FDA approves Gilead Sciences’ Harvoni hepatitis C drug for expanded use

The drug can now be used in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with human immunodeficiency virus (HIV).

It is also approved to be used for 12 weeks as an alternate therapy to Harvoni alone, which is used for 24 weeks to treat cirrhosis.

Results from the study demonstrated that about 93% of the patients with subtypes of the virus and 96% of patients co-infected with HIV showed a sustained response to the virus within 12 weeks of treatment.

Harvoni, which was initially approved by the FDA in October last year, is a once-daily pill, used in combination with antiviral ribavirin.

It combines two drugs, ledipasvir and sofosbuvir, in one pill. Harvoni targets several proteins in the Hep C virus to keep it from reproducing in the body.

Gilead Sciences executive vice president of research and development and chief scientific officer Norbert Bischofberger said: "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.

"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."

Image: Harvoni Product Photo. Photo: courtesy of Gilead.