NAIROBI, Kenya July 26- European Medicines Agency (EMA) human medicines committee 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).
The ring is recommended for use 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.
“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,” it said in a statement indicated.
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.
This is the eleventh medicine recommended by EMA under EU Medicines for all(EU-M4All), a mechanism that allows the committee 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.
The Founding Chief Executive Officer of IPM Dr. Zeda F. Rosenberg lauded the approval stating, “The EMA’s opinion is a significant step forward for women, who urgently need and deserve new, discreet options to manage their HIV risk on their own terms.”
The Committee for Medicinal Products for Human Use (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.
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, anti-retroviral 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 do not have HIV and are exposed to the virus, can take PrEP medicines daily to reduce their risk of getting infected.