Session: 044. HIV Complications: Cardiovascular, Metabolic, and other Complications, Thursday, 12:15-1:30 p.m.
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).
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.
Individuals prescribed these ART regimens varied significantly (Fig 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; Fig 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) (Fig 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 (Fig 4). No differences were observed for ART-ES initiators.
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.
Ricky Hsu– Associate Clinical Professor and Northern U.S. Medical Director AHF, NYU Langone Medical Center - AIDS Healthcare Foundation, New York, NY
Laurence Brunet– Director of Epidemiology, Epividian, Inc., Durham, NC
Jennifer Fusco– President - Chief Science Officer, Epividian, Inc., Durham, NC
Karam Mounzer– Clinical Professor of Medicine, Philadelphia FIGHT, Philadelphia, PA
Vani Vannappagari– Global Head, Epidemiology and Real World Evidence, ViiV Healthcare, Research Triangle Park, NC
Cassidy Henegar– Director, Epidemiology & Real World Evidence, ViiV Healthcare, Research Triangle Park, NC
Jean van Wyk– Medical Director, ViiV Healthcare, Brentford, England, United Kingdom
Lloyd Curtis– Medical Director, GSK, Uxbridge, England, United Kingdom
Janet Lo– Assistant Professor of Medicine, Harvard Medical School, Boston, MA
Gregory Fusco– Chief Executive Officer and Chief Medical Officer, Epividian, Inc., Durham, NC