New Once-Daily Hepatitis C Pill Effective Across 6 Genotypes
An experimental, once-daily pill for hepatitis C virus (HCV) leads to high rates of sustained virologic response across a wide range of patients, according to findings from two international, industry-supported, phase 3 trials published in the New England Journal of Medicine. The pill combines sofosbuvir with velpatasvir, a novel pan-genotypic HCV NS5A inhibitor.
Some 700 patients with HCV genotypes 1, 2, 4, and 6 were randomized to receive sofosbuvir-velpatasvir or placebo for 12 weeks; an additional 35 patients with genotype 5 were assigned to active treatment (this genotype was relatively rare in the study regions). Roughly one-third of patients had previously received HCV treatment, and nearly 20% had compensated cirrhosis.
The rate of sustained virologic response at 12 weeks after treatment ended was 99% with sofosbuvir-velpatasvir, with no differences according to genotype, prior treatment, or cirrhosis status. No placebo recipient had a sustained virologic response. Serious adverse events occurred in 2% of sofosbuvir-velpatasvir recipients (vs. 0% with placebo).
In a companion study, nearly 270 patients with HCV genotypes 1–6 (excluding 5) and decompensated cirrhosis were randomized to receive sofosbuvir-velpatasvir for 12 weeks, sofosbuvir-velpatasvir plus ribavirin for 12 weeks, or sofosbuvir-velpatasvir for 24 weeks. The rates of sustained virologic response at 12 weeks’ post-treatment were 83%, 94%, and 86%, respectively. Rates of serious adverse events ranged from 16% to 19%.
“The next-generation hepatitis C therapy is here,” says Dr. Atif Zaman of NEJM Journal Watch Gastroenterology.
Originally posted on: jwatch.org