Growth Outcomes After 48 Weeks of Dolutegravir in Children and Adolescents with HIV-1 in IMPAACT P1093 and IMPAACT 2019.

BACKGROUND: We evaluated growth outcomes in children and adolescents with HIV-1 initiating or switching to dolutegravir-based antiretroviral therapy (ART) in the single-arm trials IMPAACT P1093 (P1093) and IMPAACT 2019. METHODS: We performed descriptive post hoc analyses of body mass index-for-age (BAZ), weight-for-age (WAZ), and length/height-for-age z scores (L/HAZ) for each trial through Week 48. BAZ changes were assessed using a mixed model for repeated measures. RESULTS: We included data from 181 and 57 participants from P1093 and IMPAACT 2019, respectively (10% [23/238] were adolescents). Baseline mean BAZ was -0.1 in P1093 and - 0.7 in IMPAACT 2019. At Week 48, adjusted mean BAZ increased significantly in P1093 (0.3; 95% CI, 0.03, 0.49; p < 0.05) and non-significantly in IMPAACT 2019 (0.3; 95% CI, -0.03, 0.58; p = 0.074). Mean BAZ was in the normal range at Week 48 in both trials. Marked increases in BAZ were observed among subgroups with baseline BAZ < -2. By Week 48, 65% (117/181) of participants in P1093 and 74% (42/57) in IMPAACT 2019 remained in the same BAZ category. Improvements from severe or moderate malnutrition/thinness to normal weight occurred in 6% (10/181) and 7% (4/57) of participants in P1093 and IMPAACT 2019, respectively, while increases to overweight or obesity were observed in 9% (16/181) and 5% (3/57). Small changes were observed in overall mean WAZ and L/HAZ through Week 48 in both trials. CONCLUSIONS: Small overall increases in BAZ were observed over 1 year among pediatric participants on dolutegravir-based ART, with most participants remaining in their baseline BAZ category. CLINICAL TRIAL INFORMATION: ClinicalTrials.gov, NCT01302847 and NCT03760458.