IAS 2017: Dapivirine vaginal ring acceptable and safe in young girls

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A vaginal ring has been evaluated in the first study to examine protection in teenage girls. The results, reported at the 9th International AIDS Society Conference on HIV Science (23–26 July 2017, Paris, France), demonstrated the ring to be safe and acceptable in girls under 18 – a typically hard-to-reach risk group.

The ring, which contains antiretroviral drug dapivirine, has previously been reported to be safe and to confer protection against HIV in women aged 18–45. Two Phase III trials, termed ASPIRE and The Ring Study, have examined use of the ring in 4500 older women from four African countries.

The findings, reported in February 2016, discovered the ring reduced women’s risk of acquiring HIV by approximately 30% on average. However, an exploratory analysis on the data from ASPIRE reported the level of HIV protection was at least 56% with consistent use and could be as high as 75% with “near perfect” use.

This new study was the first to evaluate the dapivirine ring in girls under 18, and aimed to provide information about safety and tolerability. The trial, known as MTN-023/IPM 030, enrolled 96 girls aged between 15 and 17 from six sites across the US. The participants were then randomly assigned to receive either the dapivirine ring or a placebo ring, using the rings for a month at a time for a total of 6 months.

The researchers discovered there were no differences in safety outcomes between the two groups. In addition, adherence to the ring was high – the team reported that 42% of participants didn’t remove the ring except to replace it monthly.

In girls using the dapivirine ring, the team demonstrated that detectable levels of drug were present in 87% of plasma samples, suggesting the ring had been used the previous day. Finally, 95% of participants reported the ring was easy to use, and 74% indicated it was not noticeable in their daily life.

If the dapivirine ring were to be approved it would be first HIV intervention exclusively for women. The researchers are planning a second clinical trial later this year, termed REACH, which will assess safety among adolescent girls in Africa – a population who are among those at highest risk of acquiring HIV. This trial will compare the safety of the monthly ring with the drug Truvada as daily pre-exposure prophylaxis, and explore whether biological or physiological factors affect product efficacy or HIV susceptibility in young women.

Principal investigator, Sharon Hillier (University of Pittsburgh, PA, USA), concluded: “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. HIV doesn’t distinguish between a 16-year-old and an 18-year-old. Access to safe and effective HIV prevention shouldn’t either. Young women of all ages deserve to be protected.”

Sources: www.eurekalert.org/pub_releases/2017-07/mtn-hpd071917.php

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