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# FDA OKs Gilead’s Descovy for HIV Prevention
- URL: https://www.fdaweb.com/fda-oks-gileads-descovy-for-hiv-prevention/
- Published: 2019-10-03T12:00:00.000Z
- Updated: 2026-09-15T01:54:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145160

FDA has approved Gilead Sciences’ Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for use in at-risk adults and adolescents weighing at least 35kg for HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex. The drug was first approved [in 2016](https://c212.net/c/link/?t=0&l=en&o=2600765-1&h=2335554873&u=https%3A%2F%2Fwww.accessdata.fda.gov%2Fdrugsatfda%5Fdocs%2Flabel%2F2016%2F208215s000lbl.pdf&a=in+2016&ref=fdaweb.com) in combination with other antiretoviral drugs to treat HIV-1 infection in adults and pediatric patients.

An [FDA release](http://s2027422842.t.en25.com/e/es?s=2027422842&e=261164&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=69e5036c795b4988a47c3eb9e1bd7198&elqaid=9743&elqat=1&ref=fdaweb.com) says PrEP is an HIV prevention method in which people who do not have HIV take medicine on a daily basis to reduce their risk of getting HIV if they are exposed to it. “Descovy for PrEP should be used as part of a comprehensive strategy, including adherence to daily administration and safer sex practices, including condoms, to reduce the risk of sexually acquired infections,” it says.

Approval was based on data from a double-blind multinational trial in 5,387 HIV-negative men and transgender women who have sex with men and were at risk of HIV-1 infection. The trial compared once daily Descovy to Gilead’s other PrEP therapy Truvada (emtricitabine, tenofovir disoproxil fumarate, 200 mg/300 mg). The primary endpoint was the rate of HIV-1 infection in each group, and data showed that Descovy was similar to Truvada in reducing the risk of acquiring HIV-1 infection. The most common adverse reaction was diarrhea.

The approval also required a boxed warning for those who take Descovy who also have hepatitis B virus (HBV) to be aware of the risk of exacerbations of HBV if they discontinue Descovy therapy.