- Lenacapavir provides 100% HIV protection
- Drug needs only two annual doses
- Could empower young women at risk
The results overwhelmed the doctor in charge of a new HIV preventive medication trial with emotion. “I literally burst into tears,” Prof. Linda-Gail Bekker admitted.
“I’m 62, and I’ve witnessed this plague… I have family members who died from HIV, as did many, many Africans and others all around the world,” she explained.
Bekker described the difficulty of preventing HIV infection, particularly among adolescent girls and young women, as “intractable.” However, lenacapavir provided 100 percent protection to thousands of women aged 16 to 25 in South Africa and Uganda.
She expects that the medicine will allow young women more control over their lives and sexuality, as well as perhaps reduce viral transmission from mother to child.
When Bekker, CEO of the Desmond Tutu Health Foundation, delivered the Purpose 1 trial results at the Aids 2024 conference in Munich this week, she received a standing ovation from the audience.
“Even now, when I look at that [results] graph, I get shivers,” Bekker told me.
Aids originally appeared in 1981 as a scary mystery disease that was essentially a death sentence. It took scientists until 1983 to determine that the HIV virus was to blame, and another two years to create the first virus detection test.
In recent years, there has been significant scientific advancement, and antiretroviral medications now allow HIV-positive people to live healthy lives. Pre-exposure prophylaxis (PrEP) medications can help prevent infection.
However, they are not reaching everyone who needs them, and while the majority of new infections now occur outside of Sub-Saharan Africa, the UN reports that HIV incidence among teenagers and young women remains “extraordinarily high” in some parts of the region, with more than 150,000 infected every year.
Bekker’s trial encouraged women to take daily HIV prevention tablets. They continued to become infected because, as Bekker says, many of them did not take the medicines on a daily basis.
The findings for a medicine that requires only two annual doses have sparked significant interest. HIV prevention leaders describe the medicine as a “miracle” with the potential to be a “game changer.”
We know that adhering to anything is more difficult for younger people because they are busy, have full lives, and have things to do and places to go, according to Bekker.
“One of my investigators puts it beautifully: it’s a daily decision to say, ‘I’m going to take this pill to protect myself.'”
“Whereas if you take a six-monthly injection, you only have to make this decision twice a year.”
Bekker expects that lenacapavir will give girls and young women at risk of HIV more control over their lives.
“You could imagine you could quietly slip in,” she added, claiming to have obtained your contraception; no one needs to know.
Young women may find themselves in relationships “where they don’t have much say in how they have sex,” frequently with older males, in which a power imbalance may prevent them from asking their partner to use a condom, she said.
I have heard young ladies say, “This has given me incredible control over my own sexual identity.” I can now decide what happens to my body.
In a protocol that is still uncommon for drug trials, falling pregnant did not exclude women, and 193 became pregnant while taking lenacapavir. So far, there are no indicators of drug-related disorders.
Bekker and her team will continue to monitor the moms and newborns to ensure that the medicine prevents mother-to-child transmission during pregnancy, childbirth, and breastfeeding. This pathway accounts for one-tenth of all new HIV infections.
Offering mothers with newborn children an injection as they leave the hospital is likely to have a considerably higher impact than asking them to remember a daily tablet, according to Bekker, and presents the “exciting” potential of eliminating mother-to-child transmission.
However, questions remain, particularly concerning how fast and cheaply the medicine will reach the market. Gilead, the pharmaceutical company behind the medicine, is awaiting the results of more trials in other groups before pursuing regulatory approval.
At a press meeting in Munich, Gilead Science’s vice president for clinical development, Jared Baeten, committed to cooperating with manufacturers to guarantee generic versions obtained regulatory approval.
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However, he did not clarify that middle-income countries like Brazil would be able to obtain cheaper, generic versions of the medicine. Gilead has also rejected efforts to collaborate with the UN-backed Medicines Patent Pool to increase access.
Trial participants will continue to receive lenacapavir, and those in the trial’s comparison phase who are already taking pills will have the option of switching to injectable.
Bekker stated that she would “hold Gilead to account” if the firm did not follow through on its promises to enable global access, but that she had no reason to doubt their commitment.
She stated that she is not the type of clinical drug trialist who simply does the trial and then leaves. Regardless of the effectiveness of the treatment, we will not feel its impact if we lack access.
