On 10 May 2022 the South African Health Technologies Coalition (SAHTAC), in collaboration with the National Department of Health, and the South African HVTN, International Partnerships of Microbicides (IPM) and Advocates for Prevention of HIV in Africa (APHA) hosted a virtual webinar titled, ‘THE DAPIVIRINE VAGINAL RING GETS SAHPRA APPROVAL – A MILESTONE FOR WOMEN’S HIV PREVENTION: WHAT ARE THE NEXT STEPS AFTER APPROVALS AND INTRODUCTION IN SOUTH AFRICA? The webinar was attended by over 70 people including policy makers, developmental partners, civil society, and the private sector. The discussions focussed on the lessons from regulatory process leading to the approval by SAHPRA, lessons learnt from oral PrEP. Discussions were also focused on funding, accessibility, advocating for availability, and steps which will be taken to ensure the ring is available to all women.
KEY TAKE AWAY
The monthly Dapivirine Vaginal Ring (DVR) received regulatory approval from the South African Health Products Regulatory Authority (SAHPRA) for its use by women ages 18 and older to reduce the risk of HIV infection during vaginal sex. This marks a major milestone that brings the first longacting and woman-controlled product steps closer to reaching women. The ring adds to a range of options available for women to protect themselves from contracting HIV. There were1.7 million new HIV infections in 2020 – 3 times higher than the UNAIDS 2020 targets. This calls for HIV prevention to remain a key focus. Now that the ring has been approved there is a need for funding to ensure availability, affordability, and equitable access through various public health approaches.
Leonard Solai, Vice President, Product Access and External Affairs, International Partnership for Microbicides. Leonard announced that the Dapivirine Vaginal Ring was approved by SAHPRA on the 8th March 2022 and that the approved name of the ring is Dapiring. He explained that additional research was completed on the safety and use of the DVR in adolescent girls and young women between the ages of 16 to 21. Safety in pregnant women and breastfeeding mothers is still undergoing clinical research in two separate studies. Leonard highlighted key learning from the process, and these include planning around the timing and regulator’s capacity, and the adjustments because the regulator was focussed on the covid vaccines. He explained that SAHPRA submission process is electronic and this paused challenges in uploading large documents. He stressed that community engagement was critical in ensuring that participants are involved in all stages, and they understand the regulatory processes and timelines. He requested that civil society continue to advocate for the funding of the ring since funding for HIV Prevention product access is low as global donor resources are severely constrained. Advocacy for funding for HIV prevention needs to be accelerated and prioritized not only at a global level but by country advocates calling on funding mechanisms and governments to continue support.
Prof Linda-Gail Bekker, Deputy Director, Desmond Tutu Health Foundation – Prof Linda explained that HIV prevention options are numerous and ever expanding – we can now offer HIV prevention choice tailored for any population in any setting. She said the good thing about the ring is that it is woman-initiated and self-inserted monthly. She further described how it does not interfere with sex and slowly releases ARV dapivirine. Studies showed reduced HIV risk in Phase III trials: 35% in the ring Study and 27% in ASPIRE. She stressed that we are in the prevention revolution.
Ms Yvette Raphael, Executive Director, Advocates for the Prevention of HIV in Africa. Yvette said the message is clear that the South African government must ensure that the vaginal ring program and the implementation phase is funded. We must advocate for accessibility of the ring and how to mobilise it throughout South Africa and ensure that funds become available. “Rings must be available in every clinic in South Africa for every woman who demands or requests to use it”, said Yvette.
Dr Thato Director: HIV Prevention Services, National Department of Health. Dr Thato outlined that the National Health Department is in the process of updating the national policy and guidelines as the next step after SAHPRA approval of the ring. This will include: • Implementation and financial planning • Service delivery preparation • Community and social mobilisation The NDOH has broken down the planning processes of implementation into sections to ensure that the services are available for everyone who needs them, the demand creation is important.
CALL TO ACTION
‘Rings in vaginas’ ‘A swift role out of the Dapiring’:
- Investments and funding commitments from government and donors
- Ensure equitable, affordable, and timely access to the ring for all women
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To watch the full webinar, click here: https://bit.ly/3Px6Afz