Sarrazin C, et al. – Authors evaluated the interferon–free combination of once–daily faldaprevir 120 mg, twice–daily deleobuvir 600 mg, and weight–based ribavirin in two Phase III studies (HCVerso1, HCVerso2) in hepatitis C virus genotype–1b–infected, treatment–naïve patients, including those ineligible for peginterferon (HCVerso2). In treatment–naïve patients with hepatitis C virus genotype–1b infection, with or without cirrhosis, faldaprevir + deleobuvir + ribavirin treatment for 24 weeks led to adjusted SVR12 rates significantly higher than historical controls.

Methods

• Authors randomized patients without cirrhosis to 16 weeks (Arm 1; n=208 HCVerso1, n=213 HCVerso2) or 24 weeks (Arm 2; n=211 in both studies) of faldaprevir + deleobuvir + ribavirin.
• They administered open–label faldaprevir + deleobuvir + ribavirin to patients with compensated cirrhosis for 24 weeks (Arm 3; n=51, n=72).
• For this study, primary endpoints were comparisons of adjusted sustained virologic response (SVR) rates with historical rates: 71% (HCVerso1) and 68% (HCVerso2).

Results

• Significantly greater adjusted SVR12 rates were observed in comparison to historical controls for Arms 1 and 2 in HCVerso2 (76%, 95% confidence interval [CI] 71–81, P=0.002; 81%, 95% CI 76–86, P<0.0001) and Arm 2 in HCVerso1 (81%, 95% CI 77–86, P<0.0001), but not for Arm 1 of HCVerso1 (72%, 95% CI 66–77, P=0.3989).
• Arms 1, 2, and 3 indicated unadjusted SVR12 rates of 71.6%, 82.5%, and 72.5%, respectively, in HCVerso1 and 75.6%, 82.0%, and 73.6%, respectively, in HCVerso2.
• Virologic breakthrough and relapse occurred in 24–week arms in 8%–9% and 1% of patients, respectively, and in 16–week arms in 7%–8% and 9%–11% of patients, respectively.
• Nausea (46%–61%) and vomiting (29%–35%) were the most common adverse events.
• In 6%–8% of patients, adverse events resulted in discontinuation of all medications.