They call it the closest the world has ever come to a vaccine against AIDS virus.
The twice a year was 100% effective in preventing HIV infections in a study in women, and results released Wednesday show it worked almost as well in men.
Drug manufacturer Gilead said it would allow cheap, generic versions to be sold in 120 poor countries with high rates of HIV – mostly in Africa, Southeast Asia and the Caribbean. But he ruled out almost everything Latin Americawhere rates are far lower but rising, raising concerns that the world is missing a critical opportunity to stop the disease.
“This is so superior to any other prevention method we have, it’s unprecedented,” said Winnie Byanyima, executive director of UNAIDS. She credited Gilead with developing the drug, but said the world’s ability to stop AIDS depends on its use in at-risk countries.
ua report issued to mark World AIDS Day on Sunday, UNAIDS said the number of AIDS deaths last year — an estimated 630,000 — was the lowest since a peak in 2004, suggesting the world is now at a “historic crossroads.” and that the epidemic has a chance to end.
A drug called lencapavir is already sold under the brand name Sunlenca to treat HIV infections in the US, Canada, Europe and elsewhere. The company plans to seek approval soon for Sunlenca to be used to prevent HIV.
Although there are other ways to protect against infection, such as condoms, daily pills, vaginal rings and bimonthly shots, experts say Gilead’s twice-yearly shots would be particularly helpful for marginalized people who are often afraid to seek care, including gay men, sex workers and young women.
“It would be a real miracle for these groups because it means they only have to come to the clinic twice a year and then they are protected,” said UNAIDS’ Byanyima.
Such was the case for Luis Ruvalcaba, a 32-year-old man from Guadalajara, Mexico, who participated in the most recently published study. He said he was afraid to seek government-provided daily birth control pills because he was afraid of being discriminated against as gay. Because he participated in the study, he will continue to receive injections for at least another year.
“In Latin American countries there is still a big stigma, patients are ashamed to ask for pills,” said Dr. Alma Minerva Pérez, who recruited and involved a dozen volunteers in research at a private research center in Guadalajara.
It is not yet known how many vaccines will be available in Mexico through the country’s health system. Health officials declined to comment on any plans to buy Sunlence for their citizens; daily pills for HIV prevention were made freely available through the country’s public health system in 2021.
“If the possibility of using generic drugs opens up, I believe Mexico can join,” Pérez said.
Byanyima said other countries besides Mexico that participated in the study were also excluded from the generics deal, including Brazil, Peru and Argentina. “To deny them that drug now is unconscionable.” she said.
In a statement, Gilead said it has “an ongoing commitment to help provide access to HIV prevention and treatment options where the need is greatest.” Among the 120 countries eligible for the generic version are 18 mostly African countries that account for 70% of the world’s HIV burden.
The drugmaker said it is also working to establish “fast, effective ways to reach all the 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, demanding that generic Sunlenca be made available in Latin America, citing an “alarming” disparity in access to new HIV prevention tools while infection rates were rising.
While countries including Norway, France, Spain and the US have been paying more than $40,000 a year for Sunlenca, experts have calculated that it could be produced for as little as $40 per treatment once generic production is rolled out to 10 million people.
dr. Chris Beyrer, director of the Global Health Institute at Duke University, said having Sunlenca available in the hardest-hit countries in Africa and Asia will be extremely beneficial. But he said rising HIV rates among groups, including gay men and transgender populations, represented a “public health emergency” in Latin America.
Hannya Danielle Torres, a 30-year-old trans woman and artist who was at Sunlenco’s studio in Mexico, said she hopes the government will find a way to secure the footage. “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 much of Latin America when it allowed generics of its HIV prevention drugs in about 90 countries. Marketed as Apretude, the bimonthly injections are about 80% to 90% effective in preventing HIV. They cost about $1,500 a year in middle-income countries, more than most can afford.
Asia Russell, executive director of the advocacy group Health Gapsaid that with more than a million new HIV infections worldwide each year, established prevention methods are not enough. She called on countries like Brazil and Mexico to issue “compulsory licenses,” a mechanism in which countries suspend patents in a health crisis.
It’s a strategy some countries have adopted for previous HIV treatments, including in the late 1990s and 2000s when AIDS drugs were first discovered. In recent times, Colombia issued its first compulsory license for key HIV treatment Tivicay in April, without permission from its drugmaker, Viiva.
dr. Salim Abdool Karim, an AIDS expert at South Africa’s University of KwaZulu-Natal, said he had never seen a drug that proved as effective as Sunlenca in preventing HIV.
“The missing piece of the puzzle now is how we’re going to get it to everyone who needs it,” he said.
