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’ve had family members die from HIV, as have many, many Africans – many people around the world,” she said.
The problem of how to prevent HIV infection, especially in teenage girls and young women, seemed “unsolvable”, Bekker said. But lenacapavir has offered thousands of women between the ages of 16 and 25 South Africa and Uganda 100% protection.
The drug could give young women greater agency over their lives and sexuality, she hopes, and potentially eliminate mother-to-child transmission of the virus.
The results of the Aim 1 trial prompted a standing ovation for Bekker, chief executive of the Desmond Tutu Health Foundation, when she presented it at the AIDS 2024 conference in Munich this week.
“Even now, when I look at it [results] chart, I get chills,” Bekker said.
AIDS first emerged in 1981 as a terrifying mystery which was then in fact a death sentence. It took until 1983 for scientists to identify that the HIV virus was behind itand another two years before the first test was developed to detect the virus.
There have been great scientific advances in recent years, and antiretroviral drugs means that people living with HIV can have healthy lives. Pre-exposure prophylaxis (PrEP) drugs can protect against infection.
But they don’t reach everyone they need and while most new infections now occur outside sub-Saharan Africasays the UN HIV prevalence among teenagers and young women remains “extraordinarily high” in parts of the region, with more than 150,000 infected there last year.
In a comparative part of Bekker’s trial, women were asked to take pills daily as PrEP against HIV. They continued to get infected – because, Bekker explains, many of them were not actually taking the pills daily.
This illustrates why the results for a drug that only needs to be injected twice a year have caused so much excitement. Leaders in the field of HIV prevention describe the drug as a “miracle” with the potential to be a “game changer“.
“We know that complying with anything is more challenging for younger people – and that’s because 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.’
“If you take a six-monthly injection, you only have to make this decision twice a year.”
Bekker hopes lenacapavir will give girls and young women at risk of HIV infection greater control over their own lives.
“You can imagine that you can quietly slip in,” she said, “under the guise of getting your contraceptive; no one even needs 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 ‘it gave me incredible control over my own sexual identity. I now decide what happens to my body.’”
In a policy that remains relatively rare for drug trials, getting pregnant did not exclude women, and 193 became pregnant while taking lenacapavir. There are no signs of drug-related problems so far.
Bekker and her team will follow the mothers and babies for longer to confirm that the drug can prevent mother-to-child transmission during pregnancy and childbirth, and during breastfeeding. One tenth of new HIV infections come via this route.
Offering women with a newborn a shot when she leaves the hospital is likely to have a far greater impact than expecting her to remember a daily pill, Bekker said, and that creates the “exciting” prospect of eliminate mother-to-child transmission.
However, questions remain with great concern about how quickly and cheaply the drug will reach the market. The pharmaceutical company behind the drug, Gilead, is waiting for further results trials in other groups before seeking regulatory approval.
Jared Baeten, vice president of clinical development at Gilead Science, promised during a briefing for journalists in Munich that the company will work with manufacturers to ensure that generic versions receive regulatory approval.
But he would not confirm that middle-income countries like Brazil will have the opportunity to get cheaper, generic forms of the drug. Gilead also resisted calls to cooperate with the UN-backed Medicines Patent Pool widening access.
Trial participants will continue to receive lenacapavir, and those in the comparative part of the study using pills also have the chance to switch to the injectable.
Bekker said she would hold Gilead accountable if the company did not follow through on promises to allow global access, but added that she had no reason to doubt their commitment.
“I’m not the clinical drug subject who does the trial and walks away,” she said. “The impact won’t be felt – no matter how good the efficiency – if we don’t have access.”
