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Abbreviated ART noninferior to continuous ART in children with HIV

SEATTLE —Sustiva-based, first-line ART with “weekend breaks” was noninferior to continuous therapy in HIV-1 infected children and adolescents, demonstrating similar viral suppression, resistance and safety, according to data presented at CROI 2015.

“The rationale behind this study was to try to normalize the life experience for young people who have problems with facing lifelong therapy, particularly with adherence into adolescence because of the secrecy and burden that often surrounds antiretroviral treatment,” researcher Karina M. Butler, MD, from Our Lady’s Children’s Hospital, Crumlin in Dublin, said during a press conference.

Karina M. Butler

“Children may be curtailed from going on sleepovers on weekends, while adolescents going out on weekends often do not take their medicines with them because they don’t want people to see it. There is a real impact on their social lives.”

To determine the viability of this approach, adolescents (n = 199) aged 8 to 24 years were randomly assigned either to continuous Sustiva (efavirenz, Bristol-Myers Squibb) plus two nucleoside reverse transcriptase inhibitors and an HIV-RNA of less than 50 c/mL for more than 12 months or a shortened therapy cycle of 5 days of ART with a weekend “off’” or a 2-day “break” in the cycle.

The researchers followed patients for a minimum of 48 weeks, with visits at 0, 4, 12 weeks followed by 12 weekly visits. Butler and colleagues determined the variance between treatment groups in proportion by 48 weeks, using Kaplan-Meier method (12% noninferiority margin) to adjust for region and age.

“We found that short cycle therapy was non-inferior to continuous therapy with regards to virological failure, with just 6 young people failing in the short cycle of therapy arm vs. 7 children in the continuous therapy arm,” Butler said. “Similarly, there was no difference in biological outcomes, CD4 counts or adverse events between the two arms.”

The shortened-therapy group exhibited 27% decreased drug exposure as measured by adherence questionnaires. There were no significant differences in toxicity between shortened therapy and continuous therapy: grade 3/4 adverse events (8, short cycle vs. 12, continuous), ART-related adverse events (2 vs. 8 continuous) and serious adverse events (7 vs. 6).

At week 48, the researchers observed no evidence that the shortened therapy led to increased inflammation using an extensive panel of markers. Butler and colleagues wrote that adolescents expressed preference for shortened cycle in a qualitative substudy and in pre- and post-trial questionnaires, predominantly since it permitted weekend time with friends.

“We found that the children stayed in the study rather well, and most children in the shortened-cycle therapy (98%) remained on their baseline ART regimen compared with 88% of those receiving continuous therapy,” Butler said. – by Bob Stott

Reference:

Butler KM, et al. Abstract 38LB. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 23-26, 2015; Seattle.

Disclosure: The researchers report no relevant financial disclosures.