A large-scale clinical trial has shown a systemic, long-acting HIV drug to effectively prevent HIV, according to findings from a large National Institutes of Health study published May 18.
The trial evaluated the effects of long-acting injectable cabotegravir, given once every eight weeks to men who have sex with men and transgender women who have sex with men. The study was sponsored by the National Institute of Allergy and Infectious Diseases, which collaborated with ViiV Healthcare, Gilead Sciences and the HIV Prevention Trials Network.
Starting in 2016, 4,570 HIV-negative participants at 43 sites in Argentina, Brazil, Peru, South Africa, Thailand, the U.S. and Vietnam joined the study. All participants were considered at risk for HIV acquisition, two-thirds were younger than 30, and 12 percent were transgender women. Participants were randomly assigned to receive either injections of cabotegravir and placebo tablets, or placebo injections and daily oral Truvada tablets.
On May 14, 2020, an independent data and safety monitoring board found that the data clearly indicated that cabotegravir was highly effective at preventing HIV in the study. Among 50 participants who acquired HIV, 12 were receiving cabotegravir and 38 were receiving daily Truvada, which translates to an HIV incidence rate of 0.38 percent in the cabotegravir group and 1.21 percent in the Truvada group.
The board recommended that NIAID stop the trial, originally expected to continue until 2021, to share the results, which NIAID is now in the process of doing.