A once-daily, fixed-dose combination of sofosbuvir (SOF) plus velpatasvir (VEL) had high success rates for the treatment of all six genotypes of hepatitis C virus, manufacturer Gilead Sciences reported.
In three of four phase III trials (ASTRAL-1, ASTRAL-2, and ASTRAL-3), 1,035 HCV patients were given the drug combination for 12 weeks. In the fourth trial (ASTRAL-4), 267 HCV patients with decompensated cirrhosis were randomized to receive either the SOF/VEL combination for 12 weeks with or without ribavirin or 24 weeks of just SOF/VEL. The primary efficacy endpoint for all studies was a sustained virological response at 12 weeks, the company said in a statement.
Courtesy US. Dept of Veterans Affairs
Results showed that 98% of patients in the first three trials achieved the efficacy endpoint. In the ASTRAL-4 study, 94% of patients in the SOF/VEL plus ribavirin group achieved sustained virological response at 12 weeks. The rates of success in patients receiving the SOF/VEL combination for 12 or 24 weeks were 83% and 86%, respectively. The most common adverse effects were fatigue, nausea, and headache.
The FDA has designated the SOF/VEL combination as “breakthrough therapy” status, granted to “investigational medicines that may offer major advances in treatment over existing options,” the statement said.