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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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AASLD 2015: Sofosbuvir/ Ledipasvir + Vedroprevir Cures 96% of Cirrhotic Genotype 1 Patients

A triple combination of Gilead Sciences' sofosbuvir/ledipasvir (Harvoni) plus the experimental HCV protease inhibitor vedroprevir cured 96% of treatment-experienced, cirrhotic, genotype 1 hepatitis C patients without the need for ribavirin, according to study findings presented at the AASLD Liver Meeting this week in San Francisco.

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AASLD 2015: Sofosbuvir + Ravidasvir Shows High Response Rates for Genotype 4 Hepatitis C

A regimen of sofosbuvir and the pan-genotypic HCV NS5A inhibitor ravidasvir, with or without ribavirin, demonstrated sustained response rates ranging from 86% to 100% in the largest Phase 3 trial to date of interferon-free treatment for people with hepatitis C virus genotype 4, according to study findings presented at the 2015 AASLD Liver Meeting taking place this week in San Francisco.

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AASLD 2015: New AbbVie Hepatitis C Combination Cures Up to 97% with Genotype 3

A combination of 2 experimental direct-acting antivirals developed by AbbVie cured 83%-97% of people with genotype 3 hepatitis C after a 12-week course of treatment, Paul Kwo from Indiana University School of Medicine reported at the 2015 AASLD Liver Meeting this week in San Francisco.

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AASLD 2015: New AbbVie Pangenotypic Regimen Cures 97%-100% of Hepatitis C Patients in Early Study

A combination of 2 experimental direct-acting antivirals developed by AbbVie cured 97% to 100% of non-cirrhotic people with genotype 1 hepatitis C in a mid-stage Phase 2 study presented this week at the AASLD Liver Meeting in San Francisco.

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