Gilead Sciences: What’s Next in Hepatitis C?

With the potential forthcoming approval of Gilead’s new HCV DAA (direct-acting antivirals) therapy sofosbuvir/ velpatasvir (sof/vel), Dr. Bischofberger stressed that the company still saw a role, albeit relatively small, for its next late-stage HCV combination regimen: sof/vel/GS-9857. However, for the vast majority of patients he expects sof/vel, or Harvoni, to provide excellent treatment. He confirmed that the company had no intention of studying sof/vel on the shortened 8-week schedule, conceding that in those genotype 1 (G1) patients with relatively good prognostic features, 8 weeks of Harvoni is now widely accepted, and very safe and very effective. One of the opportunities for the triple combination is as salvage therapy for HCV patients who’ve failed other DAAs in earlier lines. He admitted that neither regulators nor practitioners see much clinical advantage between an 8-week and a 12-week regimen. Looking ahead, he also stressed that the utility of a next-generation HCV therapy would only be incremental at best. Given the safety and tolerability of currently available agents Harvoni and Sovaldi (and shortly expected sof/vel), he admitted there was little rationale in trying to significantly reduce the duration of therapy less than 8 weeks. Dr. Bischofberger confirmed that the company has now migrated most of its virology research effort away from HCV to HBV and other areas.