Twice-yearly shots used to treat AIDS have proven to be 100% effective in preventing new infections in women, according to a study published on Wednesday. Researchers reported that none of the young women and girls who received the shots in a study of approximately 5,000 participants in South Africa and Uganda contracted HIV. In contrast, about 2% of those given daily prevention pills became infected.
Salim Abdool Karim, director of an AIDS research center in Durban, South Africa, who was not part of the study, remarked, “To see this level of protection is stunning.”
The injections, made by US drugmaker Gilead and sold as Sunlenca, are currently approved for treating HIV in the US, Canada, Europe, and other regions. Gilead is awaiting the results of testing in men before seeking approval for its use as a preventative measure.
The study’s findings were published in the New England Journal of Medicine and discussed at an AIDS conference in Munich. Gilead funded the study, and some researchers involved are company employees. Due to the unexpectedly positive results, the study was stopped early, and all participants were offered the shots, also known as lenacapavir.
While other HIV prevention methods, such as condoms and daily pills, exist, consistent use has been a challenge in Africa. In the study, only about 30% of participants given Gilead’s Truvada or Descovy prevention pills took them consistently, with adherence decreasing over time.
Thandeka Nkosi, who helped run the Gilead research at the Desmond Tutu Health Foundation in Masiphumelele, South Africa, called the prospect of a twice-yearly shot “quite revolutionary news” for patients. “It gives participants a choice and it just eliminates the whole stigma around taking pills to prevent HIV,” she said.
Despite the excitement surrounding the Sunlenca shots, experts are concerned about the affordability of the drug for those most in need. Gilead has not yet set a price for Sunlenca in poorer countries but has indicated it will pursue a “voluntary licensing program” to allow select generic producers to manufacture the drug.
Winnie Byanyima, executive director of the Geneva-based UN AIDS agency, urged Gilead to share Sunlenca’s patent with a UN-backed program that negotiates broad contracts for generic drug production in poorer countries. As a treatment, Sunlenca costs more than $40,000 per year in the US, though individual payments vary.
Dr. Helen Bygrave of Doctors Without Borders emphasized that the injections could “reverse the epidemic if it is made available in the countries with the highest rate of new infections” and called for Gilead to publish an affordable price for all countries.
Gilead’s senior vice president of clinical development, Dr. Jared Baeten, stated that the company was already in discussions with generic manufacturers and understood the urgency of making the drug accessible.
Another HIV prevention shot, Apretude, is approved in some countries, including in Africa, and sells for about $180 per patient per year, a price still too high for most developing countries.
Byanyima noted that women and girls who are victims of domestic violence and gay men in countries where same-sex relationships are criminalized need long-lasting protection the most. In 2022, women and girls accounted for 46% of new HIV infections globally and were three times more likely than males to contract HIV in Africa.
Comparing the news about Sunlenca to the discovery of life-saving AIDS drugs decades ago, Byanyima recalled how South African President Nelson Mandela suspended patents to widen access, eventually lowering the price from $10,000 to about $50 per patient per year.
Olwethu Kemele, a health worker at the Desmond Tutu Health Foundation, predicted that the shots could increase participation in HIV prevention programs and slow the virus’s spread, as young women often hide prevention pills to avoid scrutiny from boyfriends and family members.
A UNAIDS report highlighted that fewer people were infected with HIV in 2023 than at any point since the late 1980s. Despite significant progress in Africa, HIV infections are rising in Eastern Europe, Latin America, and the Middle East. Globally, HIV infects about 1.3 million people annually and kills over 600,000, predominantly in Africa.
