Gilead reports that a combination of sofosbuvir and experimental 'pan-genotypic' NS5A inhibitor velpatasvir (GS-5816) has proven effective regardless of HCV genotype in four late-stage studies.
Three of the studies involved 1,035 people with hepatitis C genotypes ranging from 1 to 6. Twenty-one per cent of participants had cirrhosis and 28 per cent had unsuccessful prior treatment.
Participants in the first study (genotypes 1 to 6) received a 12-week once-daily fixed dose of sofosbuvir/velpatasvir or a placebo. The second study involved participants with genotype 2 who received 12 weeks of sofosbuvir/velpatasvir or sofosbuvir/ribavirin. The third study compared sofosbuvir/velpatasvir for 12 weeks or sofosbuvir/ribavirin for 24 weeks, for participants with genotype 3.
A fourth study involved 267 people with decompensated cirrhosis, genotypes ranging from 1 to 6. Participants received sofosbuvir/velpatasvir for 12 or 24 weeks, or sofosbuvir/velpatasvir/ribavirin for 12 weeks.
Participants without decompensated cirrhosis (first three studies), who were on the new regimen had 95 to 100 per cent sustained virological response (SVR), 12 weeks post treatment. The best result from the fourth study was 94 per cent SVR (12 weeks post treatment) achieved with 12 weeks of of sofosbuvir/velpatasvir/ribavirin.
Side effects from the treatment included fatigue, headache and nausea.
