Health Care

FDA approves second drug to prevent HIV infection

FDA approves second drug to prevent HIV infection”

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.

Truvada was also approved as a daily pill for pre-exposure prophylaxis, or PrEP, in 2012.

Rates of new HIV infections in the United States plateaued after years of steady decline, the Centers for Disease Control and Prevention reported in February.

Descovy is a prescription medicine approved by the US FDA for the treatment of HIV infection in adults and children who weigh at least 35 kg when used together with other HIV medicines, according to the National Institutes of Health website. But this approval for prevention does not include the women to prevent HIV infection. From 48 to 96 weeks, researchers examined participants who took Descovy and compared them to those who took Truvada.

In a statement, the FDA said that Descovy's efficacy in preventing HIV transmission was similar to Truvada (emtricitabine/tenofovir disoproxil fumarate), which became the first drug approved in the U.S. for PrEP in 2012, and has since grown into a $3bn product, with PrEP estimated to account for around $2bn of that total.

Descovy, a combination drug, was approved in 2016 to treat people already infected with HIV.

The U.S. Food and Drug Administration approved the second drug to help prevent HIV infections on Thursday. Enrollment included more than 5,300 adult cisgender men who have sex with men or transgender women (TGW) who have sex with men.

It's a victory for Cuomo's "Ending the Epidemic" initiative, launched in 2014, which aimed to connect undiagnosed patients with proper care and prevent high-risk New Yorkers from contracting the virus, the governor's office said.

The FDA recommends the drug be used as part of a comprehensive strategy to prevent HIV with daily use being combined with safer sex practices like condoms. The trial showed that Descovy was similar to Truvada in reducing the risk of acquiring HIV-1 infection.

Descovy does not prevent other sexually transmitted infections or cure HIV infection or AIDS.

More than 1 million people in the U.S. live with HIV, and 1 in 7 people living with the virus are undiagnosed. The most common adverse reaction in individuals without HIV who were taking Descovy for PrEP was diarrhea. However, it is not intended for those who have receptive vaginal sex as the effectiveness of this population has not been evaluated.

Gilead Sciences, Inc.is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.



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