BOSTON – With high rates of uptake, high rates of use, and HIV infection rates less than half of what would otherwise have been anticipated, the continued development of vaginal rings loaded with antiretroviral drug as a means of protection from the virus gained a large measure of vindication in interim trial results released here Tuesday.
The open-label HOPE and DREAM trials followed the ASPIRE and RING blinded clinical trials in which participants were randomly assigned either a flexible silicone ring releasing the antiretroviral dapivirine or a placebo product. Data from that trial had indicated that rings with time-released dapivirine offered some protection from HIV infection, but that the young women who were the primary target population that was hoped to benefit from the device did not use it with sufficient consistency to receive that benefit.
Offering the same participants a product that was known not to be a placebo and that now had been demonstrated to offer some potential protection made a pivotal difference, Dr. Jared Baeten of the HOPE study team and Zeda Rosenberg of the DREAM study team said.
“We always felt women would use the ring more if they knew the results,” Rosenberg said.
The women, in turn, older since participating in the 2012-to-2015 Ring and ASPIRE trials, may have overcome other obstacles to use in the time since those trials. In any case with HOPE and DREAM data showing a 54-percent HIV incidence reduction from the rates that modeling indicated would otherwise have prevailed, the researchers are applying for approval from European medical regulatory authorities, and plan to submit applications from the U.S. Food and Drug Administration and South Africa’s regulatory agency.
The news represented another advance for the use of antiretroviral drugs to prevent HIV infection among populations at particularly high risks, as recommended by the World Health Organization in 2015. That recommendation highlighted the unmet HIV prevention needs of millions of people who include individuals who earn income through sex work, men who have sex with men, transgender women and adolescent girls and young women in high incidence settings worldwide. Still, presentations on both obstacles to, and use of Pre-Exposure Prophylaxis, or PrEP, highlighted that of the just 220,000 people worldwide using PrEP, 153,000 of them are in the United States. And, while the U.S. Centers for Disease Control and Prevention has indicated that 1.2 people in this country are eligible for PrEP, populations among whom risks are highest are poorly represented in current uptake numbers.