The Desmond Tutu Health Foundation welcomes the positive opinion of the European Medicines Agency on the monthly dapivirine vaginal ring for use by cisgender women over the age of 18 in developing countries to reduce their risk of HIV-1 infection.
“Women in Africa have been left behind by progress against HIV for far too long, and today’s announcement is a landmark for women’s HIV prevention,” said Dr. Linda-Gail Bekker, DTHF deputy director, and national principal investigator for South Africa on The Ring Study. “Offering women multiple methods like the monthly ring and daily oral PrEP is vital to controlling the epidemic and to ensuring their sexual and reproductive health and rights.”
The ring, which was developed by nonprofit IPM (International Partnership for Microbicides) is designed to help reduce women’s HIV risk during vaginal sex. Women insert the product themselves and replace it every month. Made of flexible silicone, the ring slowly releases the ARV dapivirine locally to the site of potential infection, with minimal absorption elsewhere in the body.
As the first long-acting HIV prevention product, the monthly ring is designed to help address women’s unmet need for new methods given the persistently high rates of HIV they face, especially in sub-Saharan Africa. Today’s news opens the door to the next steps needed to seek approvals for the ring in countries where the need is most urgent.
As the EMA indicated, the monthly ring could be an important option for women who choose not to or are unable to use the daily oral antiretroviral (ARV) pill known as PrEP (or pre-exposure prophylaxis), now becoming more widely available in Africa. Oral PrEP is highly effective, but not all women are able to use it. In addition, although condoms will be indicated for use with the ring, they are not practical for women who are unable to negotiate their use with male partners or who are at risk of sexual or intimate partner violence.
The EMA’s Committee for Medicinal Products for Human Use reviewed the ring under the Article 58 procedure, in cooperation with the World Health Organization (WHO) to facilitate access to essential medicines in low- and middle-income countries using the same rigorous standards as for products intended for use in the European Union. Global partnerships with researchers, trial communities in Africa, Europe, and the United States, civil society, governments, industry, and donors spanning 16 years of research and development led to today’s positive opinion.
Rolling out the ring will require a collective effort by a range of global stakeholders, particularly as responding to COVID-19 alongside other priorities continues to challenge health systems. With strong political will and funding, it may be possible to begin making the dapivirine ring available sometime in 2021 in some communities in Africa where the need is urgent, pending several next steps, including the development of WHO recommendations and guidelines, regulatory reviews in Africa, US regulatory review and continued market and implementation research.
Yvette Raphael, who leads the Advocates for the Prevention of HIV in Africa, says the news is a welcome announcement for women across the continent who have expressed a need for tools that put them in charge of their own health. “We now look to governments and funders, always in consultation with communities, to make sure the dapivirine ring reaches the women who need it.”
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Read the EMA’ official opinion in full here; as well as IPM’s full press release here. Also see MTN’s release and NIAID’s release.
