FDA Approves New Combo Drug for HIV

The US Food and Drug Administration has approved biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF) for the treatment of HIV-1 infection in adults who have no history of antiretroviral therapy use.

It also can replace the current antiretroviral regimen in adults who are virologically suppressed on a stable antiretroviral regimen for at least 3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of biktarvy.

Biktarvy is a once-daily single tablet regimen (STR) that is the smallest integrase strand transfer inhibitor-based triple-therapy STR available.

The approval comes after a 48-week trial that showed participants taking biktarvy did not develop treatment resistance. In fact, the regimen showed antiviral efficacy, tolerability, and limited drug interactions.

Common adverse events reported by participants were diarrhea, nausea, and headache.

—Amanda Balbi

Reference:

U.S. Food and Drug Administration approves Gilead’s biktarvy® (bictegravir, emtricitabine, tenofovir alafenamide) for treatment of HIV-1 infection [press release]. Foster City, CA: Gilead; February 7, 2018. http://www.gilead.com/news/press-releases/2018/2/us-food-and-drug-administration-approves-gileads-biktarvy-bictegravir-emtricitabine-tenofovir-alafenamide-for-treatment-of-hiv1-infection. Accessed February 8, 2018.