HIV trial shows injectable prevents 100% infection in women and girls

Gilead’s injectable drug is a potential game changer in efforts to curb HIV infections, according to health experts who are calling on the pharmaceutical giant to clearly lay out plans for access to the product. Data from Gilead’s Phase 3, PURPOSE 1 trial showed that lenacapavir, a twice-yearly injectable, is 100% efficacious in preventing HIV in women and adolescent girls. There were zero cases of HIV infection among the 2,134 women who were given the drug. It was also “generally well-tolerated and no significant or new safety concerns were identified,” according to a news release. Why it matters: While current HIV prevention products known as pre-exposure prophylaxis, or PrEP, are highly effective in preventing HIV when taken as prescribed, a large number of people are still not taking them for several reasons. This includes stigma, discrimination, and difficulty in adherence to the prescribed regimen, especially for those on daily oral pills, the most common form of PrEP. But taking two injections per year could address those challenges. People won’t need to carry around their pills, or remember to take them daily. Instead, they can get an injection and not have to worry for six months. The result is also significant as the drug has shown to be efficacious among women and girls, who accounted for 46% of all new HIV infections globally in 2022. That’s 4,000 adolescent girls and young women aged 15 to 24 years old infected with HIV every week. That said, there are other HIV PrEP options available, including a long-acting injectable, called cabotegravir, and the dapivirine vaginal ring. Cabotegravir is given once each month for the first two months, followed by an injection every two months. The dapivirine vaginal ring meanwhile needs to be placed inside the vagina for a period of 28 days. Both also offer discretion and do not require people to take them daily. While an efficacious, twice-yearly injection is “exciting,” Janet Ginnard, director of strategy at Unitaid, told Devex that giving communities options is important. “What we're also hearing from community groups is that options are important, and that there's not one size fits all,” she said. “And so it is important to still emphasize that choice across different PrEP options.” What happens next: Gilead said more detailed data from the trial will be presented “at a future conference.” Health experts are also awaiting the results of the company’s other PURPOSE trials for lenacapavir. This includes the phase 3 PURPOSE 2 trial, which assesses the drug’s efficacy in preventing HIV among men who have sex with men, transgender men and women, and gender non-binary individuals who have sex with partners who are assigned as male at birth. The trial is being conducted in Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the United States, and the results are expected in late 2024 or early 2025. Other PURPOSE trials in the U.S. target adult women, and adults who inject drugs. Ensuring access: Experts are now calling on Gilead to make its plans for rapid access to the product clear, and ensure it is accessible globally. Ginnard said the company should be clear and transparent regarding its commitments to license the product for generic versions to be made. The time it takes for a product to be made available in low- and middle-income countries can take years, sometimes a decade or more, she said. “I think the ideal would be that everyone has it in all geographies, regardless of where they live,” she said. “Someone who could benefit from this product living in a low-income country shouldn't be in a queue, and only getting that years later.” Gilead can start engaging with people living with HIV or those who are affected by HIV, as well as engaging with countries and international agencies regarding plans for production, and consolidating the need for the product. It is helpful to have a “very clear picture of what can be made, and how much will be available when,” the pricing for the product, as well as the pathway for its generic versions, Ginnard said. The company should also support the speedy registration of the product in low- and middle-income countries, including countries where the trials were conducted, and ensure populations who participated in the trials have access to the drug. The company can also share information quickly with the World Health Organization to ensure a quick review to inform global guidelines on HIV. This is an important step for countries to update their national guidelines and support the early implementation of a product. “There have been some very positive statements made by Gilead about a commitment to access,” but details are key, Ginnard said. “I think the biggest determinant of access will be … understanding what product will be available from generics, but then also that product that will be available as a bridge until the generic medicines are available,” she said. In a statement, Gilead said it has been developing a strategy “to enable broad, sustainable access globally” particularly in high HIV incidence, but resource-limited countries, which are primarily low- and middle-income. The strategy “reflects extensive consultations with HIV-affected communities worldwide as well as governments, advocates, multilateral organizations, individuals who need or want PrEP, and community partners.” The company is pursuing a “two-pronged access strategy.” One is ensuring there is a dedicated supply of lenacapavir in countries where there is the greatest need “until voluntary licensing partners are able to supply high-quality, low-cost versions of lenacapavir.” The second is developing a “robust direct voluntary licensing program to expedite access to those versions of lenacapavir in high-incidence, resource-limited countries.” The company said it is “moving with urgency to negotiate these contracts.” The company said it is also exploring frameworks meant to facilitate faster access to the drug, such as through the European Medicines Agency’s EU-Medicines for all, and WHO’s review and prequalification procedures.