Dapivirine Vaginal Ring
The first microbicide to be submitted for regulatory approval is an intravaginal silicone ring, developed by the International Partnership for Microbicides (IPM) for HIV prevention. It looks like a contraceptive ring but instead releases dapivirine, an antiretroviral drug, slowly over the course of one month. It is woman-controlled (a woman inserts and removes the ring herself) and releases dapivirine locally in the vagina, directly at the site of potential infection, with very low systemic uptake (affecting the whole body).
Evidence and Research
Information on Phase III trials, open label extension studies, ring studies involving adolescent girls and young women, and pregnancy and breastfeeding studies is available below.
IPM, the ring's developer, applied to the European Medicines Agency (EMA) for review of the ring under Article 58. This procedure allows the EMA, in cooperation with the World Health Organization (WHO), to provide a scientific opinion on the safety, efficacy and quality of medicines that would be marketed exclusively outside of the European Union—specifically in low- and middle-income countries—for diseases of major public health interest. An opinion is expected by mid-2020. For the latest information, visit IPM's website here.
Planning for Introduction
IPM has chosen to focus its initial planning for introduction in Kenya, Malawi, Rwanda, South Africa, Tanzania, Uganda and Zimbabwe. These countries were selected due to the public health need and their participation in ring studies, which could facilitate the product’s introduction if it is approved. This planning involves studies, information gathering and collaboration with many organizations and key stakeholders.
Additional resources are available on planning for introduction, learning about the potential impact of the ring, marketing, demand creation and advocacy. For a one-page overview of ring resources, click here.
Last updated April 2, 2020.