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- The HIV shot that could change medicine is facing its biggest test: Getting to patients (businessinsider.com)
A groundbreaking HIV prevention drug developed by Gilead Sciences, lenacapavir, has demonstrated nearly 100% effectiveness when administered twice a year. Despite the promising results from clinical trials conducted in Latin America, access to this potentially life-saving medication remains limited in the very countries that helped prove its efficacy.
Lenacapavir offers a significant advance in the fight against HIV, requiring only two injections annually to prevent infection even with frequent exposure. However, the drug’s steep price-$14,000 per dose in the United States-poses a substantial barrier.
While Gilead has licensed generic versions at approximately $40 per dose for 120 low- and middle-income countries, many Latin American nations, including Brazil, Mexico, Argentina, and Peru, are excluded from these reduced prices due to their classification as upper-middle income countries. This leaves them caught in a difficult position: unable to afford U.S. prices yet ineligible for discounted generics.
The pricing impasse sparked visible protests at the International AIDS Society Conference in Rio de Janeiro, where activists and officials called out pharmaceutical pricing practices as a major obstacle to combating HIV. Brazil’s Health Minister, Dr.
Alexandre Padilha, criticized Gilead for demanding prices up to ten times higher than those paid by comparable countries in Southeast Asia. “Innovation without access is not an innovation.
It is an injustice,” he declared.
Gilead maintains that it is in direct negotiations with Latin American governments, but details on pricing and timelines remain undisclosed. UNAIDS Executive Director Winnie Byanyima highlighted Brazil’s prolonged efforts to reach a deal and argued that the country should not be sidelined in access to the medication.
One complicating factor may be Brazil’s constitutional mandate requiring the government to provide necessary treatments regardless of cost. This legal guarantee may lead manufacturers to set higher prices, anticipating that the government cannot forgo the purchase.
Beyond pricing, limited supply is another challenge. Lenacapavir was first licensed in its twice-yearly form in 2025, and production capacity is still ramping up. Fewer than 250,000 people in developing countries currently have access, far below UNAIDS’ target of 20 million within three years.
Meanwhile, Brazil is exploring alternatives. The country recently signed an agreement with MSD Brasil to potentially manufacture alimatravir, an emerging monthly oral PrEP drug still in Phase 3 trials. Brazil will also add ViiV Healthcare’s long-acting cabotegravir-an injectable HIV prevention treatment given every two months-to its public health program, pending regulatory approval.
Experts emphasize that long-acting PrEP options like lenacapavir could transform HIV prevention by simplifying treatment regimens and reducing stigma associated with daily pills. Yet Latin America faces a growing HIV epidemic, with new infections rising by 25% since 2010, in contrast to significant declines in other regions.
Gilead acknowledges the urgency of expanding access and is prioritizing countries with the highest HIV burdens and lowest financial resources. The company emphasizes that access involves more than pricing alone, including regulatory approval, procurement, and sustainable implementation.
As negotiations continue, the global health community urges swift action to ensure that this innovative drug reaches those who need it most, potentially marking a turning point in the decades-long battle against HIV.
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- The HIV shot that could change medicine is facing its biggest test: Getting to patients (businessinsider.com)