Results from a subanalysis of the DISCOVER trial, showed that Descovy (emtricitabine and tenofovir alafenamide), when used for HIV pre-exposure prophylaxis (PrEP) therapy, reached intracellular drug concentration levels above the estimated protective threshold significantly faster than Truvada (emtricitabine and tenofovir disoproxil fumarate).
This pharmacokinetic data from DISCOVER was presented at the 10th International AIDS Society Conference on HIV Science (IAS 2019). In the 2-year DISCOVER study, over 5000 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 for PrEP; the primary outcome measure of the study was incidence of HIV-1 infection per 100 person-years (PY). Results showed that the study met the primary end point of noninferiority.
Compared with Truvada, individuals who received Descovy for PrEP had a significantly reduced time to achieve a 90% effective concentration (EC90) of tenofovir diphosphate in peripheral blood mononuclear cells (PBMCs) and these levels were found to be 6.3-fold higher with Descovy at Week 4. “Low tenofovir diphosphate concentrations in PBMCs were associated with an increased risk of HIV acquisition,” said Christoph Spinner, School of Medicine at Technical University of Munich and lead study author. “These results provide valuable new information about the profile of Descovy for its potential use as PrEP.”
The supplemental New Drug Application (sNDA) for Descovy for PrEP was submitted for priority review by Gilead in April 2019. 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.
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