A Regimen for HCV-Infected Patients Who Fail Direct-Acting Antiviral Therapy

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Combination fixed-dose sofosbuvir-velpatasvir plus GS-9857 was highly effective in phase II studies.

This triple-DAA regimen was highly effective across HCV genotypes when given for 8 weeks in treatment-naive patients and 12 weeks in treatment-experienced patients with and without cirrhosis. A 6-week regimen was less effective, and adding ribavirin added no benefit. If subsequent phase III trials produce similar results, we might soon have a simple and effective 8–12-week regimen that is pangenotypic and ribavirin-free.

In one open-label trial involving 197 HCV genotype 1 patients, all treatment-naive patients without cirrhosis who received 8 weeks of triple therapy achieved sustained virologic response at 12 weeks posttreatment (SVR12). Among treatment-naive patients with cirrhosis, treated for 8 weeks, SVR12 rates were 81% with added weight-based ribavirin and 94% without ribavirin. A small cohort without cirrhosis receiving 6 weeks of therapy achieved an SVR12 of 71%. Treatment-experienced patients with or without cirrhosis received 12 weeks of triple therapy, and all achieved SVR12.

Another open-label trial involved 128 patients with different HCV genotypes (58% genotype 3, 26% genotype 2). Among treatment-naive patients without cirrhosis, who received 6 weeks of triple therapy, SVR12 was 88%; among those with cirrhosis, treated for 8 weeks, SVR12 was 93%. Among treatment-experienced patients with or without cirrhosis, who received therapy for 12 weeks, SVR12 was 100% with cirrhosis and 97% without.