Twice-yearly lenacapavir injection showed near-total protection against HIV in clinical trials, but exclusion from a generic supply deal has raised concerns over unequal access as infections rise in parts of Latin America.
By Bunmi Yekini
A twice-yearly injection that has demonstrated near-total protection against HIV infection is raising hopes of a major breakthrough in the fight against AIDS. However, concerns are mounting over unequal access after its manufacturer, Gilead Sciences, excluded most Latin American countries from a deal allowing cheaper generic versions.
The drug, lenacapavir, was 100% effective in preventing HIV infections in a study involving women, while results published on Wednesday showed similarly high effectiveness among men. The findings have drawn praise from global health experts, who say the injection could transform HIV prevention, particularly among vulnerable populations who face stigma, discrimination or difficulties accessing regular healthcare.
Gilead has agreed to allow generic manufacturers to produce and sell cheaper versions of the drug in 120 lower-income countries with high HIV prevalence, mainly across Africa, Southeast Asia and the Caribbean. But most of Latin America, including countries where infections are increasing, was left out of the arrangement.
UNAIDS Executive Director Winnie Byanyima described the drug as an unprecedented development in HIV prevention, arguing that its impact would depend on whether countries with significant infection risks could secure access.
In its report ahead of World AIDS Day on Sunday, UNAIDS estimated that 630,000 people died from AIDS-related illnesses last year, the lowest annual figure since deaths peaked in 2004. The agency said the decline placed the world at a historic crossroads, with an opportunity to bring the epidemic to an end.
Lenacapavir is already marketed as Sunlenca for HIV treatment in the United States, Canada, Europe and other markets. Gilead plans to seek regulatory approval for its use as a preventive treatment.
Existing HIV prevention options include condoms, daily medication, vaginal rings and injections administered every two months. Experts say a twice-yearly injection could offer particular benefits to gay men, sex workers, young women and other marginalised groups who may be reluctant to seek regular medical care.
The treatment would require patients to visit a clinic only twice a year, Byanyima said, describing the prospect as potentially transformative for vulnerable communities.
For Luis Ruvalcaba, a 32-year-old participant in the latest clinical study in Guadalajara, Mexico, the injection has offered an alternative to daily prevention pills.
Ruvalcaba said he had been reluctant to request government-provided HIV prevention medication because he feared discrimination over his sexuality. His participation in the study means he will continue receiving the injections for at least another year.
Dr Alma Minerva Pérez, who recruited 12 volunteers at a private research centre in Guadalajara, said stigma remained a significant barrier to HIV prevention in Latin America, where some patients were uncomfortable asking for preventive medication.
It remains unclear whether Mexico’s public healthcare system will make the injections available. Government health officials declined to comment on possible procurement plans, although daily HIV prevention pills have been freely available through the country’s public health system since 2021.
Pérez said she remained hopeful that Mexico could benefit from generic production if access arrangements were expanded.
Byanyima said Brazil, Peru and Argentina were among other countries involved in the research but excluded from Gilead’s generic licensing agreement. She described the exclusion as unacceptable given the drug’s potential public health benefits.
Gilead said in a statement that it remained committed to expanding access to HIV prevention and treatment in countries with the greatest need. The company said the 120 eligible countries included 18 predominantly African nations that together account for about 70% of the global HIV burden.
It added that it was working to establish faster and more efficient routes to make lenacapavir available to everyone who needed or wanted it for HIV prevention.
The exclusion has prompted calls for a broader licensing arrangement. On Thursday, 15 advocacy organisations from Peru, Argentina, Ecuador, Chile, Guatemala and Colombia wrote to Gilead urging the company to extend generic access to Latin America.
The groups warned that unequal access to emerging HIV prevention tools was becoming increasingly concerning as infections rose across parts of the region.
The cost difference could be substantial. Sunlenca has been priced at more than $40,000 annually in countries including the United States, France, Spain and Norway. Health experts estimate that generic production could reduce the cost to as little as $40 per treatment once manufacturing expands to cover 10 million people.
Chris Beyrer, director of Duke University’s Global Health Institute, said wider availability in heavily affected countries across Africa and Asia would be significant. However, he warned that rising infections among gay men and transgender people in Latin America represented a public health emergency.
Hannya Danielle Torres, a 30-year-old transgender artist who participated in the Mexican study, said she hoped authorities would find a way to provide the injections to vulnerable communities.
She noted that despite Mexico’s wealth, many people continued to live in extreme poverty and face violence, making access to effective preventive healthcare particularly important.
Gilead is not the only pharmaceutical company facing criticism over the geographical reach of its generic licensing arrangements. ViiV Healthcare also excluded most of Latin America when it authorised generic versions of its HIV prevention injection, Apretude, in about 90 countries.
Administered every two months, Apretude has been shown to reduce the risk of HIV infection by about 80% to 90%. However, its annual cost of approximately $1,500 in middle-income countries remains beyond the reach of many patients.
Asia Russell, executive director of advocacy organisation Health GAP, said existing prevention strategies were insufficient given that more than one million new HIV infections occur globally each year.
She urged countries such as Brazil and Mexico to consider compulsory licensing, a legal mechanism that allows governments to override patent protections under certain circumstances, including public health emergencies.
Several countries previously used the approach to expand access to HIV medicines during the late 1990s and 2000s. In April, Colombia issued its first compulsory licence, covering the HIV treatment Tivicay, without the permission of its manufacturer, ViiV Healthcare.
Salim Abdool Karim, an AIDS expert at South Africa’s University of KwaZulu-Natal, said he had rarely seen a preventive drug with the apparent effectiveness of lenacapavir. The central challenge, he said, was no longer simply developing an effective intervention but ensuring that it reached everyone who needed it.