The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the dapivirine vaginal ring for the reduction of risk for HIV infection in women in low- and middle-income countries outside the European Union.
"This milestone marks an important step toward expanding the number of biomedical HIV prevention options available to women in sub-Saharan Africa, who are among those most affected by the HIV epidemic," the US National Institute of Allergy and Infectious Diseases (NIAID) said in a news release.
The dapivirine vaginal ring was developed by the nonprofit International Partnership for Microbicides (IPM), which is the regulatory sponsor of the product.
The EMA reviewed the dapivirine ring under the EU-M4All pathway, which promotes the development of medicines for use in countries outside the European Union.
The flexible silicon ring slowly releases 25 mg of the antiretroviral drug dapivirine over 28 days. Women insert and replace the ring themselves monthly. Dapivirine, a nonnucleoside inhibitor of HIV-1 reverse transcriptase, reduces the risk for HIV infection after 24 hours of ring insertion.
Its intended use, the EMA said, is "[p]rophylaxis against HIV-1 infection via vaginal intercourse in HIV-uninfected women 18 years and older in combination with safer sex practices when oral pre-exposure prophylaxis is not/cannot be used or is not available."
Two large clinical trials of the dapivirine vaginal ring, one of which was funded in part by NIAID, found that the ring reduced the risk for HIV infection by about 30% overall in women aged 18 to 45 years in east and southern Africa.
However, the ring provided no statistically significant protection for women younger than 25 years, likely owing to low level of use of the product, NIAID said.
IPM will conduct further research in women aged 18 to 25 years to better understand the ring's efficacy and to collect additional data on safety and potential resistance to anti-HIV drugs.
The most common side effects with the dapivirine ring are urinary tract infection, vaginal discharge, vulvovaginal pruritus, vulvovaginitis, and pelvic and lower abdominal pain.
The World Health Organization (WHO) is expected to revise its recommendations and guidelines for HIV prevention to include the dapivirine ring. In addition, in collaboration with WHO, IPM will seek approval for the ring from African national regulatory authorities.
"This has been a long road, and by no means have we reached our ultimate goal of having multiple options for women at risk of HIV. But this positive opinion by the EMA gets us closer than we have ever been," Sharon L. Hillier, PhD, principal investigator of the National Institutes of Health (NIH)–funded Microbicide Trials Network (MTN), said in a news release.
"It is a monumental achievement for women's HIV prevention, and to that we owe IPM for its scientific leadership and vision and steadfast advocacy," added Hillier, who's with the University of Pittsburgh School of Medicine in Pennsylvania.
NIH is supporting three ongoing and planned studies to determine the safety of the dapivirine ring during adolescence and pregnancy and during periods of breastfeeding.
"These are populations who are among those in greatest need of HIV prevention tools, yet they are often overlooked in clinical trials of investigational products," Jared Baeten, MD, PhD, co–principal investigator of MTN, with the School of Public Health at the University of Washington in Seattle, said in the release.
"Ultimately, we are hoping the ring could be made available to all women, no matter their age or childbearing status," he added.
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Cite this: EMA Backs Dapivirine Vaginal Ring for HIV Prevention Outside of EU - Medscape - Jul 29, 2020.