Twice-yearly injection offers ‘stunning’ 100 percent protection against HIV, experts say

By Maria Cheng and Gerald Imray | Associated Press

CAPE TOWN, South Africa — Twice-yearly shots used to treat AIDS were 100 percent effective in preventing new infections in women, according to study results published July 24.

There were no infections in the young women and girls that got the shots in a study of about 5,000 in South Africa and Uganda, researchers reported. In a group given daily prevention pills, roughly 2 percent ended up catching HIV from infected sex partners.

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

A pharmacist holds a vial of lenacapavir, the new HIV prevention injectable drug, at the Desmond Tutu Health Foundation's Masiphumelele Research Site, in Cape Town, South Africa, Tuesday, July 23, 2024, which was one of the sites for Gilead's lenacapavir drug trial. (Nardus Engelbrecht / AP)
A pharmacist holds a vial of lenacapavir, the new HIV prevention injectable drug from U.S. drugmaker Gilead. It is currently approved to treat HIV, but if test results from men echo those of women, Gilead is likely to request permission to use it as a preventative. (Nardus Engelbrecht / The Associated Press) 

The shots made by U.S. drugmaker Gilead and sold as Sunlenca are approved in the U.S., Canada, Europe and elsewhere, but only as a treatment for HIV. The company said it is waiting for results of testing in men before seeking permission to use it to protect against infection.

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. Because of the surprisingly encouraging results, the study was stopped early and all participants were offered the shots, 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 percent of participants given Gilead’s Truvada or Descovy prevention pills actually took them — and that figure dropped over time.

The prospect of a twice-a-year shot is “quite revolutionary news” for our patients, said Thandeka Nkosi, who helped run the Gilead research at the Desmond Tutu Health Foundation in Masiphumelele, South Africa. “It gives participants a choice and it just eliminates the whole stigma around taking pills” to prevent HIV.

A woman who helped run drug-testing research poses in the lab as a lab technician works behind her with vials.
Clinical trials coordinator Thandeka Nkosi calls the prospect of a twice-a-year shot “quite revolutionary” for patients, saying it removes the stigma around taking pills to prevent HIV. Consistent use of the pills has been a problem in Africa. (Nardus Engelbrecht / The Associated Press) 

Experts working to stop the spread of AIDS are excited about the Sunlenca shots but are concerned Gilead hasn’t yet agreed on an affordable price for those who need them the most. The company said it would pursue a “voluntary licensing program,” suggesting that only a select number of generic producers would be allowed to make them.

“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 said her organization urged Gilead to share Sunlenca’s patent with a U.N.-backed program that negotiates broad contracts allowing generic drugmakers to make cheap versions of drugs for poorer countries worldwide. As an HIV treatment, the drug costs more than $40,000 a year in the U.S., although what individuals pay varies.

Lab technician, Xolile Mhlanga, works with vials of lenacapavir, the new HIV prevention injectable drug, at the Desmond Tutu Health Foundation's Masiphumelele Research Site, in Cape Town, South Africa, Tuesday, July 23, 2024. (Nardus Engelbrecht / AP)
Lab technician Xolile Mhlanga cross-checks vials of lenacapavir. (Nardus Engelbrecht / The Associated Press) 

Dr. Helen Bygrave of Doctors Without Borders said in a statement that the injections could “reverse the epidemic if it is made available in the countries with the highest rate of new infections.” She urged Gilead to publish a price for Sunlenca that would be affordable for all countries.

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