Abstract
BACKGROUND: Excess weight gain has been reported in some adults on dolutegravir (DTG), but data in children/adolescents living with human immunodeficiency virus (CALHIV) are limited. METHODS: CALHIV aged 2-17 years at DTG start from 15 observational cohorts across Europe and Thailand were included. Mixed models described changes in body-mass-index-for-age z-score (zBMI). We assessed (1) zBMI change 48 weeks before versus after DTG start; (2) zBMI change up to 96 weeks on DTG and associated factors; and (3) zBMI changes over 96 weeks in CALHIV aged 6-17 years at start of DTG versus protease inhibitor (PI)-based regimens using propensity score weighting. RESULTS: Of 948 CALHIV on DTG (>99% HIV-1, <1% HIV-2), 50% were female, the median age was 13.7 (interquartile range [IQR], 11.1-15.6]) years, median zBMI was 0.31 (IQR, -0.64 to 1.19), 48% were Black, and 30% were overweight or obese at DTG start. Among 741 participants with zBMI available before and after DTG start, zBMI (95% confidence interval (CI) increased by 0.07 (.03-.11) versus 0.13 (.09-.16) (P = .087), in the 48 weeks before and after DTG start, respectively. Mean zBMI change by 96 weeks on DTG was 0.20 (95% CI .14-.27). In multivariable models, greatest increases in zBMI were in those aged 6-11 years at DTG start (0.34 [95% CI .23-.44]), males of "other" ethnicity (0.39 [95% CI .10-.68]), Black females (0.27 [95% CI .15-.39]), and those on tenofovir alafenamide (TAF) (0.39 [95% CI .17-.61]). There was no difference in mean zBMI change at 96 weeks among those on DTG- versus PI-based regimens (0.21 [95% CI .13-.30] vs 0.30 [95% CI .13-.48]; P = .354). CONCLUSIONS: CALHIV experienced zBMI increases on DTG with the largest gains in children aged 6-11 years, on TAF, with low baseline zBMI, and some variation by sex and ethnicity. However, zBMI changes over 96 weeks were comparable between those on DTG- and PI-based regimens.