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Abbreviated ART passes phase 2/3 noninferiority trial in adolescents
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Recent findings published in Lancet HIV showed that shortcycle ART, which entails taking it for 5 days then a break for 2 days, was noninferior to continuous therapy for adolescents.
Katrina M. Butler
“The findings of this trial, supported by previous adult studies, show that a short cycle therapy strategy with 5 days on and 2 days off efavirenz-based ART with a standard dose of efavirenz is a viable option for virologically suppressed children, adolescents and young adults with 29% reduction in the cost of drugs,” Karina M. Butler, MD, clinical professor of pediatrics at University College Dublin, and colleagues wrote. “Acceptability of the short cycle therapy strategy was shown among participants from all backgrounds; in particular, it was valued because it allowed for more socializing with friends at weekends.”
Short cycle therapy can reduce the costs and long-term toxic effects of ART, the researchers wrote. Two previous studies have shown that 5 days on and 2 days off worked as well as continuous ART in adults, but no studies have been performed in adolescents, who face longer-term therapy than adults.
In an phase 2/3 randomized noninferiority trial called BREATHER, Butler and colleagues assessed 199 participants aged 8 to 24 years (median age = 14 years; median CD4 count = 735 cells per µL) who were stable on a first-line regiment of efavirenz with two nucleoside reverse transcriptase inhibitors, and had a viral load fewer than 50 copies per mL for at least 1 year. The primary outcome was a viral load higher than 50 copies per mL at any time during the 48-week assessment.
The rate of treatment failure (viral load higher than 50 copies per mL) did not differ between patients receiving short cycle therapy and those receiving continuous therapy: 6% vs. 7%, respectively (difference = –1.2%; 90% CI, –7.3 to 4.9). In addition, there were 13 grade 3 or 4 events in the short cycle group vs. 14 in continuous therapy group. Only two ART-related adverse events occurred in the short cycle group vs. 14 in the continuous therapy group (P = .02).
The results indicate no evidence that short cycle therapy was inferior to continuous therapy, the researchers concluded.
“The results from this study show that short cycle therapy might be a promising strategy for adherent children and adolescents well established on ART,” the researchers wrote. “The overall reduction in drug exposure could reduce long-term toxicity for individuals and, at a population level, result in cost savings, enabling more participants to receive treatment.” – by Will Offit
Disclosure: The researchers report no relevant financial disclosures.
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