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A Glass Half Full: Dapivirine Vaginal Ring Offers Some Protection Against HIV

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A vaginal ring containing an antiretroviral drug can offer some protection against HIV-1, though not as high as expected, say researchers based on the results of two phase III studies.

The ring, developed by the nonprofit International Partnership for Microbicides, or IPM, works by slowly releasing the antiretroviral drug Dapivirine over time directly to the site of viral transmission - with very low systemic exposure.

In one of the phase III studies, dubbed ASPIRE, a total of 2,629 HIV-negative African women of ages 18-45 were enrolled between August 2012 and June 2014. There were 1,313 women in the Dapivirine ring group and 1,316 in the placebo ring group. The assigned rings were used by the women monthly for at least one year.

According to the study findings, the overall incidence of HIV-1 infection in the Dapivirine ring group was 27% lower than that in placebo ring group. Within the Dapivirine ring group, the HIV risk was reduced by 61% in women who were 25 and older but only by 10% among those under the age of 25 years.

In another phase III study, known as Ring Study, which enrolled 1,959 HIV-negative African women of ages 18-45, the monthly Dapivirine ring reduced HIV infection overall by 31% compared to a placebo. The HIV risk was lower by 37% among participants older than 21 in the Dapivirine ring group, which reflects a strong relationship between adherence and HIV-1 protection.

No safety concerns were found to be associated with the Dapivirine ring.

Commenting on the study results, Jared Baeten of the University of Washington, who as protocol chair led the ASPIRE study said, "This is a glass half-full moment. The HIV prevention field for women has struggled in the last few years - at times the glass had seemed almost completely empty. Now, for the first time, we have two trials demonstrating that a female-controlled HIV prevention method can safely help reduce new HIV infections".

IPM, the ring's regulatory sponsor, plans to seek approval for the product in the first quarter of 2017.

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