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FDA Expands Harvoni Indication to Include Hepatitis C Genotypes 4-6 and HIV/HCV Coinfection

The U.S. Food and Drug Administration last week granted supplemental approval of Gilead Sciences' sofosbuvir/ledipasvir (Harvoni) single-tablet regimen for the treatment of hepatitis C virus genotypes 4, 5, and 6 and for HIV/HCV coinfected people. The FDA also said Harvoni plus ribavirin for 12 weeks is an alternative to a 24 weeks of Harvoni alone for treatment-experienced hepatitis C patients with liver cirrhosis.


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