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F.D.A. Approves New H.I.V.-Prevention Drug, but Not for Women

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Gilead Sciences has also received heavy criticism for selling Truvada for $20,000 per year.

The Food and Drug Administration on Thursday accepted a brand new drug, Descovy, for prevention of an infection with H.I.V., solely the second drug accepted for this function.

The first, Truvada, has turn out to be a mainstay of presidency efforts to show again the H.I.V. epidemic. But the F.D.A. accepted Descovy for use solely in males and transgender girls, as a result of its maker, Gilead Sciences, examined it solely in these teams.

The approval explicitly excludes girls, and doesn’t define a plan for making the drug out there to them. Some activists and scientists mentioned the approval units a harmful precedent by permitting corporations to dodge the costly trials wanted to check medicines in girls.

Such an exclusion of ladies “should be unacceptable in these days and times,” mentioned Dr. Rochelle Walensky, chief of infectious illnesses at Massachusetts General Hospital.

It’s essential to check the drug particularly in girls, she added, as a result of Descovy may match in a different way within the vagina than in rectal tissues.

The F.D.A., the truth is, would require Gilead to check the Descovy in girls, firm officers mentioned. Gilead is contemplating a trial in Africa.

Gilead additionally makes Truvada. Both medicines are to be taken day by day, an H.I.V.-prevention technique known as pre-exposure prophylaxis, or PrEP.

The firm has come under heavy criticism for promoting Truvada at a excessive value, at the moment about $20,000 a yr. Critics have mentioned the expense retains the drug out of attain of Americans who would profit from it. Few sufferers truly pay the total worth, Gilead has mentioned.

Less costly generic variations of Truvada are anticipated subsequent yr, because the drug’s patent protections expire. But Descovy’s approval ensures Gilead’s continued dominance of the market for PrEP, mentioned Jeremiah Johnson, a undertaking director at Treatment Action Group, an advocacy group.

Descovy shouldn’t be simpler than Truvada, Mr. Johnson famous. But in numerous presentation supplies, Gilead occasionally has hinted that it’s, and Mr. Johnson and others concern sufferers could reject reasonably priced and accessible generic variations of Truvada in favor of the costlier Descovy.

CreditStephen Lam/Reuters

Any suggestion that Descovy is simpler than Truvada was unintentional, mentioned Dr. Diana Brainard, who oversees Gilead’s H.I.V. division. The firm’s message, she added, is that each Descovy and Truvada are extremely efficient at stopping H.I.V. an infection when taken day by day.

“It’s always good to have choice,” she mentioned.

Descovy’s patent is meant to run out in 2026, but a nonprofit group known as Prep4All Collaboration hopes to discover a option to finish it in 2022.

The group had been working a marketing campaign known as “Break the Patent” to restrict Truvada’s patent safety, which was presupposed to expire in 2021. But in May, Gilead introduced {that a} generic model could be out there subsequent yr.

“As of today, we’re adding an ‘s’ — it’s ‘Break the Patents,’” mentioned Peter Staley, a founding father of the collaboration.

Descovy comprises a more recent model of tenofovir, the energetic ingredient in Truvada. Gilead examined Descovy in a multinational trial that included 5,313 males and 74 transgender girls who’ve intercourse with males. There have been no cisgender girls, and 84 p.c of the contributors have been white.

“They did a terrible job of inclusion for a company that dominates the market,” Mr. Johnson mentioned.

There are some knowledge suggesting that Descovy has fewer uncomfortable side effects on bones and kidneys than Truvada, but these issues have solely been seen in a small variety of individuals taking Truvada, Dr. Walensky mentioned.

She additionally famous that though Gilead scientists have introduced a few of their knowledge at conferences, they’ve but to publish their ends in a peer-reviewed journal.

At a listening to in August, some activists urged the F.D.A. to disclaim approval for use of Descovy in girls, or to require Gilead to check the drug in a lot of girls promptly after approval.

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Unless pressured to take action by the F.D.A., critics mentioned, the corporate has no motivation to check the drug in girls.

“We had at least hoped that they would say something the day they approved it 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,” Mr. Staley mentioned.

Although the F.D.A.’s announcement doesn’t point out it, the company is requiring such a examine.

Dr. Brainard mentioned Gilead plans to begin the examine in a minimum of 1,500 high-risk girls in southern Africa — the place the incidence of H.I.V. in girls is increased than within the United States — by the tip of 2020. The F.D.A.’s approval letter requires the corporate to finish the trial by December 2024.

Dr. Walensky mentioned she is dissatisfied by the numbers and timeline of that trial.

“I want to see a large-scale, rapid effort to get data in women as soon as possible,” she mentioned. “That, in my thoughts, is the one option to rectify this.”

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