U.S. FDA approves Gilead's Descovy for HIV prevention

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"PrEP drugs are highly effective when taken as indicated in the drug labeling and can prevent HIV infection", said Jeffrey Murray, M.D., deputy director of the Antiviral products division at the FDA.

Gilead's chief executive Daniel O'Day said that Descovy's offers "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".

Since 2012, Americans at risk of HIV-1 infection from sex have had just a single option for reducing their odds of acquiring it: a daily dose of Gilead Sciences Inc.'s Truvada (emtricitabine and tenofovir disoproxil fumarate).

However, the FDA followed the advice of its advisor committee and didn't approve use of the drug in people at-risk for HIV from receptive vaginal sex, saying the data in this case wasn't strong enough.

The U.S. Food and Drug Administration approved the second drug to help prevent HIV infections on Thursday.

Descovy (emtricitabine and tenofovir alafenamide) has been cleared for adolescents and adults who are at risk of HIV infection because they have sex with an HIV-positive partner.

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That excludes cisgender women from the label, in other words women whose perceived gender corresponds to their birth sex, a group thought to account for around 7% of current PrEP prescriptions.

Results from the DISCOVER trial demonstrated that Descovy achieved non-inferiority to Truvada in study participants who were at risk of HIV acquisition.

What do the drugs Truvada and Descovy treat? . These data, which were presented in March at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI), included 5,387 individuals who were randomized 1:1 to receive either Descovy or Truvada.

Gilead has for some time been struck by HIV activists like the PrEP4All alliance over the significant expense of Truvada and the conditions of Truvada's advancement and testing, which was to a great extent subsidized by private benefactors and the USA government. Both Descovy and Truvada are manufactured by the pharmaceutical company Gilead Sciences. It does not prevent other sexually transmitted infections or cure HIV infections or AIDS.

Today, the U.S. Food and Drug Administration approved Gilead's drug Descovy to be used as PrEP, an HIV prevention strategy that when taken properly makes it virtually impossible to contract the virus from someone who's living with HIV.

Prevention methods, including PrEP, and safer sex practices are essential tools in the effort to end the HIV epidemic. It is because the FDA has not evaluated the effectiveness of this significant population.

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