New Indications Approved for Harvoni

The FDA has approved Gilead Sciences’ supplemental new drug applications for ledipasvir/sofosbuvir (Harvoni), which can treat chronic hepatitis C patients with advanced liver disease.

Harvoni is now approved for use in patients who have hepatitis C virus (HCV) 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.

Previously, Harvoni was approved for a narrower range of patients with the virus. Harvoni, in combination with ribavirin for 12 weeks, was approved to treat HCV genotype 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis, and for HCV genotype 1-infected patients with decompensated cirrhosis, including those who have undergone liver transplantation.

“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,” said Norbert Bischofberger, executive vice president of Research and Development and Chief Scientific Officer at Gilead, in a press release. “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.”

The most common adverse reactions to Harvoni include fatigue, headache, and asthenia.

Harvoni is not recommended for patients taking other sofosbuvir products.