Trial Outcomes & Findings for Vaniprevir Administered With Pegylated-interferon and Ribavirin in Japanese Treatment-Naïve Chronic Hepatitis C Participants (MK-7009-043) (NCT NCT01370642)

NCT ID: NCT01370642

Last Updated: 2018-10-18

Results Overview

SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 294 participants
• Primary outcome timeframe: 24 weeks after 24 or 48 weeks of study therapy (up to 72 weeks)
• Results posted on: 2018-10-18

Participant Flow

Japanese patients 20-70 years old (inclusive) who had chronic, compensated, genotype 1 Hepatitis C (HCV) infection, and HCV ribonucleic acid (RNA) levels ≥ 5.0 log IU/mL peripheral blood at screening were recruited from 55 sites in Japan.

Of 294 randomized participants, 293 received at least 1 dose of study treatment and comprised the All Participants As Treated Population (APaT) as well as the Full Analysis Set (FAS). One treated participant was excluded from the FAS and APaT due to a protocol violation.

Participant milestones

Measure	Vaniprevir 12 Week Arm Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.	Vaniprevir 24 Week Arm Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.	Control Arm Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
Overall Study STARTED	98	98	98
Overall Study FAS Population	98	97	98
Overall Study COMPLETED	90	92	69
Overall Study NOT COMPLETED	8	6	29

Reasons for withdrawal

Measure	Vaniprevir 12 Week Arm Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.	Vaniprevir 24 Week Arm Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.	Control Arm Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
Overall Study Adverse Event	2	1	1
Overall Study Detectable HCV RNA	0	0	22
Overall Study Lost to Follow-up	0	0	1
Overall Study Physician Decision	4	1	2
Overall Study Withdrawal by Subject	2	4	3

Baseline Characteristics

Vaniprevir Administered With Pegylated-interferon and Ribavirin in Japanese Treatment-Naïve Chronic Hepatitis C Participants (MK-7009-043)

Baseline characteristics by cohort

Measure	Vaniprevir 12 Week Arm n=98 Participants Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.	Vaniprevir 24 Week Arm n=98 Participants Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.	Control Arm n=98 Participants Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.	Total n=294 Participants Total of all reporting groups
Age, Continuous	53.2 years STANDARD_DEVIATION 12.0 • n=5 Participants	55.5 years STANDARD_DEVIATION 9.7 • n=7 Participants	54.8 years STANDARD_DEVIATION 9.9 • n=5 Participants	54.5 years STANDARD_DEVIATION 10.6 • n=4 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	49 Participants n=7 Participants	52 Participants n=5 Participants	157 Participants n=4 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	49 Participants n=7 Participants	46 Participants n=5 Participants	137 Participants n=4 Participants

PRIMARY outcome

Timeframe: 24 weeks after 24 or 48 weeks of study therapy (up to 72 weeks)

Population: Full Analysis Set (FAS) population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.

SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy.

Outcome measures

Measure	Vaniprevir 12 Week Arm n=98 Participants Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.	Vaniprevir 24 Week Arm n=97 Participants Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.	Control Arm n=98 Participants Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)	83.7 percentage of participants	84.5 percentage of participants	55.1 percentage of participants

PRIMARY outcome

Timeframe: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)

Population: All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment. One treated participant was excluded from the APaT due to a protocol violation.

An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an adverse experience. For this study, safety parameters or AEs of special interest that were identified a priori constituted "Tier 1" safety endpoints that were subject to inferential testing for statistical significance. Tier 1 AEs on this study included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal adverse (GI) experiences (vomiting, nausea, and diarrhea).

Outcome measures

Measure	Vaniprevir 12 Week Arm n=98 Participants Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.	Vaniprevir 24 Week Arm n=97 Participants Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.	Control Arm n=98 Participants Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
Percentage of Participants With One or More Tier 1 Adverse Events (AEs) During the Study With ≥1 Tier 1 AEs	89.8 percentage of participants	83.5 percentage of participants	85.7 percentage of participants
Percentage of Participants With One or More Tier 1 Adverse Events (AEs) During the Study anaemia	60.2 percentage of participants	51.5 percentage of participants	64.3 percentage of participants
Percentage of Participants With One or More Tier 1 Adverse Events (AEs) During the Study bilirubin increased	7.1 percentage of participants	12.4 percentage of participants	701 percentage of participants
Percentage of Participants With One or More Tier 1 Adverse Events (AEs) During the Study GI AEs	62.2 percentage of participants	52.6 percentage of participants	46.9 percentage of participants
Percentage of Participants With One or More Tier 1 Adverse Events (AEs) During the Study neutropenia	59.2 percentage of participants	51.5 percentage of participants	51.0 percentage of participants

PRIMARY outcome

Timeframe: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)

Population: All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment. One treated participant was excluded from the APaT due to a protocol violation.

An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an adverse experience.

Outcome measures

Measure	Vaniprevir 12 Week Arm n=98 Participants Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.	Vaniprevir 24 Week Arm n=97 Participants Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.	Control Arm n=98 Participants Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
Percentage of Participants Who Discontinued Study Drug Due to an AE	7.1 percentage of participants	3.1 percentage of participants	11.2 percentage of participants

SECONDARY outcome

Timeframe: 12 weeks after 24 or 48 weeks of study therapy (up to 60 weeks)

Population: FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.

SVR12 was defined as having an undetectable HCV RNA level 12 weeks after completion of all study therapy.

Outcome measures

Measure	Vaniprevir 12 Week Arm n=98 Participants Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.	Vaniprevir 24 Week Arm n=97 Participants Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.	Control Arm n=98 Participants Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
Percentage of Participants Achieving SVR12	83.7 percentage of participants	84.5 percentage of participants	54.1 percentage of participants

SECONDARY outcome

Timeframe: At Week 4

Population: FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.

RVR was defined as having an undetectable HCV RNA level at Week 4.

Outcome measures

Measure	Vaniprevir 12 Week Arm n=98 Participants Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.	Vaniprevir 24 Week Arm n=97 Participants Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.	Control Arm n=98 Participants Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
Percentage of Participants Achieving Rapid Virologic Response (RVR)	86.7 percentage of participants	85.6 percentage of participants	9.2 percentage of participants

SECONDARY outcome

Timeframe: At Week 12

Population: FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.

cEVR was defined as having an undetectable HCV RNA level at Week 12.

Outcome measures

Measure	Vaniprevir 12 Week Arm n=98 Participants Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.	Vaniprevir 24 Week Arm n=97 Participants Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.	Control Arm n=98 Participants Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
Percentage of Participants Achieving Complete Early Virologic Response (cEVR)	94.9 percentage of participants	96.9 percentage of participants	46.9 percentage of participants

SECONDARY outcome

Timeframe: At Week 24 or 48

Population: FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.

Participants were assessed for undetectable HCV RNA levels at the end of all study therapy.

Outcome measures

Measure	Vaniprevir 12 Week Arm n=98 Participants Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.	Vaniprevir 24 Week Arm n=97 Participants Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.	Control Arm n=98 Participants Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)	95.9 percentage of participants	97.9 percentage of participants	79.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 24

Population: FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.

HCV RNA levels were assessed at baseline (BL) and during treatment weeks 2, 4, 8, 12, and 24 using the Roche TaqMan HCV assay, and transformed to Log 10 values. HCV RNA values below the limit of reliable quantification (LoQ) or the limit of detection (LoD) at any time point were handled as follows (imputations done for computational purposes): values below the LoQ but above the LoD were imputed with the LoQ minus 0.1; values below the LoD were imputed with the value of 0 Log IU/mL. HCV RNA levels below the LoD were considered "undetectable".

Outcome measures

Measure	Vaniprevir 12 Week Arm n=98 Participants Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.	Vaniprevir 24 Week Arm n=97 Participants Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.	Control Arm n=98 Participants Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
Least Squares (LS) Mean Change From Baseline in HCV RNA (Log 10) Change From BL at Week 2	-5.3 Log IU/ml Interval -5.5 to -5.1	-5.5 Log IU/ml Interval -5.7 to -5.3	-2.0 Log IU/ml Interval -2.2 to -1.8
Least Squares (LS) Mean Change From Baseline in HCV RNA (Log 10) Change From BL at Week 4	-6.0 Log IU/ml Interval -6.3 to -5.8	-6.1 Log IU/ml Interval -6.3 to -5.9	-3.0 Log IU/ml Interval -3.3 to -2.8
Least Squares (LS) Mean Change From Baseline in HCV RNA (Log 10) Change From BL at Week 8	-6.1 Log IU/ml Interval -6.4 to -5.9	-6.2 Log IU/ml Interval -6.4 to -5.9	-4.2 Log IU/ml Interval -4.5 to -4.0
Least Squares (LS) Mean Change From Baseline in HCV RNA (Log 10) Change From BL at Week 12	-6.1 Log IU/ml Interval -6.4 to -5.9	-6.2 Log IU/ml Interval -6.4 to -5.9	-4.8 Log IU/ml Interval -5.0 to -4.5
Least Squares (LS) Mean Change From Baseline in HCV RNA (Log 10) Change From BL at Week 24	-6.0 Log IU/ml Interval -6.3 to -5.8	-6.1 Log IU/ml Interval -6.4 to -5.9	-5.3 Log IU/ml Interval -5.5 to -5.0

Adverse Events

Vaniprevir 12 Week Arm

Serious events: 5 serious events

Other events: 98 other events

Deaths: 0 deaths

Vaniprevir 24 Week Arm

Serious events: 6 serious events

Other events: 97 other events

Deaths: 0 deaths

Control Arm

Serious events: 9 serious events

Other events: 98 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vaniprevir 12 Week Arm n=98 participants at risk Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.	Vaniprevir 24 Week Arm n=97 participants at risk Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.	Control Arm n=98 participants at risk Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
Infections and infestations Cellulitis	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/97 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/98 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Injury, poisoning and procedural complications Heat stroke	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/97 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Injury, poisoning and procedural complications Ligament injury	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/97 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	1.0% 1/98 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/97 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/97 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/98 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/97 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/97 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/98 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Investigations Glycosylated haemoglobin increased	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/97 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/98 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Metabolism and nutrition disorders Decreased appetite	1.0% 1/98 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/97 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Metabolism and nutrition disorders Dehydration	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/97 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Metabolism and nutrition disorders Diabetes mellitus	1.0% 1/98 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/97 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/97 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Cardiac disorders Atrial fibrillation	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/97 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Cardiac disorders Pericarditis	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/97 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/98 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/97 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Ear and labyrinth disorders Endolymphatic hydrops	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/97 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/98 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/97 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/98 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Endocrine disorders Inappropriate antidiuretic hormone secretion	1.0% 1/98 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/97 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Gastrointestinal disorders Ileus	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/97 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/98 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Gastrointestinal disorders Vomiting	1.0% 1/98 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/97 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
General disorders Fatigue	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/97 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/98 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/97 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/97 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/97 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/98 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.

Other adverse events

Measure	Vaniprevir 12 Week Arm n=98 participants at risk Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.	Vaniprevir 24 Week Arm n=97 participants at risk Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.	Control Arm n=98 participants at risk Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
Injury, poisoning and procedural complications Accidental overdose	2.0% 2/98 • Number of events 2 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	3.1% 3/97 • Number of events 3 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	6.1% 6/98 • Number of events 9 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Investigations Alanine aminotransferase increased	2.0% 2/98 • Number of events 2 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	7.2% 7/97 • Number of events 7 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	7.1% 7/98 • Number of events 8 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Investigations Aspartate aminotransferase increased	2.0% 2/98 • Number of events 2 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	6.2% 6/97 • Number of events 6 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	7.1% 7/98 • Number of events 8 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Investigations Bilirubin conjugated increased	2.0% 2/98 • Number of events 2 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	5.2% 5/97 • Number of events 5 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	2.0% 2/98 • Number of events 2 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Blood and lymphatic system disorders Anaemia	25.5% 25/98 • Number of events 26 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	19.6% 19/97 • Number of events 19 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	22.4% 22/98 • Number of events 24 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Blood and lymphatic system disorders Neutropenia	8.2% 8/98 • Number of events 10 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	4.1% 4/97 • Number of events 4 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	7.1% 7/98 • Number of events 8 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Ear and labyrinth disorders Vertigo	3.1% 3/98 • Number of events 4 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	3.1% 3/97 • Number of events 3 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	5.1% 5/98 • Number of events 7 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Eye disorders Dry eye	7.1% 7/98 • Number of events 7 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	7.2% 7/97 • Number of events 7 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	2.0% 2/98 • Number of events 2 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Eye disorders Retinal haemorrhage	1.0% 1/98 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/97 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	6.1% 6/98 • Number of events 6 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Eye disorders Retinopathy	3.1% 3/98 • Number of events 3 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	7.2% 7/97 • Number of events 7 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	12.2% 12/98 • Number of events 12 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Gastrointestinal disorders Abdominal discomfort	16.3% 16/98 • Number of events 19 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	18.6% 18/97 • Number of events 20 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	10.2% 10/98 • Number of events 13 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Gastrointestinal disorders Abdominal pain upper	12.2% 12/98 • Number of events 14 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	10.3% 10/97 • Number of events 10 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	8.2% 8/98 • Number of events 10 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Gastrointestinal disorders Cheilitis	6.1% 6/98 • Number of events 6 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	7.2% 7/97 • Number of events 7 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	4.1% 4/98 • Number of events 4 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Gastrointestinal disorders Constipation	11.2% 11/98 • Number of events 12 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	12.4% 12/97 • Number of events 13 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	11.2% 11/98 • Number of events 12 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Gastrointestinal disorders Dental caries	2.0% 2/98 • Number of events 2 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	5.2% 5/97 • Number of events 6 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	0.00% 0/98 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Gastrointestinal disorders Diarrhoea	30.6% 30/98 • Number of events 32 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	21.6% 21/97 • Number of events 25 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	22.4% 22/98 • Number of events 31 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Gastrointestinal disorders Dyspepsia	13.3% 13/98 • Number of events 14 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	7.2% 7/97 • Number of events 7 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	6.1% 6/98 • Number of events 6 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Gastrointestinal disorders Gastritis	1.0% 1/98 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	6.2% 6/97 • Number of events 6 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	4.1% 4/98 • Number of events 4 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Gastrointestinal disorders Nausea	36.7% 36/98 • Number of events 39 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	33.0% 32/97 • Number of events 38 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	27.6% 27/98 • Number of events 29 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Gastrointestinal disorders Stomatitis	12.2% 12/98 • Number of events 13 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	29.9% 29/97 • Number of events 32 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	22.4% 22/98 • Number of events 25 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Gastrointestinal disorders Vomiting	24.5% 24/98 • Number of events 29 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	30.9% 30/97 • Number of events 40 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	9.2% 9/98 • Number of events 10 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
General disorders Chills	1.0% 1/98 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	6.2% 6/97 • Number of events 6 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/98 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
General disorders Fatigue	28.6% 28/98 • Number of events 31 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	29.9% 29/97 • Number of events 29 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	19.4% 19/98 • Number of events 21 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
General disorders Influenza like illness	6.1% 6/98 • Number of events 8 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	10.3% 10/97 • Number of events 10 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	12.2% 12/98 • Number of events 13 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
General disorders Injection site erythema	11.2% 11/98 • Number of events 12 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	14.4% 14/97 • Number of events 14 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	16.3% 16/98 • Number of events 17 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
General disorders Injection site pruritus	4.1% 4/98 • Number of events 4 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	8.2% 8/97 • Number of events 8 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	9.2% 9/98 • Number of events 10 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
General disorders Injection site reaction	24.5% 24/98 • Number of events 24 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	26.8% 26/97 • Number of events 26 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	28.6% 28/98 • Number of events 28 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
General disorders Malaise	31.6% 31/98 • Number of events 33 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	33.0% 32/97 • Number of events 33 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	37.8% 37/98 • Number of events 41 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
General disorders Pyrexia	80.6% 79/98 • Number of events 91 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	71.1% 69/97 • Number of events 108 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	81.6% 80/98 • Number of events 135 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Hepatobiliary disorders Hepatic function abnormal	6.1% 6/98 • Number of events 6 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	3.1% 3/97 • Number of events 3 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	4.1% 4/98 • Number of events 4 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Infections and infestations Cystitis	6.1% 6/98 • Number of events 6 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	3.1% 3/97 • Number of events 4 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	3.1% 3/98 • Number of events 3 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Infections and infestations Nasopharyngitis	21.4% 21/98 • Number of events 27 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	29.9% 29/97 • Number of events 33 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	31.6% 31/98 • Number of events 42 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Investigations Blood albumin decreased	2.0% 2/98 • Number of events 2 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	5.2% 5/97 • Number of events 5 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	1.0% 1/98 • Number of events 1 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Investigations Blood alkaline phosphatase increased	4.1% 4/98 • Number of events 4 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	6.2% 6/97 • Number of events 6 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	8.2% 8/98 • Number of events 8 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Investigations Blood bilirubin increased	7.1% 7/98 • Number of events 7 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	12.4% 12/97 • Number of events 12 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	7.1% 7/98 • Number of events 7 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Investigations Blood calcium decreased	7.1% 7/98 • Number of events 7 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	10.3% 10/97 • Number of events 11 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	6.1% 6/98 • Number of events 6 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Investigations Blood lactate dehydrogenase increased	7.1% 7/98 • Number of events 11 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	6.2% 6/97 • Number of events 7 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	6.1% 6/98 • Number of events 7 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Investigations Blood phosphorus decreased	5.1% 5/98 • Number of events 6 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	3.1% 3/97 • Number of events 3 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	5.1% 5/98 • Number of events 6 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Investigations Blood thyroid stimulating hormone increased	2.0% 2/98 • Number of events 2 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	3.1% 3/97 • Number of events 3 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	11.2% 11/98 • Number of events 11 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Investigations Blood uric acid increased	8.2% 8/98 • Number of events 8 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	5.2% 5/97 • Number of events 5 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	5.1% 5/98 • Number of events 5 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Investigations Gamma-glutamyltransferase increased	6.1% 6/98 • Number of events 6 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	9.3% 9/97 • Number of events 9 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	11.2% 11/98 • Number of events 12 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Investigations Haematocrit decreased	8.2% 8/98 • Number of events 8 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	2.1% 2/97 • Number of events 2 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	3.1% 3/98 • Number of events 3 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Investigations Haemoglobin decreased	35.7% 35/98 • Number of events 37 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	32.0% 31/97 • Number of events 32 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	42.9% 42/98 • Number of events 49 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Investigations Lymphocyte count decreased	5.1% 5/98 • Number of events 6 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	3.1% 3/97 • Number of events 3 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	2.0% 2/98 • Number of events 2 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Investigations Neutrophil count decreased	51.0% 50/98 • Number of events 57 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	47.4% 46/97 • Number of events 50 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	43.9% 43/98 • Number of events 54 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Investigations Platelet count decreased	28.6% 28/98 • Number of events 29 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	37.1% 36/97 • Number of events 36 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	36.7% 36/98 • Number of events 36 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Investigations Red blood cell count decreased	7.1% 7/98 • Number of events 7 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	7.2% 7/97 • Number of events 7 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	7.1% 7/98 • Number of events 7 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Investigations Weight decreased	15.3% 15/98 • Number of events 15 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	12.4% 12/97 • Number of events 12 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	9.2% 9/98 • Number of events 9 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Investigations White blood cell count decreased	45.9% 45/98 • Number of events 47 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	45.4% 44/97 • Number of events 46 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	45.9% 45/98 • Number of events 45 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Metabolism and nutrition disorders Decreased appetite	31.6% 31/98 • Number of events 32 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	33.0% 32/97 • Number of events 33 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	35.7% 35/98 • Number of events 36 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Musculoskeletal and connective tissue disorders Arthralgia	30.6% 30/98 • Number of events 32 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	35.1% 34/97 • Number of events 35 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	29.6% 29/98 • Number of events 31 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Musculoskeletal and connective tissue disorders Back pain	15.3% 15/98 • Number of events 15 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	17.5% 17/97 • Number of events 18 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	18.4% 18/98 • Number of events 18 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	3.1% 3/98 • Number of events 3 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	6.2% 6/97 • Number of events 7 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	3.1% 3/98 • Number of events 3 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Musculoskeletal and connective tissue disorders Myalgia	9.2% 9/98 • Number of events 10 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	17.5% 17/97 • Number of events 18 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	12.2% 12/98 • Number of events 12 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Nervous system disorders Dizziness	8.2% 8/98 • Number of events 9 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	6.2% 6/97 • Number of events 6 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	13.3% 13/98 • Number of events 14 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Nervous system disorders Dysgeusia	26.5% 26/98 • Number of events 26 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	23.7% 23/97 • Number of events 23 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	19.4% 19/98 • Number of events 19 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Nervous system disorders Headache	50.0% 49/98 • Number of events 55 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	48.5% 47/97 • Number of events 62 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	46.9% 46/98 • Number of events 59 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Psychiatric disorders Insomnia	14.3% 14/98 • Number of events 15 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	23.7% 23/97 • Number of events 23 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	20.4% 20/98 • Number of events 20 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Respiratory, thoracic and mediastinal disorders Cough	7.1% 7/98 • Number of events 7 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	11.3% 11/97 • Number of events 12 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	14.3% 14/98 • Number of events 15 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.1% 6/98 • Number of events 6 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	3.1% 3/97 • Number of events 3 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	3.1% 3/98 • Number of events 3 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.1% 6/98 • Number of events 6 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	11.3% 11/97 • Number of events 12 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	10.2% 10/98 • Number of events 12 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Skin and subcutaneous tissue disorders Alopecia	31.6% 31/98 • Number of events 31 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	30.9% 30/97 • Number of events 30 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	33.7% 33/98 • Number of events 33 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Skin and subcutaneous tissue disorders Dry skin	5.1% 5/98 • Number of events 5 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	7.2% 7/97 • Number of events 7 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	5.1% 5/98 • Number of events 5 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Skin and subcutaneous tissue disorders Eczema	8.2% 8/98 • Number of events 9 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	4.1% 4/97 • Number of events 4 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	12.2% 12/98 • Number of events 14 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Skin and subcutaneous tissue disorders Erythema	6.1% 6/98 • Number of events 6 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	5.2% 5/97 • Number of events 6 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	6.1% 6/98 • Number of events 7 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Skin and subcutaneous tissue disorders Pruritus	29.6% 29/98 • Number of events 29 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	35.1% 34/97 • Number of events 35 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	35.7% 35/98 • Number of events 36 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.
Skin and subcutaneous tissue disorders Rash	42.9% 42/98 • Number of events 45 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	34.0% 33/97 • Number of events 41 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.	45.9% 45/98 • Number of events 50 • From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks) AEs reported for APaT population. AEs were not reported for one participant in the Vaniprevir 24 Week Arm.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
• Publication restrictions are in place

Restriction type: OTHER