Lima, Peru — Africa is contributing to groundbreaking data from the PURPOSE 2 study, which explores twice-yearly lenacapavir for HIV prevention. This study, with participants from South Africa and Uganda , is one of the scientific highlights showcased at the 5th HIV Research for Prevention Conference, better known as HIVR4P 2024, in Lima, Peru.
A key development is the promising results from the PURPOSE 1 study, which demonstrated that lenacapavir, a biannual HIV prevention injectable, reduced HIV acquisitions by 100% in cisgender women in Africa.
This study complements the PURPOSE 2 trial, which showed a 96% reduction in HIV acquisitions among trial participants .
"These findings confirm that lenacapavir for PrEP has the potential to transform the global HIV prevention landscape for people of all genders," said Beatriz Grinsztejn, the President of the International AIDS Society (IAS), a nd also a member of the PURPOSE 2 study team, and an HIVR4P 2024 Organising Committee member.
Lenacapavir's potential as a twice-yearly preventive option opens up new doors for HIV prevention in resource-limited settings. The convenience and reduced stigma associated with long-acting methods may lead to better adherence and outcomes, especially for women who often face challenges with daily PrEP use.
In addition to lenacapavir, African women are at the forefront of another exciting advancement—the three-month dapivirine vaginal ring. The monthly version of this ring, which was the world's first woman-controlled HIV prevention product, is already approved in 11 African countries. Now, new data from South Africa suggests that the three-month version is even more promising, with lower costs and improved convenience.
The dapivirine vaginal ring (DVR) is flexible silicone ring that is inserted in the vagina and slowly releases an antiretroviral (ARV) drug called dapivirine, according to AVAC - an international non-profit organisation that is a key player in the global fight against HIV.
"It's becoming increasingly clear that the HIV prevention field is focusing on expanding choice for women and on long-acting prevention technologies. And, in fact, the dapiverine vaginal ring was the 1st long-acting prevention technology to receive a positive regulatory assessment," said Jeremy Nuttall, of the Population Council Center for Biomedical Research.
"The 3-month ring offers important benefits over the one-month ring. It's only 4 rings a year rather than 12, which is a two-thirds reduction in the number of rings and packaging materials required per year. The estimated cost is not more than U.S.$16, excluding distribution costs, and that represents a 60% reduction in cost per year compared to the one-month ring," said Nuttall.
A study conducted in five African countries - the CATALYST study - shed light on women's choices when it comes to HIV prevention on the continent . Conducted in Kenya, Lesotho, South Africa, Uganda, and Zimbabwe, the study found that many women selected the dapivirine vaginal ring when offered a choice of PrEP methods. While most chose oral PrEP, the growing preference for the ring—particularly among women with multiple sex partners—demonstrates its potential to offer women increased freedom over their HIV prevention options.
"... it is feasible to offer PrEP Choice in African public health facilities that are already doing oral PrEP work and using their existing infrastructure," said Elizabeth Irungu, the Regional Technical Advisor for Implementation Science for the international health organisation Jhpiego.
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if lenacapavir for PrEP is approved, Gilead Sciences said it is ensuring the the results from PURPOSE 1 and PURPOSE 2 translate into decreased HIV incidence globally, by keeping more than 100 global health advocates and organizations informed and finding the most efficient paths for the regulatory review and approval of lenacapavir for PrEP. Data from both trials will support a series of global regulatory filings for lenacapavir for PrEP that will begin by the end of 2024.
On October 2, Gilead announced it signed non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical companies to manufacture and supply high-quality, low-cost versions of lenacapavir for 120 primarily low- and lower-middle-income countries.
