TUESDAY, March 9, 2021 (HealthDay News) – A vaginal ring that slowly releases an antiviral drug could protect women from HIV for up to three months, according to a preliminary study.
Two formulations of a vaginal ring that release the antiretroviral dapivirin into the vagina over a period of 90 days were studied. One version contained 100 milligrams (mg) of dapivirine and the other 200 mg.
The study was conducted at two US sites affiliated with the Microbicide Trials Network (MTN) funded by the US National Institutes of Health.
Among them were 49 healthy HIV-negative women. They were divided into three groups: one used the 100 mg dapivirine ring continuously for 13 weeks; A second group used the 200 mg ring continuously for 13 weeks. and a third group used a 30 day ring that was replaced every four weeks during the study period.
All three rings were well tolerated by the participants and there were no safety concerns. Compared to those with the monthly ring, those with the two 90-day rings had 1.3 to 1.9 times higher concentrations of dapivirine in blood plasma and 1.5 to 2.9 times higher concentrations of the drug in vaginal fluid as well as higher concentrations of the drug in the cervical tissue.
continuation
The results, due to be presented at a virtual meeting of the conference on retroviruses and opportunistic infections on Tuesday, suggest that the 90-day ring could provide long-lasting and sustained protection against HIV, according to the researchers. However, this research is deemed tentative until published in a peer-reviewed journal.
The three-month ring builds on the development of a monthly dapivirine ring by the not-for-profit International Partnership for Microbicides (IPM), which was approved by the European Medicines Agency last year for its use in women aged 18 and over in developing countries.
Soon after, the monthly ring was added to the World Health Organization’s list of prequalified drugs, and earlier this year WHO recommended the ring as another HIV prevention choice for women at high risk of HIV.
IPM applies for approval of the monthly dapivirine ring in eastern and southern Africa. The first of these decisions could be made by the middle of the year. IPM is also seeking regulatory approval for the ring from the US Food and Drug Administration.
continuation
“The regulatory approval of the monthly ring would be an incredible milestone for women who have been the face of the HIV epidemic in much of the world and who need and deserve a range of safe and effective methods,” said study director Dr. Albert Liu said in an MTN press release. He is the director of clinical research in the San Francisco Department of Public Health.
“Hopefully, a longer-lasting dapivirine ring that women replace every three months may be another option for women in the not too distant future,” said Liu.
More information
The US Office for Women’s Health is more concerned with women and HIV prevention.
Source: Microbicide Trials Network, press release, March 9, 2021
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