Connie Celum, University of Washington Professor of Public Health (University of Washington photo)
Researchers at the University of Washington will test a pill once a month to prevent HIV in women with a new $ 122 million grant from the Bill and Melinda Gates Foundation.
The grant is one of the first to emerge from the Gates Foundation since Bill and Melinda French Gates announced their divorce in May, and days after Warren Buffett stepped down as the organization’s sole other trustee. The research is in line with French Gates’s focus on women and girls.
The phase 3 randomized trial will compare the efficacy of the monthly islatravir, a pill in development by Merck, with a standard daily pill that prevents HIV-1.
The daily pill is already approved for HIV prevention, an approach called pre-exposure prophylaxis.
The study will involve 4,500 healthy HIV-uninfected women in 21 locations in Africa and 500 women in the United States. Young women in Africa account for approximately 25% of new HIV infections worldwide.
A monthly pill offers the possibility of greater ease of use and adherence. “The entire field is moving toward less adherence-dependent and user-friendly strategies of HIV prevention,” said Connie Celum, the study’s principal investigator and a professor of global health at the University of Washington, in a statement.
Taking a daily pill can also create barriers in populations where sexual activity is stigmatized. A study conducted last year by Celum Jared Baeten, also a professor of global health at the University of Washington, found that young African women had some of the biggest concerns about pre-exposure prophylaxis, citing issues such as discreet product storage. .
“If you only had to take a small tablet once a month and not deal with taking and storing the pills daily, that’s a totally different ball game,” Celum said.
To assess the efficacy of islatravir, the researchers arrived at a ‘double-blind, double-dummy’ trial design. Participants will receive one of two treatments: a daily pre-exposure prophylaxis pill and a monthly placebo that resembles islatravir, or a daily placebo and a monthly dose of islatravir. The researchers will compare the HIV infection rate of women in the two arms of the trial.
The new study has begun enrollment in the US and will begin testing subjects in Africa this month.
The Gates Foundation has awarded more than $ 3 billion in HIV grants to date and nearly $ 3 billion to the Global Fund to Fight AIDS, Tuberculosis and Malaria.
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