Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)

Summary

The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.

Timeline

Start

2011-06

Primary completion

2013-02

Completion

2014-05

Outcome

Met primary endpoint

registry Adjusted percent difference 54.7 (95% CI 44.4 to 65.0); Cochran-Mantel-Haenszel; note: Adjusted for genotype and previous response to treatment NCT01358864 ↗

registry Relapser & Partial: Placebo vs Relapser & Partial: Faldaprevir 12 Weeks; p <0.0001 NCT01358864 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Faldaprevir	Small molecule	240 mg	—
Background	Pegylated Interferon-alpha	Protein / enzyme biologic	—	—
Background	Ribavirin	Small molecule	—	—

Indications