; Week 48; n=6, 6, 0, 2
-1.3 Grams per liter
Standard Deviation 3.61
-0.3 Grams per liter
Standard Deviation 2.16
NA Grams per liter
Standard Deviation NA
The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of NA indicates not applicable for the mean and the standard deviation).
-4 Grams per liter
Standard Deviation 1.41
Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12
Albumin; PT Week 4; n=33, 34, 11, 11
-0.7 Grams per liter
Standard Deviation 3.93
-0.2 Grams per liter
Standard Deviation 2.84
0.5 Grams per liter
Standard Deviation 2.3
-0.7 Grams per liter
Standard Deviation 1.79

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Blood samples were collected for the measurement of ALP, ALT, AST, CK and GGT at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
ALP; Week 18; n=38, 34, 13, 12
2.5 International units per liter
Standard Deviation 17.25
1.1 International units per liter
Standard Deviation 16.95
2.2 International units per liter
Standard Deviation 21.77
6.4 International units per liter
Standard Deviation 20.08
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
ALP; Week 24; n=35, 33, 12, 11
0.8 International units per liter
Standard Deviation 19.71
3.3 International units per liter
Standard Deviation 18.83
2.1 International units per liter
Standard Deviation 20.24
4.5 International units per liter
Standard Deviation 22.82
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
ALP; Week 30; n=13, 10, 3, 2
1.8 International units per liter
Standard Deviation 15.79
-6.4 International units per liter
Standard Deviation 18.62
-8 International units per liter
Standard Deviation 8.54
22.5 International units per liter
Standard Deviation 14.85
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
ALP; Week 36; n=10, 7, 2, 2
2 International units per liter
Standard Deviation 17.49
2.7 International units per liter
Standard Deviation 9.45
2.5 International units per liter
Standard Deviation 0.71
18 International units per liter
Standard Deviation 7.07
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
ALP; Week 42; n=9, 6, 1, 2
5.3 International units per liter
Standard Deviation 13.4
3.3 International units per liter
Standard Deviation 8.45
-2 International units per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
17.5 International units per liter
Standard Deviation 2.12
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
ALT; Week 18; n=38, 34, 13, 12
-38.9 International units per liter
Standard Deviation 61.39
-22.9 International units per liter
Standard Deviation 61.65
-38.6 International units per liter
Standard Deviation 40.89
-38.4 International units per liter
Standard Deviation 32.63
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
ALT; Week 24; n=35, 33, 12, 11
-43.9 International units per liter
Standard Deviation 62.25
-31.3 International units per liter
Standard Deviation 56.12
-39.7 International units per liter
Standard Deviation 38.19
-41.7 International units per liter
Standard Deviation 28.32
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
ALT; Week 30; n=13, 10, 3, 2
-34.8 International units per liter
Standard Deviation 30.82
-45.1 International units per liter
Standard Deviation 95.76
-57.7 International units per liter
Standard Deviation 58.31
-26 International units per liter
Standard Deviation 22.63
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
ALT; Week 36; n=10, 7, 2, 2
-30.2 International units per liter
Standard Deviation 28.15
-16.6 International units per liter
Standard Deviation 13.7
-69 International units per liter
Standard Deviation 74.95
-20.5 International units per liter
Standard Deviation 16.26
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
ALT; Week 42; n=9, 6, 1, 2
-34.3 International units per liter
Standard Deviation 35.15
-14.3 International units per liter
Standard Deviation 20.07
-122 International units per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-28 International units per liter
Standard Deviation 25.46
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
ALT; Week 48; n=6, 6, 0, 2
-38.8 International units per liter
Standard Deviation 42.1
-10.8 International units per liter
Standard Deviation 27.11
NA International units per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-26.5 International units per liter
Standard Deviation 26.16
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
ALT; PT Week 4; n=33, 34, 11, 11
-45.5 International units per liter
Standard Deviation 62.76
-33.3 International units per liter
Standard Deviation 56.81
-31.5 International units per liter
Standard Deviation 22.68
-43.9 International units per liter
Standard Deviation 27.71
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
AST; Week 18; n=38, 34, 13, 12
-13.1 International units per liter
Standard Deviation 27.49
-3.5 International units per liter
Standard Deviation 37.25
-18.8 International units per liter
Standard Deviation 27.32
-16.3 International units per liter
Standard Deviation 15.11
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
AST; Week 24; n=35, 33, 12, 11
-16.5 International units per liter
Standard Deviation 26.86
-11.8 International units per liter
Standard Deviation 30.51
-23.8 International units per liter
Standard Deviation 26.91
-15.7 International units per liter
Standard Deviation 18.91
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
AST; Week 30; n=13, 10, 3, 2
-15.1 International units per liter
Standard Deviation 17.35
-18.7 International units per liter
Standard Deviation 43.89
-27.7 International units per liter
Standard Deviation 20.13
-6.5 International units per liter
Standard Deviation 7.78
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
AST; Week 36; n=10, 7, 2, 2
-11.8 International units per liter
Standard Deviation 13.81
-7.3 International units per liter
Standard Deviation 9.5
-27.5 International units per liter
Standard Deviation 31.82
-2.5 International units per liter
Standard Deviation 2.12
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
AST; Week 42; n=9, 6, 1, 2
-14.2 International units per liter
Standard Deviation 16.81
-5.8 International units per liter
Standard Deviation 10.03
-54 International units per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-9 International units per liter
Standard Deviation 7.07
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
AST; PT Week 4; n=33, 34, 11, 11
-19.5 International units per liter
Standard Deviation 26.41
-15.6 International units per liter
Standard Deviation 34.38
-17.7 International units per liter
Standard Deviation 14.67
-16 International units per liter
Standard Deviation 31.8
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
CK; Week 18; n=38, 34, 13, 12
-44 International units per liter
Standard Deviation 55.77
-28.3 International units per liter
Standard Deviation 36.59
-38.7 International units per liter
Standard Deviation 45.46
-60.7 International units per liter
Standard Deviation 75.8
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
CK; Week 24; n=35, 33, 12, 11
-34.5 International units per liter
Standard Deviation 66.48
-18.7 International units per liter
Standard Deviation 77.24
-39 International units per liter
Standard Deviation 36.68
60.1 International units per liter
Standard Deviation 475.39
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
CK; Week 30; n=13, 10, 3, 2
-33 International units per liter
Standard Deviation 83.25
-15.8 International units per liter
Standard Deviation 51.92
-30 International units per liter
Standard Deviation 24.27
-78.5 International units per liter
Standard Deviation 55.86
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
CK; Week 48; n=6, 6, 0, 2
10.5 International units per liter
Standard Deviation 71.39
22.3 International units per liter
Standard Deviation 77.32
NA International units per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-82.5 International units per liter
Standard Deviation 70
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
CK; PT Week 4; n=33, 34, 11, 11
-17.9 International units per liter
Standard Deviation 48.82
-26.4 International units per liter
Standard Deviation 49.42
-21.7 International units per liter
Standard Deviation 42.62
258.7 International units per liter
Standard Deviation 994.88
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
GGT; Week 18; n=38, 34, 13, 12
-37.3 International units per liter
Standard Deviation 71.19
-12.3 International units per liter
Standard Deviation 60.35
-30.2 International units per liter
Standard Deviation 42.04
-34.2 International units per liter
Standard Deviation 56.52
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
GGT; Week 42; n=9, 6, 1, 2
-44.6 International units per liter
Standard Deviation 46.61
-19.7 International units per liter
Standard Deviation 25.06
-17 International units per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-9 International units per liter
Standard Deviation 1.41
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
GGT; Week 48; n=6, 6, 0, 2
-37.8 International units per liter
Standard Deviation 28.74
-16.8 International units per liter
Standard Deviation 24.38
NA International units per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-9.5 International units per liter
Standard Deviation 6.36
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
GGT; PT Week 4; n=33, 34, 11, 11
-43.4 International units per liter
Standard Deviation 78.29
-17.7 International units per liter
Standard Deviation 78.22
-30.7 International units per liter
Standard Deviation 41.91
-41.4 International units per liter
Standard Deviation 61.06
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
ALP; Week 48; n=6, 6, 0, 2
9.8 International units per liter
Standard Deviation 17.36
4.2 International units per liter
Standard Deviation 9.62
NA International units per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
30 International units per liter
Standard Deviation 24.04
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
ALP; PT Week 4; n=33, 34, 11, 11
-4.9 International units per liter
Standard Deviation 19.71
-6.3 International units per liter
Standard Deviation 17.88
-7 International units per liter
Standard Deviation 17.93
-3.9 International units per liter
Standard Deviation 22.15
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
AST; Week 48; n=6, 6, 0, 2
-12.8 International units per liter
Standard Deviation 18.65
-2.2 International units per liter
Standard Deviation 13.61
NA International units per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-6.5 International units per liter
Standard Deviation 9.19
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
CK; Week 36; n=10, 7, 2, 2
-18.9 International units per liter
Standard Deviation 34.18
-26.7 International units per liter
Standard Deviation 32.22
-37.5 International units per liter
Standard Deviation 6.36
-69 International units per liter
Standard Deviation 53.74
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
CK; Week 42; n=9, 6, 1, 2
-0.2 International units per liter
Standard Deviation 51.5
-29.7 International units per liter
Standard Deviation 43.42
-32 International units per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-81 International units per liter
Standard Deviation 57.98
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
GGT; Week 24; n=35, 33, 12, 11
-38.3 International units per liter
Standard Deviation 72.79
-12.5 International units per liter
Standard Deviation 86.73
-37.4 International units per liter
Standard Deviation 45.44
-35.7 International units per liter
Standard Deviation 59.63
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
GGT; Week 30; n=13, 10, 3, 2
-44.2 International units per liter
Standard Deviation 41.3
-32.8 International units per liter
Standard Deviation 31.81
-38.7 International units per liter
Standard Deviation 36.02
-12 International units per liter
Standard Deviation 4.24
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
GGT; Week 36; n=10, 7, 2, 2
-51.5 International units per liter
Standard Deviation 45.03
-19.7 International units per liter
Standard Deviation 24.52
-40.5 International units per liter
Standard Deviation 33.23
-10 International units per liter
Standard Deviation 4.24

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Blood samples were collected for the measurement of total bilirubin and creatinine at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment afterl Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12
Total bilirubin; Week 24; n=35, 33, 12,11
-0.1 Micromoles per liter
Standard Deviation 5.73
1 Micromoles per liter
Standard Deviation 4.08
-1.3 Micromoles per liter
Standard Deviation 11.9
1.3 Micromoles per liter
Standard Deviation 6.26
Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12
Total bilirubin; Week 30; n=13, 10, 3, 2
-0.2 Micromoles per liter
Standard Deviation 5.99
0.8 Micromoles per liter
Standard Deviation 4.76
-2.3 Micromoles per liter
Standard Deviation 9.29
-4 Micromoles per liter
Standard Deviation 5.66
Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12
Total bilirubin; Week 36; n=10, 7, 2, 2
0 Micromoles per liter
Standard Deviation 4.29
1.9 Micromoles per liter
Standard Deviation 4.95
-3 Micromoles per liter
Standard Deviation 11.31
-3 Micromoles per liter
Standard Deviation 7.07
Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12
Total bilirubin; Week 42; n=9, 6, 1, 2
0.1 Micromoles per liter
Standard Deviation 5.11
1.5 Micromoles per liter
Standard Deviation 5.79
-14 Micromoles per liter
Standard Deviation NA
The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of NA indicates not applicable for the mean and the standard deviation).
-4 Micromoles per liter
Standard Deviation 5.66
Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12
Total bilirubin; Week 48; n=6, 6, 0, 2
-0.7 Micromoles per liter
Standard Deviation 4.72
3.5 Micromoles per liter
Standard Deviation 7.2
NA Micromoles per liter
Standard Deviation NA
The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of NA indicates not applicable for the mean and the standard deviation).
-4 Micromoles per liter
Standard Deviation 2.83
Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12
Total bilirubin PT Week 4; n=33, 34, 11,11
-4.6 Micromoles per liter
Standard Deviation 3.57
-2.4 Micromoles per liter
Standard Deviation 3.3
-0.4 Micromoles per liter
Standard Deviation 5.68
-2.2 Micromoles per liter
Standard Deviation 2.71
Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12
Creatinine; Week 24; n=35, 33, 12, 11
-1.55 Micromoles per liter
Standard Deviation 9.507
-2.4 Micromoles per liter
Standard Deviation 8.413
-3.12 Micromoles per liter
Standard Deviation 9.408
1.31 Micromoles per liter
Standard Deviation 10.377
Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12
Creatinine; Week 18; n=38, 34, 13, 12
-2.24 Micromoles per liter
Standard Deviation 9.186
-1.97 Micromoles per liter
Standard Deviation 9.65
-1.75 Micromoles per liter
Standard Deviation 9.874
0.09 Micromoles per liter
Standard Deviation 10.668
Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12
Creatinine; Week 30; n=13, 10, 3, 2
0.66 Micromoles per liter
Standard Deviation 4.603
2.82 Micromoles per liter
Standard Deviation 8.123
-8.47 Micromoles per liter
Standard Deviation 8.693
-8.85 Micromoles per liter
Standard Deviation 3.748
Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12
Creatinine; Week 36; n=10, 7, 2, 2
2.33 Micromoles per liter
Standard Deviation 11.096
2.99 Micromoles per liter
Standard Deviation 8.179
-5.5 Micromoles per liter
Standard Deviation 16.829
-8 Micromoles per liter
Standard Deviation 1.273
Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12
Creatinine; Week 42; n=9, 6, 1, 2
1.23 Micromoles per liter
Standard Deviation 10.32
4.97 Micromoles per liter
Standard Deviation 11.697
-14.3 Micromoles per liter
Standard Deviation NA
The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of NA indicates not applicable for the mean and the standard deviation).
-7.55 Micromoles per liter
Standard Deviation 5.586
Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12
Creatinine; Week 48; n=6, 6, 0, 2
-2.35 Micromoles per liter
Standard Deviation 4.222
10.07 Micromoles per liter
Standard Deviation 17.173
NA Micromoles per liter
Standard Deviation NA
The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of NA indicates not applicable for the mean and the standard deviation).
-7.1 Micromoles per liter
Standard Deviation 1.273
Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12
Creatinine; PT Week 4; n=33, 34, 11,11
1.23 Micromoles per liter
Standard Deviation 8.22
-0.34 Micromoles per liter
Standard Deviation 7.624
-1.7 Micromoles per liter
Standard Deviation 6.897
-1.25 Micromoles per liter
Standard Deviation 6.228
Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12
Total bilirubin; Week 18; n=38, 34, 13, 12
0.5 Micromoles per liter
Standard Deviation 5.01
1.7 Micromoles per liter
Standard Deviation 5.32
-1.4 Micromoles per liter
Standard Deviation 11.37
0.6 Micromoles per liter
Standard Deviation 6.49

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Population: Safety Population

Blood pressure measurements were taken to observe vital signs and included SBP and DBP at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. All abnormal values and statistical summary tables were not available after week 12.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Population: Safety Population

Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from Baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. All abnormal values and statistical summary tables were not available after week 12.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Population: Safety Population

The ECG data was only collected "Perform as needed", therefore, no such summary table was generated. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Population: Safety Population

The ECG data was only collected "Perform as needed", therefore, no such summary table was generated. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/bun at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Bun values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Sodium; Week 42; n=9, 6, 1, 2
0.4 Millimoles per liter
Standard Deviation 2.07
-0.5 Millimoles per liter
Standard Deviation 1.38
3 Millimoles per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-1.5 Millimoles per liter
Standard Deviation 0.71
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Chloride; Week 18; n=38, 34, 13, 12
1.9 Millimoles per liter
Standard Deviation 2.75
1 Millimoles per liter
Standard Deviation 2.5
1.8 Millimoles per liter
Standard Deviation 2.41
0.5 Millimoles per liter
Standard Deviation 2.94
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Chloride; Week 24; n=35, 33, 12, 11
2 Millimoles per liter
Standard Deviation 2.33
0.7 Millimoles per liter
Standard Deviation 2.73
2.9 Millimoles per liter
Standard Deviation 2.81
-0.2 Millimoles per liter
Standard Deviation 3.52
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Chloride; Week 30; n=13, 10, 3, 2
1.9 Millimoles per liter
Standard Deviation 2.72
0.3 Millimoles per liter
Standard Deviation 2.87
5.3 Millimoles per liter
Standard Deviation 3.21
3 Millimoles per liter
Standard Deviation 0
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Chloride; Week 36; n=10, 7, 2, 2
1.3 Millimoles per liter
Standard Deviation 2.11
-0.1 Millimoles per liter
Standard Deviation 2.54
4.5 Millimoles per liter
Standard Deviation 6.36
1 Millimoles per liter
Standard Deviation 0
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Chloride; Week 42; n=9, 6, 1, 2
1.3 Millimoles per liter
Standard Deviation 2.78
0 Millimoles per liter
Standard Deviation 2
10 Millimoles per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
0.5 Millimoles per liter
Standard Deviation 0.71
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Chloride; PT Week 4; n=33, 34, 11, 11
0.5 Millimoles per liter
Standard Deviation 2.69
0.2 Millimoles per liter
Standard Deviation 2.54
0.6 Millimoles per liter
Standard Deviation 2.29
-1.5 Millimoles per liter
Standard Deviation 2.25
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Bicarbonate; Week 24; n=35, 33, 12,11
-1 Millimoles per liter
Standard Deviation 2.41
-1.2 Millimoles per liter
Standard Deviation 2.21
-1.8 Millimoles per liter
Standard Deviation 2.41
-0.4 Millimoles per liter
Standard Deviation 3.35
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Bicarbonate; Week 30; n=13, 10, 3, 2
0.4 Millimoles per liter
Standard Deviation 2.33
-2.2 Millimoles per liter
Standard Deviation 4.02
-1.3 Millimoles per liter
Standard Deviation 1.53
-2 Millimoles per liter
Standard Deviation 2.83
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Bicarbonate; Week 36; n=10, 7, 2, 2
-0.9 Millimoles per liter
Standard Deviation 2.92
0.1 Millimoles per liter
Standard Deviation 1.86
-2.5 Millimoles per liter
Standard Deviation 2.12
-1.5 Millimoles per liter
Standard Deviation 2.12
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Bicarbonate; Week 42; n=9, 6, 1, 2
-0.7 Millimoles per liter
Standard Deviation 1.73
-0.2 Millimoles per liter
Standard Deviation 2.04
-4 Millimoles per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-1 Millimoles per liter
Standard Deviation 2.83
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Bicarbonate; Week 48; n=6, 6, 0, 2
-1 Millimoles per liter
Standard Deviation 1.67
-1.3 Millimoles per liter
Standard Deviation 2.66
NA Millimoles per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-0.5 Millimoles per liter
Standard Deviation 3.54
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Glucose; Week 18; n=38, 34, 13, 12
-0.28 Millimoles per liter
Standard Deviation 1.326
-0.13 Millimoles per liter
Standard Deviation 1.188
-0.06 Millimoles per liter
Standard Deviation 0.702
-0.23 Millimoles per liter
Standard Deviation 2.134
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Glucose; Week 24; n=35, 33, 12, 11
-0.33 Millimoles per liter
Standard Deviation 1.552
0.27 Millimoles per liter
Standard Deviation 2.986
-0.23 Millimoles per liter
Standard Deviation 0.672
-0.22 Millimoles per liter
Standard Deviation 1.349
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Glucose; Week 30; n=13, 10, 3, 2
0.03 Millimoles per liter
Standard Deviation 1.383
-0.26 Millimoles per liter
Standard Deviation 0.587
-0.13 Millimoles per liter
Standard Deviation 0.252
0.9 Millimoles per liter
Standard Deviation 0.707
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Glucose; Week 36; n=10, 7, 2, 2
-0.38 Millimoles per liter
Standard Deviation 0.758
-0.37 Millimoles per liter
Standard Deviation 1.09
-0.1 Millimoles per liter
Standard Deviation 0.99
-0.7 Millimoles per liter
Standard Deviation 0.283
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Glucose; Week 42; n=9, 6, 1, 2
-0.28 Millimoles per liter
Standard Deviation 1.663
-0.12 Millimoles per liter
Standard Deviation 0.794
0.4 Millimoles per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-0.15 Millimoles per liter
Standard Deviation 0.919
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Glucose; Week 48; n=6, 6, 0, 2
0.25 Millimoles per liter
Standard Deviation 1.358
-0.3 Millimoles per liter
Standard Deviation 0.867
NA Millimoles per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
4.55 Millimoles per liter
Standard Deviation 4.596
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Glucose; PT Week 4; n=33, 34, 11, 11
0.24 Millimoles per liter
Standard Deviation 3.122
0.18 Millimoles per liter
Standard Deviation 0.684
-0.12 Millimoles per liter
Standard Deviation 0.735
-0.07 Millimoles per liter
Standard Deviation 1.234
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Sodium; Week 48; n=6, 6, 0, 2
-0.2 Millimoles per liter
Standard Deviation 2.14
-1.2 Millimoles per liter
Standard Deviation 2.79
NA Millimoles per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-2.5 Millimoles per liter
Standard Deviation 3.54
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Potassium; Week 18; n=38, 34, 13, 12
-0.19 Millimoles per liter
Standard Deviation 0.399
-0.24 Millimoles per liter
Standard Deviation 0.376
-0.41 Millimoles per liter
Standard Deviation 0.236
-0.2 Millimoles per liter
Standard Deviation 0.424
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Potassium; Week 30; n=13, 10, 3, 2
-0.03 Millimoles per liter
Standard Deviation 0.48
-0.23 Millimoles per liter
Standard Deviation 0.377
-0.1 Millimoles per liter
Standard Deviation 0.2
-0.1 Millimoles per liter
Standard Deviation 0.424
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Potassium; Week 36; n=10, 7, 2, 2
0.24 Millimoles per liter
Standard Deviation 0.599
-0.1 Millimoles per liter
Standard Deviation 0.365
0.15 Millimoles per liter
Standard Deviation 0.071
0.2 Millimoles per liter
Standard Deviation 0.424
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Potassium; Week 42; n=9, 6, 1, 2
-0.1 Millimoles per liter
Standard Deviation 0.555
-0.2 Millimoles per liter
Standard Deviation 0.415
-0.1 Millimoles per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
0.1 Millimoles per liter
Standard Deviation 0.566
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Potassium; Week 48; n=6, 6, 0, 2
0.1 Millimoles per liter
Standard Deviation 0.566
-0.3 Millimoles per liter
Standard Deviation 0.322
NA Millimoles per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
0.05 Millimoles per liter
Standard Deviation 0.495
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Potassium; PT Week 4; n=33, 34, 11,11
-0.16 Millimoles per liter
Standard Deviation 0.382
-0.13 Millimoles per liter
Standard Deviation 0.398
-0.25 Millimoles per liter
Standard Deviation 0.532
-0.1 Millimoles per liter
Standard Deviation 0.316
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Sodium; Week 18; n=38, 34, 13, 12
0.7 Millimoles per liter
Standard Deviation 2.04
0.1 Millimoles per liter
Standard Deviation 2.27
0.7 Millimoles per liter
Standard Deviation 2.32
0.4 Millimoles per liter
Standard Deviation 3.37
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Sodium; Week 24; n=35, 33, 12, 11
0.4 Millimoles per liter
Standard Deviation 1.86
-0.1 Millimoles per liter
Standard Deviation 2.61
1.5 Millimoles per liter
Standard Deviation 2.24
0.4 Millimoles per liter
Standard Deviation 3.53
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Sodium; Week 30; n=13, 10, 3, 2
1.1 Millimoles per liter
Standard Deviation 3.25
-1.4 Millimoles per liter
Standard Deviation 2.72
1.3 Millimoles per liter
Standard Deviation 1.53
0 Millimoles per liter
Standard Deviation 1.41
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Sodium; Week 36; n=10, 7, 2, 2
0.4 Millimoles per liter
Standard Deviation 2.67
-0.7 Millimoles per liter
Standard Deviation 1.98
2 Millimoles per liter
Standard Deviation 2.83
-0.5 Millimoles per liter
Standard Deviation 0.71
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Sodium; PT Week 4; n=33, 34, 11, 11
-0.1 Millimoles per liter
Standard Deviation 2.3
0.1 Millimoles per liter
Standard Deviation 2.45
1.1 Millimoles per liter
Standard Deviation 2.47
-0.5 Millimoles per liter
Standard Deviation 2.7
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Inorganic phosphorus; Week 18; n=38,34,13,12
-0.161 Millimoles per liter
Standard Deviation 0.1971
-0.13 Millimoles per liter
Standard Deviation 0.1928
-0.092 Millimoles per liter
Standard Deviation 0.1537
-0.111 Millimoles per liter
Standard Deviation 0.2648
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Inorganic phosphorus; Week 24; n=35,33,12,11
-0.139 Millimoles per liter
Standard Deviation 0.2268
-0.13 Millimoles per liter
Standard Deviation 0.2354
-0.119 Millimoles per liter
Standard Deviation 0.1991
-0.107 Millimoles per liter
Standard Deviation 0.2205
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Inorganic phosphorus; Week 30; n=13,10,3,2
-0.156 Millimoles per liter
Standard Deviation 0.1644
-0.118 Millimoles per liter
Standard Deviation 0.2071
-0.267 Millimoles per liter
Standard Deviation 0.2023
-0.225 Millimoles per liter
Standard Deviation 0.1768
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Inorganic phosphorus; Week 36; n=10,7,2,2
-0.121 Millimoles per liter
Standard Deviation 0.2564
-0.167 Millimoles per liter
Standard Deviation 0.1906
-0.195 Millimoles per liter
Standard Deviation 0.0495
-0.125 Millimoles per liter
Standard Deviation 0.2475
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Inorganic phosphorus; Week 42; n=9,6,1,2
-0.08 Millimoles per liter
Standard Deviation 0.2248
-0.108 Millimoles per liter
Standard Deviation 0.0794
-0.15 Millimoles per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-0.1 Millimoles per liter
Standard Deviation 0.3536
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Inorganic phosphorus; Week 48; n=6,6,0,2
-0.167 Millimoles per liter
Standard Deviation 0.1715
-0.108 Millimoles per liter
Standard Deviation 0.1665
NA Millimoles per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-0.35 Millimoles per liter
Standard Deviation 0.0707
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Inorganic phosphorus; PT Week 4;n=33,34,11,11
-0.084 Millimoles per liter
Standard Deviation 0.2375
-0.003 Millimoles per liter
Standard Deviation 0.2162
0.009 Millimoles per liter
Standard Deviation 0.0798
-0.085 Millimoles per liter
Standard Deviation 0.2247
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Urea/BUN; Week 18; n=38, 34, 13, 12
-0.19 Millimoles per liter
Standard Deviation 1.166
-0.23 Millimoles per liter
Standard Deviation 1.403
-0.49 Millimoles per liter
Standard Deviation 1.233
-0.25 Millimoles per liter
Standard Deviation 1.688
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Urea/BUN; Week 24; n=35, 33, 12, 11
-0.22 Millimoles per liter
Standard Deviation 1.263
-0.55 Millimoles per liter
Standard Deviation 1.252
-0.43 Millimoles per liter
Standard Deviation 1.106
0.02 Millimoles per liter
Standard Deviation 2.007
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Urea/BUN; Week 30; n=13, 10, 3, 2
0.69 Millimoles per liter
Standard Deviation 1.107
-0.16 Millimoles per liter
Standard Deviation 1.027
-0.5 Millimoles per liter
Standard Deviation 1.082
-0.5 Millimoles per liter
Standard Deviation 0
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Urea/BUN; Week 36; n=10, 7, 2, 2
0.65 Millimoles per liter
Standard Deviation 1.775
0.04 Millimoles per liter
Standard Deviation 1.172
-0.15 Millimoles per liter
Standard Deviation 0.636
-0.25 Millimoles per liter
Standard Deviation 1.061
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Urea/BUN; Week 42; n=9, 6, 1, 2
0.34 Millimoles per liter
Standard Deviation 1.65
0.5 Millimoles per liter
Standard Deviation 1.239
0.5 Millimoles per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-0.5 Millimoles per liter
Standard Deviation 1.414
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Urea/BUN; Week 48; n=6, 6, 0, 2
0.67 Millimoles per liter
Standard Deviation 1.353
0.4 Millimoles per liter
Standard Deviation 1.607
NA Millimoles per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
-0.5 Millimoles per liter
Standard Deviation 0.707
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Urea/BUN; PT Week 4; n=33, 34, 11,11
0.35 Millimoles per liter
Standard Deviation 1.284
-0.19 Millimoles per liter
Standard Deviation 1.311
-0.62 Millimoles per liter
Standard Deviation 1.012
-0.47 Millimoles per liter
Standard Deviation 0.969
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Chloride; Week 48; n=6, 6, 0, 2
1.3 Millimoles per liter
Standard Deviation 2.34
-1 Millimoles per liter
Standard Deviation 3.16
NA Millimoles per liter
Standard Deviation NA
System value of NA indicates not applicable (too few participants).
0 Millimoles per liter
Standard Deviation 0
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Bicarbonate; Week 18; n=38, 34, 13,12
-0.3 Millimoles per liter
Standard Deviation 2.18
-1 Millimoles per liter
Standard Deviation 2.16
-1.2 Millimoles per liter
Standard Deviation 2.27
0 Millimoles per liter
Standard Deviation 2.95
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Bicarbonate; PT Week 4; n=33, 34, 11,11
-0.7 Millimoles per liter
Standard Deviation 2.1
-0.5 Millimoles per liter
Standard Deviation 2.46
-0.9 Millimoles per liter
Standard Deviation 2.43
1 Millimoles per liter
Standard Deviation 3.07
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Potassium; Week 24; n=35, 33, 12, 11
-0.13 Millimoles per liter
Standard Deviation 0.452
-0.12 Millimoles per liter
Standard Deviation 0.459
-0.34 Millimoles per liter
Standard Deviation 0.403
-0.32 Millimoles per liter
Standard Deviation 0.494

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Blood samples were collected for the measurement of estimated creatinine clearance by Cockcroft-Gault formula at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the estimated creatinine clearance values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Outcome measures

Outcome measures
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 Participants
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 Participants
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 Participants
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 Participants
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12
Creatinine clearance; Week 18; n=38, 34, 13, 12
-0.1 mL/min
Standard Deviation 17.36
-1.1 mL/min
Standard Deviation 20.69
-2.5 mL/min
Standard Deviation 16.25
-4.3 mL/min
Standard Deviation 19.37
Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12
Creatinine clearance; Week 24; n=35, 33, 12, 11
-1.9 mL/min
Standard Deviation 16.77
-1 mL/min
Standard Deviation 18.53
-4.1 mL/min
Standard Deviation 15.11
-6.1 mL/min
Standard Deviation 19.05
Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12
Creatinine clearance; Week 30; n=13,10,3,2
-4.8 mL/min
Standard Deviation 13.91
-10.4 mL/min
Standard Deviation 14.41
-3.7 mL/min
Standard Deviation 13.58
7 mL/min
Standard Deviation 0
Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12
Creatinine clearance; Week 36; n=10,7,2,2
-11 mL/min
Standard Deviation 23.3
-8.1 mL/min
Standard Deviation 13.28
-1 mL/min
Standard Deviation 29.7
1.5 mL/min
Standard Deviation 9.19
Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12
Creatinine clearance; Week 42; n=9, 6,1,2
-6.1 mL/min
Standard Deviation 16.86
-13.3 mL/min
Standard Deviation 16.13
9 mL/min
Standard Deviation NA
The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of NA indicates not applicable for the mean and the standard deviation).
-1.5 mL/min
Standard Deviation 0.71
Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12
Creatinine clearance; Week 48; n=6, 6,0,2
3.2 mL/min
Standard Deviation 10.23
-15.8 mL/min
Standard Deviation 16.18
NA mL/min
Standard Deviation NA
The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of NA indicates not applicable for the mean and the standard deviation).
-4 mL/min
Standard Deviation 11.31
Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12
Creatinine clearance; PT Week 4; n=33,34,11,11
-1.5 mL/min
Standard Deviation 34.53
-1.3 mL/min
Standard Deviation 23.85
-2.7 mL/min
Standard Deviation 11.38
-5.3 mL/min
Standard Deviation 13.95

SECONDARY outcome

Timeframe: Week 4 and Week 12

Population: Intensive PK Population

Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (eRVR and no eRVE) was performed. eRVR is defined as plasma HCV RNA \<LLOQ and target not detected at Weeks 4 and 12. AUC (0-tau) is area under the concentration-time curve over the dosing interval. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected pharmacokinetic parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 4 and Week 12

Population: Intensive PK Population

Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus eRVR status (eRVR and no eRVR) was performed. eRVR is defined as plasma HCV RNA \<LLOQ and target not detected at Weeks 4 and 12. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 4

Population: Intensive PK Population

Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (RVR and no eVE) was performed. RVR is defined as plasma HCV RNA \<LLOQ and target not detected 4 weeks after initiation of therapy. AUC (0-tau) is area under the concentration-time curve over the dosing interval. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 4

Population: Intensive PK Population

Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus RVR status (RVR and no RVR) was performed. RVR is defined as plasma HCV RNA \<LLOQ and target not detected 4 weeks after initiation of therapy. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 4 and Week 12

Population: PK/PD Analysis Population

Correlation of individual GSK2336805 dose with pre-dose plasma concentration at Week 4 and Week 12 versus eRVR status was performed. eRVR is defined as plasma HCV RNA \<LLOQ and target not detected at Weeks 4 and 12. The PK/Pharmacodynamic (PD) analysis population comprised of all participants with available PD measures (e.g., safety and/or efficacy data) and with evaluable GSK2336805 plasma concentration data considered suitable for investigation of relationship with the PD measures. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 2

Population: PK/PD Analysis Population

Correlation GSK2336805 pre-dose plasma concentration (ng/mL) on Day 2 versus reduction in HCV RNA (log IU/mL) on Day 2 was performed. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.

Outcome measures

Outcome data not reported

Adverse Events

GSK2336805 40 mg, Genotype 1 HCV

Serious events: 2 serious events
Other events: 41 other events
Deaths: 0 deaths

GSK2336805 60 mg, Genotype 1 HCV

Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths

Telaprevir, Genotype 1 HCV

Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths

GSK2336805 60 mg, Genotype 4 HCV

Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 participants at risk
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 participants at risk
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 participants at risk
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 participants at risk
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Injury, poisoning and procedural complications
Overdose
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Gastrointestinal disorders
Haemorrhoids
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Skin and subcutaneous tissue disorders
Dermatitis allergic
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Infections and infestations
Anal abscess
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Infections and infestations
Clostridium difficile infection
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Infections and infestations
Erysipelas
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Infections and infestations
Injection site abscess
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Infections and infestations
Otitis externa
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).

Other adverse events

Other adverse events
Measure
GSK2336805 40 mg, Genotype 1 HCV
n=41 participants at risk
Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food.
GSK2336805 60 mg, Genotype 1 HCV
n=40 participants at risk
Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Telaprevir, Genotype 1 HCV
n=17 participants at risk
Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
GSK2336805 60 mg, Genotype 4 HCV
n=13 participants at risk
Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food.
Nervous system disorders
Dysgeusia
4.9%
2/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.0%
2/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Nervous system disorders
Headache
36.6%
15/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
35.0%
14/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
29.4%
5/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
30.8%
4/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Nervous system disorders
Hyperaesthesia
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Nervous system disorders
Restless legs syndrome
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Nervous system disorders
Syncope
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Eye disorders
Conjunctivitis
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Eye disorders
Dry eye
4.9%
2/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Eye disorders
Eye pain
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Eye disorders
Eye pruritus
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Eye disorders
Vision blurred
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.5%
3/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Ear and labyrinth disorders
Ear discomfort
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Ear and labyrinth disorders
Ear pain
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Ear and labyrinth disorders
Tinnitus
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Ear and labyrinth disorders
Vertigo
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Gastrointestinal disorders
Abdominal pain
4.9%
2/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.5%
3/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Gastrointestinal disorders
Abdominal pain upper
4.9%
2/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
23.1%
3/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Gastrointestinal disorders
Anal pruritus
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Gastrointestinal disorders
Constipation
7.3%
3/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Gastrointestinal disorders
Diarrhoea
14.6%
6/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.0%
2/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
23.5%
4/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
23.1%
3/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Gastrointestinal disorders
Dry mouth
4.9%
2/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
15.4%
2/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Gastrointestinal disorders
Dyspepsia
4.9%
2/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
23.1%
3/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Gastrointestinal disorders
Gingival bleeding
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Gastrointestinal disorders
Lip swelling
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Gastrointestinal disorders
Nausea
17.1%
7/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
20.0%
8/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
41.2%
7/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
30.8%
4/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Gastrointestinal disorders
Stomatitis
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
15.4%
2/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Gastrointestinal disorders
Toothache
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.0%
2/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Gastrointestinal disorders
Vomiting
7.3%
3/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
10.0%
4/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
23.5%
4/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
15.4%
2/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Hepatobiliary disorders
Hyperbilirubinaemia
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Skin and subcutaneous tissue disorders
Alopecia
4.9%
2/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
10.0%
4/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
17.6%
3/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
15.4%
2/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Skin and subcutaneous tissue disorders
Dermal cyst
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Skin and subcutaneous tissue disorders
Dermatitis
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Skin and subcutaneous tissue disorders
Dermatitis allergic
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Skin and subcutaneous tissue disorders
Dry skin
4.9%
2/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
12.5%
5/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Skin and subcutaneous tissue disorders
Erythema
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
11.8%
2/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Skin and subcutaneous tissue disorders
Pruritus
7.3%
3/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
12.5%
5/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
11.8%
2/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Skin and subcutaneous tissue disorders
Pruritus generalised
14.6%
6/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
10.0%
4/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
41.2%
7/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Skin and subcutaneous tissue disorders
Rash
19.5%
8/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
12.5%
5/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
41.2%
7/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
23.1%
3/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Skin and subcutaneous tissue disorders
Rash generalised
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
10.0%
4/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
11.8%
2/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Skin and subcutaneous tissue disorders
Rash macular
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Skin and subcutaneous tissue disorders
Rash maculo-papular
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Skin and subcutaneous tissue disorders
Rash pruritic
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Musculoskeletal and connective tissue disorders
Arthralgia
4.9%
2/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.5%
3/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
11.8%
2/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Musculoskeletal and connective tissue disorders
Back pain
7.3%
3/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.5%
3/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Musculoskeletal and connective tissue disorders
Costochondritis
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Musculoskeletal and connective tissue disorders
Myalgia
12.2%
5/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
17.5%
7/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
11.8%
2/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
23.1%
3/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Musculoskeletal and connective tissue disorders
Pain in extremity
4.9%
2/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Endocrine disorders
Hyperthyroidism
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Endocrine disorders
Hypothyroidism
4.9%
2/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.0%
2/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Metabolism and nutrition disorders
Decreased appetite
9.8%
4/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.5%
3/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
11.8%
2/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
23.1%
3/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Metabolism and nutrition disorders
Dehydration
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Metabolism and nutrition disorders
Hyperphosphataemia
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Metabolism and nutrition disorders
Hypophosphataemia
4.9%
2/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.0%
2/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Infections and infestations
Asymptomatic bacteriuria
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Infections and infestations
Body tinea
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Infections and infestations
Herpes simplex
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Infections and infestations
Hordeolum
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Infections and infestations
Influenza
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
15.4%
2/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Infections and infestations
Nasopharyngitis
4.9%
2/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Infections and infestations
Oral herpes
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Infections and infestations
Periodontitis
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Infections and infestations
Pharyngitis
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Infections and infestations
Tooth abscess
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Infections and infestations
Upper respiratory tract infection
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Infections and infestations
Urinary tract infection
4.9%
2/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
11.8%
2/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
General disorders
Feeling hot
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Vascular disorders
Hypertension
7.3%
3/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Vascular disorders
Hypotension
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
General disorders
Asthenia
12.2%
5/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
General disorders
Chills
12.2%
5/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
General disorders
Drug withdrawal syndrome
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
General disorders
Injection site erythema
14.6%
6/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.5%
3/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
General disorders
Fatigue
22.0%
9/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
30.0%
12/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
41.2%
7/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
30.8%
4/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
General disorders
Influenza like illness
19.5%
8/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
22.5%
9/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
17.6%
3/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
61.5%
8/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
General disorders
Injection site bruising
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
General disorders
Injection site pain
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
General disorders
Injection site pruritus
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.0%
2/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
General disorders
Injection site reaction
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
General disorders
Injury associated with device
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
General disorders
Irritability
9.8%
4/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
15.4%
2/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
General disorders
Mucosal dryness
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
General disorders
Non-cardiac chest pain
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
General disorders
Pain
9.8%
4/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
11.8%
2/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
General disorders
Pyrexia
26.8%
11/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
20.0%
8/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
29.4%
5/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
15.4%
2/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
General disorders
Temperature intolerance
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Psychiatric disorders
Anxiety
12.2%
5/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.5%
3/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Psychiatric disorders
Depressed mood
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Psychiatric disorders
Depression
9.8%
4/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.5%
3/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Psychiatric disorders
Insomnia
17.1%
7/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
20.0%
8/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
23.1%
3/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Psychiatric disorders
Libido decreased
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Psychiatric disorders
Mood swings
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Psychiatric disorders
Nervousness
7.3%
3/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Psychiatric disorders
Nightmare
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Psychiatric disorders
Panic attack
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Reproductive system and breast disorders
Erectile dysfunction
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Injury, poisoning and procedural complications
Gingival injury
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Injury, poisoning and procedural complications
Laceration
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Injury, poisoning and procedural complications
Post procedural complication
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Injury, poisoning and procedural complications
Procedural pain
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Injury, poisoning and procedural complications
Road traffic accident
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Investigations
Blood thyroid stimulating hormone increased
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Investigations
Body temperature increased
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Investigations
International normalised ratio decreased
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Investigations
Weight decreased
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.0%
2/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Investigations
White blood cell count increased
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Cardiac disorders
Palpitations
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Cardiac disorders
Tachycardia
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Respiratory, thoracic and mediastinal disorders
Cough
12.2%
5/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.5%
3/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
11.8%
2/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
15.4%
2/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Respiratory, thoracic and mediastinal disorders
Dyspnoea
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.5%
3/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.0%
2/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Respiratory, thoracic and mediastinal disorders
Wheezing
4.9%
2/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.0%
2/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Blood and lymphatic system disorders
Anaemia
53.7%
22/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
35.0%
14/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
52.9%
9/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
15.4%
2/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Blood and lymphatic system disorders
Coagulopathy
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Blood and lymphatic system disorders
Eosinopenia
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Blood and lymphatic system disorders
Leukopenia
14.6%
6/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
25.0%
10/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
35.3%
6/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Blood and lymphatic system disorders
Lymphadenopathy
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Blood and lymphatic system disorders
Lymphopenia
12.2%
5/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.0%
2/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Blood and lymphatic system disorders
Monocytopenia
0.00%
0/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
5.9%
1/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Blood and lymphatic system disorders
Neutropenia
29.3%
12/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
30.0%
12/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
11.8%
2/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
23.1%
3/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Blood and lymphatic system disorders
Thrombocytopenia
26.8%
11/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
12.5%
5/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
23.5%
4/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Nervous system disorders
Disturbance in attention
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
2.5%
1/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
0.00%
0/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Nervous system disorders
Dizziness
2.4%
1/41 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
12.5%
5/40 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
11.8%
2/17 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
7.7%
1/13 • SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

  • Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
  • Publication restrictions are in place

Restriction type: OTHER