Tolerability of lopinavir versus dolutegravir in children and adolescents with HIV (LoDoCA): a prospective cohort study in lesotho, Southern Africa
Blankenberger J., Devendra A., Bakaya M., Lee T., Steffy T., Makhesi T., Gilbride CJ., Belus JM., Thahane L., Tschumi N., Marake NB., Tarumbiswa T., Huber R., Chammartin F., Labhardt ND., Brown JA.
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 <18 years transitioned from LPV/r- to DTG-based ART during the national programmatic DTG rollout in 2022–2023. Virally suppressed participants ≥6 years 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 post-transition. Co-primary endpoints were i) change in treatment satisfaction, using the HIV Treatment Satisfaction Questionnaire change version (HIVTSQc; Teen and Parent versions) at 4 weeks, and ii) difference in mean sleep period length over a two-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 female 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” post-transition. Among 69 (28%) actigraphy participants, mean sleep period length was 9.0 hours (standard deviation [SD] 1.0) before and 9.2 hours (SD 1.0) 2–4 weeks post-transition (mean difference 0.2, 95% CI 0.0–0.4). Secondary outcomes did not change meaningfully. Conclusions: – Observed treatment satisfaction and tolerability support the rollout of DTG in pediatric HIV care.