Gilead’s Hepatitis C Drug Combination Proves Effective in Clinical Trials
California biopharmaceutical company Gilead is reporting the first single table regimen combining two drugs proved effective in treating all six genotypes of hepatitis C in four clinical trials.
The international Phase 3 trials monitored 1,302 patients with all genotypes of infection and varying degrees of scarring from liver disease. The patients were treated with a fixed-dose combination of sofosbuvir and pan-genotypic NS5A inhibitor velpatasvir.
The primary endpoint was sustained viral response at 12 weeks, and 98 percent of patients overall met that endpoint. Among those patients, 21 percent had compensated cirrhosis and 28 percent had failed on prior treatments. The company says the topline results suggest smoother disease management and potential for the combination as the first oral pan-genotypic single tablet regimen.
Gilead plans to submit an NDA to the FDA and European regulatory agencies by the end of the year. — Victoria Pelham