Body weight changes in people living with HIV starting dolutegravir versus efavirenz-based regimens in a large cohort in rural Tanzania.

Objectives: To analyze weight changes associated with dolutegravir- versus efavirenz-based antiretroviral therapy (ART) in people living with HIV (PLHIV) in rural Tanzania, where undernutrition is prevalent.

Design: Longitudinal, observational study of the prospective Kilombero and Ulanga Antiretroviral Cohort (KIULARCO).

Methods: We included adult, ART-naïve, non-pregnant PLHIV initiating efavirenz-based ART 12/2016-02/2019 or dolutegravir-based ART 03/2019-12/2022. We used multivariable linear mixed-effects models to assess adjusted weight changes during 18 months after ART start and Cox regression models to assess factors associated with incident obesity, weight gain ≥10% and hypertension.

Results: Of 1,205 PLHIV at ART start (median age 40 years (IQR 32-48); 719 (59.7%) females), 166 (13.8%) individuals were underweight and 317 (26.3%) overweight/obese; 621 (51.5%) initiated efavirenz-based and 584 (48.5%) dolutegravir-based ART. After 18 months, estimated weight gain was 5.1 kg (95%CI 4.7-5.5) in the dolutegravir versus 4.0 kg (95%CI 3.7-4.4) in the efavirenz group. The weight gain difference between treatment groups was high in men (1.7 kg (95%CI 0.8-2.6; p < 0.001), in those aged 30-49 years (1.5 kg (0.8-2.1); p < 0.001) and those with CD4 counts ≥500/ul (2.5 kg (1.4 - 3.7), p < 0.001). Cumulative obesity incidence at 18 months was 10.9% (95%CI 8.3-14.0) in the dolutegravir and 5.1% (95%CI 3.6-7.1) in the efavirenz group. Associated factors were dolutegravir and a pre-ART body mass index (BMI) of 25-29 kg/m2. Dolutegravir and age, but not weight gain were associated with incident of hypertension.

Conclusions: Dolutegravir-based ART was associated with more weight gain, higher obesity and hypertension - especially in those with a higher pre-ART BMI compared to efavirenz-based regimens.