Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 2)

Phase 3 Completed 658 enrolled Boehringer Ingelheim

RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.

Timeline

Start: 2011-04
Primary completion: 2014-04
Completion: 2014-04

Outcome

Met primary endpoint

registry Faldaprevir 120mg and PegIFN/RBV vs Placebo and PegIFN/RBV; p <0.0001; Mean Difference (Final Values) 20.7 (95% CI 10.7 to 30.6) NCT01297270 ↗

registry Faldaprevir 240mg and PegIFN/RBV vs Placebo and PegIFN/RBV; p = 0.0007; Mean Difference (Final Values) 17.4 (95% CI 7.3 to 27.4) NCT01297270 ↗

Publications

Jensen DM, Asselah T, Dieterich D, Foster GR, Sulkowski MS, Zeuzem S, Mantry P, Yoshida EM, Moreno C, Ouzan D, Wright M, Morano LE, Buynak R, Bourliere M, Hassanein T, Nishiguchi S, Kao JH, Omata M, Paik SW, Wong DK, Tam E, Kaita K, Feinman SV, Stern JO, Scherer J, Quinson AM, Voss F, Gallivan JP, Bocher WO, Ferenci P. Faldaprevir, pegylated interferon, and ribavirin for treatment-naive HCV genotype-1: pooled analysis of two phase 3 trials. Ann Hepatol. 2016 May-Jun;15(3):333-49. doi: 10.5604/16652681.1198803.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Faldaprevir	Small molecule	120 mg	—
Subject	Faldaprevir	Small molecule	240 mg	—
Background	Peginterferon alfa-2a	Protein / enzyme biologic	—	—
Background	Ribavirin	Small molecule	—	—