Dapivirine Vaginal Ring 25 mg - opinion on medicine for use outside EU
dapivirine
EU-M4allHuman
Overview
Dapivirine Vaginal Ring 25 mg is a vaginal ring used to reduce the risk of a woman getting infected with human immunodeficiency virus type 1 (HIV-1) through vaginal intercourse.
It is for use with safer sex practices (such as use of condoms) by women 18 years of age or above, when taking pre-exposure prophylaxis (PrEP) medicines by mouth is not feasible. It is intended for use outside the EU.
Dapivirine Vaginal Ring 25 mg contains the active substance dapivirine.
Dapivirine Vaginal Ring 25 mg is a silicone ring that is inserted into the vagina and slowly releases dapivirine, an antiviral medicine, over the course of one month. The ring should be removed after four weeks of use, and replaced straight away with a new ring.
Arrangements for supply of the medicine will be the responsibility of national medicines regulators. For more information about using Dapivirine Vaginal Ring 25 mg, see the package leaflet or contact your healthcare provider.
The active substance in Dapivirine Vaginal Ring 25 mg, dapivirine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows the virus to make more copies of itself in the cells it has infected and to spread in the body. By blocking reverse transcriptase, dapivirine, which is released from the silicone ring at the site of potential infection in the vagina, stops the virus from multiplying and spreading in the body if the woman is exposed to the virus.
A main study conducted in almost 2,000 women in sub-Saharan Africa showed that 4.2% of women who used Dapivirine Vaginal Ring 25 mg became infected after two years of treatment, compared with 6.4% of women who used placebo (a vaginal ring not releasing any medicine). This means that Dapivirine Vaginal Ring 25 mg lowered the chances of being infected with HIV-1 by over a third (35.1%).
The most common side effects with Dapivirine Vaginal Ring 25 mg (which may affect more than 1 in 20 people) are urinary tract infection (infection of the structures that carry urine), vaginal discharge, vulvovaginal pruritus (itching), vulvovaginitis (inflammation or irritation of the skin of the vulvar and vaginal area) and pelvic (lower belly) pain. For the full list of side effects of Dapivirine Vaginal Ring 25 mg, see the package leaflet.
Dapivirine Vaginal Ring 25 mg must not be used by women with unknown or positive HIV status. For the full list of restrictions, see the package leaflet.
There were some uncertainties about the risk of resistance and the benefits in younger women in particular, which need to be addressed by further study, Overall, however, Dapivirine Vaginal Ring 25 mg was shown to be moderately effective at lowering the risk of HIV-1 infection following vaginal intercourse, and its side effects are considered manageable. The European Medicines Agency therefore decided that its benefits are greater than its risks in women who are not using PrEP medicines by mouth.
The organisation that markets Dapivirine Vaginal Ring 25 mg will conduct a study in women between 18 and 25 years of age to address the current uncertainty regarding effectiveness in younger women and the development of resistance in women who become HIV positive, and to confirm the overall effect of the medicine.
The company will also provide educational materials to healthcare professionals expected to prescribe and dispense the medicine and a user guide for women, with information on the safety of the medicine, the importance of compliance during treatment and how to use the medicine correctly.
Recommendations and precautions to be followed by healthcare professionals and women for the safe and effective use of Dapivirine Vaginal Ring 25 mg have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Dapivirine Vaginal Ring 25 mg are continuously monitored. Side effects reported with Dapivirine Vaginal Ring 25 mg are carefully evaluated and any necessary action taken to protect patients.
The European Medicines Agency gave a positive opinion for Dapivirine Vaginal Ring 25 mg on 23 July 2020.
The Agency assessed Dapivirine Vaginal Ring 25 mg as part of the its cooperation with the World Health Organization, whereby the Agency evaluates medicines that are not intended for use in the EU but are needed to prevent or treat diseases of major public health importance around the world.
Product information
Latest procedure affecting product information: IA/24
01/03/2024
Product information documents contain:
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturer responsible for batch release
- Annex IIB - Recommendations to the opinion holder - conditions of use
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Pharmacotherapeutic group
Other antiinfectives and antisepticsTherapeutic indication
Reducing the risk of HIV-1 infection via vaginal intercourse in HIV-uninfected women 18 years and older in combination with safter sex practices when oral PrEP is not/cannot be used or is not available.
Opinion details
Product details
- Name of medicine
- Dapivirine Vaginal Ring 25 mg
- EMA opinion number
- H-W-2168
- Opinion status
- Positive opinion
- Active substance
- dapivirine
- International non-proprietary name (INN) or common name
- dapivirine
- Therapeutic area (MeSH)
- Anti-HIV Agents
- Anatomical therapeutic chemical (ATC) code
- G01AX17
Publication details
- Opinion holder
- International Partnership for Microbicides Belgium AISBL
Square de Meeus 38/40
1000 Brussels
Belgium - Date of opinion