AIDS Foundation Chicago (AFC) applauds the HIV Prevention Trials Network (HPTN), the National Institute of Allergy and Infectious Diseases, and ViiV Healthcare for demonstrating that injections of long-acting cabotegravir (CAB-LA), delivered every other month, appear to be safe and highly effective in preventing HIV in gay and bisexual cisgender men and transgender women who have sex with men. This exciting news paves the way for the first-ever injection to prevent HIV transmission.
The data come from a large-scale efficacy trial, HPTN 083, which is ongoing with 4,570 participants at sites in the Americas, Asia and South Africa. Over 50% of trial participants at the U.S. sites are Black, and 12% are transgender women – the highest proportion of trans women so far in a biomedical HIV prevention study.
Following a regularly scheduled review by its data and safety monitoring board (DSMB), researchers found that CAB-LA provided significant protection against HIV. The protection achieved is “non-inferior” to the protection offered by daily Truvada (a pill taken orally), which means they are essentially equally effective.
As reported, the DSMB recommended that all HPTN 083 trial participants be told which active drug (CAB-LA or oral Truvada) they were receiving and that placebos be dropped from the study. The study will continue to completion with all participants receiving one of the two active products.
A sister study called HPTN 084, which is being conducted among cisgender women in Africa, remains active and has not yet reported any data with regard to safety or efficacy among cisgender women.
“Adding a new item to our buffet of HIV prevention options expands people’s choices and will result in more protected sex among disproportionately impacted populations — which is fantastic, and why today is a wonderful day,” said Jim Pickett, Senior Director of Prevention Advocacy at AIDS Foundation Chicago. “We look forward to data on efficacy among cisgender women, who bear the largest burden of the HIV epidemic in sub-Saharan Africa and comprise nearly 20% of new HIV diagnoses in the United States. The Food and Drug Administration should look at data from cisgender men, transgender women, and cisgender women before considering this drug as an approved means of HIV prevention.”
AFC expects to see more complete data from HPTN-083 published in the next few months.
If CAB-LA is also shown to be safe and effective among cisgender women in the HPTN-084 study, Getting to Zero Illinois will have an important new tool to deploy to end new cases of HIV in the state by 2030. Robust implementation of CAB-LA will need to address cost, the country’s frayed health systems infrastructure, and the burden individuals will face going to the clinic for their shots six times a year.
The timeline for approval of CAB-LA for HIV prevention is unknown.