Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2

Phase 3 Completed 496 enrolled Boehringer Ingelheim

RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

Timeline

Start: 2012-11
Primary completion: 2014-02
Completion: 2015-01

Outcome

Mixed primary results

registry analysis (superiority or other test); 24-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group; p <0.0001; Adjusted response rate 81.10 (95% CI 76.34 to 85.87); z-test NCT01728324 ↗

registry 24-wk Non-cirrhotic (NC) Treatment Group vs 16-wk Non-cirrhotic (NC) Treatment Group; p = 0.0532; SVR12 Rates difference 6.4 NCT01728324 ↗

Publications

Sarrazin C, Castelli F, Andreone P, Buti M, Colombo M, Pol S, Calinas F, Puoti M, Olveira A, Shiffman M, Stern JO, Kukolj G, Roehrle M, Aslanyan S, Deng Q, Vinisko R, Mensa FJ, Nelson DR. HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naive patients with chronic hepatitis C virus genotype-1b infection. Clin Exp Gastroenterol. 2016 Nov 24;9:351-363. doi: 10.2147/CEG.S111116. eCollection 2016.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Deleobuvir	Small molecule	600 mg	—
Subject	Faldaprevir	Small molecule	120 mg	—
Subject	Ribavirin	Small molecule	—	—