The world’s first long-acting option to protect women from HIV will hit the market next year, following its development in Belfast.
For the past 20 years, researchers from the School of Pharmacy at Queen’s University Belfast have been supporting the development of a new drug-releasing vaginal ring to protect women from infection with the human immunodeficiency virus (HIV).
The product, announced on World Aids Day, is proven to reduce the risk of women catching HIV, and has been recommended for use by the World Health Organization (WHO).
Known as the dapivirine ring, it was developed by the International Partnership for Microbicides (IPM) with research and development support by Queen’s University and other organisations.
It is predicted that it will hit the market in 2022, with a focus on sub-Saharan Africa, where urgent prevention is needed.
HIV, if left untreated, leads to acquired immunodeficiency syndrome (Aids).
According to recent estimates, there were 37.7m people in the world living with HIV in 2020.
The virus has reportedly claimed more than 35m lives since it was first identified in 1984.
The ring is made of a flexible rubber-like material known as silicone elastomer. It is simple to insert and comfortable to use.
It works by releasing the antiretroviral drug dapivirine from the ring into the vagina slowly over 28 days. The sustained delivery of dapivirine has been shown to reduce HIV infection in two large-scale clinical trials, supporting its later market approval.
Professor Karl Malcom and Dr Peter Boyd from the School of Pharmacy at Queen’s University Belfast have long been involved in developing tools for women, including different types of vaginal rings.
They are long-time collaborators with the not-for-profit International Partnership for Microbicides (IPM).
IPM and the Microbicide Trials Network conducted two large-scale randomised clinical trials that found the ring reduced the overall risk of HIV-1 infection in women by 35% and 27%, respectively. Further studies suggested an improved risk reduction of about 50%.
The ring received a positive opinion from the European Medicines Agency for use by women over 18 in developing countries who are unable to or choose not to take the daily preventative pill, PrEP.
The WHO has recommended that the dapivirine vaginal ring be included as part of a combined prevention package for women at substantial risk of HIV infection.
Regulatory approval for the ring has been granted in Zimbabwe, with regulatory reviews ongoing in additional countries in eastern and southern Africa.
Queen’s researchers are also working with IPM on a follow-on product, providing a continuous release of two drugs — dapivirine and levonorgestrel — over three months, for protection against both sexually transmitted HIV infection and unintended pregnancy.