Doctors in HIV prevention drug trial talk about breakthrough moment | Global Development

Doctors in charge of a clinical trial of a new HIV prevention drug were overcome with emotion when they heard the results. “I literally burst into tears,” Professor Linda Gayle Becker said.

“I'm 62 years old and I've lived through this epidemic. My family has died from HIV, so have many people in Africa and so many people around the world,” she said.

Becker said the problem of how to prevent HIV infection, especially among teenage girls and young women, seemed “unsolvable.” But lenacapavir has been shown to be effective in treating thousands of women between the ages of 16 and 25. South Africa Uganda is 100% protected.

She hopes the drug could give young women greater agency over their lives and sexuality, and potentially end mother-to-child transmission of the virus.

Results Objective 1 Test When Becker, CEO of the Desmond Tutu Health Foundation, presented the findings at the AIDS 2024 conference in Munich this week, the audience gave him a standing ovation.

“Even now, when I see it [results] “When you look at the graphs, it's scary,” Becker said.

AIDS First appeared in 1981 At the time, it was considered a terrible, mysterious disease that was virtually a death sentence. The HIV virus was behind it.It took another two years before the first tests were developed to detect the virus.

In recent years, science has made great advances. Antiretroviral drugs It means people with HIV can lead healthy lives. Preexposure prophylaxis (PrEP) Medicines can prevent infection.

But they are not reaching everyone who needs them. Most new infections are occurring outside sub-Saharan AfricaUN says HIV infection rates remain high among teenagers and young women “Very expensive.” More than 150,000 people were infected in parts of the region last year.

In Becker's controlled trial, women were asked to take a pill every day as a preventative measure against HIV, but as Becker explains, many of them didn't actually take the pills daily and so remained infected.

This explains why a drug that requires only a twice-yearly injection has attracted so much attention. Leaders in the HIV prevention field have described the drug as “miracle“Hidden potential”Game Changer“

“We know it's harder for younger people to comply with anything because they're busy, they have full lives, they have things to do and places they have to go,” Becker said.

“One of my investigators put it beautifully: 'I'm going to take this medicine to protect myself,' is a decision that has to be made every day.”

“On the other hand, if you get an injection every six months, you only have to make this decision twice a year.”

Becker hopes that lenacapavir will give girls and young women at risk of HIV more control over their lives.

“You could sneak in there on the pretext of getting birth control and no one would know,” she said.

Young women can often find themselves in relationships with older men where they “don't have much of a say in how sex happens,” and the power imbalance can make it impossible to ask their partners to use condoms, she said.

“I've heard young women say, 'This surgery has given me incredible control over my sexual identity. I can now decide what happens to my body.'”

Although this is a relatively rare policy in drug testing, Pregnancy does not exclude womenOf these, 193 women have become pregnant while taking lenacapavir. So far, there have been no signs of problems related to the drug.

Becker and his team plan to follow mothers and babies for a longer period to confirm that the drug can prevent transmission of the virus during pregnancy, birth and breastfeeding. 1 in 10 new HIV infections Please come this route.

Becker said offering women with newborns a shot when they leave hospital would have a much bigger impact than expecting them to remember to take their daily pills, and offer the “exciting” prospect of eliminating mother-to-child transmission.

But major concerns remain about how quickly and cheaply the drug can get to market, as Gilead, the pharmaceutical company that developed it, is awaiting the results of further studies. test Please review with other groups before seeking regulatory approval.

Jared Baeten, Gilead Sciences' vice president of clinical development, said at a press conference in Munich that the company would work with manufacturers to help get generic versions approved by regulators.

But he declined to acknowledge whether middle-income countries like Brazil have access to cheaper generic versions of the drug. Seeking cooperation with the UN-backed Medicines Patent Pool To broaden access.

Trial participants will continue to receive lenacapavir, and comparison subjects in the study who are taking the pill will be given the opportunity to switch to the injectable form.

Becker said he would “hold Gilead accountable” if it didn't live up to its promise to allow global access, but added that he had no reason to doubt the company's commitment.

“I'm not a clinical drug tester who does a trial and walks away,” she says. “If there's no access, no matter how good the efficacy is, the impact isn't felt.”