One-pill, once-daily combination superior to sofosbuvir plus ribavirin, with no cases of virologic failure in open-label phase III trial.
Use of shorter 12-week treatment regimen highly effective in patients with F3 disease.
Similar SVR24 rates in white patients vs black patients; SVR12 rate not affected by baseline RAVs in patients with genotype 1a HCV infection.
Low rates of discontinuation due to AEs, treatment-related serious AEs, and/or grade 3 and 4 lab abnormalities in this interim analysis.
Analysis finds 8-week regimen is underused, despite being highly effective in qualifying patients.
High SVR rates maintained across patient subgroups, including cirrhotic and treatment-experienced patients; adverse event rates similar to placebo.
Both 12-week and 16-week regimens of daclatasvir plus sofosbuvir plus ribavirin were well tolerated, even in cirrhotic, treatment-experienced patients usually considered difficult to treat.
No relapse in noncirrhotic patients regardless of inclusion of ribavirin; no relapse in cirrhotic patients with 16 weeks of treatment including ribavirin.