EMA’s human medicines committee (CHMP) has adopted a positive opinion for Dapivirine Vaginal Ring (dapivirine) used to reduce the risk of infection with the human immunodeficiency virus type 1 (HIV-1), in combination with safer sex practices when oral pre-exposure prophylaxis (PrEP) is not used, cannot be used or is not available. Placed in the vagina, the ring slowly releases the antiretroviral medicine dapivirine over a period of 28 days.
This is the eleventh medicine recommended by EMA under EU Medicines for all (EU-M4All), a mechanism that allows the CHMP to assess and give opinions on medicines that are intended for use in countries outside the European Union under Article 58 of Regulation (EC) No 726/2004.
HIV-1 is a virus that causes acquired immune deficiency syndrome (AIDS). HIV targets the body’s immune system, particularly white blood cells that are important in helping to fight infections. The virus can be transmitted via blood, blood products, sexual fluids, other fluids containing blood, and breast milk. Sexual intercourse is the most common form of transmission of HIV.
According to the World Health Organization (WHO), at the end of 2019 there were 38 million people living with HIV worldwide. While there is no cure for HIV infection, antiretroviral medicines can control the virus and help prevent transmission. A number of HIV prevention strategies are available, including the use of protective methods during sexual encounters and PrEP. People who don’t have HIV and are exposed to the virus, can take PrEP medicines daily to reduce their risk of getting infected.
In some parts of the world, particularly in sub-Saharan Africa, women are especially vulnerable to being exposed to HIV, because they cannot negotiate the use of protective methods during sexual encounters or cannot access oral PrEP. The Dapivirine Vaginal Ring is an option for the prevention of HIV infection that women can control and use discreetly in case they cannot use or do not have access to oral PrEP.
Women insert Dapivirine Vaginal Ring into the vagina and replace it with a new one every 28 days. Dapivirine reduces the risk of HIV-1 infection after 24 hours of ring insertion. In order to maintain efficacy, a new ring is to be inserted immediately after the previous one is removed.
The safety and efficacy of Dapivirine Vaginal Ring were studied in a randomised clinical study in which 1959 women were assigned to either Dapivirine Vaginal Ring or a placebo ring. Dapivirine vaginal ring achieved a reduction in the development of HIV-1 antibodies (i.e. seroconversion), which is a measure for the presence of HIV in the body, of 35% compared to the placebo group. The CHMP is looking for further safety and efficacy data in younger women (18 to 25 years old) and on resistance testing in women who become HIV positive (seroconverters).
The most commonly reported adverse events for Dapivirine Vaginal Ring were infection of the structures that carry urine, vaginal discharge and itching of the vulva and the vagina.
EMA has worked in close collaboration with WHO and patient representatives during the assessment of Dapivirine Vaginal Ring. In particular, the CHMP listened directly to the testimony of two women living in endemic countries during the evaluation process.
Dapivirine Vaginal Ring was submitted to EMA under a regulatory procedure (Article 58) which allows the Agency to assess the quality, safety and efficacy of a medicine and give an opinion on its benefit-risk balance when used in low- and middle-income countries outside the EU. Medicines submitted under this programme are assessed by EMA in collaboration with WHO and regulators of target countries. These medicines must meet the same standards as those intended for EU citizens. More information is available here.
The scientific opinion from the CHMP helps to support regulators in countries where regulatory capacity may be limited, by providing expert evaluation of the medicine when used in local practice. National regulators can use the CHMP‘s scientific assessment to decide on the use of the medicine in their countries.