03 Dec Dapivirine Vaginal Ring Helps Prevent HIV Infection in Women
MedicalResearch.com Interview with:
Ms. Neliëtte Van Niekerk M.Com
and Dr. Annalene Nel M.B., Ch.B., Ph.D.
From International Partnership for Microbicides
Silver Spring, MD
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Existing prevention methods have not done enough to stop the alarming rates of infection among women and girls, especially in sub-Saharan Africa, where young women are at least twice as likely to have HIV as young men. Rates of new infections among women aged 15-24 were more than four times greater than that of men the same age, and this age group accounted for 25 percent of new infections in South Africa. To provide women with more prevention options, the nonprofit International Partnership for Microbicides (IPM) developed a vaginal ring that contains an antiretroviral drug called dapivirine. Women insert the ring themselves and replace it every month.
The Ring Study was a Phase III clinical trial that assessed the safety and long-term efficacy of the monthly dapivirine ring among nearly 2,000 women in South Africa and Uganda. We found that the ring reduced the risk of HIV-1 infection in about one-third of the women in the trial, and it was safe, with no difference in adverse effects between the active and placebo ring groups.
MedicalResearch.com: What should readers take away from your report?
Response:This study, along with a “sister” study called ASPIRE, marked the first time a long-acting HIV risk reduction method was shown to be safe and effective against HIV-1 in two Phase III trials. Additional analyses from the ASPIRE study announced in July suggest that the ring could cut a woman’s HIV risk by more than half when used most consistently, and by 75 percent or more with near-perfect use. We are also continuing to analyze the data from The Ring Study and expect to add more to the picture of the ring’s efficacy when all analyses are available next year.
The need for new options has never been more urgent. Just last week, UNAIDS released a report warning that the rate of new HIV infections is not decreasing quickly enough to end the epidemic — and that women and girls are especially at risk. The promising results from The Ring Study (and its sister study, ASPIRE) offer hope for women at high risk for HIV.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: We need to better understand how the ring could fit into women’s lives in the “real world”. To that end, we are now conducting open-label extension studies (the DREAM and HOPE studies) to provide the active ring to former Phase III participants. We hope that ring use and HIV risk reduction will increase now that the product’s safety and efficacy are known, as seen in open-label studies of other prevention products. We are also planning a study in 2017 that would look at the use of the monthly ring and daily oral PrEP among young women and adolescent girls in Africa.
MedicalResearch.com: Is there anything else you would like to add?
Response: As the dapivirine ring’s regulatory sponsor, IPM will seek regulatory approval for the product in developing countries. We are now compiling the comprehensive dossier required by regulatory authorities, with the first submissions in 2017. The first approvals for the ring could potentially come in late 2018 in some countries. We are also working with government, civil society, private and other partners to plan for the ring’s potential introduction and roll-out — collaborations will be critical to realizing the promise of these study results.
Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women
Annalene Nel, M.B., Ch.B., Ph.D., Neliëtte van Niekerk, M.Com., Saidi Kapiga, M.D., Sc.D., M.P.H., Linda-Gail Bekker, M.B., Ch.B., Ph.D., Cynthia Gama, M.B., Ch.B., Katherine Gill, M.B., Ch.B., Anatoli Kamali, M.B., Ch.B., Ph.D., Philip Kotze, M.B., Ch.B., M.Med., Cheryl Louw, M.B., Ch.B., Zonke Mabude, M.A., Nokuthula Miti, M.B., Ch.B., Sylvia Kusemererwa, M.B., Ch.B., M.P.H., Hugo Tempelman, M.D., Hannelie Carstens, Ph.D., Brid Devlin, Ph.D., Michelle Isaacs, B.Pharm., B.Sc., Mariëtte Malherbe, B.Sc., Winel Mans, M.B., Ch.B., Jeremy Nuttall, M.Sc., Marisa Russell, B.Sc., Smangaliso Ntshele, Dip.G.N.M., Marlie Smit, B.Diet., Leonard Solai, M.B.A., Patrick Spence, Ph.D., John Steytler, M.B., Ch.B., Kathleen Windle, B.Sc., Maarten Borremans, M.Sc., Sophie Resseler, M.Sc., Jens Van Roey, M.D., Wim Parys, M.D., Tony Vangeneugden, Ph.D., Ben Van Baelen, M.Sc., and Zeda Rosenberg, Sc.D., for the Ring Study Team*
N Engl J Med 2016; 375:2133-2143
December 1, 2016DOI: 10.1056/NEJMoa1602046
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