Gilead’s Harvoni Bags Additional Indications From FDA

The FDA has given Gilead Sciences the green light for two additional indications for Harvoni in chronic hepatitis C patients with advanced liver disease.

The treatment now is approved in combination with ribavirin for 12 weeks for use in genotype 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis. It also was given a thumbs-up for use in HCV genotype 1-infected subjects with decompensated cirrhosis, including those who have undergone liver transplants.

Harvoni was approved by the FDA in October 2014 for the treatment of chronic hepatitis C genotype 1 infection in adults.