Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)

Summary

The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI 201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated interferon α-2a (PegIFN) and ribavirin (RBV), with or without a 3-day lead-in, was assessed in treatment-naïve (TN) and treatment experienced (TE) patients.

Timeline

Start

2008-10

Primary completion

2011-11

Completion

—

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo-TN vs 240 mg QD / LI-TN; p = 0.0213; Fisher Exact NCT00774397 ↗

Drugs

Indications