Enanta announced results from AbbVie’s ongoing, Phase 3b RUBY-1 study evaluating Viekirax (ombitasvir/paritaprevir/ritonavir) plus Exviera (dasabuvir) with or without ribavirin (RBV) in treatment naïve, non-cirrhotic, genotype 1 (GT1) chronic hepatitis C patients with severe renal impairment (stage 4 or 5), including those on hemodialysis.
RUBY-I is an ongoing multi-center, open-label study with two cohorts designed to evaluate the safety and efficacy of 12 or 24 weeks of treatment with Viekirax plus Exviera with or without ribavirin. Cohort 1 consists of 20 patients without cirrhosis and cohort 2 will evaluate approximately 20 patients with or without compensated cirrhosis. The primary endpoint of the study is the percentage of patients achieving sustained virologic response at 12 weeks post-treatment (SVR12).
The first ten patients, or 100%, who have reached post-treatment week four to date (n=10 of 20 enrolled) achieved SVR4 (n=10/10). There have been no virologic failures to date.
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