FDA on Thursday approved Gilead Science's Descovy to prevent HIV infection in men and transgender women, and some critics are taking issue with the agency's decision to approve the drug before Gilead tested it on a large scale in cisgender women, Apoorva Mandavilli reports for the New York Times.

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Details on the drug

Descovy is part of an HIV-prevention strategy called pre-exposure prophylaxis (PrEP), whereby patients at very high risk for HIV infection take medication to reduce the likelihood of infection. Descovy is only the second PrEP drug that has been approved by FDA, according to Mandavilli. The other is Gilead's Truvada.

For the latest approval, Gilead tested Descovy in a multinational randomized double blind trial of HIV-negative patients. The trial included 5,313 men and 74 transgender women who have sex with men, Mandavilli reports. The trial did not include cisgender women. In the trial, 84% of participants were white.

Based on the trial results, FDA approved Descovy as PrEP treatment for adults and adolescents who weigh at least 35kg, "excluding those who have receptive vaginal sex." FDA in a release explained, "Descovy is not indicated in individuals at risk of HIV-1 infection from receptive vaginal sex because the effectiveness in this population has not been evaluated."

According to Gilead, FDA has required the company to conduct trials in women, though the agency did not outline a plan for how it will test the drug in cisgender women.

Rochelle Walensky, chief of infectious diseases at Massachusetts General Hospital, said it's important the drug is specifically tested in cisgender women, as it may work differently in the vagina than in rectal tissue.

Gilead should've tested Descovy in women, critics say

Some critics have argued that approving the drug under the current circumstances "sets a dangerous precedent by allowing companies to dodge the expensive trials needed to test medicines in cisgender women," Mandavilli writes.

For instance Walensky said the exclusion of cisgender women from FDA's approval of the drug "should be unacceptable in these days and times."

Separately, Jeremiah Johnson, a project director at Treatment Action Group, an advocacy organization, said Gilead "did a terrible job of inclusion for a company that dominates the market."

Peter Staley, founder of the Prep4All Collaboration, a nonprofit that aims to promote generic versions of PrEP, said, "We had at least hoped that [FDA] would say something the day they approved [Descovy] without an indication for women, that they would have a plan or forceful language laid out on how this disgraceful situation is going to be rectified."

Diana Brainard, who oversees Gilead's HIV division, said the drugmaker by the end of 2020 plans to study at least 1,500 high-risk cisgender women in southern Africa, where HIV rates among cisgender women are higher than the United States. FDA is requiring Gilead to complete its trial by December 2024.

Walensky said she was disappointed by FDA's timeline. "I want to see a large-scale, rapid effort to get data in women as soon as possible," she said. "That, in my mind, is the only way to rectify this" (Mandavilli, New York Times, 10/4; "Pre-Exposure Prophylaxis," CDC.gov, 9/26; FDA release, 10/3).