How Close Is a Once A Month PrEP-Like Drug?

Health researchers at the University of Washington received a five-year grant from the Bill and Melinda Gates Foundation worth $122 million to test the effectiveness of a once-monthly pill that could prevent HIV.

The grant will go to support a randomized trial of the effectiveness of islatravir, a monthly oral pill that has been developed by Merck. The study will compare that drug to a standard daily pill in preventing HIV transmission.

“This could be a game-changer,” said Dr. Connie Celum, a University of Washington professor of global health and leader of the study, in a release. “The whole field is moving toward less adherence-dependent and easier strategies for users of HIV prevention.”

Simply put, a once-monthly pill is easier than a daily pill that requires consistent adherence.

Celum also directs the university’s International Clinical Research Center — the center that runs large-scale HIV trials such as the study that allowed the once-daily pill to be available to the public, according to the release.

The study will involve 4,500 HIV-negative women across 21 sites in different African countries as well as 500 women in the U.S. Those in the trial will either be given a daily dose of PrEP and a once-monthly placebo or a daily dose of a placebo and the once-monthly islatravir.

“For some people, a daily pill is easy. But when you’re talking about populations where sexual activity is stigmatized, particularly young African women, men who have sex with men, or female sex workers, there are a lot of barriers to taking a pill a day,” she said.

Depending on the success of the trial, islatravir could eventually go to the U.S. Food and Drug Administration for review.

“If we’re going to impact the HIV epidemic through prevention, we have to do it at a much larger scale,” said Celum. “If you only had to take one little tablet once per month and not deal with daily pill-taking and storage, that’s a totally different ball game.”