It has been said to be the closest the world has ever come to a vaccine against the AIDS virus.
One shot, given twice a year, has been shown to be 100% effective in preventing HIV infections in a study of women, and published results show it worked almost as well in men.
Pharmaceutical company Gilead said it will allow the sale of cheap generic versions in 120 poor countries with high HIV ratesmainly in Africa, Southeast Asia and the Caribbean. But it has excluded almost all of Latin America, where rates are much lower but rising, raising concerns that the world is missing a critical opportunity to stop the disease.
This prevention method is so superior to any other we have, it is unprecedented,” said Winnie Byanyima, Executive Director of UNAIDS. He thanked Gilead for developing the drug, but said the world’s ability to stop AIDS depends on its use in at-risk countries.
In a report, UNAIDS said the number of AIDS deaths in 2023 (about 630,000) was the lowest since it reached its peak in 2004, suggesting the world is now in “a historical crossroads” and has the opportunity to end the epidemic.
The drug, called lenacapavir, is already sold under the brand name Sunlenca to treat HIV infections in the United States, Canada, Europe and other countries. The company plans to soon apply for authorization to use Sunlenca for HIV prevention.
While there are other ways to protect against infection, such as condoms, daily pills, vaginal rings, and bimonthly injections, experts say that Gilead’s semiannual injections would be particularly helpful for marginalized people who are often afraid seeking medical care, including gay men, sex workers and young women.
“It would be a miracle for these groups because it would mean that they only have to show up twice a year at a clinic and then they are protected,” said Byanyima of UNAIDS.
Such was the case of Luis Ruvalcaba, a 32-year-old man from Guadalajara, Mexico, who participated in the latest published study. He said he was afraid to ask for the daily preventative pills provided by the government, for fear of being discriminated against for being gay. Because you participated in the study, you will continue receiving the injections for at least another year.
In Latin American countries there is still a lot of stigma, patients are ashamed to ask for pills,” said Dr. Alma Minerva Pérez, who recruited and enrolled a dozen volunteers for the study at a private research center in Guadalajara.
It is not yet known how widely the vaccines will be available in Mexico through the country’s health system. Health officials declined to comment on plans to purchase Sunlenca for their citizens; Daily pills to prevent HIV were made available for free through the country’s public health system in 2021.
If the possibility of using generics has been opened, I have faith that Mexico can join in,” said Pérez.
Byanyima said countries other than Mexico that participated in the investigation were also excluded from the generics agreement, including Brazil, Peru and Argentina. “Denying them that medication now is unacceptable”said.
In a statement, Gilead said it has “an ongoing commitment to helping facilitate access to prevention options and HIV treatment where the need is greatest.” Among the 120 countries eligible for the generic version are 18 countries, mostly African, that represent 70% of the global HIV burden.
The pharmaceutical company said it is also working to establish “rapid and efficient pathways to reach all people who need or want lenacapavir for HIV prevention.”
15 advocacy groups from Peru, Argentina, Ecuador, Chile, Guatemala and Colombia wrote to Gilead calling for generic Sunlenca to be made available in Latin America, citing the “frightening” inequity in access to new HIV prevention tools while infection rates were increasing.
Although countries such as Norway, France, Spain and the United States have paid more than $40,000 a year for Sunlenca, experts have estimated that it could be produced for as little as $40 per treatment once generic production is expanded to cover 10 million. of people.
Dr. Chris Beyrer, director of the Duke University Global Health Institute, said it would be enormously helpful to make Sunlenca available in the hardest-hit countries in Africa and Asia, but added that rising HIV rates between groups such as homosexual men and transgender populations constitute “a public health emergency” in Latin America.
Hannya Danielle Torres, a 30-year-old trans woman and artist who participated in Sunlenca’s study in Mexico, said she hoped the government would find a way to provide the vaccines. “Mexico may have some of the richest people in the world, but it also has some of the most vulnerable people living in extreme poverty and violence”Torres said.
Another pharmaceutical company, Viiv Healthcare, also excluded most of Latin America by allowing the sale of generics of its HIV vaccine in about 90 countries. The bimonthly injections, sold under the name Apretude, are 80% to 90% effective in preventing HIV and cost about $1,500 a year in middle-income countries, more than most can pay.
Asia Russell, executive director of advocacy group Health Gap, said that with more than a million new HIV infections each year worldwide, established prevention methods are not enough. He urged countries like Brazil and Mexico to issue “compulsory licenses”a mechanism by which countries suspend patents in the event of a health crisis.
This is a strategy that some countries adopted to previous HIV treatmentsincluding in the late 1990s and 2000s, when the first AIDS drugs were discovered. More recently, Colombia issued its first compulsory license for key HIV treatment Tivicay in April 2024, without the permission of its drugmaker, Viiv.
Dr. Salim Abdool Karim, an AIDS expert at the University of KwaZulu-Natal in South Africa, said he had never seen a drug that appeared to be as effective as Sunlenca in preventing HIV.
“The missing piece of the puzzle now is how to get the medicine to all those who need it,” he said.
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