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FDA expands Gilead’s Harvoni indications for Hep C

Published on 13/11/15 at 02:51pm
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Gilead’s Harvoni has been approved by the FDA for expanded use in patients with genotypes 4, 5 and 6 chronic hepatitis C virus (HCV) infection, and in patients who also have HIV.

In addition, Harvoni (ledipasvir/sofosbuvir) plus ribavirin (RBV) for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for genotype 1 patients with cirrhosis who have already had treatment.

The new indications come a year after Harvoni’s initial approval in the US for the treatment of chronic HCV genotype 1 infection in adults. The additional approval for HCV/HIV co-infection is particularly important, as this is a group of patients that represent approximately 30% of the total HIV-infected population in the US.

Compared with HCV infection alone, HIV/HCV co-infection is associated with an increased risk of cirrhosis and the subsequent complications of end-stage liver disease and hepatocellular carcinoma (liver cancer).

“Harvoni – the first and only single-tablet regimen for the treatment of HCV – continues to demonstrate high cure rates and a tolerable side effect profile across a range of patient populations, including those who have historically been considered among the most difficult to cure,” says Norbert Bischofberger, executive vice president of research and development and chief scientific officer at Gilead Sciences. “We are pleased that the Harvoni label and prescribing information now includes guidance for health care providers on its use in these important HCV patient populations.”

The EMA also recently approved updates to the Harvoni label to allow for the use of shorter durations of therapy with Harvoni in combination with RBV. Specifically, these include the use of Harvoni plus RBV for 12 weeks in genotypes 1 and 4 HCV-infected patients with compensated cirrhosis, decompensated cirrhosis and post-liver transplant patients.

The new label also includes data further supporting use of Harvoni for 12 weeks in patients with genotypes 1 or 4 who are co-infected with HIV, and in patients who had previously failed treatment with Sovaldi and RBV with or without pegylated interferon.

Joel Levy

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