The supplemental New Drug Application (sNDA) for Descovy (emtricitabine 200mg and tenofovir alafenamide 25mg tablets; Gilead), for pre-exposure prophylaxis (PrEP) to prevent HIV-1 infection in those who are HIV-negative and at risk for HIV, has been submitted to the Food and Drug Administration (FDA) for review.
The sNDA includes data from the phase 3 DISCOVER trial. In the 2-year 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 (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg tablets; Gilead); 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). In addition, the study showed statistically significant improvements in renal and bone laboratory parameters in patients receiving Descovy compared with those on Truvada.
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.
The sNDA for Descovy for PrEP was filed by Gilead for Priority Review by the FDA. “If approved, Descovy may help equip healthcare providers with an additional preventive option thereby potentially expanding the impact of PrEP,” said Edwin DeJesus, MD, FACP, FIDSA, Medical Director, Orlando Immunology Center.
For more information visit Gilead.com.