US biotechnology company Gilead has reported positive data from the 96-week DISCOVER trial of Descovy for HIV pre-exposure prophylaxis (PrEP) in at-risk populations.
The multi-year global Phase III registrational DISCOVER trial evaluated the safety and efficacy of once-daily Descovy for PrEP compared with Truvada for PrEP in men and transgender women at risk for sexually acquired HIV infection.
The study demonstrated continued non-inferior efficacy and continued favourable changes in key markers of renal and bone safety at week 96 compared with Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg, F/TDF) for PrEP.
It also found that participants receiving Descovy had stable lipid levels through the 96 weeks, whereas those receiving Truvada reported decreases in lipid levels after 48 and 96 weeks.
These results were obtained in the overall study population of men and transgender women at risk for HIV infection. The sub-populations of the study included participants aged 50 and older, those younger than 25, and those with moderate renal impairment.
Gilead Sciences HIV and Emerging Viral Infections senior vice-president Diana Brainard said: “At Gilead, we believe continued scientific innovation is essential to altering the future of the HIV epidemic.
“The longer-term efficacy and safety outcomes from the DISCOVER trial continue to demonstrate that Descovy is effective for HIV prevention with non-inferior efficacy to Truvada, and that Descovy has an improved bone and renal safety profile compared with Truvada.”
Descovy for PrEP in the US, is indicated to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents weighing at least 35kg.
Another analysis of the DISCOVER trial found that Descovy and Truvada were effective and well-tolerated in Black and Hispanic/Latinx participants.