A Study of TMC435 in Combination With Pegylated Interferon Alp\Fa-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received Treatment
Summary
The purpose of this study is to evaluate the efficacy of 4 different regimens of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the proportion of patients with sustained virologic response at Week 72 (patients with undetectable plasma HCV RNA \[less than 25 IU per mL undetectable\] at the end of treatment and at Week 72), compared to the control group receiving PegIFN and RBV in combination with TMC435-matched placebo.
Timeline
- Start
- 2009-06
- Primary completion
- 2010-04
- Completion
- 2011-04
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry p = 0.051; Difference in proportions of SVRW72 13.0 (97.5% CI -1.9 to 28.0) reads as mixed primary results NCT00882908 ↗
registry p = 0.004; Difference in proportions of SVRW72 18.9 (97.5% CI 4.4 to 33.5) reads as mixed primary results NCT00882908 ↗
paper P < 0.05 for all comparisons [SMV versus placebo], except SMV 75 mg for 24 weeks. reads as mixed primary results PMID 23907700 ↗
release “final PILLAR analysis showed that TMC435 administered in combination with peginterferon α-2a and ribavirin (PR) resulted in significantly higher sustained virologic response (SVR) rates” reads as met primary endpoint medivir.com ↗
Publications
- Lenz O, Verbinnen T, Fevery B, Tambuyzer L, Vijgen L, Peeters M, Buelens A, Ceulemans H, Beumont M, Picchio G, De Meyer S. Virology analyses of HCV isolates from genotype 1-infected patients treated with simeprevir plus peginterferon/ribavirin in Phase IIb/III studies. J Hepatol. 2015 May;62(5):1008-14. doi: 10.1016/j.jhep.2014.11.032. Epub 2014 Nov 28.
- Scott J, Rosa K, Fu M, Cerri K, Peeters M, Beumont M, Zeuzem S, Evon DM, Gilles L. Fatigue during treatment for hepatitis C virus: results of self-reported fatigue severity in two Phase IIb studies of simeprevir treatment in patients with hepatitis C virus genotype 1 infection. BMC Infect Dis. 2014 Aug 26;14:465. doi: 10.1186/1471-2334-14-465.
- Fried MW, Buti M, Dore GJ, Flisiak R, Ferenci P, Jacobson I, Marcellin P, Manns M, Nikitin I, Poordad F, Sherman M, Zeuzem S, Scott J, Gilles L, Lenz O, Peeters M, Sekar V, De Smedt G, Beumont-Mauviel M. Once-daily simeprevir (TMC435) with pegylated interferon and ribavirin in treatment-naive genotype 1 hepatitis C: the randomized PILLAR study. Hepatology. 2013 Dec;58(6):1918-29. doi: 10.1002/hep.26641. Epub 2013 Oct 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Simeprevir | Small molecule | 75 mg | Oral |
| Subject | Simeprevir | Small molecule | 150 mg | Oral |
| Background | Peg-IFNα2a | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Background | Ribavirin | Small molecule | 200 mg | Oral |