Cape Town, South Africa — Biannual injections used to treat AIDS were 100% effective in preventing new infections in women, according to study results published Wednesday.
There were no infections among young women and girls who got the vaccines in a study of nearly 5,000 in South Africa and Uganda, the researchers reported. In a group who received daily preventative pills, about 2% ended up contracting HIV from infected sexual partners.
“Seeing this level of protection is impressive,” Salim Abdool Karim said of the injections. He is director of an AIDS research center in Durban, South Africa, which was not part of the research.
The shots fired by North American pharmaceutical company Gilead and sold as Sunlenca are approved in the US, Canada, Europe and elsewhere, but only as a treatment for HIV. The company said it is awaiting test results on men before requesting permission to use it to protect against infections.
The results in women were published Wednesday in the New England Journal of Medicine and discussed at an AIDS conference in Munich. Gilead paid for the study and some of the researchers are company employees. Due to the surprisingly encouraging results, the study was stopped early and all participants received the injections, also known as lenacapavir.
While there are other ways to prevent HIV infection, like condoms or daily pills, consistent use has been a problem in Africa. In the new study, only about 30% of participants who received Gilead’s Truvada or Descovy prevention pills actually took them — and that number dropped over time.
The prospect of a twice-a-year injection is “pretty revolutionary news” for our patients, said Thandeka Nkosi, who helped direct Gilead’s research at the Desmond Tutu Health Foundation in Masiphumelele, South Africa. “It gives participants a choice and simply eliminates all the stigma around taking pills to prevent HIV.
Experts working to stop the spread of AIDS are excited about the Sunlenca shots, but are concerned that Gilead has not yet reached an agreement on an affordable price for those who need them most. The company said it would follow a “voluntary licensing program,” suggesting that only a select number of generic producers would be allowed to produce them.
“Gilead has a tool that can change the trajectory of the HIV epidemic,” he said Winnie Byanyimaexecutive director of the Geneva-based UN AIDS agency.
She said her organization urged Gilead to share Sunlenca’s patent with a U.N.-backed program that negotiates broad contracts that allow generic drugmakers to manufacture cheap versions of medicines for the world’s poorest countries. As a treatment for HIV, the drug costs more than $40,000 a year in the US, although the amount paid by individuals varies.
Dr Helen Bygrave of Doctors Without Borders said in a statement that the shots could “reverse the epidemic if they were made available in countries with the highest rate of new infections”. She urged Gilead to publish a price for Sunlenca that would be affordable for all countries.
In a statement last month, Gilead said it was too early to say how much Sunlenca would cost for prevention in poorer countries. Jared Baeten, senior vice president of clinical development at Gilead, said the company was already talking to generic manufacturers and understood how “profoundly important it is that we move quickly.”
Another HIV prevention vaccine, Apretude, administered every two months, is approved in some countries, including Africa. It sells for about $180 per patient per year, which is still too expensive for most developing countries.
Byanyima said those most in need of lasting protection include women and girls who are victims of domestic violence and gay men in countries where same-sex relationships are criminalized. According to UNAIDS, 46% of new HIV infections globally in 2022 occurred in women and girls, who were three times more likely to contract HIV than men in Africa.
Byanyima compared the news about Sunlenca to the discovery decades ago of AIDS drugs that could transform HIV infection from a death sentence to a chronic illness. At that time, South African President Nelson Mandela suspended patents to allow broader access to medicines; the price subsequently dropped from about $10,000 per patient per year to about $50.
Olwethu Kemele, a health professional at the Desmond Tutu Health Foundation, predicted that vaccines could increase the number of people seeking HIV prevention and slow the spread of the virus. She said young women often hide pills to avoid questions from boyfriends and family. “It makes it difficult for girls to continue,” she said.
In a report on the state of the global epidemic released this week, UNAIDS said fewer people will be infected with HIV in 2023 than at any time since the late 1980s. Globally, HIV infects about 1.3 million people every year and kills more than 600,000, mainly in Africa. While significant progress has been made in Africa, HIV infections are rising in Eastern Europe, Latin America and the Middle East.
In other research presented at the AIDS conference, Andrew Hill of the University of Liverpool and colleagues estimated that once production of Sunlenca is expanded to treat 10 million people, the price should drop to about $40 per treatment. He said it was critical that health authorities had access to Sunlenca as quickly as possible.
“This is as close as you can get to an HIV vaccine,” he said.
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Cheng reported from London.
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