Study shows drug may eliminate need for HCV genotype testing altogether
A new Gilead Sciences drug combination that targets six genotypes of the hepatitis C virus (HCV) has achieved promising results in four international phase III clinical studies.
Gilead has announced results from ASTRAL-1, ASTRAL-2, ASTRAL-3, and ASTRAL-4. The studies evaluated a once-daily, fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF) with velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of genotype 1 to 6 chronic HCV infection.
In the ASTRAL-1, ASTRAL-2, and ASTRAL-3 studies, 1,035 patients with genotype 1 to 6 HCV infection received 12 weeks of SOF/VEL. Among these patients, 21%% had compensated cirrhosis and 28% had failed prior treatments. The ASTRAL-4 study randomized 267 patients with decompensated cirrhosis (Child-Pugh class B) to receive 12 weeks of SOF/VEL with or without ribavirin (RBV), or 24 weeks of SOF/VEL. The primary endpoint for all studies was a sustained virological response at week 12 post-treatment (SVR12)
Labels: Gilead, HCV Genotypes, HCV Treatment, Phase 3, sofobuvir, velapatasvir