Experts Hail Twice-Yearly Injection With 100% HIV Protection As ‘Stunning’ Breakthrough

In a study published Wednesday, researchers found that twice-yearly shots for treating AIDS were 100% effective in preventing new infections among women. The study, conducted in South Africa and Uganda with around 5,000 participants, reported zero new infections among young women and girls who received the injections. In contrast, about 2% of those given daily prevention pills contracted HIV from infected partners.

“To see this level of protection is stunning,” said Salim Abdool Karim of the injections.He is the director of an AIDS research center in Durban, South Africa, but was not involved in the study.

The shots, produced by U.S. drugmaker Gilead and marketed as Sunlenca, are approved for use as an HIV treatment in the U.S., Canada, Europe, and other regions. However, the company stated that it is awaiting results from testing in men before seeking approval for using the shots as a preventive measure against infections.

The findings regarding women were published Wednesday in the New England Journal of Medicine and presented at an AIDS conference in Munich. Funded by Gilead, which also employs some of the researchers, the study was terminated early due to its unexpectedly positive results, with all participants subsequently offered the shots, known as lenacapavir.

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Although there are existing methods to prevent HIV infection, such as condoms and daily pills, adherence has been a challenge in Africa. In the study, only about 30% of participants taking Gilead’s Truvada or Descovy pills consistently used them, with this adherence rate declining over time.

Thandeka Nkosi, who helped oversee the Gilead research at the Desmond Tutu Health Foundation in Masiphumelele, South Africa, described the possibility of a twice-yearly shot as “revolutionary news” for patients. “It gives participants a choice and it just eliminates the whole stigma around taking pills” to prevent HIV.

Experts focused on combating AIDS are enthusiastic about the Sunlenca shots but are concerned that Gilead has not yet established an affordable price for those who need the treatment the most.The company said it would pursue a “voluntary licensing program,” implying that only a limited number of generic manufacturers would be permitted to produce them.

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“Gilead has a tool that could change the trajectory of the HIV epidemic,” said Winnie Byanyima, executive director of the Geneva-based U.N. AIDS agency.

She mentioned that her organization has urged Gilead to transfer Sunlenca’s patent to a U.N.-backed program that negotiates large contracts enabling generic drug manufacturers to produce affordable versions for low-income countries around the world. In the U.S., the drug costs over $40,000 per year as an HIV treatment, though individual costs may vary.

In a statement last month, Gilead indicated that it was premature to determine the cost of Sunlenca for prevention in low-income countries. Dr. Jared Baeten, Gilead’s Senior Vice President of Clinical Development, noted that the company was in discussions with generic manufacturers and was aware of the implications “deeply important it is that we move at speed.”

Another HIV prevention shot, Apretude, administered every two months, is approved in several countries, including some in Africa. It costs approximately $180 per patient per year, which remains too expensive for most developing nations.

Byanyima highlighted that those in greatest need of long-lasting protection include women and girls who are victims of domestic violence, as well as gay men in countries where same-sex relationships are criminalized. According to UNAIDS, women and girls accounted for 46% of new HIV infections globally in 2022 and were three times more likely to contract HIV than men in Africa.

Byanyima likened the announcement about Sunlenca to the breakthrough decades ago when AIDS drugs transformed HIV from a fatal diagnosis into a manageable chronic illness. At that time, South African President Nelson Mandela had suspended patents to increase drug accessibility, resulting in the price dropping from around $10,000 per patient per year to approximately $50.

Olwethu Kemele, a health worker at the Desmond Tutu Health Foundation, anticipated that the new shots could increase the number of individuals seeking HIV prevention and help slow the virus’s spread. She noted that young women often conceal their pills to avoid questions from boyfriends and family members. “It makes it hard for the girls to continue,” she said.

In a report on the global epidemic released this week, UNAIDS stated that HIV infections in 2023 were at their lowest level since the late 1980s. Each year, around 1.3 million people worldwide are newly infected with HIV, and the virus causes over 600,000 deaths, predominantly in Africa. Despite significant progress in Africa, HIV infections are increasing in Eastern Europe, Latin America, and the Middle East.

In additional research presented at the AIDS conference, Andrew Hill from the University of Liverpool and his team estimated that expanding Sunlenca production to treat 10 million people could reduce the price to approximately $40 per treatment. He emphasized the importance of ensuring that health authorities gain access to Sunlenca as soon as possible.

“This is about as close as you can get to an HIV vaccine,” he said.

Cheng reported from London.

The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Science and Educational Media Group, which provides financial backing for its work. The department is solely responsible for all content.

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