| Abstrakt: |
Background Limited data exist on the risk of type 2 diabetes mellitus (T2DM) with the use of integrase inhibitors. We assessed the risk of incident T2DM with antiretroviral therapy (ART). Methods ART-naïve (ART-N) and -experienced, suppressed (ART-ES; baseline viral load 13 years of age initiating dolutegravir (DTG), elvitegravir/cobicistat (EVG/c), raltegravir (RAL) or boosted darunavir (bDRV) in the OPERA® cohort. After excluding prevalent prediabetes/T2DM and missing baseline covariates, incidence rates of T2DM (i.e. diagnosis, antidiabetic drug, and/orHbA1C >6.5%) were estimated with Poisson regression. The association between core agents and incident T2DM was estimated with multivariate Cox proportional hazards regression adjusted for age, sex, race, HCV co-infection and BMI at baseline. Median (IQR) absolute BMI change from baseline was evaluated at 6, 12, 18, and 24 months in those who developed incident T2DM and those who did not. All analyses were stratified by ART experience. Results Individuals prescribed these ART regimens varied significantly (Figure 1). Overall, incidence rate per 1,000 person-years was low for T2DM (ART-N IR: 9.1; 95% CI: 7.5, 10.9; ART-ES IR: 13.3; 95% CI: 11.6, 15.2; Figure 2). Among ART-N initiators, no statistical difference was observed in the risk of progression to T2DM between DTG and EVG/c (aHR: 0.70; 95% CI: 0.47, 1.05) or bDRV (aHR: 0.53; 95% CI: 0.26, 1.04); RAL could not be evaluated due to the small number of T2DM events. Among ART-ES initiators; no difference was observed between DTG and EVG/c (aHR: 0.96; 95% CI: 0.70, 1.33), RAL (aHR: 1.17; 95% CI: 0.70, 1.96) or bDRV (aHR: 0.90; 95% CI: 0.57, 1.42) (Figure 3). A greater absolute change in BMI was observed for ART-N initiators developing T2DM at all timepoints; reaching statistical significance at 12 and 18 months (Figure 4). No differences were observed for ART-ES initiators. Conclusion Incident T2DM was uncommon among ART-N and ART-ES persons initiating DTG, EVG/c, RAL or bDRV in this large clinical population. None of the comparisons between DTG and other core agents showed a statistically significant increased risk of T2DM. However, due to the small number of events in the ART-N population differential risk cannot be excluded and monitoring HbA1c remains prudent. Disclosures All authors: No reported disclosures. [ABSTRACT FROM AUTHOR] |
