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• Posted July 24, 2024

Twice-Yearly Shot Protects At-Risk Women Against HIV

Just two shots a year of an HIV treatment provided complete protection against infections in highly at-risk women, researchers reported Wednesday.

In the study of about 5,000 women in South Africa and Uganda, those given injections of lenacapavir were 100% protected, while roughly 2% of those given daily prevention pills were infected by their sex partners.

“These data confirm that twice-yearly lenacapavir for HIV prevention is a breakthrough advance with huge public health potential," Sharon Lewin, president of the International AIDS Society, said in a statement. "If approved and delivered -- rapidly, affordably and equitably -- to those who need or want it, this long-acting tool could help accelerate global progress in HIV prevention. We all owe a debt of gratitude to the thousands of young women in South Africa and Uganda who volunteered to be part of this study."

The shots, made by Gilead and sold as Sunlenca, are already approved to treat HIV infection in the United States, Canada, Europe and elsewhere, the Associated Press reported. The company said it is waiting for the results of testing in men before seeking permission to use the medication to guard against HIV infection.

Still, these early results prompted the researchers to stop the company-funded trial early so that all the women could get the shots. The findings were published July 24 in the New England Journal of Medicine and presented simultaneously at an AIDS conference in Munich.

“To see this level of protection is stunning,” Salim Abdool Karim, director of an AIDS research center in South Africa, told the AP.

While condoms or daily pills can help guard against HIV infection, consistent use has remained a problem in Africa. In the new study, only about 30% of women given Gilead’s Truvada or Descovy daily prevention pills actually took them.

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

Still, experts are concerned that Gilead hasn’t yet agreed on an affordable price for the shots for those who need them most.

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.”

“Gilead also needs to urgently publish a price for lenacapavir that is affordable for governments and people everywhere,” Bygrave added. “Research released today shows that one year’s supply of lenacapavir could be sold at a profit for under $100 per person per year, but Gilead currently charges over $42,000 per year in the U.S. This kind of pricing undermines the potential of this scientific breakthrough and slows the global effort to turn the tide on HIV and AIDS.”

In a statement, Gilead said it was too early to say how much Sunlenca would cost. But Dr. Jared Baeten, Gilead’s senior vice president of clinical development, told the AP that the company was already talking to generics manufacturers and understood how “deeply important it is that we move at speed.”

Olwethu Kemele, a health worker at the Desmond Tutu Health Foundation, said the shots could prompt more people to come in for HIV prevention because young women often have to hide the daily pills to avoid questions from boyfriends and family members.

More information

The U.S. Centers for Disease Control and Prevention has more on HIV prevention.

SOURCES: New England Journal of Medicine, July 24, 2024; International AIDS Society, news release, July 24, 2024; Gilead, news release, July 24, 2024; Associated Press