FDA approves two new indications for Gilead Sciences’ Harvoni to treat chronic hepatitis C

The new indications allow to treat liver transplant recipients with genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis, and for genotype 1-infected patients with decompensated cirrhosis.

The indications are supported by data from the phase 2 Solar-1 and Sloar-2 clinical trials, in which treatment-naive and treatment-experienced patients with genotype 1 and 4 infection were treated with Harvoni, plus ribavirin, for 12 and 24 weeks.

In the Solar-2 trial, SVR12 rates in the non-cirrhotic or compensated arm for genotype 1 patients were 98% after 24 weeks of therapy.

SVR12 rates for genotype 1 patients in the more severe group were 88% after 12 weeks of treatment and 89% after 24 weeks of treatment

Gilead Sciences executive vice president of research and development and chief scientific officer Norbert Bischofberger said: "Hepatitis C-infected patients who have decompensated cirrhosis and those who have previously received a liver transplant have an urgent need for treatment, but historically their options have been limited.

"We are pleased that health care providers now have the information needed to offer these patients an all-oral, 12-week duration therapy with high cure rates and a tolerable side effect profile."

Harvoni is now approved to treat chronic hepatitis C virus in several patient populations including genotypes 1, 4, 5 and 6, HCV/HIV-1 coinfection, HCV genotype 1 and 4 liver transplant recipients, and genotype 1-infected patients with decompensated cirrhosis.

Image: Harvoni product photo. Photo: courtesy of Gilead.