Gilead Sciences Inc. has reported positive results from its phase 2 and phase 3 studies on ledipasvir 90 mg/sofosbuvir 400 mg in patients with chronic hepatitis C virus.
Gilead Sciences Inc. has reported positive results from its phase 2 and phase 3 studies on ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni) in patients with chronic hepatitis C virus (HCV).
Results from the studies showed 96% of patients achieved sustained virologic response (SVR) for 12 weeks after taking Harvoni either alone or with ribavirin. These patients were considered cured of HCV infection, according to a Gilead press release.
The studies included patients with decompensated cirrhosis and HCV recurrence after a liver transplant, in addition to individuals whose treatment with other direct-acting antivirals had failed in the past.
However, taking Harvoni in conjunction with rifampin and St. John’s wort reduced the drug’s positive effects, according to the manufacturer. Products containing sofosbuvir (Sovaldi) were not recommended for use with Harvoni, either.
"Chronic hepatitis C patients with advanced liver disease are among the most difficult to cure and traditionally have had limited or no treatment options," said Norbert Bischofberger, PhD, executive vice president of research and development and chief scientific officer for Gilead. "The data presented this week demonstrate that Harvoni provides high cure rates for patients with advanced liver disease, as well as for those who failed prior treatment with other antivirals, including sofosbuvir-based regimens."
The FDA approved Harvoni in October 2014, and it is the first once-daily single tablet resource to treat adults with HCV genotype 1 infection.