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By Eleanor Frederick – CNS Contributor
ST JOHN’S, Antigua, Mar 18 2016 – On March 13, 2016, The National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH), based in Bethesda, Maryland, announced it would commence an Open-label Prevention Extension (HOPE) or MTN-025, a multi-site, open-label, Phase 3b trial that will collect additional data on the safety of the dapivirine ring which is an HIV prevention tool for women.
The dapivirine vaginal ring is a silicone ring that continuously releases the experimental antiretroviral drug dapivirine in the vagina, they will also evaluate the study participants’ adherence to the use of the vaginal ring. According to the NIH this product is one of several HIV prevention tools in development within NIAID’s portfolio of research that could be leveraged to reduce the high incidence of HIV infection among women in sub-Saharan Africa. The study will be conducted by the NIH-funded Microbicide Trials Network
This study will build on recent announcement from the Conference on Retroviruses and Opportunistic Infections (CROI) in February, on results from the ASPIRE Trial which found that “the dapivirine ring safely provided a modest level of protection against HIV infection in sub-Saharan African women. The dapivirine ring reduced the risk of HIV infection by 27 percent in the study population overall and by 61 percent among women ages 25 years and older, but provided no statistically significant protection in women younger than 25 years”.
The NIH states that “although the data show only partial efficacy for the dapivirine ring, this signal is a welcome development given the rate of infection for women in sub-Saharan Africa. The dapivirine ring merits additional study to begin to answer the scientific questions that remain and to see if this experimental product can offer increased protection against HIV in an open-label setting in which all participants are invited to use the dapivirine ring”
According to the NIH, eligible volunteers from the recently completed ASPIRE study will be invited to participate in HOPE. HOPE participants will have already been informed of whether they received the dapivirine ring or a placebo in ASPIRE, and all will be offered active product and counseled on the efficacy results from the ASPIRE trial. The specific details of HOPE’s research protocol are currently being adjusted to optimize the collection of data on safety, adherence and acceptability of the dapivirine ring.
Based on the results of the ASPIRE study, overall the dapivirine ring was only moderately effective and not effective among the youngest women in the study the 18-21 year olds, a critical age group of those most urgently in need of an increase in HIV prevention tools. Younger women enrolled in ASPIRE appeared to use the dapivirine ring less consistently than older participants, in whom efficacy was higher.
The NIH states that ASPIRE and other studies indicate that adherence to HIV prevention tools like daily oral PrEP can be challenging for some women, particularly young women. Long-acting injectables and implants, which would only require infrequent dosing, offer a potentially promising way to deliver HIV protection in a way that better fits into women’s lives.
The NIH also as states that beyond long-acting antiretrovirals, other prevention tools may also hold promise for women. A multinational clinical trial of an intravenously delivered antibody for preventing HIV infection in women is planned to launch in sub-Saharan Africa this spring. The trial will test whether giving women a potent, broadly neutralizing HIV antibody called VRC01 as an intravenous infusion every eight weeks is safe, tolerable and effective at preventing HIV, answering fundamental questions for the fields of HIV prevention and vaccine research.
The NIH further states that In addition to ensuring that optimal HIV prevention products are available for women, additional studies are being planned in both clinical and laboratory settings to understand why the dapivirine ring did not protect the youngest women enrolled in ASPIRE. Researchers will explore the critical gaps in scientific knowledge on female behavior and biology that have been identified as a result of the age-stratified results from ASPIRE. Together with ongoing studies investigating strategies to improve adherence in women to daily PrEP, this effort will enhance the scientific understanding of women’s unique needs, and help deliver the best evidence-based HIV prevention products for women.
