FDA approves second PrEP drug to prevent HIV infection

pharmafile | October 4, 2019 | News story | Medical Communications  

The US FDA has approved Gilead’s Descovy (emtricitabine/tenofovir alafenamide) as a second pre-exposure prophylaxis (PrEP) drug in at-risk adults and adolescents weighing at least 75lbs for the prevention of HIV infection.

The safety and efficacy of the drug were evaluated in the randomised, double-blind multinational DISCOVER trial in 5387 HIV-negative men and transgender women who have sex with men. The trial compared the once-daily Descovy to Truvada.

Participants in the study were followed for 48 to 96 weeks with the primary endpoint being the rate of HIV-1 infection in each group.

The trial ultimately showed that Descovy was similar to Truvada in reducing the risk of acquiring HIV-1 infection. The most common adverse reaction in individuals without HIV who were taking Descovy for PrEP was diarrhoea.

Among the 2,694 participants who were at risk of HIV-1 infection and received once-daily Descovy, only seven reported HIV infection. This was similar to Truvada in which out of 2,693 patients there were only 15 reported infections.

Daniel O’Day, Chairman and Chief Executive Officer at Gilead Sciences, said: “Descovy for PrEP provides a new HIV prevention option that matches Truvada’s high efficacy and statistically significant improvements in renal and bone safety, which can be an important consideration as people at risk increasingly use PrEP for longer periods of time.

“This is a reflection of Gilead’s continued commitment to addressing the evolving needs of people living with or at risk for HIV and to driving innovation across the HIV care continuum.”

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