Trial Outcomes & Findings for An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants (NCT NCT00528528)
NCT ID: NCT00528528
Last Updated: 2014-06-25
Results Overview
Virologic response was either defined as having undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) (i.e., no HCV RNA was detected in the participants' plasma samples) or less than 25 international units/milliliter (IU/mL) HCV RNA (i.e., the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
166 participants
Primary outcome timeframe
End of treatment (EOT) (up to Week 48)
Results posted on
2014-06-25
Participant Flow
Out of 166 participants who were randomly assigned to treatment, only 161 participants received the study treatment.
Participant milestones
| Measure |
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet
Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
42
|
40
|
39
|
|
Overall Study
Ongoing at Time of Cut-off
|
0
|
0
|
1
|
0
|
|
Overall Study
COMPLETED
|
37
|
39
|
37
|
36
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
3
|
Reasons for withdrawal
| Measure |
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet
Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
|
Overall Study
Ineligible to continue the trial
|
0
|
0
|
0
|
1
|
|
Overall Study
Other
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
1
|
1
|
|
Overall Study
Ongoing participant
|
0
|
0
|
1
|
0
|
Baseline Characteristics
An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants
Baseline characteristics by cohort
| Measure |
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet
n=40 Participants
Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule
n=42 Participants
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet
n=40 Participants
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
n=39 Participants
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
160 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Continuous
|
46.5 Years
n=5 Participants
|
45.5 Years
n=7 Participants
|
40 Years
n=5 Participants
|
49 Years
n=4 Participants
|
46 Years
n=21 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Region of Enrollment
Austria
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Region of Enrollment
France
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Region of Enrollment
Netherland
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: End of treatment (EOT) (up to Week 48)Population: Full analysis set (FAS) population included all randomly assigned participants who received at least 1 dose of the study medication.
Virologic response was either defined as having undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) (i.e., no HCV RNA was detected in the participants' plasma samples) or less than 25 international units/milliliter (IU/mL) HCV RNA (i.e., the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).
Outcome measures
| Measure |
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet
n=40 Participants
Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule
n=42 Participants
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet
n=40 Participants
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
n=39 Participants
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Virologic Response at Week 12
|
92.5 Percentage of participants
|
88.1 Percentage of participants
|
92.5 Percentage of participants
|
87.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to EOT (up to Week 48)Population: FAS population included all randomly assigned participants who received at least 1 dose of the study medication.
Virologic response was either defined as having undetectable HCV RNA (i.e., no HCV RNA was detected in the participants' plasma samples) or less than 25 IU/mL HCV RNA (i.e., the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).
Outcome measures
| Measure |
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet
n=40 Participants
Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule
n=42 Participants
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet
n=40 Participants
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
n=39 Participants
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
|---|---|---|---|---|
|
Time to First Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level
|
22 Days
Interval 8.0 to 99.0
|
22.5 Days
Interval 8.0 to 99.0
|
22 Days
Interval 2.0 to 99.0
|
29 Days
Interval 2.0 to 169.0
|
SECONDARY outcome
Timeframe: EOT (up to Week 48)Population: FAS population included all randomly assigned participants who received at least 1 dose of the study medication.
Viral breakthrough was defined as a confirmed increase of more than 1 log 10 in HCV RNA level from the lowest level reached or a confirmed value of HCV RNA more than 100 IU/mL in participants whose HCV RNA was previously less than 25 IU/mL.
Outcome measures
| Measure |
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet
n=40 Participants
Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule
n=42 Participants
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet
n=40 Participants
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
n=39 Participants
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Viral Breakthrough at End of Treatment (EOT)
|
1 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to EOT (up to Week 48)Population: FAS population included all randomly assigned participants who received at least 1 dose of the study medication.
Partial response was defined as having at least 2 log drop in HCV RNA from Baseline, but not having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants' plasma samples).
Outcome measures
| Measure |
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet
n=40 Participants
Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule
n=42 Participants
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet
n=40 Participants
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
n=39 Participants
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Partial Response
|
5 Percentage of participants
|
0 Percentage of participants
|
2.5 Percentage of participants
|
5.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (pre-dose), Week 12Population: FAS population included all randomly assigned participants who received at least 1 dose of the study medication.
Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology. HCV RNA samples were taken pre-dose of Peg-IFN administration.
Outcome measures
| Measure |
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet
n=40 Participants
Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule
n=42 Participants
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet
n=40 Participants
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
n=39 Participants
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at Week 12
Change from Baseline at Week 12
|
-5.2 log 10 IU/mL
Standard Error 0.24
|
-5.4 log 10 IU/mL
Standard Error 0.23
|
-4.8 log 10 IU/mL
Standard Error 0.36
|
-5.1 log 10 IU/mL
Standard Error 0.29
|
|
Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at Week 12
Baseline
|
6.4 log 10 IU/mL
Standard Error 0.09
|
6.5 log 10 IU/mL
Standard Error 0.10
|
6.4 log 10 IU/mL
Standard Error 0.09
|
6.5 log 10 IU/mL
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline (pre-dose), EOT (up to Week 48)Population: FAS population included all randomly assigned participants who received at least 1 dose of the study medication.
Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology.
Outcome measures
| Measure |
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet
n=40 Participants
Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule
n=42 Participants
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet
n=40 Participants
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
n=39 Participants
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at End of Treatment (EOT)
|
-5.5 log 10 IU/mL
Standard Error 0.14
|
-5.2 log 10 IU/mL
Standard Error 0.25
|
-5.4 log 10 IU/mL
Standard Error 0.22
|
-5.3 log 10 IU/mL
Standard Error 0.23
|
SECONDARY outcome
Timeframe: EOT (up to Week 48) and up to 24 weeks after EOTPopulation: FAS population included all randomly assigned participants who received at least 1 dose of the study medication.
SVR24 was defined as having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants' plasma samples) at EOT and no confirmed detectable HCV RNA levels between EOT and 24 weeks after the last dose of study medication.
Outcome measures
| Measure |
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet
n=40 Participants
Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule
n=42 Participants
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet
n=40 Participants
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
n=39 Participants
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Viral Response 24 Weeks After End of Treatment (SVR24)
|
85.0 Percentage of participants
|
81.0 Percentage of participants
|
82.5 Percentage of participants
|
82.1 Percentage of participants
|
Adverse Events
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet
Serious events: 5 serious events
Other events: 40 other events
Deaths: 0 deaths
Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet
Serious events: 4 serious events
Other events: 39 other events
Deaths: 0 deaths
Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet
n=40 participants at risk
Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule
n=42 participants at risk
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet
n=40 participants at risk
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
n=39 participants at risk
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
4/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
7.5%
3/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
General disorders
Hyperthermia
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Nervous system disorders
Headache
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
2.4%
1/42 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
2.6%
1/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/39 • Baseline up to end of telaprevir treatment (Week 12)
|
Other adverse events
| Measure |
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet
n=40 participants at risk
Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule
n=42 participants at risk
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet
n=40 participants at risk
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
|
Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
n=39 participants at risk
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
62.5%
25/40 • Baseline up to end of telaprevir treatment (Week 12)
|
35.7%
15/42 • Baseline up to end of telaprevir treatment (Week 12)
|
37.5%
15/40 • Baseline up to end of telaprevir treatment (Week 12)
|
35.9%
14/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
40.0%
16/40 • Baseline up to end of telaprevir treatment (Week 12)
|
52.4%
22/42 • Baseline up to end of telaprevir treatment (Week 12)
|
47.5%
19/40 • Baseline up to end of telaprevir treatment (Week 12)
|
56.4%
22/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.5%
3/40 • Baseline up to end of telaprevir treatment (Week 12)
|
21.4%
9/42 • Baseline up to end of telaprevir treatment (Week 12)
|
15.0%
6/40 • Baseline up to end of telaprevir treatment (Week 12)
|
15.4%
6/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.5%
3/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.1%
3/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
2.6%
1/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.1%
3/42 • Baseline up to end of telaprevir treatment (Week 12)
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
23.1%
9/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
4.8%
2/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
5.1%
2/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
5.1%
2/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Gastrointestinal disorders
Nausea
|
45.0%
18/40 • Baseline up to end of telaprevir treatment (Week 12)
|
33.3%
14/42 • Baseline up to end of telaprevir treatment (Week 12)
|
40.0%
16/40 • Baseline up to end of telaprevir treatment (Week 12)
|
59.0%
23/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
10/40 • Baseline up to end of telaprevir treatment (Week 12)
|
21.4%
9/42 • Baseline up to end of telaprevir treatment (Week 12)
|
30.0%
12/40 • Baseline up to end of telaprevir treatment (Week 12)
|
33.3%
13/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Gastrointestinal disorders
Vomiting
|
17.5%
7/40 • Baseline up to end of telaprevir treatment (Week 12)
|
11.9%
5/42 • Baseline up to end of telaprevir treatment (Week 12)
|
17.5%
7/40 • Baseline up to end of telaprevir treatment (Week 12)
|
30.8%
12/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
5/40 • Baseline up to end of telaprevir treatment (Week 12)
|
11.9%
5/42 • Baseline up to end of telaprevir treatment (Week 12)
|
7.5%
3/40 • Baseline up to end of telaprevir treatment (Week 12)
|
12.8%
5/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
5/40 • Baseline up to end of telaprevir treatment (Week 12)
|
11.9%
5/42 • Baseline up to end of telaprevir treatment (Week 12)
|
15.0%
6/40 • Baseline up to end of telaprevir treatment (Week 12)
|
23.1%
9/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
5/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.1%
3/42 • Baseline up to end of telaprevir treatment (Week 12)
|
7.5%
3/40 • Baseline up to end of telaprevir treatment (Week 12)
|
20.5%
8/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Gastrointestinal disorders
Haemorrhoids
|
10.0%
4/40 • Baseline up to end of telaprevir treatment (Week 12)
|
11.9%
5/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.7%
3/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Gastrointestinal disorders
Anal discomfort
|
7.5%
3/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.1%
3/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.7%
3/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Gastrointestinal disorders
Pruritus ani
|
7.5%
3/40 • Baseline up to end of telaprevir treatment (Week 12)
|
19.0%
8/42 • Baseline up to end of telaprevir treatment (Week 12)
|
7.5%
3/40 • Baseline up to end of telaprevir treatment (Week 12)
|
10.3%
4/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Gastrointestinal disorders
Constipation
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
2.4%
1/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.7%
3/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
9.5%
4/42 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.7%
3/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
2.4%
1/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
5.1%
2/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
General disorders
Fatigue
|
37.5%
15/40 • Baseline up to end of telaprevir treatment (Week 12)
|
35.7%
15/42 • Baseline up to end of telaprevir treatment (Week 12)
|
40.0%
16/40 • Baseline up to end of telaprevir treatment (Week 12)
|
38.5%
15/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
General disorders
Influenza like illness
|
37.5%
15/40 • Baseline up to end of telaprevir treatment (Week 12)
|
45.2%
19/42 • Baseline up to end of telaprevir treatment (Week 12)
|
27.5%
11/40 • Baseline up to end of telaprevir treatment (Week 12)
|
51.3%
20/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
General disorders
Asthenia
|
30.0%
12/40 • Baseline up to end of telaprevir treatment (Week 12)
|
38.1%
16/42 • Baseline up to end of telaprevir treatment (Week 12)
|
20.0%
8/40 • Baseline up to end of telaprevir treatment (Week 12)
|
35.9%
14/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
General disorders
Pyrexia
|
20.0%
8/40 • Baseline up to end of telaprevir treatment (Week 12)
|
33.3%
14/42 • Baseline up to end of telaprevir treatment (Week 12)
|
20.0%
8/40 • Baseline up to end of telaprevir treatment (Week 12)
|
28.2%
11/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
General disorders
Chills
|
7.5%
3/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.1%
3/42 • Baseline up to end of telaprevir treatment (Week 12)
|
12.5%
5/40 • Baseline up to end of telaprevir treatment (Week 12)
|
10.3%
4/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
General disorders
Injection site erythema
|
7.5%
3/40 • Baseline up to end of telaprevir treatment (Week 12)
|
14.3%
6/42 • Baseline up to end of telaprevir treatment (Week 12)
|
17.5%
7/40 • Baseline up to end of telaprevir treatment (Week 12)
|
17.9%
7/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
General disorders
Feeling cold
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
2.6%
1/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
General disorders
Injection site reaction
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
4.8%
2/42 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
5.1%
2/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
General disorders
Irritability
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.1%
3/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
2.6%
1/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
General disorders
Chest discomfort
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Blood and lymphatic system disorders
Anaemia
|
42.5%
17/40 • Baseline up to end of telaprevir treatment (Week 12)
|
33.3%
14/42 • Baseline up to end of telaprevir treatment (Week 12)
|
35.0%
14/40 • Baseline up to end of telaprevir treatment (Week 12)
|
51.3%
20/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Blood and lymphatic system disorders
Leukopenia
|
15.0%
6/40 • Baseline up to end of telaprevir treatment (Week 12)
|
19.0%
8/42 • Baseline up to end of telaprevir treatment (Week 12)
|
20.0%
8/40 • Baseline up to end of telaprevir treatment (Week 12)
|
23.1%
9/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.5%
3/40 • Baseline up to end of telaprevir treatment (Week 12)
|
14.3%
6/42 • Baseline up to end of telaprevir treatment (Week 12)
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.7%
3/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
4.8%
2/42 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
2.6%
1/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
2.4%
1/42 • Baseline up to end of telaprevir treatment (Week 12)
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
2.6%
1/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Nervous system disorders
Headache
|
32.5%
13/40 • Baseline up to end of telaprevir treatment (Week 12)
|
42.9%
18/42 • Baseline up to end of telaprevir treatment (Week 12)
|
35.0%
14/40 • Baseline up to end of telaprevir treatment (Week 12)
|
41.0%
16/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Nervous system disorders
Dizziness
|
10.0%
4/40 • Baseline up to end of telaprevir treatment (Week 12)
|
4.8%
2/42 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
15.4%
6/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Nervous system disorders
Disturbance in attention
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
4.8%
2/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
15.4%
6/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Nervous system disorders
Paraesthesia
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
2.4%
1/42 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
5.1%
2/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Nervous system disorders
Dysgeusia
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
4.8%
2/42 • Baseline up to end of telaprevir treatment (Week 12)
|
15.0%
6/40 • Baseline up to end of telaprevir treatment (Week 12)
|
5.1%
2/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Nervous system disorders
Tremor
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
5.1%
2/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Psychiatric disorders
Insomnia
|
20.0%
8/40 • Baseline up to end of telaprevir treatment (Week 12)
|
23.8%
10/42 • Baseline up to end of telaprevir treatment (Week 12)
|
17.5%
7/40 • Baseline up to end of telaprevir treatment (Week 12)
|
23.1%
9/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Psychiatric disorders
Depression
|
15.0%
6/40 • Baseline up to end of telaprevir treatment (Week 12)
|
14.3%
6/42 • Baseline up to end of telaprevir treatment (Week 12)
|
10.0%
4/40 • Baseline up to end of telaprevir treatment (Week 12)
|
15.4%
6/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Psychiatric disorders
Sleep disorder
|
10.0%
4/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.1%
3/42 • Baseline up to end of telaprevir treatment (Week 12)
|
10.0%
4/40 • Baseline up to end of telaprevir treatment (Week 12)
|
17.9%
7/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Psychiatric disorders
Nervousness
|
7.5%
3/40 • Baseline up to end of telaprevir treatment (Week 12)
|
2.4%
1/42 • Baseline up to end of telaprevir treatment (Week 12)
|
7.5%
3/40 • Baseline up to end of telaprevir treatment (Week 12)
|
10.3%
4/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Psychiatric disorders
Anxiety
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.1%
3/42 • Baseline up to end of telaprevir treatment (Week 12)
|
7.5%
3/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.7%
3/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Psychiatric disorders
Depressed mood
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
4.8%
2/42 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
2.6%
1/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Psychiatric disorders
Libido decreased
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
2.4%
1/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.7%
3/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
8/40 • Baseline up to end of telaprevir treatment (Week 12)
|
16.7%
7/42 • Baseline up to end of telaprevir treatment (Week 12)
|
22.5%
9/40 • Baseline up to end of telaprevir treatment (Week 12)
|
12.8%
5/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.0%
6/40 • Baseline up to end of telaprevir treatment (Week 12)
|
14.3%
6/42 • Baseline up to end of telaprevir treatment (Week 12)
|
22.5%
9/40 • Baseline up to end of telaprevir treatment (Week 12)
|
17.9%
7/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.5%
3/40 • Baseline up to end of telaprevir treatment (Week 12)
|
16.7%
7/42 • Baseline up to end of telaprevir treatment (Week 12)
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
5.1%
2/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.5%
3/40 • Baseline up to end of telaprevir treatment (Week 12)
|
4.8%
2/42 • Baseline up to end of telaprevir treatment (Week 12)
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
5.1%
2/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.7%
3/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
4.8%
2/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
5.1%
2/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Investigations
Weight decreased
|
10.0%
4/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.1%
3/42 • Baseline up to end of telaprevir treatment (Week 12)
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
5.1%
2/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Investigations
Blood uric acid increased
|
7.5%
3/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.1%
3/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
20.5%
8/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Investigations
Blood phosphorus decreased
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
2.4%
1/42 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Investigations
Haemoglobin decreased
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.7%
3/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Investigations
Platelet count decreased
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
5.1%
2/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.7%
3/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
8/40 • Baseline up to end of telaprevir treatment (Week 12)
|
9.5%
4/42 • Baseline up to end of telaprevir treatment (Week 12)
|
15.0%
6/40 • Baseline up to end of telaprevir treatment (Week 12)
|
38.5%
15/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Metabolism and nutrition disorders
Anorexia
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
4.8%
2/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
10.3%
4/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
4.8%
2/42 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.7%
3/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
4/40 • Baseline up to end of telaprevir treatment (Week 12)
|
11.9%
5/42 • Baseline up to end of telaprevir treatment (Week 12)
|
22.5%
9/40 • Baseline up to end of telaprevir treatment (Week 12)
|
12.8%
5/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.1%
3/42 • Baseline up to end of telaprevir treatment (Week 12)
|
12.5%
5/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.7%
3/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
4.8%
2/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.7%
3/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Infections and infestations
Nasopharyngitis
|
7.5%
3/40 • Baseline up to end of telaprevir treatment (Week 12)
|
2.4%
1/42 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
2.6%
1/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Infections and infestations
Urinary tract infection
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.1%
3/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Eye disorders
Dry eye
|
7.5%
3/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
5.1%
2/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Eye disorders
Vision blurred
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
2.4%
1/42 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.7%
3/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Cardiac disorders
Tachycardia
|
5.0%
2/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.1%
3/42 • Baseline up to end of telaprevir treatment (Week 12)
|
7.5%
3/40 • Baseline up to end of telaprevir treatment (Week 12)
|
5.1%
2/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Cardiac disorders
Palpitations
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
4.8%
2/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
7.7%
3/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Ear and labyrinth disorders
Vertigo
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
4.8%
2/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
10.3%
4/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
2.5%
1/40 • Baseline up to end of telaprevir treatment (Week 12)
|
5.1%
2/39 • Baseline up to end of telaprevir treatment (Week 12)
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/42 • Baseline up to end of telaprevir treatment (Week 12)
|
0.00%
0/40 • Baseline up to end of telaprevir treatment (Week 12)
|
5.1%
2/39 • Baseline up to end of telaprevir treatment (Week 12)
|
Additional Information
Clinical Leader
Janssen Research & Development, LLC Titusville, NJ
Phone: 609-730-3174
Results disclosure agreements
- Principal investigator is a sponsor employee As per revised Protocol dated 21 Dec 2007, Investigator may not submit for publication or presentation, the results of trial without prior written consent of Sponsor. The Investigator agrees to allow at least 45 days for Sponsor to review prepublication manuscript prior to submission to Publisher. In accordance with generally recognized principles of scientific collaboration, co-authorship with any company personnel will be discussed and mutually agreed upon before submission to Publisher.
- Publication restrictions are in place
Restriction type: OTHER