Assessing Real-world Weight Change in the Treatment and Prevention of HIV-1 with a Cabotegravir-containing Regimen

Background Initiation of several Integrase Strand-transfer Inhibitors (INSTIs) has been associated with weight gain in clinical trials. However, the data evaluating weight change with cabotegravir, the newest INSTI, is limited. Objective The primary objective was to assess the real-world weight change in patients who switched to long-acting injectable (LAI) cabotegravir or cabotegravir-rilpivirine from another antiretroviral regimen. Methods In this retrospective study, patients receiving HIV-1 treatment with cabotegravir-rilpivirine, or pre-exposure prophylaxis (PrEP) with cabotegravir, were identified through an Epic-generated report. Patients on a cabotegravir-containing regimen who met inclusion criteria were followed for 12 months from treatment initiation. The primary endpoint was weight change from month 0 of treatment initiation to 3, 6, and 12 months in all patients on cabotegravir-based LAI. Results A total of 48 patients were included in the study. At month 3, the mean weight change was 0.3 kg (95% CI, -0.8 to 1.4; p=0.56). At month 6, the mean weight change was 1.1 kg (95% CI, -0.4 to 2.7; p=0.14). At month 12, the mean weight change was 0.0 kg (95% CI, -2.5 to -2.3; p=0.97). Virologic failure was confirmed in 2 patients on cabotegravir-rilpivirine. Adverse events were documented in 28 patients (58%), including injection site pain, nodules at the injection site, and depression, and 10% discontinued therapy because of an adverse event. Conclusion Bimonthly injections of cabotegravir and cabotegravir-rilpivirine were not associated with significant weight change. Adverse reactions were common and frequently led to discontinuation of therapy. This real-world data may be used to influence provider clinical decision-making.