When the doctor behind the trial of a new HIV prevention drug heard the results, she couldn’t contain her emotions. “I literally burst into tears,” said Prof. Linda-Gail Bekker.
“I’m 62, I’ve lived through this epidemic… I had family members who died of HIV, as did many Africans – many people all over the world,” she said.
The problem of how to prevent HIV infection, particularly in teenage girls and young women, seemed “insoluble,” Bekker said. But lenacapavir offered 100 percent protection to thousands of women aged 16 to 25 in South Africa and Uganda.
She hopes the drug can give young women more control over their own lives and sexuality and prevent the transmission of the virus from mother to child.
The results of the Objective 1 trial earned Bekker, CEO of the Desmond Tutu Health Foundation, a standing ovation when she presented them this week at the AIDS 2024 conference in Munich.
“Even now, when I look at that (results) graph, I get shivers,” said Bekker.
AIDS first appeared in 1981 as a terrifying mystery disease that was effectively a death sentence at the time. It wasn’t until 1983 that scientists discovered that the HIV virus was behind it, and another two years before the first test was developed to detect the virus.
Tremendous scientific advances have been made in recent years and antiretroviral drugs are allowing people with HIV to lead healthy lives. Pre-exposure prophylaxis (PrEP) Medicines can provide protection against infections.
But they are not reaching everyone who needs them and while most new infections are now occurring outside sub-Saharan Africa, the UN says HIV incidence among teenagers and young women remains low. “exceptionally high” in parts of the region, where more than 150,000 people were infected last year.
In a comparative part of Bekker’s trial, women were asked to take daily pills as PrEP against HIV. They continued to get infected – because, Bekker explains, many of them were not taking the pills daily.
It illustrates why the results for a drug that only needs to be injected twice a year have generated so much excitement. Leaders in the HIV prevention field describe the drug as a “miracle“with the potential to be a “game changer”.
“We know that it’s more challenging for young people to stick to something because they’re busy, they have full lives, they have things to do and they have places to go,” Bekker said.
“One of my researchers puts it beautifully: It’s a daily decision you have to make: ‘I’m going to take this pill and protect myself.’
“Whereas if you take a six-monthly injection, you only have to make this decision twice a year.”
Bekker hopes that girls and young women at risk of HIV infection will gain more control over their own lives with lenacapavir.
“You can imagine sneaking in,” she said, “under the guise of getting your birth control; no one even has to know.”
Young women can find themselves in relationships “where they don’t have much say in how they have sex,” often with older men, where a power imbalance can make it impossible to ask their partner to use a condom, she said.
“I’ve heard young women say, ‘This has given me incredible control over my own sexual identity. I now control what happens to my body.’”
In a policy that remains relatively rare for drug trials, pregnancy did not exclude women, and 193 became pregnant while taking lenacapavir. There have been no signs of drug-related problems so far.
Bekker and her team will follow the mothers and babies longer to confirm that the drug can prevent transmission from mother to child during pregnancy, childbirth and breastfeeding. One-tenth of new HIV infections come via this route.
According to Bekker, offering a woman with a newborn baby an injection when she leaves the hospital is likely to have a much greater impact than expecting her to take a pill every day. Moreover, it raises the “exciting” prospect of eliminating mother-to-child transmission.
Questions remain, however, with major concerns about how quickly and cheaply the drug will come to market. The pharmaceutical company behind the drug, Gilead, is awaiting the results of further samples in other groups before seeking regulatory approval.
At a press conference in Munich, Jared Baeten, vice president of clinical development at Gilead Science, promised that the company would work with manufacturers to ensure that generic versions receive regulatory approval.
But he would not confirm that middle-income countries such as Brazil would have the opportunity to get cheaper, generic forms of the drug. Gilead has also resisted calls to work with the U.N.-backed Medicines Patent Pool to broaden access.
Study participants will continue to receive lenacapavir, and those in the comparison part of the study who were taking pills will also have the option of switching to injectables.
Bekker said she would “hold Gilead accountable” if the company failed to deliver on its promises to provide global access, but added that she had no reason to doubt its commitment.
“I’m not the clinical drug researcher who runs the trial and walks away,” she said. “The impact is not going to be felt — no matter how good the efficacy is — if we don’t have access.”