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News From the Food and Drug Administration
November 5, 2019

PrEP Drug Is Approved for Some Patients but Not for Others

JAMA. 2019;322(17):1644. doi:10.1001/jama.2019.17814

A second drug has received approval as preexposure prophylaxis (PrEP) for HIV-1. The combination of emtricitabine and tenofovir alafenamide is indicated for men and transgender women who have sex with men. But the drug isn’t indicated for cisgender (those whose gender identity aligns with their birth sex) women because they weren’t included in an international clinical trial.

Marketed as Descovy, the drug was approved in 2016 to treat HIV-1 infection. As HIV prevention, it follows another combination—emtricitabine and tenofovir disoproxil fumarate—that was approved in 2012 and is marketed as Truvada. Descovy is safer for kidneys and bones and produces higher intracellular tenofovir diphosphate levels and lower plasma levels of tenofovir than Truvada.

In a phase 3 clinical trial involving 5387 HIV-negative men and transgender women who have sex with men, investigators compared the safety and efficacy of Descovy with Truvada, each given once daily. The primary end point was the HIV infection rate per 100 person-years when half the participants had completed 96 weeks of treatment. Investigators reported that the drugs were similarly effective at preventing HIV infection among cisgender men and transgender women at high risk of acquiring HIV sexually.

The FDA’s Antimicrobial Drugs Advisory Committee in August was divided on questions concerning approval. The panel thought data supported Descovy as PrEP for cisgender men and transgender women but not cisgender women. Drugmaker Gilead Sciences, Inc took heat from the panel for excluding cisgender women from the international trial. Temporary committee member Dawn K. Smith, MD, MPH, of the Centers for Disease Control and Prevention was quoted in Medscape as calling the company’s approach “bad science” and “disrespectful.”

Descovy carries a boxed warning that cautions patients with hepatitis B virus infection of potential exacerbations upon discontinuing the drug.