Could an Antiretroviral Vaginal Ring Provide HIV Protection to At-Risk Women?

2,600 women, deemed at-risk for HIV infection, were part of the study
2,600 women, deemed at-risk for HIV infection, were part of the study

A vaginal ring with sustained release of an experimental antiretroviral drug provided partial protection against HIV infection in women, results from a large clinical trial has shown. Findings from the study are published in the New England Journal of Medicine

The objective of the ASPIRE study (MTN-020) was to determine whether dapivirine, an experimental antiretroviral agent, could safely and effectively prevent HIV infection through sustained release in the vagina via a silicone ring replaced every 4 weeks. The study included over 2,600 women ages 18-45 without HIV infection who were at high risk of being infected. The women, who were from sub-Saharan Africa (Malawi, South Africa, Uganda, Zimbabwe), were randomized to receive either the dapivirine ring or a placebo ring. 

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The study subjects received a HIV prevention services package at each study visit, which included HIV risk-reduction counseling, partner HIV testing, treatment of sexually transmitted infections, and condoms.

Among all women, the dapivirine ring reduced the risk of HIV infection by 27%. After excluding data where it was evident early on that many women were not returning for study visits or were using the ring inconsistently, the risk reduction was 37%. The data also showed the dapivirine ring reduced the risk of HIV infection by 61% among women ages ≥25 years. However, no statistically significant protection was seen in women <25 years; these women seemed to use the ring less consistently than others as measured by levels of dapivirine in the blood. 

Additional age-related analyses found that the dapivirine ring reduced the risk of HIV infection by 56% in women aged >21 years but no protection among women ages 18-21 years. The rate of adverse events was also found to be comparable among study subjects who received the dapivirine ring vs. placebo ring. 

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Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), added, "Further research is needed to understand the age-related disparities in the observed level of protection."

For more information visit nih.gov.

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