Exploratory findings further support the launch of two open-label studies and continued research as IPM pursues regulatory approval
July 18, 2016 - Durban, South Africa - International Partnership for Microbicides. New data analyses announced at the AIDS 2016 conference today provide additional evidence suggesting that the monthly dapivirine vaginal ring developed by the nonprofit International Partnership for Microbicides (IPM) provides significant protection against HIV infection in women when used consistently. The new data were released as two open-label studies of the ring begin and as IPM pursues regulatory approvals for the product for its use in developing countries.
Earlier this year, results from two large Phase III clinical trials in Africa – The Ring Study, led by IPM, and ASPIRE, led by the U.S. National Institutes of Health-funded Microbicide Trials Network (MTN) – showed the monthly dapivirine ring safely reduced HIV-1 infection overall by 31 percent and 27 percent, respectively, compared to a placebo. In the new analyses announced by MTN today at AIDS 2016, researchers found that, among women who appeared to use the monthly ring consistently, HIV risk was cut by at least 56 percent — a statistically significant finding. Additional subgroup analyses of women who appeared to use the ring the most suggest the product reduced HIV risk by 75 percent or more.
Although the new exploratory analyses of ASPIRE need to be validated by further research, they indicate the important relationship between consistent ring use and HIV protection.
"We are encouraged by these new analyses, which further support that the dapivirine ring could be an important option for women who urgently need new tools to protect themselves from HIV," said Dr. Zeda Rosenberg, founder and chief executive officer of IPM. "While IPM seeks regulatory approval for the ring, we will continue to work to understand how we can best support women to use it consistently, and advance research to expand women’s options with additional new methods that make sense for their lives and needs." Continue reading...