Friday, November 20, 2015

ASTRAL-2: Sovaldi/velpatasvir bests standard therapy in HCV genotype 2

Healio: Additional headlines from Highlights from The Liver Meeting 2015

ASTRAL-2: Sovaldi/velpatasvir bests standard therapy in HCV genotype 2
SAN FRANCISCO — A fixed-dose combination of Sovaldi and velpatasvir yielded better sustained virologic response rates in patients with genotype 2 hepatitis C virus than Sovaldi and ribavirin, the current standard of care, according to findings presented at The Liver Meeting 2015.
Mark S. Sulkowski, MD, of Johns Hopkins University, noted that there is currently no ribavirin-free regimen approved for the treatment of this patient population. The open-label study had broad inclusion criteria, allowing for patients with treatment experience and cirrhosis, and was conducted at 51 centers in the U.S.

November 17, 2015
SAN FRANCISCO — A fixed-dose combination of Sovaldi and velpatasvir yielded 99% SVR12 across a number of genotypes, according to a presentation…

Sovaldi, velpatasvir, GS-9857 show efficacy in challenging populations
November 17, 2015
SAN FRANCISCO — A cohort including patients with genotype 3 disease demonstrated high SVR12 rates after treatment with Sovaldi, velpatasvir (or…

New England Journal Of Medicine 

Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection
Here, we present the results of two randomized, controlled, phase 3 trials (ASTRAL-2 and ASTRAL-3) in which treatment with a fixed-dose combination tablet of sofosbuvir and velpatasvir for 12 weeks was compared with standard treatment with sofosbuvir plus ribavirin for 12 or 24 weeks in patients who had received prior treatment for HCV genotype 2 or 3 infection and in those who had not received such treatment, including those with compensated cirrhosis.

Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis
The NS5B nucleotide inhibitor sofosbuvir is approved for the treatment of HCV infection in combination with other agents.13,14 Velpatasvir (formerly known as GS-5816, Gilead Sciences) is an investigational inhibitor of the HCV NS5A protein with antiviral activity against all HCV genotypes.15-17 The combination of velpatasvir and sofosbuvir with or without ribavirin provided high rates of sustained virologic response in patients with all HCV genotypes in phase 2 clinical trials.18,19 In the phase 3 ASTRAL-1, ASTRAL-2, and ASTRAL-3 trials (now published in theJournal),20,21 treatment with sofosbuvir–velpatasvir in a fixed-dose combination tablet for 12 weeks resulted in high rates of sustained virologic response among patients with HCV genotypes 1 through 6 without cirrhosis or with compensated cirrhosis.

Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection
We conducted a phase 3 trial (ASTRAL-1) to assess the efficacy and safety of 12 weeks of treatment with a fixed-dose combination of velpatasvir and sofosbuvir among both previously treated and untreated patients who were chronically infected with HCV genotype 1, 2, 4, 5, or 6, including those with compensated cirrhosis.

Slide presentation with full text @ NATAP

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