FDA News

FDA grants priority review of Sovaldi/velpatasvir for all HCV genotypes

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.

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.