Findings from the 96-week DISCOVER trial demonstrated the continued noninferiority of Descovy (emtricitabine and tenofovir alafenamide; Gilead) to Truvada (emtricitabine and tenofovir disoproxil fumarate; Gilead) for HIV pre-exposure prophylaxis (PrEP) and statistically significant differences over Truvada for pre-specified secondary end points.
In the phase 3, randomized, double-blind trial, 5387 participants (men who have sex with men and transgender women at risk for sexually acquired HIV infection) were randomized 1:1 to receive either once-daily Descovy or Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg tablets; Gilead). The primary end point of the study was incidence of HIV-1 infection per 100 person-years (PY); a key secondary end point included the incidence rate ratio (IRR) of Descovy to Truvada.
Results showed that among the 2670 participants who received Descovy over 96 weeks, 8 HIV infections were reported (HIV incidence 0.16/100 PY), while among those who received Truvada (N=2665), 15 HIV infections were reported (0.30/100 PY). The 96-week data confirmed the noninferiority of Descovy to Truvada (IRR: 0.54; 95% CI 0.23, 1.26).
In addition, the study showed statistically significant improvements in renal and bone laboratory parameters in patients receiving Descovy compared with those on Truvada. At Week 96, lumbar spine bone mineral density (BMD) and hip BMD increased by 0.95% and 0.65% in the Descovy group, respectively, compared with a decrease of 1.39% and 1.01% in the Truvada group (both P<.001). As for renal safety, statistically significant differences favoring Descovy were noted in mean serum creatinine level, median creatinine clearance and markers of proximal tubular function.
Full data will be presented at the 17th European AIDS Conference (EACS) in Basel, Switzerland.
“The 96-week data from the DISCOVER trial further support the comparable efficacy of Descovy and Truvada for PrEP and offer new insights into the improved renal and bone safety profile of Descovy as measured by key bone and renal markers,” said Diana Brainard, MD, Senior VP, HIV and Emerging Viruses, Gilead Sciences. “As more at-risk people use PrEP for longer periods of time, the data affirm the value of Descovy for PrEP as a new HIV prevention option.”
Descovy is currently approved for HIV-1 PrEP in at-risk adults and adolescents (≥35kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at-risk from receptive vaginal sex (effectiveness in this population has not been evaluated). It is also approved in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients weighing ≥35kg; or 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 ≥25kg and <35kg.
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