ARTICLE | Clinical News

Viekirax: Phase II data

February 9, 2015 8:00 AM UTC

Top-line data from the Japanese Phase III GIFT-1 trial in 363 patients with chronic HCV genotype 1b infection showed that ombitasvir/paritaprevir/ritonavir for 12 weeks led to an SVR 12 weeks after the end of treatment in 95% of patients in a subgroup of treatment-naïve patients without cirrhosis who were eligible for therapy with interferon with or without ribavirin and had a viral load >=100,000 IU/mL (n=112). There were no on-treatment virologic failures and 2.8% of patients experienced relapse. The trial consists of a double-blind, placebo-controlled portion in non-cirrhotic patients and an open-label portion in patients with compensated cirrhosis. This quarter, AbbVie plans to submit a regulatory application in Japan for ombitasvir/paritaprevir/ritonavir. ...