“Weekends off” Sustiva ART Effective, Safer for Adolescents with HIV

According to recent research in The Lancet HIV, short cycle therapy was effective and safer for adherent HIV-infected young adults taking Sustiva-based (efavirenz; Bristol-Myers Squibb) antiretroviral therapy, when compared with continuous therapy at 48 weeks.

The open-label, non-inferiority BREATHER (Breaks in Adolescent and child Therapy using Efavirenz and two NRTIs) trial, investigated HIV-1 infected young people who faced lifelong ART, short cycle therapy with long-acting drugs offering the potential for drug-free weekends, less toxicity, and better quality-of-life. Researchers aimed to compare the efficacy and safety of short cycle therapy compared to continuous ART, among adolescents and young adults. Short cycle therapy, also known as “weekends off,” consists of 5 days on treatment and 2 days off.

“For this population, innovative treatment strategies are needed to address their lifestyle needs, to help maintain long-term retention-in-care, and to improve adherence to ART, which is particularly problematic during adolescence,” Karina M. Butler, MD, lead study author and clinical professor of pediatrics at University College Dublin, and colleagues wrote. “Short cycle therapy aims to maintain suppression of HIV-1 RNA during planned short breaks from ART, thereby reducing ART intake, long-term toxic effects, and costs.”

The researchers studied 199 patients aged 8 to 24 years who were stable on first-line efavirenz with two nucleoside reverse transcriptase inhibitors (NRTIs) and had a  viral load less than 50 copies per mL for 12 months or longer. Researchers randomly assigned 100 patients to remain on continuous therapy and 99 patients to short cycle therapy. The primary endpoint was the proportion of participants with confirmed viral load, 50 copies per mL or higher, at any time up to the 48-week assessment. Patients received treatment between April 1, 2011 and June 28, 2013, and researchers followed up until the last patient reached 48 weeks.
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Study results showed that 6% of patients receiving short cycle therapy had confirmed viral load 50 copies per mL or higher, compared with 7% of patients assigned to continuous therapy.

Furthermore, each group experienced grade 3 or 4 events – 13 occurred in the short cycle therapy group, and 14 in the continuous therapy group. Two ART-related adverse events occurred in the short cycle group compared to continuous therapy group, which had 14 (P = .02) adverse events. Adverse events included lipodystrophy, gynaecomastia, suicidal ideation, dizziness, headache spontaneous abortion, neutropenia, and raised transaminases.

The researchers concluded that “weekend off” therapy could be an ideal treatment option for adolescents and young adults with HIV.

“The results from this study show that short cycle therapy might be a promising strategy for adherent children and adolescents well established on ART,” Butler and colleagues wrote. “ Ongoing longer-term follow-up will further inform sustainability and further research is required for settings where viral load monitoring is less accessible." ---Julie Gould

Reference:

The BREATHER (PENTA 16) Trial Group. Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents, and young adults (BREATHER): a randomised, open-label, non-inferiority, phase 2/3 trial [published online June 20, 2016]. The Lancet HIV. DOI: dx.doi.org/10.1016/S2352-3018(16)30054-6.