FDA supports Gilead's cutting edge HIV PrEP pill, Descovy

Henrietta Brewer
October 7, 2019

"Descovy for PrEP provides a new HIV prevention option that matches Truvada's high efficacy with 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", Daniel O'Day, Gilead's CEO, said in an announcement.

The approval is part of long-term efforts to end the HIV epidemic by 2030.

The aim is to reduce new infections by 75% in the next five years and by 90% in the next ten years, averting more than 250,000 HIV infections in that span.

Descovy had previously been approved in 2016 for HIV treatment when taken in combination with antiretroviral drugs. The drug is a fixed-dose combination containing 200mg of emtricitabine and 25 mg of tenofovir alafenamide.

Descovy is presently affirmed for HIV PrEP in everybody with the exception of individuals who have vaginal sex, since its adequacy has not been concentrated in this populace; for these patients, Truvada is an endorsed alternative.

An FDA panel in August recommended approval for the drug in reducing the risk of HIV infection in men and transgender women who have sex with men.

What do the drugs Truvada and Descovy treat? . This is a medicine taken daily by an HIV-negative patient to prevent contraction of the virus.

Food and Drug Administration approves Gilead's Descovy as a preventive drug for HIV but not for vaginal infection: Food and Drug Administration, on 3rd October, approves Gilead's Descovy drug for HIV prevention.

The U.S. Food and Drug Administration on Thursday approved Gilead Sciences Inc's drug, Descovy, to reduce the risk of sexually acquired HIV infection. 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.

"PrEP drugs are highly effective when taken as indicated in the drug labeling and can prevent HIV infection", said Dr. Jeffrey Murray, deputy director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research.

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. But it is not approved for the prevention of HIV transmitted by vaginal sex.

The FDA-approved label for Descovy, while more limited than Truvada's, "comes as expected", RBC Capital Markets analyst Brian Abrahams said in a research note. But Descovy not preventing HIV from vaginal sex is unsafe if misconstrued for it.

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