Science Magazine has named an injectable drug that prevents HIV with two yearly shots the 2024 breakthrough of the year. The drug, lenacapavir from Gilead, protected all African women and girls in clinical trials from acquiring HIV compared to the company’s Truvada pill, which must be taken daily. Why it matters: Lenacapavir was initially developed as a treatment for patients with drug-resistant HIV, but its ability to prevent HIV with a single shot every six months makes it a game-changer, Science said. Once licensed, the drug would make it easier for people at risk for HIV to adhere to preventive treatment, especially if they face stigma or access challenges, according to Science. But the big question is whether all the people who need it, particularly in developing countries, would have access to it. California-based Gilead signed voluntary licensing agreements with six pharma companies, including India-based Dr. Reddy’s and Pennsylvania-based Mylan, to produce generic versions of the drug for use in 120 low- and lower-middle-income countries once the drug is licensed. But global public health activists raised concerns that the deal excludes countries, including in Latin America and Eastern Europe, with expanding HIV epidemics among key groups, such as gay and bisexual men, sex workers and people who use drugs. More than a dozen civil society groups, including Health GAP and Public Citizen, asked the White House this month to pressure Gilead to expand the licensing deal to include middle-income countries. In a letter to National Security Adviser Jake Sullivan shared with Future Pulse, the groups also asked the U.S. not to punish countries that pursue compulsory licenses for the drug, which allow its production without Gilead’s approval for public health purposes. HIV advocacy groups in Latin America are also calling on Gilead to make generic lenacapavir accessible in the region, noting that the company owes it to countries like Brazil, Mexico, Peru and Argentina, where it ran clinical trials. Global HIV officials and scientists called for faster, wider licensing of lenacapavir and other HIV prevention drugs in an article in The New England Journal of Medicine this week. Decentralized production, they added, would ensure people in developing countries have access as fast as those in wealthy nations. The White House referred questions to the President's Emergency Plan for AIDS Relief, better known as PEPFAR, which did not immediately respond to a request for comment. A spokesperson for Gilead said ensuring access to the drug in middle-income and upper-middle-income countries, including those in Latin America, is a priority for the company. Planning to expand access is ongoing. Gilead is looking at tiered pricing and other strategies to ensure access in middle-income countries and “working with payers to establish fast, efficient pathways to help reach people who need or want” preventive treatment, the spokesperson said.
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