February 22, 2016
IAVI Welcomes New Data from Dapivirine Ring Studies
The International AIDS Vaccine Initiative (IAVI) welcomes new data from two late-stage clinical studies indicating that vaginal rings containing the antiretroviral drug dapivirine can safely help protect vulnerable women in sub-Saharan Africa from HIV infection.
Results of the ASPIRE and The Ring studies, announced Monday at the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, indicate that, when used consistently, the ring reduced the risk of HIV infection by approximately 30 percent in study participants overall (the study enrolled HIV-negative women aged 18-45). The results also indicate higher efficacy in women 21 and older, who also appeared to use the ring more consistently. Lower to no protection was found among participants 18 to 21 years of age.
The studies confirmed the very high-incident HIV infection rates among women in sub-Saharan Africa, and found rates even higher than anticipated among some groups of younger participants.
“These results represent a significant step in advancing biomedical research of effective approaches to preventing HIV infection in women, and provide important insights into both opportunities and challenges to developing innovations capable of protecting those at greatest risk of infection in Sub-Saharan Africa,” said Mark Feinberg, MD, PhD, IAVI President and CEO.
“The data also underscore yet again the critical need for choices in HIV prevention – and the power to exercise those choices – for women in low-income countries who bear the brunt of this epidemic. We must ensure that all those living with HIV get access to antiretroviral treatment, that all biomedical prevention strategies with demonstrated efficacy are available to those who need them, and that research efforts to develop new highly effective prevention modalities are redoubled and sustained,” said Feinberg. “The sponsors, investigators and participants in the studies announced today all deserve tremendous recognition for their dedication and efforts to ensure the successful conduct of these important studies.”
The sister studies ASPIRE (A Study to Prevent Infection with a Ring for Extended Use) and The Ring Study were both randomized, placebo-controlled Phase 3 clinical studies and together included almost 4,000 HIV-negative women ages 18-45 in South Africa, Uganda, Malawi and Zimbabwe. The ASPIRE trial was conducted by the National Institutes of Health (NIH)-supported Microbicides Trial Network (MTN). The Ring Study was conducted by the International Partnership for Microbicides (IPM) and supported by the United States Agency for International Development (USAID). Further information about these important findings is available from MTN, the NIH National Institute of Allergy and Infectious Diseases, IPM, USAID and AVAC.