Dapivirine Vaginal Ring

dapivirine 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 user-controlled (a woman can remove the ring herself if she wants to) and its effect is localized (limited to the vagina) rather than systemic (affecting the whole body).

Overview of the ring introduction process

Evidence and Research

Information on Phase III trials, open label extension studies, use by adolescent girls and young women, and pregnancy and breastfeeding studies available below.

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Regulatory Status

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-2019. For the latest information, visit IPM's website here.

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Planning for Introduction

IPM has chosen to focus their initial planning for introduction in Kenya, Malawi, Rwanda, South Africa, Tanzania, Uganda and Zimbabwe. This planning involves studies, information gathering and collaboration with many organizations.

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Ring Resources

Additional resources are available on planning for introduction, learning about the potential impact of the ring, marketing, demand creation and advocacy.

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Last updated October 16, 2019.