Findings from a phase 3 study evaluating the use of once-daily Descovy (emtricitabine 200mg and tenofovir alafenamide 25mg; Gilead) for HIV pre-exposure prophylaxis (PrEP) demonstrated that the treatment was non-inferior to Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg) for prevention of HIV-1 infection.
In the 2-year DISCOVER study, 5387 participants (men who have sex with men and transgender women at risk for sexually acquired HIV infection) were randomized to receive either once-daily Descovy or Truvada; the primary outcome measure of the study was incidence of HIV-1 infection per 100 person-years (PY).
Results showed that among the 2694 participants (4370 patient-years) who received Descovy, 7 HIV infections were reported (HIV incidence 0.16/100 PY), while among those who received Truvada (N=2693; 4386 patient-years), 15 HIV infections were reported (0.34/100 PY). “The very low incidence of HIV in both treatment arms, combined with Descovy’s improved renal and bone safety as compared with Truvada, demonstrate that Descovy for PrEP may help build on the progress made by Truvada, a proven public health tool in the fight against HIV,” said Brad Hare, MD, Chief of Infectious Diseases at Kaiser-Permanente, San Francisco.
Descovy is currently approved in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients weighing at least 35kg. It is also indicated, in combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor, for the treatment of HIV-1 infection in pediatric patients weighing at least 25kg and less than 35kg.
“We look forward to filing regulatory applications for Descovy for the PrEP indication as a potential important new option to prevent individuals from becoming infected and contribute to the achievement of national and global HIV prevention goals,” said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences.
For more information visit Gilead.com.