Paving the way for possible introduction

 

If approved, the dapivirine ring could become the first microbicide and the longest-acting HIV prevention product. The product is currently under review by the European Medicines Agency (EMA) under the Article 58 procedure, which allows the EMA to issue a scientific opinion, in conjunction with the World Health Organization, on the ring’s use in low- and middle-income countries. An opinion is currently expected in 2020.

 

 

 

 

 

 

IPM is also preparing applications to the US Food and Drug Administration and the South African Health Products Regulatory Agency for submission in 2020. Following next steps with the WHO, additional regulatory submissions are planned for other countries in Africa, including Kenya, Malawi, Rwanda, Tanzania, Uganda and Zimbabwe. These seven target countries in Africa were selected for product launch based on the public health need and their participation in previous ring studies, which could facilitate education among women and health providers and support policy development in the future.

 

As the ring moves through the complex regulatory review process, IPM has been partnering closely with Janssen Pharmaceutical Companies of Johnson & Johnson, which granted IPM exclusive worldwide rights to dapivirine, to enable a rapid product launch as soon as approval is received. In 2018, market research was ongoing to understand who might use the ring and factors that may affect use. The results from these studies, being conducted in the four countries where the Phase III trials took place, will be used to design targeted demand creation materials and strategies.

 

Studies are also underway in the seven countries targeted for the first phase of market introduction to understand health providers’ willingness to prescribe the ring, results from which will be incorporated into the development of health provider support tools. Additional work led by IPM’s partner, the USAID-funded OPTIONS Consortium, included country readiness assessments in the seven launch countries, as well as public health impact modeling to inform decision-making.

If the dapivirine ring is approved, continued community outreach will be essential to its uptake.