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

At 48 weeks, six of 99 children in the short cycle treatment group v 7 of 100 in the continuous treatment group had virological rebound (HIV viral load >50 copies/mL; difference –1•2%, 90% CI –7.3 to 4.9), showing that short cycle treatment is non-inferior to continuous treatment

This was an open-label trial, comparing continuous daily antiretroviral therapy with short cycle treatment enabling 2 days off treatment every week.

 

In a related editorial, the author comments that a strategy which allows 2-days off antiretroviral therapy is risky as it might give out the message that missing doses is acceptable and seems not to affect viral load. Therefore, appropriate counselling is crucial to ensure that the results are not misinterpreted and that patients understand that there is a maximum break in treatment of the designated 2 days per week.

 

Additionally, it should be noted that the findings of this study are only generalisable to patients who are stable and well established on antiretroviral therapy. The median time on ART before randomisation in this trial was 6 years and children had been virally suppressed for at least 12 months.