According to study results, twice-yearly injections used to treat AIDS were completely effective in preventing new HIV infections among women. In a trial involving around 5,000 young women and girls in South Africa and Uganda, none of those who received the injections contracted HIV. In contrast, about 2% of those given daily prevention pills ended up with HIV from infected partners.
Salim Abdool Karim, director of an AIDS research center in Durban, South Africa, praised the results, calling the level of protection “stunning,” though he was not involved in the study.
The injections, produced by U.S. drugmaker Gilead and marketed as Sunlenca, are currently approved for HIV treatment in the U.S., Canada, Europe, and other regions. Gilead is awaiting results from ongoing tests in men before seeking approval for the injections as a preventive measure against HIV.
Gilead funded the study, and some of the researchers are employees of the company. Due to the unexpectedly positive results, the study was concluded early, and all participants were given the injections, known as lenacapavir.
While there are existing methods to prevent HIV infection, such as condoms or daily pills, adherence has been a challenge in Africa. In this study, only about 30% of those who were provided with Gilead’s Truvada or Descovy pills consistently used them, and this rate declined over time.
Thandeka Nkosi, who helped oversee the Gilead research at the Desmond Tutu Health Foundation in Masiphumelele, South Africa, described the twice-yearly injection as “quite revolutionary news” for patients. She noted that it offers participants an alternative and removes the stigma associated with daily pill use for HIV prevention.
Experts combating the spread of AIDS are enthusiastic about the potential of Sunlenca shots but are concerned that Gilead has not yet agreed on a pricing strategy that would make the medication affordable for those who need it most. Gilead has announced plans for a “voluntary licensing program,” which may restrict generic production to a limited number of manufacturers.
Winnie Byanyima, executive director of the U.N. AIDS agency based in Geneva, highlighted that Gilead possesses a tool that could significantly alter the course of the HIV epidemic. She urged the company to share Sunlenca’s patent with a U.N.-supported initiative that negotiates broad agreements for generic drug production, allowing affordable versions of drugs to be made for poorer countries. In the U.S., the drug costs over $40,000 annually, though individual prices can vary.
Dr. Helen Bygrave from Doctors Without Borders stated that the injections have the potential to “reverse the epidemic if made accessible in the countries with the highest rates of new infections.” She called on Gilead to set a price for Sunlenca that would be affordable across all countries.
Gilead responded last month, indicating it was premature to determine the cost of Sunlenca for prevention in less affluent nations. Dr. Jared Baeten, Gilead’s senior vice president of clinical development, mentioned that the company is in discussions with generic drug manufacturers and recognizes the urgency of advancing the process.
A similar HIV prevention shot, Apretude, which is administered every two months, is available in some countries, including parts of Africa, at around $180 per patient annually. However, this price remains too high for many developing countries.
UNAIDS reports that in 2022, 46% of new HIV infections globally were among women and girls, who are three times more likely to contract HIV than men in Africa.
Byanyima likened the announcement of Sunlenca to the breakthrough discovery of AIDS medications decades ago that transformed HIV from a fatal condition into a manageable chronic illness. At that time, South African President Nelson Mandela suspended patents to increase drug accessibility, reducing the cost from approximately $10,000 per patient per year to around $50.
Olwethu Kemele, a health worker at the Desmond Tutu Health Foundation, anticipated that the injections could increase the number of individuals seeking HIV prevention and help slow the virus’s spread. She noted that young women often conceal the pills to avoid scrutiny from boyfriends and family, making it challenging for them to adhere to the medication.
In a recent report on the global HIV epidemic, UNAIDS revealed that fewer people were infected with HIV in 2023 than at any time since the late 1980s. Each year, approximately 1.3 million people are newly infected with HIV, and more than 600,000 people die from the disease, predominantly in Africa. Despite notable progress in Africa, HIV cases are on the rise in Eastern Europe, Latin America, and the Middle East.
At the AIDS conference, research by Andrew Hill from the University of Liverpool and his team suggested that expanding Sunlenca production to cover 10 million people could reduce the treatment cost to around $40. Hill emphasized the urgency for health authorities to gain access to Sunlenca as soon as possible, describing it as “about as close as you can get to an HIV vaccine.”
