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Twice-Yearly Lenacapavir Shot Shows Promise in HIV Prevention, Faces Access Challenges

• Lenacapavir, a twice-yearly injectable drug, has demonstrated near-perfect effectiveness in preventing HIV infections in clinical trials, marking a potential breakthrough in AIDS prevention. • Gilead, the drug's developer, plans to offer affordable generic versions in 120 low-income countries, primarily in Africa, Southeast Asia, and the Caribbean, but excludes most of Latin America. • Health experts and advocacy groups are raising concerns about equitable access, urging Gilead to expand the generic distribution deal to include Latin American nations where HIV infection rates are rising. • Experts suggest governments consider compulsory licensing to bypass patents and ensure affordable access to lenacapavir, especially for marginalized communities facing stigma and unequal healthcare access.

A new HIV prevention shot, lenacapavir, administered just twice a year, is being hailed as a potential game-changer in the fight against AIDS, demonstrating near-perfect results in clinical trials. Developed by Gilead, the drug has shown 100% effectiveness in preventing HIV infections among women and nearly as effective results in men, offering hope for marginalized communities. However, concerns are rising about equitable access, particularly in Latin America, where infection rates are increasing.

Lenacapavir's Efficacy and Global Impact

Lenacapavir, marketed by Gilead under the brand name Sunlenca, is already approved for HIV treatment in parts of North America and Europe. The recent study results have prompted discussions about its potential as a preventative measure. Winnie Byanyima, executive director of UNAIDS, emphasized the need for widespread access, calling it "the most effective prevention tool we’ve seen." UNAIDS' latest report indicates that global deaths from AIDS reached a record low of 630,000 in 2022, highlighting a critical moment in combating the disease.

Access Disparities and Advocacy Efforts

Gilead plans to provide affordable generic versions of lenacapavir in 120 low-income countries heavily impacted by HIV, including many in Africa, Southeast Asia, and the Caribbean. However, the exclusion of most Latin American nations, where infection rates are climbing, has sparked criticism from health experts and advocates. Advocacy groups from Latin America have urged Gilead to include their region in the generic distribution deal, citing rising infection rates and limited access to new HIV prevention tools.
Dr. Alma Minerva Pérez, a researcher in Mexico, highlighted the reluctance of vulnerable groups, such as gay men, to seek daily prevention pills due to societal stigma. For them, a semi-annual injection would be life-changing. Despite Mexico's provision of free daily pills since 2021, the government has yet to announce plans to make Sunlenca accessible. Advocacy groups have called for compulsory licensing, a strategy used in past health crises, to bypass patents and make the drug affordable.

Pricing and Production Costs

The pricing disparity has also raised concerns. While Sunlenca costs over $40,000 annually in high-income countries, experts estimate it could be manufactured for as little as $40 per treatment with generic production. A similar issue exists with Viiv Healthcare's bi-monthly HIV prevention shot, Apretude, which costs $1,500 annually in middle-income nations. Advocacy groups argue these high prices block access for populations in need.

Call for Equitable Distribution

Health leaders stress the importance of making lenacapavir universally accessible, especially in regions with the highest HIV burden. While Gilead has pledged to streamline access to the drug, experts believe governments must act decisively to integrate it into public health programs. Dr. Salim Abdool Karim, a South African AIDS expert, stated, "The missing piece is ensuring equitable distribution."
With over 1 million new HIV infections reported annually, lenacapavir offers an unprecedented opportunity to prevent the spread of the virus. The global health community now faces the challenge of translating this scientific breakthrough into accessible care for vulnerable populations.
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