Dapivirine Ring: Developing a Global Action Plan for Introduction and Access
Purpose of the Global Action Plan
The Dapivirine Ring Global Action Plan
is a living document that will serve as a consolidated map that describes current and planned activities at the global level to support ring introduction. Its primary objective is to support coordination across partners for the planning, funding and introduction of the dapivirine ring in Africa in the context of combination prevention, including oral PrEP and integrated service delivery.
Highlights from Global Action Plan: Where we are today:
- In July 2020, the European Medicines Agency (EMA) issued a positive scientific opinion for the dapivirine ring’s (the ring) use by cisgender women ages 18 and older in developing countries to reduce their HIV risk.
- In November 2020, the dapivirine ring received WHO prequalification, a designation that confirms the ring meets global standards for quality, safety and efficacy and that will help guide global and national procurement decisions.
- In January 2021, the ring was recommended for use by the WHO as an additional prevention choice for women at substantial risk of HIV infection who cannot or choose not to use oral PrEP.
- In March 2021, WHO updated its clinical guidelines on antiretroviral (ARV) drugs for HIV prevention to include the ring.
- The ring is currently under review at the US FDA, with a decision anticipated by Q4 2021.
- The ring is currently under review by National Medical Regulatory Authorities in Kenya, Malawi, Rwanda, South Africa, Tanzania, Uganda, Zambia, Zimbabwe with decisions anticipated in Q2 and Q3 2021, although COVID-19 may cause delays.
- Dapivirine Ring Design Guide developed, using a human-centered design (HCD) approach, offering design concepts and tools to increase the adoption and sustained use of the ring.
- Ring included in the PEPFAR Country Operating Plan (COP) guidance for 2021.
For more information on supply chain, demand and market considerations, national policy and program support and donor and advocacy support, you can read the full Global Action Plan