Vaginal Ring Could Protect Women From HIV for 3 Months
TUESDAY, March 9, 2021 (HealthDay News) – A vaginal ring that slowly releases an antiviral drug could protect women against HIV for up to three months, a preliminary trial suggests.
He evaluated two formulations of a vaginal ring that releases the antiretroviral dapivirine into the vagina over a 90-day period. One version contained 100 milligrams (mg) of dapivirine and the other 200 mg.
The trial was conducted at two US sites affiliated with the US National Institutes of Health’s Microbicide Testing Network (MTN).
It included 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, replacing it every four weeks during the study period.
The 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 levels. of the drug in the vaginal fluid, as well as higher concentrations of the drug. in cervical tissue.
The results – which will be presented at a virtual meeting of the Conference on Retroviruses and Opportunistic Infections on Tuesday – suggest that the 90-day ring may provide long-acting and sustained protection against HIV, the researchers say. But such research is considered preliminary until it is published in a peer-reviewed journal.
The three-month ring builds on the development by the non-profit International Partnership for Microbicides (IPM) of a monthly dapivirine ring, which last year received a positive review from the European Agency for medicines for use in women aged 18 years 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 the WHO recommended the ring as another HIV prevention choice for women at high risk of contracting HIV.
IPM is seeking approval of the monthly dapivirine ring in East and Southern Africa, and the first of these decisions could be made by mid-year. IPM is also seeking regulatory approval for the ring from the United States Food and Drug Administration.
“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 secure methods. effective, ”said study chair Dr. Albert Liu. said in a press release from MTN. He is director of clinical research at the San Francisco Department of Public Health.
“Hopefully a long-lasting dapivirine ring that women replace every three months may be another option available to women in the not too distant future,” Liu said.
The US Bureau of Women’s Health has more on women and HIV prevention.
SOURCE: Microbicide Trials Network, press release, March 9, 2021
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