SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for HIV from Gilead Sciences. The company announced Monday that it had received the agency’s approval for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg, F/TAF).
The drug is indicated to treat HIV in combination with other antiretroviral agents in patients 12 years of age and older. It is not indicated as pre-exposure prophylaxis to reduce the risk of contracting sexually acquired HIV-1. Descovy has a similar antiviral efficacy to Gilead’s Viread (tenofovir disoproxil fumarate), but contains one-tenth the dose of tenofovir as Viread, the company said.
“As the first new HIV treatment backbone approved by the FDA in more than a decade, Descovy represents an important evolution in HIV care,” Gilead chief scientific officer and EVP research and development Norbert Bischofberger said. “As part of a single tablet regimen or partnered with a third agent, the components of Descovy offer patients a simple and effective combination with a safety profile that has the potential to improve health.”
Descovy comes with a boxed warning about the risk of lactic acidosis/severe hepatomegaly with steatosis, as well as post-treatment acute exacerbation of hepatitis B.