‘Significant step’ for HIV prevention as vaginal ring gets green light from the European Medicines Agency

The possibility of a vaginal ring that can protect women against HIV has moved a step closer after the European Medicines Agency (EMA) reacted positively to trials that found a ring containing the antiretroviral drug dapivirine can reduce a woman’s risk of acquiring HIV during vaginal sex by 30 to 50%.

The ring, which has been developed by the International Partnership for Microbicides (IPM), works in a similar way to contraceptive rings that release hormones to prevent pregnancy. Women insert the ring themselves and, over the course of a month, the device slowly releases dapivirine to protect against HIV infection.

Nearly 4,600 women (aged 18 to 45) in Malawi, South Africa, Uganda and Zimbabwe took part in two Phase III studies to test the ring’s effectiveness, with the data reported in 2016.

The Ring Study, led by IPM, found the ring reduced overall HIV risk by 35%, while the ASPIRE study, conducted by IPM’s clinical trial partner the National Institutes of Health-funded Microbicide Trials Network, found the ring reduced overall risk by 27%.

In both trials, HIV risk was much lower in older women, aged over 21, than in younger women, who reported more intermittent ring use.

More recent data from two open-label extension studies suggested a greater risk reduction of more than 50%.

IPM will now seek regulatory approval for the ring from the World Health Organization and in countries where the need is greatest. There will be a particular focus on sub-Saharan Africa where around 4,500 adolescent girls and young women become HIV-positive every week.

Dependent on political will and funding IPM suggests the ring could be available by 2021 in areas where the need is particularly urgent.

If approved for use, the ring will provide an important alternative for women at heightened risk of HIV who are either unable or choose not to use oral pre-exposure prophylaxis (PrEP) or condoms – although condoms will be recommended for use with the ring.

Dr Zeda F. Rosenberg, founding Chief Executive Officer of IPM, described the EMA’s move as a “significant step forward for women, who urgently need and deserve new, discreet options to manage their HIV risk on their own terms.”

Dr Rosenberg added: “As we celebrate today’s news with the many partners around the world involved in the ring’s development, we also look ahead to the collective effort still needed to obtain country approvals to make the ring available to women in sub-Saharan Africa.”

Additional research is planned and underway with adolescent girls, young women, pregnant women and breastfeeding women to better understand the ring’s efficacy among these groups and to collect additional data on safety and potential drug resistance.

Research will also accelerate on a longer-acting, three-month dapivirine ring and a multipurpose ring that offers both HIV prevention and contraception. Both rings recently completed Phase I safety clinical trials.

UNAIDS welcomed the development, saying it was “hopeful” the ring would soon become available for women in sub-Saharan Africa.

Winnie Byanyima, Executive Director of UNAIDS, urged for “continued investment in research to fill the HIV prevention gap for women and girls and give them the options they need to protect themselves from HIV”.

Research on the dapivirine ring began 16 years ago and has involved researchers, trial communities, civil society, governments and donors in Africa, Europe and the United States.