Tolerability of lopinavir versus dolutegravir in children and adolescents with HIV

BACKGROUND: Children and adolescents with HIV previously taking ritonavir-boosted lopinavir (LPV/r)-based antiretroviral therapy (ART) were recently programmatically transitioned to dolutegravir (DTG)-based ART in Lesotho, southern Africa. We investigated associated changes in treatment satisfaction and potential side effects. METHODS: This single-center prospective cohort study enrolled participants younger than 18 years transitioned from LPV/r-based to DTG-based ART during the national programmatic DTG rollout in 2022-2023. Virally suppressed participants who were at least 6 years old and able to handle a sleep diary and actigraphy were eligible for additional sleep monitoring. Enrollment occurred 2 weeks before (with actigraphy) or at (without actigraphy) transition with follow-up until 4 weeks posttransition. Co-primary endpoints were change in treatment satisfaction assessed with the HIV Treatment Satisfaction Questionnaire change version (HIVTSQc; Teen and Parent versions) at 4 weeks, and difference in mean sleep period length over a 2-week period before and after transition (only actigraphy participants). Secondary endpoints assessed treatment satisfaction status, gastrointestinal symptoms, depressive symptoms, and additional sleep measures. RESULTS: Among 245 participants with transition and 4-week data, 115 (47%) were girls and median age was 11.1 (interquartile range 8.9-13.6) years. HIVTSQc outcomes favored DTG, with 88/92 (96%) HIVTSQc-Teen and 149/151 (99%) HIVTSQc-Parent responses indicating being 'much more satisfied now' posttransition. Among 69 (28%) actigraphy participants, mean sleep period length was 9.0 h standard deviation (SD) 1.0 before and 9.2 h (SD 1.0) 2-4 weeks posttransition mean difference 0.2, 95% confidence interval (CI) 0.0-0.4. Secondary outcomes did not change meaningfully. CONCLUSION: Observed treatment satisfaction and tolerability support the rollout of DTG in pediatric HIV care.