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Vincent Lo Re, MD, MSCE J Tate, MJ Kallan, JK Lim, MB Goetz, D Rimland, MB Klein,

Increased Risk of Hepatic Decompensation in HIV/HCV-Coinfected Versus HCV-Monoinfected Patients Despite ART. Vincent Lo Re, MD, MSCE J Tate, MJ Kallan, JK Lim, MB Goetz, D Rimland, MB Klein, MC Rodriguez-Barradas, AA Butt, CL Gibert, ST Brown,

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Vincent Lo Re, MD, MSCE J Tate, MJ Kallan, JK Lim, MB Goetz, D Rimland, MB Klein,

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  1. Increased Risk of Hepatic Decompensation in HIV/HCV-Coinfected VersusHCV-Monoinfected Patients Despite ART Vincent Lo Re, MD, MSCE J Tate, MJ Kallan, JK Lim, MB Goetz, D Rimland, MB Klein, MC Rodriguez-Barradas, AA Butt, CL Gibert, ST Brown, JR Kostman, BL Strom, KR Reddy, AC Justice, R Localio for the Veterans Aging Cohort Study (VACS) Team Division of Infectious Diseases Center for Clinical Epidemiology and Biostatistics University of Pennsylvania

  2. HCV-Related Liver Complications in HIV/HCV Patients on ART Hepatic decompensation (HD), hepatocellular ca (HCC) contribute to morbidity in HIV/HCV pts ART slows progression of HCV fibrosis Few data compare liver complications between ART-treated HIV/HCV and HCV only pts Unclear if rates of HD in HIV/HCV pts on ART similar to those with HCV alone Qurishi N et al. Lancet. 2003;362:1708-13. Brau N et al. J Hepatol 2006;44:47-55.

  3. Specific Aim Aim: To compare the incidence of HD between ART-treated HIV/HCV-coinfected and HCV-monoinfected pts • Hypothesis: Rates of HD would remain higher in HIV/HCV pts despite ART

  4. Study Design / Setting • Design: Retrospective cohort study • Setting: VACS Virtual Cohort (1997 – 2010) • Electronic medical record data from: • HIV-infected veterans across U.S. • 1:2 age-, race/ethnicity-, and site-matched sample of HIV-uninfected veterans • Diagnoses, lab, pharmacy fill data • Death date recorded • Cause of death (National Death Index)

  5. Study Subjects:Inclusion / Exclusion Criteria • From HIV+, HIV- groups  chronic HCV pts • Inclusion criteria: • Excluded if during initial 12 months: • Hepatic decompensation, hepatocellular ca • Received interferon-based HCV therapy

  6. Primary Outcome:Hepatic Decompensation (HD) • Defined by: 1 hospital ICD-9 diagnosis or 2 outpatient diagnoses for: • Ascites • Spontaneous bacterial peritonitis • Esophageal variceal bleed • HD date: hospital admission, 1st outpatient visit • 91% had HD by case arbitration* • Hepatic encephalopathy, non-obstructive jaundice evaluated, but had low positive predictive value *Lo Re V et al. Pharmacoepidemiol Drug Saf 2011;20:689-99.

  7. Secondary Outcomes Hepatocellular ca (HCC): VA Cancer Registry (pathology, cytology, consistent CT / MRI) Severe liver event: HD, HCC, or liver-related death* Death from any cause *Liver-related death = death from HD, alcoholic liver disease, viral hepatitis, liver cancer, or non-alcoholic liver disease

  8. Data Collection

  9. Data Analysis: Follow-up 12 mo In VA HIV/HCV on ART Study Endpoint Death HCV Therapy Last Visit BeforeSept. 30, 2010 Baseline Follow-up Start of Follow-up 12 mo in VA HCV Baseline Follow-up Start of Follow-up

  10. Data Analysis: Evaluation of Outcomes • Compared incidence, rates of outcomes: HIV/HCV vs. HCV cohorts • Cox regression (hazard ratios [HRs]) • Competing risk regression (HRs)* • Standardized cumulative incidence of HD • Exploratory (HIV/HCV pts): evaluated pre-ART CD4 and HCV RNA level as risk factors for HD *Fine J, Gray RJ. J Am Stat Assoc 1999;94:496-509.

  11. HIV/HCV Patient Selection 9,086 HIV/HCV Patients Prescribed ART in VACS Virtual Cohort (1997-2010) 4,806 Did not meet inclusion criteria: 122 Decompensation at baseline 62 Interferon prior to start of follow-up 1,466 HIV RNA <500 within 6 months prior to ART 1,089 Missing HIV RNA within 6 months prior to ART 851 Negative HCV RNA 1,216 Missing HCV RNA 4,280 HIV/HCV Patients on ART

  12. HCV Patient Selection 11,237 HCV Patients in VACS Virtual Cohort (1997-2010) 5,158 Did not meet inclusion criteria: 214 Without 12 months of follow-up 216 Decompensation at baseline 91 Interferon prior to start of follow-up 730 Negative HCV RNA 3,906 Missing HCV RNA 1 Cause of death listed as HIV/AIDS 6,079 HCV Patients

  13. Baseline Characteristics

  14. Hepatic Decompensation Events* p=0.1 Frequency of Decompensation Events At Incident Decompensation Percent with Decompensation Event * Initial hepatic decompensation may have presented with >1 event.

  15. Frequency of Secondary Outcomes

  16. Risk of Outcomes in ART-Treated HIV/HCV vs. HCV * Adjusted for age, race, BMI, history of alcohol / drug abuse, and size of VA center. Similar results observed with competing risk regression analyses.

  17. Standardized Cumulative Incidence of Hepatic Decompensation* ART-Treated HIV/HCV-Coinfected Log-rank p<0.001 HCV-Monoinfected * Based on competing risk regression analysis.

  18. Risk Factors for Decompensation in HIV/HCV Patients on ART Similar results observed with competing risk regression analyses.

  19. Potential Limitations • May have missed outcomes • Incidence rates of HD similar to published rates • Identified liver-related deaths outside VA • Unmeasured confounders: duration, stage of HCV • Generalizability 1Pineda JA et al. Hepatology 2007;46:622-30. 2Thomas DL et al. JAMA 2000;284:450-6.

  20. Conclusions • Despite ART, HIV/HCV pts had higher risk of HD than HCV-monoinfected pts • Future directions: evaluate risk factors, develop predictive index

  21. VACS Liver Core: Joseph K. Lim (Co-Chair) Janet Tate Matthew B. Goetz Adeel A. Butt David Rimland Maria Rodriguez-Barradas Cynthia L. Gibert Sheldon T. Brown Marina B. Klein Lesley Park Robert Dubrow Amy C. Justice Penn: A. Russell Localio Michael J. Kallan K. Rajender Reddy Jay R. Kostman Brian L. Strom Funding source: K01 AI 07001 (NIAID) VACS patients Acknowledgements

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