Date: 2016-04-16
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at The International Liver CongressTM 2016 in Barcelona, Spain
Company: Gilead Sciences (USA - CA)
Product: sofosbuvir and velpatasvir
Action
mechanism: direct-acting antiviral agent/nucleotide analog/enzyme inhibitor. Sofosbuvir is an oral nucleotide analog inhibitor of the HCV NS5B polymerase enzyme, which plays an essential role in HCV replication. This direct-acting agent interferes directly with the HCV life cycle by suppressing viral replication. Velpatasvir (GS-5816) is a second-generation investigational NS5A inhibitor.
Disease: patients with HCV genotype 1-6 who are co-infected with HIV
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: * On April 16, 2016, Gilead Sciences announced results from several Phase 2 and Phase 3 studies evaluating fixed-dose combination of sofosbuvir/velpatasvir. Results from the open-label, Phase 3 ASTRAL-5 study (PS104), led by David L. Wyles , MD, Associate Professor of Medicine, Division of Infectious Diseases , University of California, San Diego, California , evaluating once-daily SOF/VEL for 12 weeks among patients with HCV genotype 1-6 who are co-infected with HIV demonstrated that SOF/VEL was well-tolerated and resulted in high SVR12 rates. The SVR12 rate was 95 percent (n=99/104) overall, and 100 percent (n=19/19) and 97 percent (n=28/29) in patients with cirrhosis and prior treatment-failure, respectively. Two patients relapsed, while three patients were lost to follow up or withdrew consent. Two patients achieved SVR4 but have not yet returned for the post-treatment week 12 visit. The most common adverse events (>10 percent) were fatigue and headache.
