Phase III data on Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir) shows response rates in hepatitis C- AbbVie

AbbVie announced new data showing high response rates with just eight weeks of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets) treatment. In the Phase IIIb GARNET study, 98 percent (n=160/163) of previously untreated patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection without cirrhosis achieved sustained virologic response rates at 12 weeks post-treatment (SVR12). The Phase IIIb GARNET study is a multicenter, open-label, single-arm study, investigating the safety and efficacy of eight weeks of treatment with Viekirax + Exviera without ribavirin in treatment-na�ve patients with GT1b chronic HCV infection without cirrhosis. The study enrolled 166 patients across 20 sites around the world. Of the 166 patients enrolled, 163 patients had GT1b chronic HCV infection without cirrhosis and three patients with other HCV genotypes were excluded from the efficacy analysis. The primary endpoint is the percentage of patients who achieved a sustained virologic response 12 weeks after treatment (SVR12).

Two patients experienced post-treatment relapse and one subject discontinued due to noncompliance. Less than one percent of patients experienced serious adverse events or clinically significant (Grade more than 3) laboratory abnormalities. One patient discontinued treatment on Day 45 due to an adverse event but achieved SVR12. In the GARNET study, the most commonly reported adverse events (at least 5 percent) were headache (21 percent), fatigue (17 percent), nasopharyngitis (8 percent), pruritus (8 percent), nausea (6 percent) and asthenia (5 percent). These adverse events were mostly mild, with one patient discontinuing treatment due to adverse events. These data were presented at the 2016 EASL Special Conference: New Perspectives in Hepatitis C Virus Infection � The Roadmap for Cure, in Paris, France and included in the newly published EASL Recommendations on Treatment of Hepatitis C.