13 hours ago
HIV Prevention Vaginal Ring Recommended for 16-Year-Olds
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended an extension of indication for dapivirine vaginal ring 25 mg to include its use in women from 16 years of age.
The EMA said there had been some uncertainties about the risk for resistance and the benefits in younger women, which needed to be addressed. Upon further study, the ring was shown to be moderately effective at lowering the risk for HIV-1 infection following vaginal intercourse, with its side effects considered manageable. As such, the EMA decided that its benefits outweigh the risks in women who are not using oral pre-exposure prophylaxis (PrEP).
The dapivirine ring was originally approved in July 2020 to reduce the risk for HIV-1 infection in women 18 years and older through vaginal intercourse, when taking PrEP medicines by mouth was not feasible. It is the first long-acting technology approved for HIV prevention in women and is intended for use outside the EU.
The device was submitted under a regulatory procedure, EU- Medicines for all (EU-M4All) that enables the EMA, in collaboration with the World Health Organization (WHO), to provide scientific opinions on high priority human medicines that are intended for markets outside the EU. The process allows the European agency to support global regulatory capacity building and contributes to the protection and promotion of public health beyond the EU. Its overall aim is to facilitate access to essential medicines in low- and middle-income countries that are intended to prevent or treat diseases of major public health interest.
The flexible silicone ring is inserted in the vagina for a period of 28 days, after which it should be replaced by a new one. It works by slowly releasing dapivirine over the course of a month, which blocks the ability of HIV to make copies of itself inside healthy cells. It can be inserted and removed by the user.
A study conducted in almost 2000 women in sub-Saharan Africa showed that dapirivine vaginal ring 25 mg lowered the chances of being infected with HIV by more than one third over the course of 24 months compared with the placebo group. It was first developed by the International Partnership for Microbicides and since acquired by the Population Council in 2022. It was first approved in 2021 by the Medicines Control Authority of Zimbabwe and has since been approved in several additional African countries.
The ring has been on the WHO's prequalification list of medicines since November 2020 following positive scientific opinion from the EMA. The WHO has said it is intended to reduce the risk of acquiring HIV during vaginal sex for women who are at substantial HIV risk as a complementary prevention approach in addition to other safer-sex practices.
The CHMP's opinion to extend the indication for this medicine to include its use in women from 16 years of age expands the HIV prevention choice beyond condoms and oral PrEP and could be an important tool to protect younger women from becoming HIV-positive.
