A new way to prevent HIV delivers dramatic results in trial

From the article:

Now a new trial —- called PURPOSE 1 —- points the way to a new preventive strategy —- a twice yearly injection of a drug called lenacapavir. The trial was sponsored by Gilead Sciences, the California-based maker of the drug.

In this double-blind, randomized study of 5,300 cisgender women in South Africa and Uganda, 2,134 got the injection and the others took one of two types of daily PrEP pills. The trial began on August 2021 and, so far, not a single woman who received the injections has contracted HIV. The participants who received either of the oral PrEP options, Truvada and Descovy, had infection rates of about 2% — consistent with the infection rates of oral PrEP in other clinical trials.

These results were significant enough for the Data Monitoring Committee —- an independent group of experts appointed to assess the progress of clinical trials —- to recommend that Gilead halt its blinded trial and offer lenacapavir to all study participants. On June 20, Gilead announced these results, and now, all participants can choose to receive the injection.

…

Lenacapavir is not a new drug. It’s been approved by the FDA in the United States for multi-drug resistant HIV treatment since 2022. But PURPOSE 1 is the first clinical trial to test it for HIV prevention.

…

Any eventual approval and widespread use would come with challenges. According to an analysis presented at the 24th International AIDS Conference (AIDS 2022), PrEP medications would needto cost less than $54 a year per patient for South Africa, for example, to afford them. Lenacapavir’s cost as HIV treatment in the United States in 2023 was $42,250 per new patient per year. Oral PrEP options, on the other hand, can cost less than $4 a month.

…

Since sharing lenacapavir’s early success, Gilead has announced that they intend to “deliver lenacapavir swiftly, sustainably and in sufficient volumes, if approved, to high-incidence, resource-limited countries.” Their access strategy includes developing a voluntary licensing program that would enable generic versions to be produced before the original patent expires. When NPR asked Dr. Jared Baeten, Gilead’s vice president of HIV Clinical Development, about timeframes, he said that estimates will depend on "another trial, a regulatory review and approval."

Edit: looks like there was a similar article posted already. Sorry about that!