IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1

Phase 3 Completed 470 enrolled Boehringer Ingelheim

RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

Timeline

Start: 2012-12
Primary completion: 2015-01
Completion: 2015-01

Outcome

Mixed primary results

registry analysis (superiority or other test); 24 wk FDV+DBV+RBV; p <0.0001; Adjusted response rate 81.4 (95% CI 76.6 to 86.2); Stratified one sample z-test NCT01732796 ↗

registry analysis (superiority or other test); 16 wk FDV+DBV+RBV; p = 0.3989; Adjusted response rate 71.7 (95% CI 66.1 to 77.4); Stratified one sample z-test NCT01732796 ↗

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	—	—