Gilead’s Descovy approved in HIV prophylaxis
The FDA has approved Gilead’s combination drug Descovy for HIV prophylaxis in the US, offering a way of cutting the risk of sexually acquired infection with an improved safety profile compared with the company’s older drug, Truvada.
Descovy (emtricitabine+tenofovir alafenamide) has similar active ingredients to Gilead’s older Truvada, except that tenofovir is combined with a different salt to reduce the chance of side effects involving the bones and kidneys.
The combination drug is already approved to suppress viral activity in infected individuals, and the FDA has expanded this to include HIV pre-exposure prophylaxis (PrEP) to reduce risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex.
The exclusion for vaginal sex comes as no surprise: the expert advisory panel that gave non-binding advice on the new pre-exposure prophylaxis (PrEP) indication raised concerns that there was a lack of data on cisgender women at risk of being infected with HIV by a partner.
There were too few people in this patient group included in Gilead’s clinical trials, the experts said, voting 10 to eight against including them in the label.
Descovy, first approved to keep the virus at bay in infected individuals in 2016, breezed through the main vote on approval in the new PrEP indication, with 16 people on the panel in favour and two against.
According to the US Centers for Disease Control and Prevention, 38,739 people received an HIV diagnosis in the US in 2017.
President Donald Trump has since launched an initiative, Ending the HIV Epidemic: A Plan for America in his State of the Union address in February this year.
The new initiative seeks to reduce the number of new HIV infections in the US by 75% within five years and then by at least 90% within 10 years, averting an estimated 250,000 HIV infections.
Trump aims to use Descovy as part of the strategy, including adherence to daily administration and safe sex practices, including condoms, to reduce risk of sexually acquired infections.
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