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The Ring Study, conducted by IPM, and the ASPIRE trial, conducted by the US National Institutes of Health’s Microbicide Trials Network (MTN), were carried out at 22 sites in sub-Saharan Africa to assess the long-term safety and efficacy of a dapivirine vaginal ring in preventing HIV infection in healthy women. These trials demonstrated that the monthly dapivirine ring reduced HIV infection by about 30% in women aged 18–45. The monthly ring was generally safe and well-tolerated for up to 24 months of continuous use. Follow-on data suggest risk reduction may be greater than demonstrated in the trials, potentially more than 50%.
These and other data were submitted to the European Medicines Agency (EMA), which provided a positive scientific opinion. The monthly dapivirine ring has also been recommended by WHO as an additional prevention choice for women at substantial risk of HIV infection as part of combination prevention approaches. It has been approved for use in several African countries, including Kenya, Rwanda, South Africa, Uganda and Zimbabwe.
Women are particularly affected by the HIV epidemic – despite representing only 10% of the total population, young women aged 15–24 account for 25% of new HIV infections. There is therefore great interest in protective measures that women have control over.
The International Partnership for Microbicides (IPM) has overseen the development of a vaginal ring impregnated with an antiretroviral, the monthly dapivirine ring, as a preventive measure, with support from PSIAs funded by The Netherlands, Norway and the Republic of Ireland.
EDCTP Participating States’ Initiated Activities (PSIAs) have helped to progress an antiretroviral-impregnated vaginal ring now in use in several sub-Saharan African countries.
Preventing HIV infection in women