A twice-yearly vaccination could help end AIDS. But will it reach everyone who needs it?

MEXICO CITY (AP) — There’s talk that the world is the closest it’s ever come to a vaccine for the AIDS virus.

The twice-yearly shot was 100% effective at preventing HIV infections in a study of women, and results released Wednesday show it worked almost as well in men.

Drugmaker Gilead said it would allow cheap, generic versions to be sold in 120 poor countries with high HIV rates – mostly in Africa, Southeast Asia and the Caribbean. However, almost all of Latin America was excluded, where rates are far lower but rising, raising concerns that the world is missing a crucial opportunity to contain the disease.

“This is so far superior to any other prevention method we have that it is unprecedented,” said Winnie Byanyima, executive director of UNAIDS. She praised Gilead for developing the drug but said the world’s ability to stop AIDS depends on its use in vulnerable countries.

In a report issued to mark World AIDS Day on Sunday, UNAIDS said the number of AIDS deaths last year – an estimated 630,000 – was at its lowest level since its peak in 2004, suggesting that the world is now at a “historic crossroads” and has a chance 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 elsewhere. The company plans to soon file for approval for Sunlenca for HIV prevention.

While there are other ways to protect yourself from infections, such as condoms, daily pills, vaginal rings and every other month, experts say the twice-yearly Gilead vaccinations would be particularly useful for marginalized people who are often afraid of to seek medical care, including gay men, and sex workers and young women.

“It would be a miracle for these groups because it means they only have to show up at a clinic twice a year and then they are protected,” said Byanyima of UNAIDS.

This was the case for Luis Ruvalcaba, a 32-year-old man from Guadalajara, Mexico, who took part in the latest published study. He said he was afraid to ask for the government-provided daily prevention pills for fear of being discriminated against as a gay man. Because he took part in the study, he will continue to receive the vaccinations for at least another year.

“In Latin American countries there is still a lot of stigmatization, patients are ashamed to ask for the 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 widespread vaccinations will be in Mexico across the country’s health system. Health officials declined to comment on plans to purchase Sunlenca for its citizens. Daily HIV prevention pills were made available free of charge through the country’s public health system in 2021.

“If the possibility of using generics opens up, I am confident that Mexico can join,” Pérez said.

Byanyima said that in addition to Mexico, other countries that participated in the study were also excluded from the generic drug deal, including Brazil, Peru and Argentina. “To now deny them that drugs are ruthless,” she said.

In a statement, Gilead said it is “continuously committed to providing access to HIV prevention and treatment options where the need is greatest.” Among the 120 countries eligible for the generic version There are 18 predominantly African countries that account for 70% of the global HIV burden.

The drugmaker said it is also working to “create fast and efficient ways to reach all people who need or want lenacapavir for HIV prevention.”

On Thursday, 15 advocacy groups in Peru, Argentina, Ecuador, Chile, Guatemala and Colombia wrote to Gilead requesting that generic Sunlenca be made available in Latin America. They cited “alarming” inequalities in access to new HIV prevention tools and infection rates were rising.

While countries such as Norway, France, Spain and the United States have paid more than $40,000 a year for Sunlenca, experts have calculated that it could be manufactured for as little as $40 per treatment once generic production is expanded to cover 10 million people becomes.

Dr. Chris Beyrer, director of the Global Health Institute at Duke University, said it would be enormously useful to have Sunlenca available in the hardest-hit countries in Africa and Asia. But he said rising HIV rates among groups including gay and transgender people constituted a “public health emergency” in Latin America.

Hannya Danielle Torres, a 30-year-old trans woman and artist who took part in the Sunlenca trial in Mexico, said she hoped the government would find a way to provide the vaccinations. “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 drugmaker, Viiv Healthcare, also left out most of Latin America when it approved generics of its HIV prevention shot in about 90 countries. The bimonthly vaccinations sold as Apretude are about 80 to 90% effective in preventing HIV. In middle-income countries, they cost about $1,500 a year, higher than what most can afford.

Asia Russell, chief executive of advocacy group Health Gap, said established prevention methods are not enough with more than a million new HIV infections worldwide each year. She called on countries like Brazil and Mexico to issue “compulsory licensing,” a mechanism by which countries suspend patents during a health crisis.

It’s a strategy that some countries have adopted in previous HIV treatments, including in the late 1990s and 2000s when AIDS drugs were first discovered. Most recently, Colombia issued its first compulsory license for the key HIV drug Tivicay in April, without the permission of its drugmaker Viiv.

Dr. Salim Abdool Karim, an AIDS expert at South Africa’s University of KwaZulu-Natal, said he had never seen a drug that appeared to be as effective at preventing HIV as Sunlenca.

“The missing piece of the puzzle now is how do we get it to everyone who needs it,” he said.

Cheng reported from London.

The Associated Press Health and Science Department receives support from the Science and Educational Media Group of the Howard Hughes Medical Institute. The AP is solely responsible for all content.