Harvoni gets 2 more indications

SILVER SPRING, Md. — The Food and Drug Administration has approved Gilead Sciences’ Harvoni (ledipasvir and sofosbuvir) for two new indications, the company announced Tuesday. The specialty drug has been approved, in combination with ribavirin, to treat patients with genotype 1 and 4 chronic hepatitis C virus (HCV) who have received a liver transplant, as well as for genotype 1 patients with decompensated cirrhosis. 

 

“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, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “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.”

 

In addition to the new indications, Harvoni has approval to treat HCVS genotypes 1, 4, 5, and 6, as well as HCV/HIV-1 coinfection.