Gilead Sciences announces data from Phase III studies of switching from Truvada (emtricitabine and tenofovir disoproxil fumarate 200mg/300mg; FTC/TDF) to Descovy (emtricitabine and tenofovir alafenamide 200mg/25mg; FTC/TAF).

Gilead Sciences, Inc. announced two-year (96-week) data from a Phase III study and 48-week data from two Phase IIIb studies evaluating the safety and efficacy of switching virologically suppressed HIV-1 infected patients from regimens containing Truvada (emtricitabine and tenofovir disoproxil fumarate 200mg/300mg; FTC/TDF) to regimens containing Descovy (emtricitabine and tenofovir alafenamide 200mg/25mg; FTC/TAF). Results demonstrated regimens containing Descovy to be statistically non-inferior to regimens containing Truvada, with improvements in certain renal and bone laboratory parameters among patients receiving Descovy (FTC/TAF)-based regimens. The data were presented in an oral session (Treatment Strategies) at the 2016 HIV Glasgow conference in Glasgow, Scotland, UK.

Descovy is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients 12 years of age and older. Descovy should not be used as pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV-1 infection. Descovy has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B.