SAMRC welcomes the Positive Opinion adopted by the European Medicines Agency on the Dapivirine Vaginal Ring to reduce HIV risk among women
Cape Town | 28 August 2020 | The South African Medical Research Council (SAMRC) welcomes the recent Positive Opinion adopted by the European Medicines Agency (EMA) on the Dapivirine Vaginal Ring (DVR) for use by non-pregnant, cisgender women of ages 18 and older in developing countries to reduce their risk of HIV-1 infection. Six SAMRC clinical research sites within the HIV Prevention Research Unit (HPRU), namely Botha’s Hill, Chatsworth, Isipingo, Verulam, Tongaat and Umkomaas, were part of this pivotal, global study.
In July 2020, the EMA has announced that the DVR, a first long-acting woman-initiated HIV Prevention Option may be part of the HIV prevention toolkit for many women in Sub-Saharan Africa – a plus for South African women as the country is commemorating National Women’s Month.
Inserted and replaced monthly by women themselves, the ring is designed to help address women’s unmet need for new HIV prevention methods given the persistently high rates of HIV they face. The DVR may help reduce women’s HIV risk during vaginal sex. Made of flexible silicone, the ring slowly releases the antiretroviral (ARV) dapivirine locally to the site of potential infection, with minimal absorption elsewhere in the body.
Based on the data, the DVR is safe and may reduce women's risk of HIV acquisition by 35%. Following these game-changing findings, work is currently underway by researchers, sponsors and partners to facilitate access to the DVR at low cost. Furthermore, additional research is currently underway to assess the efficacy of the DVR among young women (18 to 25 years), pregnant and breastfeeding women.
The EMA’s Committee for Medicinal Products for Human Use reviewed the ring under the Article 58 procedure, which it conducts 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.
International Partnership for Microbicides (IPM), a non-profit that developed the ring said given the urgency for women, it has been working with partners to shorten the time to potential introduction as much as possible but 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 DVR available sometime in 2021 in some communities in Africa where the need is urgent, pending several next steps, including amongst others developing WHO guidelines, ensuring WHO prequalification as well as Regulatory reviews in Africa.
“IPM is collaborating with MTN to study the monthly ring among adolescent girls, pregnant women and breastfeeding women, who are also at elevated HIV risk. Results from these studies could inform next steps on potentially expanding the indication for the ring to these groups in the future.”
Globally, research teams, communities, participants and advocates of the DVR, have welcomed the news saying they are committed to working on the next steps needed to seek approvals for the ring in countries where the need is most urgent.
Through its HIV Prevention Research Unit (HPRU), the SAMRC together with many research partners in Africa and South Africa are communicating this milestone message to the participants and community members.
Prof Ameena Goga, Interim Unit Director at the HPRU welcomed the news, and said the HPRU and SAMRC are extremely excited at the HIV prevention prospects that the DVR brings for women at risk of HIV acquisition – It allows them a level of control over their own HIV prevention.
“We will focus on working with key local stakeholders and advocates towards local regulatory approval of the DVR, health worker acceptance of the additional intervention, demand-generation amongst women at risk of HIV infection and trial participants’ access tothe DVR” said Prof Goga.
Rita Bantjies, one of the trial participants based at the Verulam Clinical Research Site (CRS) said she was extremely happy about the news of the virginal ring, adding that it’s a great milestone for poor women. “We hope it gets adopted in South Africa as one of the HIV prevention strategy that is available to all women who need to use it,” said Bantjies.
She also added that it’s a dream come true for her personally as she had participated in one of the first studies that were testing a woman-controlled HIV intervention which was not successful.
“I have made a decision to support researchers to ensure that one day they find a prevention strategy for HIV that give women power to protect themselves from HIV not to be decided by their partners,” concluded Bantjies who is also a member of the Community Working Group (CWG) and former MDP trials participants.
Another participant, Gugulethu Dlamini, expressed her excitement over these developments. She feels proud to hear that a product she used when she voluntarily participated in a research trial could now be available to women who need it to prevent being infected with HIV.
“I hope that the South Africa government and SADC countries accepts and approve the ring to be used widely by women – I think this will be very important for the rest of us as women because we really need more preventative measures that will give power to women” she said.
NOTE TO THE EDITOR:
About the SAMRC:
The SAMRC is dedicated to improving the health of the people in South Africa, through research, innovation, development and technology transfer. The scope of research includes laboratory investigations, clinical research, and public health studies.
The organisation ran one of the many clinical trials around the world to test the safety and efficacy of the Dapivirine Vaginal Ring (DVR) to reduce women's HIV risk.
About Dapivirine:
Dapivirine is a non-nucleoside reverse transcriptase inhibitor that blocks HIV’s ability to replicate itself inside a healthy cell. IPM holds an exclusive worldwide license for dapivirine from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The license is designed to ensure that women in low-resource settings have affordable access to any dapivirine-based vaginal HIV prevention method.
Resources and further reading: