A drug-laced vaginal ring that gives women more control over potential HIV infection can help safely prevent the disease, according to results from two long-awaited studies.
The ring, which contains the
That’s according to the first large, late-stage clinical trials to show that a long-acting microbicide can help halt HIV-1. Results were publiches on Monday.
One study, dubbed ASPIRE, was conducted through the US National Institutes of Health’s Microbicide Trials Network and led by Dr Jared Baeten, vice chairman of global health in the University of Washington’s School of Public Health. A second piece of research, called The Ring Study was led by the nonprofit International Partnership for Microbicides, or IPM.
“I’m really optimistic about the results,” Baetten said. “To see statistically significant HIV protection is a great step forward.”
Results of both studies, which were conducted in Africa, were presented Monday at the annual Conference on Retroviruses and Opportunistic Infections in Boston.
In the ASPIRE study, published online in the New England Journal of Medicine, use of the ring reduced risk of HIV infection by 27 per cent overall. It reduced infection by about 56 per cent in women older than 21, who appeared to use the device more consistently, the study showed. The Ring Study also showed a higher effect — 37 per cent—for women older than 21, IPM officials reported.
However, both studies found little or no effect in younger women, those ages 18 to 21, who may not have used the devices consistently, IPM officials said.
“The ring must be used consistently to achieve protection,” the IPM’s Annalene Nel said MOnday.
That underscores the need for further study of multiple ways to prevent HIV and Aids, and the global burden that falls disproportionately on women. In sub-Saharan Africa, 25.8 million people were living with HIV in 2014, according to the World Health Organisation. Women make up nearly 60 per cent of that population, according to amFAR, the Foundation for AIDS Research.
In Africa, women may not have control over certain HIV-prevention decisions, said Baeten, who has been working on the issue in Africa since 1997. By contrast, the ring can be used privately with or without the partner’s consent.
The ring is designed to be left in place and changed once a month.
“She may not be able to ask or require a male partner to use a condom,” Baeten said. “Developing protection tools that women can use and control is incredibly empowering.”
The ASPIRE trial, which began in 2012 and ended in 2015, enrolled more than 2,600 HIV-negative women ages 18 to 45 at seven sites in Malawi, South Africa, Uganda and Zimbabwe. The Ring Study, which also started in 2012, enrolled nearly 2,000 HIV-negative women at seven sites in South Africa and Uganda. IPM is reporting results early after an independent safety board recommended proceeding to final analysis.
The results are a significant step forward, noted Dr. Larry Corey, member of the Vaccine and Infectious Disease Division at Seattle’s Fred Hutchinson Cancer Research Center.
“I’m glad to see results from two such important studies,” said Corey, who was not involved in the research. “We continue to need additional tools for the HIV prevention toolbox to slow down the spread of new HIV infections in women most at risk in southern Africa.”
Based on the results, IPM officials said they plan to seek regulatory approval to license the ring.