The US Food and Drug Administration has green-lighted Gilead Sciences’ Descovy for the treatment of HIV, marking the first approval of new core therapy for the disease in more than 10 years.
Descovy consists of emtricitabine and tenofovir alafenamide (F/TAF), a novel targeted prodrug of tenofovir that has shown high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread (tenofovir disoproxil fumarate, TDF).
Because TAF enters cells more efficiently than TDF it can be given at a much lower dose, and the drug has also shown an improvement in renal and bone safety in clinical trials in combination with other antiretroviral agents.
The drug has been approved for use alongside other other antiretroviral agents to fight the virus in adults and paediatric patients 12 years of age and older; it it not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of becoming infected with the disease.
According to Norbert Bischofberger, Gilead’s chief scientific officer, Descovy represents “an important evolution” in the treatment of HIV. “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,” he said.
The drug carries a boxed warning in its product label informing physicians and patients of the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B.