Weight gain and metabolic disturbances in people living with HIV who start antiretroviral therapy with, or switch to, bictegravir/emtricitabine/tenofovir alafenamide after 48 weeks of treatment: A real-world prospective study

Background: People living with HIV (PLWH) starting or switching to an integrase strand transfer inhibitor-based regimen are more likely to experience weight gain than other classes of antiretroviral regimens. The aim of this study was to evaluate the weight gain and metabolic disturbances in PLWH who start antiretroviral therapy (ART) with bictegravir/emtricitabine/ tenofovir alafenamide and in individuals who switch from another ART to BIC/FTC/TAF after 48 weeks. Methods: A prospective longitudinal study was conducted in an HIV clinic in Mexico. Weight and metabolic parameters were measured at baseline, 24 and 48 weeks. A paired t test and Wilcoxon signed-rank test were applied to evaluate weight and metabolic changes. Results: 160 participants completed measurements, median age was 29 (IQR 26-32) and 30 (IQR 27-34) years old for the treatment-naive and switch group respectively. In the treatment-naive group, mean weight change was 3.8 kg (+/- 5.8) (p <.001) and BMI increased 1.3 kg/m(2) (+/- 2) (p <.001) at 48 weeks. Incidence of BMI >25 kg/m(2) was 28% (95%CI; 18%-40%) and BMI >30 kg/m(2) was 7% (95%CI; 2%-16%) at 48 weeks in treatment-naive individuals. In the switch group, mean weight gain and BMI change at 48 weeks was 2.8 kg (+/- 5.9) and 0.9 kg/m2 (+/- 2.0) respectively (p <.001). Incidence of BMI >25 kg/m2 was 17% (95%CI; 8%-32%) and BMI >30 kg/m2 12.8% (95%CI; 5%-26%) at 48 weeks respectively. Conclusions: Weight gain should be considered when men PLWH are treated with BIC/FTC/TAF regimen. They should be informed about this possible adverse event and strategies of intervention.