- New hepatitis C therapies from giants Gilead and Merck are now being judged on effectiveness in specific sub-populations, as well as overall faster cure rates.
- Gilead's new therapy in development is a triple hep C drug that combines Sovalid (sofosbuvir), the experimental NS5A inhibitor GS-5816, and GS-9857, an NS3/4A protease inhibitor.
- Merck's new hep C drug is a grazoprevir/elbasvir combo, which is targeted for chronic kidney disease patients.
In virology, it's always about what's next. What's next for Gilead is a hep C three-in-one therapy. So far, clinical trial results have been mixed, with a 93% response rate among treatment-naive non-cirrhotic patients, which dropped to 87% for cirrhotic patients and 67% for treatment-resistant patients.
In contrast, Merck's combo, which has been granted Breakthrough Therapy designation, resulted in a 99% cure rate in 12 weeks in patients with chronic kidney disease (CKD). One problem, however, is that 5% of the patients in the original group were missing from the analysis for various reasons. More than ever, the medical community and the FDA are looking for intent-to-treat (ITT) data.
Ever since the advent of Sovaldi—and then Harvoni and Viekira Pak—the bar has been raised. The goals now are to treat a broader population of patients, including those with treatment-resistant disease and those who are already very sick.