FDA Approves PrEP Drug

Henrietta Strickland
October 7, 2019

Descovy is a PrEP or pre-exposure prophylaxis drug, which means the drug is taken daily to lower the risk of getting HIV among people who don't have the disease but are at risk.

The company also said in a statement that the latest data have shown that major metropolitan areas in the U.S. with HIV PreEP have experienced the greatest decreases in new diagnoses.

Like Truvada, Descovy is taken once every day and can decrease the transmission of HIV by more than 95 percent.

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

Descovy had previously been approved in 2016 for HIV treatment when taken in combination with antiretroviral drugs.

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). Men who have sex with other men remain at a disproportionately high risk for contracting the virus, and most new cases are reported in the South, the fund reported.

This opportunity to eliminate new HIV infections in our nation seeks to provide our hardest-hit communities with additional expertise, technology and resources required to address the HIV epidemic.

Descovy is approved as a pre-exposure prophylaxis for HIV prevention in men and transgender women who have sex with men. 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. 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.

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.

The plan would pinpoint "geographic hotspots" with high rates of HIV infections, increase early diagnoses and widen the availability viral suppression treatment and preventative drugs, according to the Minority HIV/AIDS Fund. The most common adverse reaction in individuals without HIV who were taking Descovy for PrEP was diarrhea.

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. However, it is not intended for those who have receptive vaginal sex as the effectiveness of this population has not been evaluated.

Other reports by Click Lancashire

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