Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)
Summary
A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response (RVR) i.e., undetectable hepatitis C virus \[HCV\] viral ribonucleic acid \[RNA\] at Week 4 in participants with chronic HCV infection. The primary hypothesis was that the proportion of participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were co-administered with Peg-IFN/Ribavirin.
Timeline
- Start
- 2008-07-25
- Primary completion
- 2008-12-12
- Completion
- 2010-04-14
Outcome
Met primary endpoint
paper Rates of RVR were significantly higher in each of the vaniprevir dose groups, compared to the control regimen (68.8%-83.3% versus 5.6%; P < 0.001 for all comparisons). PMID 22473713 ↗
registry Placebo + Peg-IFN/Ribavirin vs Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin; p <0.001; Adjusted difference in % 69.3 (95% CI 40.3 to 86.7) NCT00704184 ↗
registry Placebo + Peg-IFN/Ribavirin vs Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin; p <0.001; Adjusted difference in % 73.6 (95% CI 46.0 to 88.6) NCT00704184 ↗
Publications
- Results Manns MP, Gane E, Rodriguez-Torres M, Stoehr A, Yeh CT, Marcellin P, Wiedmann RT, Hwang PM, Caro L, Barnard RJ, Lee AW; MK-7009 Protocol 007 Study Group. Vaniprevir with pegylated interferon alpha-2a and ribavirin in treatment-naive patients with chronic hepatitis C: a randomized phase II study. Hepatology. 2012 Sep;56(3):884-93. doi: 10.1002/hep.25743. Epub 2012 Jul 17.
- Lawitz E, Sulkowski M, Jacobson I, Kraft WK, Maliakkal B, Al-Ibrahim M, Gordon SC, Kwo P, Rockstroh JK, Panorchan P, Miller M, Caro L, Barnard R, Hwang PM, Gress J, Quirk E, Mobashery N. Characterization of vaniprevir, a hepatitis C virus NS3/4A protease inhibitor, in patients with HCV genotype 1 infection: safety, antiviral activity, resistance, and pharmacokinetics. Antiviral Res. 2013 Sep;99(3):214-20. doi: 10.1016/j.antiviral.2013.05.015. Epub 2013 Jun 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vaniprevir | Small molecule | 300 mg | — |
| Subject | Vaniprevir | Small molecule | 600 mg | — |
| Subject | Vaniprevir | Small molecule | 800 mg | — |
| Background | Pegylated Interferon | Unknown | 180 ug | Subcutaneous |
| Background | Ribavirin | Small molecule | 200 mg | — |