Previous Phase 3 studies enrolling >4,500 women (ASPIRE and The Ring Study) have already demonstrated the vaginal ring to be safe and effective in protecting women aged 18–45 years against HIV.
MTN-023/IPM 030 (n=96) is the first study to evaluate the antiretroviral-containing monthly vaginal ring in teenage girls <18 years of age. The new study was intended to produce the necessary safety and tolerability data for expanding the use of the ring to females <18 years of age. In the study, patients were randomized to either monthly use of the dapivirine ring (n=73) or a placebo ring (n=23) for 6 months. The data showed no differences in safety outcomes between the two rings.
The study also found high adherence to the ring with 42% of patients reporting no removal until the time of monthly replacement. Specifically, 87% of the dapivirine ring group had detectable drug levels suggesting the ring has been used the previous day. Also, 95% of the returned rings had drug levels that were indicative of consistent use the previous month. Moreover, a questionnaire administered at 3 months and 6 months into the study showed the ring was highly acceptable among participants with 95% reporting ease of use and 74% reporting being unaware of the ring during daily activities. Overall, 93% of patients responded that they liked the ring.
“If the ring is approved for women older than age 18, it’s imperative that we have the data in hand to show that the ring is safe to use in younger women as well,” explained Sharon Hillier, Ph.D., principal investigator of the Microbicide Trials Network (MTN), and professor and vice chair of the department of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh School of Medicine. “HIV doesn’t distinguish between a 16-year-old and an 18-year-old. Access to safe and effective HIV prevention shouldn’t either.”
Approval of the dapivirine vaginal ring would mark the first biomedical preventive agent indicated specifically for women. A second trial, REACH, is being planned for 2017 to compile safety data among 300 adolescent girls and young women (ages 16–21) in Africa who are at greater risk of acquiring HIV. This researchers plan to collect safety data on the monthly ring and Truvada as daily pre-exposure prophylaxis (PrEP) as well as evaluate preferences for either or both methods.
For more information visit mtnstopshiv.org.