Prof Linda-Gail Bekker receives ovation at Aids summit after presenting trial results of ‘miracle’ drug lenacapavir.
When the doctor leading the trial of a groundbreaking HIV prevention drug received the results, she was overwhelmed with emotion. “I literally burst into tears,” shared Prof. Linda-Gail Bekker.
“At 62, I’ve lived through this epidemic. I’ve lost family members to HIV, as have countless others in Africa and across the globe,” she reflected.
The challenge of preventing HIV, particularly among teenage girls and young women, had once seemed insurmountable, according to Bekker. However, lenacapavir has now provided 100% protection to thousands of women aged 16 to 25 in South Africa and Uganda.
She hopes the drug will empower young women with greater control over their lives and sexuality, and potentially eradicate mother-to-child transmission of the virus.
The results of the Purpose 1 trial earned Prof. Linda-Gail Bekker, the chief executive of the Desmond Tutu Health Foundation, a standing ovation when she presented them at the AIDS 2024 conference in Munich this week.
“Even now, when I look at that results graph, I get shivers,” Bekker remarked.
AIDS first emerged in 1981 as a terrifying mystery disease, essentially a death sentence at the time. It wasn’t until 1983 that scientists identified the HIV virus as the cause, and another two years passed before the first test was developed to detect it.
While there has been tremendous scientific progress in recent years—with antiretroviral drugs enabling people with HIV to live healthy lives and pre-exposure prophylaxis (PrEP) drugs offering protection against infection—these advancements aren’t reaching everyone who needs them. Despite the global decline in new infections, the UN reports that HIV incidence remains “extraordinarily high” among teenagers and young women in parts of sub-Saharan Africa, with more than 150,000 new cases reported there last year.
In a comparative part of Bekker’s trial, women were asked to take daily pills as PrEP against HIV. Many continued to become infected, as Bekker explained, because they did not consistently take the pills.
This highlights why the results for a drug that requires only two injections per year have generated such excitement. Experts in HIV prevention are calling the drug a “miracle” and a potential “gamechanger.”
“We know that adherence to anything is more challenging for younger people—they’re busy, their lives are full, they have things to do, places to be,” Bekker said.
“One of my investigators puts it beautifully: it’s a daily decision you have to make, ‘I’m going to take this pill and protect myself.’ But with a six-monthly injection, you only have to make that decision twice a year,” Bekker explained.
Prof. Bekker hopes lenacapavir will empower girls and young women at risk of HIV infection to have greater control over their lives. “You could imagine quietly slipping in,” she suggested, “under the guise of getting your contraceptive; nobody even needs to know.”
She noted that young women are often in relationships with older men where they lack the power to negotiate condom use, which can make it impossible for them to protect themselves. “I’ve heard young women say, ‘this has given me incredible control over my own sexual identity. I now decide what happens to my body.’”
In an uncommon move for drug trials, women were not excluded if they became pregnant, and 193 participants did so while on lenacapavir. So far, no drug-related issues have been observed. Bekker and her team plan to monitor the mothers and babies longer to confirm whether the drug can prevent mother-to-child transmission during pregnancy, childbirth, and breastfeeding—a route responsible for a tenth of new HIV infections.
Offering women a postpartum injection as they leave the hospital, instead of relying on them to remember a daily pill, could have a much greater impact and raises the “exciting” possibility of eliminating mother-to-child transmission, according to Bekker.
However, questions remain about how quickly and affordably the drug will reach the market. Gilead, the pharmaceutical company behind lenacapavir, is awaiting results from further trials in other groups before seeking regulatory approval.
At a briefing for journalists in Munich, Jared Baeten, Gilead’s vice-president for clinical development, assured that the company would collaborate with manufacturers to ensure generic versions receive regulatory approval. However, he did not confirm whether middle-income countries like Brazil would have access to cheaper, generic forms of the drug. Gilead has also resisted calls to work with the UN-backed Medicines Patent Pool to widen access.
Trial participants will continue receiving lenacapavir, and those in the study’s comparison group using pills can switch to the injectable.
Bekker emphasized that she would “hold Gilead to account” if they did not follow through on their pledges to ensure global access but added that she had no reason to doubt their commitment. “I’m not the clinical drug trialist who does the trial and walks away,” she said. “The impact will not be felt—no matter how good the efficacy is—if we don’t have access.”
