Twice-Yearly Injection Promises 100% HIV Protection

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July 24, 2024 – A twice-yearly injection to prevent HIV could dramatically alter the course of an epidemic that has lead to the deaths of more than 40 million people since the 1980s.

Twice-yearly shots were 100% effective at preventing new transmissions of HIV, a new landmark study shows. Separately, just 2% of a group who took daily pills to prevent HIV were infected. The study included more than 5,000 women and girls ages 16 to 25 living in South Africa and Uganda.

The results were published Wednesday in the New England Journal of Medicine and also presented at an international AIDS conference in Germany. The trial was halted early because the twice yearly injections were so successful.

An estimated 1.3 million people worldwide are newly infected with HIV annually. More than 600,000 people die from AIDS-related illnesses each year. One of the main challenges of implementing campaigns for effective preventive medicine (known as preexposure prophylaxis, or PrEP) is that many people at high risk of HIV do not take them daily because of a variety of factors, including access.

The shots, marketed under the name Sunlenca, are made by the U.S. pharmaceutical company Gilead. Also known by its generic name of lenacapavir, Sunlenca is currently approved in the U.S. as a treatment for HIV, and Gilead said it may seek approval for the medicine as a preventive measure, pending results of an ongoing study among men.

“These data confirm that twice-yearly lenacapavir for HIV prevention is a breakthrough advance with huge public health potential,” said Sharon Lewin, PhD, a physician-researcher and president of the International AIDS Society, 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 current price for lenacapavir is more than $40,000 for the first year, but a separate study also presented at the conference estimated that producing the medicine at a larger scale could pave the way for a cost of $40 per treatment. The group Doctors Without Borders called for global action to make the medicine affordable and accessible as soon as possible, adding that the organization is eager to start offering the medicine through its medical programs.

“100-percent effectiveness demands 100-percent access,” said Asia Russell, executive director of Health GAP, a global HIV advocacy organization, in a statement issued by Doctors Without Borders. “Lenacapavir for HIV prevention is a potentially pandemic defeating intervention.”