South African Health Products Regulatory Authority’s (SAHPRA) has approved the monthly Dapivirine Vaginal Ring for use by women ages 18 and older to reduce their HIV risk.
The Dapivirine Vaginal Ring is a much-needed addition to a proven HIV prevention method mix that also includes male and female condoms, daily oral PrEP, voluntary medical male circumcision (VMMC) and injectable cabotegravir (CAB) in some countries.
South Africa joins Zimbabwe as the first countries to approve the ring, which is also under review in several other Eastern and Southern African countries, and is recommended by the World Health Organization as an additional prevention option.
“This is a critical step forward in providing a new prevention option that many South African women need and can use,” said Mitchell Warren, AVAC executive director. “It will be important for South Africa to ensure that the Ring is integrated into HIV prevention guidelines and made available to women as quickly as possible. Regulatory approval of the Ring must be accompanied by strategic, effective and equitable rollout that transforms the growing list of HIV prevention options into real and accessible choices for the women most in need of HIV prevention.”
“We know that the most effective intervention is the one someone picks for themselves among an array of effective choices,” said Nandi Luthuli, AVAC’s Regional Stakeholder Engagement Manager, based in South Africa. “It’s very exciting that South African women will soon have a broader choice in HIV prevention options. More choices can mean more HIV infections averted, which will help South Africa control the HIV epidemic.”
“The SAPHRA approval is a critical step in translating scientific research into public health impact,” said Manju Chatani-Gada, AVAC’s Director of Partnerships and Capacity Strengthening. “We hope that other countries currently reviewing the Ring will follow the examples of South Africa and Zimbabwe and take the necessary steps to provide this important HIV prevention option to women. At the same time, we hope countries reviewing injectable cabotegravir as a new prevention option will move quickly to add yet another proven effective and much needed HIV prevention option to the toolbox.”
“We thank the thousands of women who participated in the trials that provided the evidence that the Ring works as well as dozens of advocates and community members in South Africa and across the globe who have tirelessly advocated for this important new prevention option for women,” Chatani-Gada added.
The monthly Dapivirine Ring is a longer-acting HIV prevention product that women can control and use discreetly to reduce the risk of HIV transmission during vaginal sex. Women insert the product themselves and replace it every month. Made of flexible silicone, the ring slowly releases the antiretroviral (ARV) drug dapivirine directly in the vagina at the site of potential infection, with minimal exposure elsewhere in the body.
The Ring was proven effective in two Phase III studies, received a positive opinion from the European Medicines Agency (EMA) and is recommended by the World Health Organization (WHO) as a prevention option for women.
Recent data from the REACH Study showed that nearly all of the adolescent girls and young women aged 16-21 in the study accepted the Ring and daily oral PrEP as prevention options and that when young women had access to and experience with two biomedical prevention options, almost all of them chose to continue using one of them – and most of them actually chose to use the dapivirine vaginal ring.
“SAHPRA’s approval for women over 18 is great news, but we hope that soon the ring can also be made available to adolescent girls as young as 16,” said Maureen Luba, AVAC’s Senior Policy and Advocacy Manager and a member of the IPM Board of Directors. “We know that in South Africa and other Eastern and Southern African countries the HIV infection rates among girls and young women are very high in many communities. The Ring could also be an important option to help empower adolescent girls to protect themselves.”
AVAC officials say they look forward to working closely with civil society partners, the South African National Department of Health, IPM, the USAID-funded MOSAIC and CASPR Projects, and many other partners to ensure this regulatory milestone can be rapidly translated into public health impact.