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San Francisco—A once a day, single tablet therapy taken for 12 weeks appears to vanquish hepatitis C (HCV) in patients with most common genotypes. This was the finding of the Astral-1 study, reported by JJ Feld, et al, in Late Breaking abstract 2 (LB-2) at the 2015 meeting of the AASLD. You can find the entire abstract here.

Treatment with the all oral regimen of sofosbuvir/velpatasvir for 12 weeks is well tolerated and results in 99% sustained virologic response rates 12 weeks post-treatment in both treatment-naïve and treatment-experienced genotype 1, 2, 4, 5, and 6 HCV-infected patients with and without cirrhosis.

The Phase 3 ASTRAL-1 study tested a fixed dose of the combination of sofosbuvir (SOF) and velpatasvir (VEL) versus placebo in a 5:1 ratio in 740 patients with HCV genotypes 1, 2, 4, and 6. All participants with genotype 5 received the SOF/VEL combination. Results of testing on patients with genotype 3, which is particularly challenging, were reported separately.

Two patients of 325 patients with genotype 1 infection experienced virologic relapse. Those patients included one treatment-naïve non-cirrhotic individual and one treatment-experience patient with cirrhosis. No other patients experienced relapse, with or without cirrhosis.

One patient receiving the SOF/VEL combination terminated treatment due to adverse effects as did 2 patients in the placebo arm. Fifteen patients receiving the combination tablet reported serious adverse effects, although they were not determined to be associated with the study drug. No patient in the placebo arm experienced a serious adverse effect.

LB-2: A Phase 3 Double-Blind Placebo-Controlled Evaluation of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Naïve and Experienced Genotype 1, 2, 4, 5, 6 HCV Infected Patients with and without cirrhosis: Results of the ASTRAL-1 Study