Vaginal ring gives women more options for HIV prevention
Access to a long-acting vaginal ring, which was tested in SA and showed promising results, is getting closer to reality after Europe’s regulatory body gave it the thumbs-up.
The monthly dapivirine ring is the first discrete, long-acting, HIV-prevention product designed specifically for women.
On Friday the ring’s developer, International Partnership for Microbicides (IPM), welcomed a positive opinion from the European Medicines Agency (EMA), saying this would open the door to the next steps needed to have the ring regulated in countries where it’s needed the most.
The silicone ring, which provides sustained release of the antiretroviral drug dapivirine over one month, reduces HIV infection by 35%. The ring was also found to have a favourable safety profile in all clinical trials to date.
Prof Linda-Gail Bekker, deputy director of the Desmond Tutu HIV Centre and a SA principal investigator of the The Ring study, said the ring would give local women different options to protect themselves.
“Offering women multiple methods like the monthly ring and daily oral PrEP (pre-exposure prophylaxis) is vital to controlling the epidemic and to ensuring their sexual and reproductive health and rights.
“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,” she said.
The ring 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.
The European Medicines Agency’s committee for medicinal products for human use reviewed the ring under the Article 58 procedure, which it conducts in co-operation with the World Health Organisation (WHO) to facilitate access to essential medicines in low- and middle-income countries
The ring was tested on about 3,700 young women, aged 18-25, in two open-label extension studies, HOPE and DREAM, in four countries including SA, Malawi, Zimbabwe, and Uganda.
Regulatory submissions are under way to license the product for use in countries where women face the highest rates of HIV infection in the world. WHO is also expected to review evidence on the ring as part of its guideline process and consider using an abbreviated review of the product for prequalification.
Dr Zeda Rosenberg, CEO of IPM, said the European regulator’s opinion “is a significant step forward for women, who urgently need and deserve new, discreet options to manage their HIV risk on their own terms”.
“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.”
Leonard Solai, spokesperson for IPM, said the NGO will soon be submitting the ring for country reviews in Africa through the WHO’s collaborative registration procedure, “which facilitates accelerated reviews by national regulatory authorities in Africa for a product that has already received a positive decision from a stringent regulatory body”.
“We currently hope to begin those submissions by the end of 2020. In parallel, the World Health Organisation plans to revise HIV/Aids treatment and prevention guidelines with recommendations on the ring’s use, and review the ring for prequalification, a quality assurance designation that ensures a product meets global standards for quality, safety and efficacy,” said Solai.