A monthly vaginal ring containing the antiretroviral dapivirine has demonstrated efficacy in girls younger than 18 years, according to phase 2a study results presented at the IAS Conference on HIV Science.
“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,” Sharon Hillier, PhD, professor and vice chair of the department of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh School of Medicine, said in a press release. “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.”
Two phase 3 trials have demonstrated the ring’s efficacy in more than 4,500 African women between 18 and 45 years of age. The developers of the dapivirine ring are currently seeking approval in this age group, which would make it the first biomedical prevention product made exclusively for women.
To assess the drug’s safety and tolerability in teenagers, the researchers conducted a trial in collaboration with Microbicide Trials Network (MTN) and Adolescent Medicine Trials Network (ATN) that included 96 girls between the ages of 15 and 17. Seventy-three received the dapivirine ring, and 23 were administered a placebo. The rings were used for 1-month periods for a total of 6 months
All girls receiving the device lived within six U.S. sites, including University of Pittsburgh, University of Alabama at Birmingham, St. Jude Children’s Research Hospital, The Fenway Institute in Boston, Children’s Hospital at Montefiore Medical Center in Bronx, N.Y., and University of Colorado Denver School of Medicine. Participants were involved with the study from July 2014 to July 2016.
The researchers observed that the safety of the dapivirine ring was no different from that of the placebo, and adherence was high among participants. The ring had not been removed by 42% of the girls except to administer a new dose, and 87% had detectable drug levels in their plasma; 95% of the rings after use also had drug levels that related to use throughout the month.
Through a patient survey, the researchers found that the dapivirine ring had other benefits, including ease of use (95%) and patients were not aware of the ring during daily activities (74%). A large majority of the participants (93%) said that they enjoyed using the ring.
“We are encouraged by these results of the dapivirine ring in 15- to 17-year-old girls,” Hillier said in a NIH press release. “This study has demonstrated that the ring is safe in U.S. teens, and now we need data on the safety and acceptability of the ring in African adolescent girls.” —by Katherine Bortz
Hillier S, et al. Safety and acceptability of the dapivirine vaginal ring in US adolescents: Abstract TUAC0206LB. Presented at: IAS Conference on HIV Science; July 23-26, 2017; Paris.
Disclosure: Infectious Diseases in Children was unable to determine financial disclosures prior to publication.