Phase 3
Completed N=294
Vaniprevir Administered With Pegylated-interferon and Ribavirin in Japanese Treatment-Naïve Chronic Hepatitis C Participants (MK-7009-043)
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01370642 ↗
Enrolled (actual)
294
Serious AEs
6.8%
Results posted
Oct 2014
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24) — 83.7; 84.5; 55.1 percentage of participants — p=<0.001
Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) versus treatment with peg-IFN and RBV alone in Japanese treatment-naïve participants with chronic hepatitis C (CHC) genotype (GT)1. The primary efficacy hypothesis is that the percentage of participants achieving sustained virologic response 24 weeks after completion of all study therapy (SVR24) in at least one of the vaniprevir arms is superior to the percentage of participants achieving SVR24 in the control arm.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24) |
83.7; 84.5; 55.1 | <0.001 sig |
| PRIMARY Percentage of Participants With One or More Tier 1 Adverse Events (AEs) During the Study |
89.8; 83.5; 85.7; 60.2; 51.5; 64.3 | 0.385 |
| PRIMARY Percentage of Participants Who Discontinued Study Drug Due to an AE |
7.1; 3.1; 11.2 | — |
| SECONDARY Percentage of Participants Achieving SVR12 |
83.7; 84.5; 54.1 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Rapid Virologic Response (RVR) |
86.7; 85.6; 9.2 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Complete Early Virologic Response (cEVR) |
94.9; 96.9; 46.9 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT) |
95.9; 97.9; 79.6 | <0.001 sig |
| SECONDARY Least Squares (LS) Mean Change From Baseline in HCV RNA (Log 10) |
-5.3; -5.5; -2.0; -6.0; -6.1; -3.0 | — |
Eligibility Criteria
Inclusion criteria
- Japanese participant diagnosed with compensated CHC GT 1
- Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease.
- IFN treatment naive
- No evidence of cirrhosis
Exclusion criteria
- Co-infection with human immunodeficiency virus (HIV)
- Positive hepatitis B surface antigen or other evidence of active hepatitis B infection
- Any other condition that is contraindicated or for which caution is required for treatment with peg-IFN or RBV
- Any condition or pre-study laboratory abnormality, or history of any illness, that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs, peg-IFN and RBV, to the participant.
Data sourced from ClinicalTrials.gov (NCT01370642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.