Vaniprevir Administered With Pegylated-interferon and Ribavirin in Japanese Treatment-Naïve Chronic Hepatitis C Participants (MK-7009-043)
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.
Timeline
- Start
- 2011-06-27
- Primary completion
- 2013-07-31
- Completion
- 2014-03-17
Outcome
Met primary endpoint
registry analysis (superiority or other test); Vaniprevir 12 Week Arm vs Control Arm; p <0.001; Adjusted Difference in Percentages 29.0 (95% CI 17.2 to 40.5); Miettinen and Nurminen method NCT01370642 ↗
registry analysis (superiority or other test); Vaniprevir 24 Week Arm vs Control Arm; p <0.001; Adjusted Difference in Percentages 28.6 (95% CI 17.4 to 40.0); Miettinen and Nurminen method NCT01370642 ↗
paper SVR24 was achieved in 83.7, 84.5, and 55.1 % of the patients in the vaniprevir 12-week, vaniprevir 24-week, and control arms, respectively. PMID 26403160 ↗
Publications
- Results Hayashi N, Nakamuta M, Takehara T, Kumada H, Takase A, Howe AY, Ludmerer SW, Mobashery N. Vaniprevir plus peginterferon alfa-2b and ribavirin in treatment-naive Japanese patients with hepatitis C virus genotype 1 infection: a randomized phase III study. J Gastroenterol. 2016 Apr;51(4):390-403. doi: 10.1007/s00535-015-1120-x. Epub 2015 Sep 25.
- Ludmerer SW, Hirano T, Black S, Howe AY, Chang W, Takase A, Nakamura K, Tanaka Y, Kumada H, Hayashi N, Nickle D. HCV evolutionary genetics of SVR versus virologic failure assessed from the vaniprevir phase III registration trials. Antiviral Res. 2016 Jun;130:118-29. doi: 10.1016/j.antiviral.2016.03.004. Epub 2016 Mar 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vaniprevir | Small molecule | 300 mg | Oral |
| Background | Peg-IFN | Protein / enzyme biologic | 1.5 ug/kg | Subcutaneous |
| Background | Ribavirin | Small molecule | 600 mg | Oral |
| Background | Ribavirin | Small molecule | 800 mg | Oral |
| Background | Ribavirin | Small molecule | 1000 mg | Oral |