Weight, blood glucose and lipid changes in the course of long-acting cabotegravir + rilpivirine: A prospective two-year evaluation

Introduction: There are little real-world data from observational cohorts regarding the impact of long-acting (LA) cabotegravir (CAB) and rilpivirine (RPV) treatment on weight and blood lipids. Methods: This multicentre, prospective, observational study included people with human immunodeficiency virus initiating LA CAB+RPV within the Surveillance Cohort Long-Term Toxicity Antiretrovirals (SCOLTA) cohort. Weight and cholesterol levels (total, high-density lipoprotein cholesterol (HDL) and low-density lipoprotein cholesterol (LDL)) were collected at six-month intervals within two-year follow-ups. A multivariate mixed linear model was run to determine the association between change from baseline and participants' characteristics. Results: A total of 671 participants were enrolled, with a median follow-up of 22 (interquartile range [IQR]: 13-29) months. The median age was 49 years (IQR 40-58) and median duration of antiretroviral therapy (ART) was 10.3 years (IQR 6.4-16.7). There was no significant change in mean weight after 1 year and 2 years, with differences of -0.25 kg (95% CI: -0.59 to +0.08, p = 0.14) and -0.18 kg (95% CI: -0.70 to +0.33, p = 0.48), respectively. The multivariable analysis revealed that weight change was significantly associated with baseline body mass index (BMI). People with obesity and overweight experienced a significantly greater reduction in weight, compared to those of normal weight (mean estimate -1.66 kg, 95% CI -2.69 to -0.64, and -0.72 kg, 95% CI: -1.24 to -0.19, respectively). Total cholesterol (+6 mg/dL, 95% CI: +1.4 to +10.7), HDL cholesterol (+2.9 mg/dL, 95% CI: +1.2 to +4.7) and LDL cholesterol (+2.4 mg/dL, 95% CI: -1.8 to +6.6) increased at 2 years, with no change in the total/HDL ratio. Conclusions: Body weight remained stable in the SCOLTA cohort after switching to LA CAB+RPV for 2 years. There was a modest but significant increase in cholesterol levels, though the ratio of total to HDL cholesterol remained stable.