Issue: March 2016
January 06, 2016
1 min read
Save

Sofosbuvir/Velpastasvir Receives Priority Review for All HCV Genotypes

Issue: March 2016
You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Gilead Sciences announced the FDA has granted priority review designation of its new drug application for a fixed combination of Sovaldi and velpatasvir for the treatment of all genotypes of chronic hepatitis C virus infection.

The application consists of an all-oral, once daily combination regimen of Sovaldi (sofosbuvir, Gilead Sciences) and velpatasvir, a pan-genotypic NS5A inhibitor. Gilead submitted the application in October 2015, with the FDA granting breakthrough therapy designation shortly after, according to a previous press release.

Clinical results from the phase 3 ASTRAL trials showed high sustained virologic response rates after investigating the safety and efficacy of the combination among patients with HCV genotypes 1 through 6.

In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 trials, 1,035 patients underwent therapy with the fixed combination regimen for 12 weeks. Of these patients, 98% achieved SVR at 12 weeks (1,015). In the ASTRAL-4 trial, 267 patients with decompensated cirrhosis were randomly assigned to receive either sofosbuvir/velpatasvir with or without ribavirin for 12 weeks or 24 weeks of sofosbuvir/velpatasvir. Ninety-four percent of patients who received sofosbuvir/velpatasvir plus ribavirin for 12 weeks achieved SVR12, whereas 83% of patients who received sofosbuvir/velpatasvir for 12 weeks achieved SVR12 and 86% of patients who received sofosbuvir/velpatasvir for 24 weeks achieved SVR.

Data from the ASTRAL-4 trial was presented as a Late Breaker highlight at The Liver Meeting 2015.

In a previous press release, Norbert Bischofberger, PhD, chief scientific officer at Gilead, stated: “The ASTRAL study results demonstrate that a 12-week course of therapy with the first fixed-dose combination of two pangenotypic compounds can provide high cure rates for patients with all HCV genotypes. We are pleased to have now brought forward our second single-tablet regimen for HCV infection that complements Harvoni, our first single-tablet regimen approved specifically for patients with genotype 1 infection, and which could eliminate the need for HCV genotype testing.”

Disclosure: Bischofberger is employed by Gilead Sciences.