FDA Expands Use of Gilead's Liver Drug to Rare Subset of Patients

By Reuters Staff

February 17, 2016

(Reuters) - The U.S. Food and Drug Administration has expanded the use of Gilead Sciences Inc's drug Harvoni (ledipasvir and sofosbuvir) to some hepatitis C patients in the advanced stage of cirrhosis, including those who have undergone liver transplant.

"Harvoni in combination with ribavirin for 12 weeks was approved for use in chronic hepatitis C virus (HCV) genotype 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and for HCV genotype 1-infected patients with decompensated cirrhosis (Child-Pugh B or C), including those who have undergone liver transplantation," the company said in a February 16 press statement.

"Harvoni is now approved for use in a broader range of patient populations, including 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," according to the statement.

"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 Dr. Norbert Bischofberger, Gilead's Executive Vice President of Research and Development and Chief Scientific Officer. "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 had $13.86 billion worldwide sales in 2015.