As advocates for access to lifesaving and innovations, the South African Health Technologies Advocacy Coalition (SAHTAC) welcomes the approval of the dapivirine vaginal ring for use in South Africa.
The coalition hailed the announcement by the South African Health Products Regulatory Authority (SAHPRA) as a great stride for HIV prevention and one which demonstrate the impact of health research and development (R&D).
The ring developed by the International Partnership for Microbicides (IPM), is made of flexible silicone, and slowly releases the antiretroviral (ARV) drug dapivirine directly in the vagina which is the site of potential HIV infection. It is replaced monthly and is important option for women from the age of 18, who cannot or choose not to use daily oral pre-exposure prophylaxis (PrEP).
Women in South Africa (SA) bare a disproportionate burden of HIV. UNAIDS estimates the HIV prevalence for young women at 10.4% compared to the prevalence among young men which is at 3.5%
Dr Pearl Selepe, The Aurum Institute (SAHTAC secretariat) Klerksdorp Clinical Research Site Leader, said women are more affected by HIV compared to men due to gender disparities. “This adds to the inability of women to negotiate safer sex with condoms, access HIV/sexual health services and adhere to daily oral PrEP regimens despite proven efficacy of these methods. It is therefore clear that women need discrete, forgiving, less user -dependant and long-acting HIV prevention methods such as the Dapivirine ring, that they can easily control and adhere to in order to change the tide against HIV.” said Selepe.
SAHTAC member organisation said this was; “a breakthrough.”
Makhosazana Mkhatshwa, Research Officer at Treatment Action Campaign the ring; “will give women an opportunity to have control of their decision to prevent HIV.
She called for the National Department of Health (NDOH) will immediately include the dapivirine vaginal ring in procurement decisions along with a vibrant communication strategy implemented to make sure women in all the provinces are aware of the availability of the ring as a prevention option. “As part of civil society, we can help raise awareness about the ring and to ensure that women are well informed about this prevention option. We are looking forward to a speedy rollout of the ring at healthcare facilities in the whole country,” she said.
Mkhatshwa added this approval opens the door for more innovative research, such as the 3-month ring currently under study. “As advocates of Health research, we’re always pushing for access to new drugs to broaden the options for communities, dapivirine is an important additional tool that will enhance our efforts to end AIDS as a global health threat as per the global AIDS strategy.”
Yvette Raphael, Executive Director of Advocates for the Prevention of HIV in Africa (APHA) said this news could not come at a better time for women in SA. “It will go down in history as revolutionary for women’s health. It is important that we do not forget the courage of the trial participants, and the resilience of advocates, their allies and communities. Womandla!” she said.
This was echoed by Neetha Morar, Senior Research Manager at HIV and other Infectious Diseases Research Unit (HIDRU). She also congratulated those involved in the development of the ring, particularly the clinical trial participants. “This is a proud moment for the women in SA as their voluntary contribution to the trial outcome helped SAHPRA make this decision. We now need to have transparent conversations with NDOH and IPM on the process of getting access and distribution of the effective vaginal ring. ‘We’ is a collective of all decision makers to work in partnership and cohesively to share a realistic timeline of access and be honest if access is not feasible in the next two years.” said Morar.