New TAF-Based HIV Treatment Approved

The FDA has approved Gilead Sciences' emtricitabine 200 mg/tenofovir alafenamide 25 mg (Descovy), a treatment for HIV.

The FDA has approved Gilead Sciences’ emtricitabine 200 mg/tenofovir alafenamide 25 mg (F/TAF) (Descovy), a treatment for HIV.

The fixed-dose drug is designed to be used in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients aged 12 years or older.

Descovy should not be used as pre-exposure prophylaxis.

The treatment has a boxed warning on the risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment acute exacerbation of hepatitis B.

The FDA’s decision was based on data from 2 phase 3 studies involving 48 weeks’ worth of data. The treatment met its primary objective of noninferiority compared with elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg in treatment-naive patients.

Tests of certain renal and bone laboratory parameters favored the intervention treatment.

In addition, bioequivalence studies showed that Descovy achieved the same drug levels of TAF and emtricitabine in the blood as Genvoya.

“As the first new HIV treatment backbone approved by the FDA in more than a decade, Descovy represents an important evolution in HIV care,” said Norbert Bischofberger, executive vice president of research and development and chief scientific officer at Gilead Sciences, in a press release. “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.”

Some of the side effects observed in patients using Descovy include changes in body fat, immune system changes, and new or worsening kidney problems. Some bone problems, such as pain or softening, have also occurred in patients.