Dana D Byrne1,2,3, Janet P Tate4,5, Kimberly A Forde1,2, Joseph K Lim4,5, Matthew Bidwell Goetz6, David Rimland7, Maria C Rodriguez-Barradas8, Adeel A Butt9,10,11, Cynthia L Gibert12, Sheldon T Brown13, Roger Bedimo14,15, Matthew S Freiberg16, Amy C Justice4,5, Jay R Kostman17, Jason A Roy2, Vincent Lo Re1,2. 1. Departments of Medicine, Penn Center for AIDS Research. 2. Biostatistics, Epidemiology, and Informatics, Center for Clinical Epidemiology and Biostatistics, Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine, University of Pennsylvania, Philadelphia. 3. Department of Medicine, Cooper University Hospital, Camden, New Jersey. 4. Veterans Affairs Connecticut Healthcare System, West Haven. 5. Yale University School of Medicine, New Haven, Connecticut. 6. Veterans Affairs Greater Los Angeles Healthcare System and David Geffen School of Medicine at the University of California, Los Angeles. 7. Atlanta Veterans Affairs Medical Center and Emory University School of Medicine, Georgia. 8. Infectious Diseases Section, Michael E. DeBakey Veterans Affairs Medical Center and Department of Medicine, Baylor College of Medicine, Houston, Texas. 9. Veterans Affairs Pittsburgh Healthcare System, Pennsylvania. 10. Hamad Healthcare Quality Institute, Hamad Medical Corporation, Doha, Qatar. 11. Weill Cornell Medical College, Doha, Qatar and New York, New York. 12. Washington DC Veterans Affairs Medical Center and George Washington University Medical Center. 13. James J. Peters Veterans Affairs Medical Center and Mount Sinai School of Medicine, New York, New York. 14. Medical Service, Veterans Affairs North Texas Healthcare System. 15. Department of Medicine, University of Texas Southwestern Medical Center, Dallas. 16. Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee. 17. John Bell Health Center, Philadelphia Field Initiating Group for HIV Trials, Pennsylvania.
Abstract
BACKGROUND: Patients with human immunodeficiency virus (HIV) and/or chronic hepatitis C virus (HCV) infection may be prescribed statins as treatment for metabolic/cardiovascular disease, but it remains unclear if the risk of acute liver injury (ALI) is increased for statin initiators compared to nonusers in groups classified by HIV/HCV status. METHODS: We conducted a cohort study to compare rates of ALI in statin initiators vs nonusers among 7686 HIV/HCV-coinfected, 8155 HCV-monoinfected, 17739 HIV-monoinfected, and 36604 uninfected persons in the Veterans Aging Cohort Study (2000-2012). We determined development of (1) liver aminotransferases >200 U/L, (2) severe ALI (coagulopathy with hyperbilirubinemia), and (3) death, all within 18 months. Cox regression was used to determine propensity score-adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) of outcomes in statin initiators compared to nonusers across the groups. RESULTS: Among HIV/HCV-coinfected patients, statin initiators had lower risks of aminotransferase levels >200 U/L (HR, 0.66 [95% CI, .53-.83]), severe ALI (HR, 0.23 [95% CI, .12-.46]), and death (HR, 0.36 [95% CI, .28-.46]) compared with statin nonusers. In the setting of chronic HCV alone, statin initiators had reduced risks of aminotransferase elevations (HR, 0.57 [95% CI, .45-.72]), severe ALI (HR, 0.15 [95% CI, .06-.37]), and death (HR, 0.42 [95% CI, .32-.54]) than nonusers. Among HIV-monoinfected patients, statin initiators had lower risks of aminotransferase increases (HR, 0.52 [95% CI, .40-.66]), severe ALI (HR, 0.26 [95% CI, .13-.55]), and death (HR, 0.19 [95% CI, .16-.23]) compared with nonusers. Results were similar among uninfected persons. CONCLUSIONS: Regardless of HIV and/or chronic HCV status, statin initiators had a lower risk of ALI and death within 18 months compared with statin nonusers.
BACKGROUND: Patients with human immunodeficiency virus (HIV) and/or chronic hepatitis C virus (HCV) infection may be prescribed statins as treatment for metabolic/cardiovascular disease, but it remains unclear if the risk of acute liver injury (ALI) is increased for statin initiators compared to nonusers in groups classified by HIV/HCV status. METHODS: We conducted a cohort study to compare rates of ALI in statin initiators vs nonusers among 7686 HIV/HCV-coinfected, 8155 HCV-monoinfected, 17739 HIV-monoinfected, and 36604 uninfected persons in the Veterans Aging Cohort Study (2000-2012). We determined development of (1) liver aminotransferases >200 U/L, (2) severe ALI (coagulopathy with hyperbilirubinemia), and (3) death, all within 18 months. Cox regression was used to determine propensity score-adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) of outcomes in statin initiators compared to nonusers across the groups. RESULTS: Among HIV/HCV-coinfected patients, statin initiators had lower risks of aminotransferase levels >200 U/L (HR, 0.66 [95% CI, .53-.83]), severe ALI (HR, 0.23 [95% CI, .12-.46]), and death (HR, 0.36 [95% CI, .28-.46]) compared with statin nonusers. In the setting of chronic HCV alone, statin initiators had reduced risks of aminotransferase elevations (HR, 0.57 [95% CI, .45-.72]), severe ALI (HR, 0.15 [95% CI, .06-.37]), and death (HR, 0.42 [95% CI, .32-.54]) than nonusers. Among HIV-monoinfected patients, statin initiators had lower risks of aminotransferase increases (HR, 0.52 [95% CI, .40-.66]), severe ALI (HR, 0.26 [95% CI, .13-.55]), and death (HR, 0.19 [95% CI, .16-.23]) compared with nonusers. Results were similar among uninfected persons. CONCLUSIONS: Regardless of HIV and/or chronic HCV status, statin initiators had a lower risk of ALI and death within 18 months compared with statin nonusers.
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