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Original Research |

Hepatic Decompensation in Antiretroviral-Treated Patients Co-Infected With HIV and Hepatitis C Virus Compared With Hepatitis C Virus–Monoinfected Patients: A Cohort Study

Vincent Lo Re III, MD, MSCE; Michael J. Kallan, MS; Janet P. Tate, ScD; A. Russell Localio, PhD; Joseph K. Lim, MD; Matthew Bidwell Goetz, MD; Marina B. Klein, MD, MS; David Rimland, MD; Maria C. Rodriguez-Barradas, MD; Adeel A. Butt, MD, MS; Cynthia L. Gibert, MD, MS; Sheldon T. Brown, MD; Lesley Park, MPH; Robert Dubrow, MD, PhD; K. Rajender Reddy, MD; Jay R. Kostman, MD; Brian L. Strom, MD, MPH; and Amy C. Justice, MD, PhD
[+] Article and Author Information

From the University of Pennsylvania and Philadelphia VA Medical Center, Philadelphia, Pennsylvania; VA Connecticut Healthcare System, West Haven, Connecticut; Yale University School of Medicine and Yale School of Public Health, New Haven, Connecticut; VA Greater Los Angeles Healthcare System and David Geffen School of Medicine at UCLA, Los Angeles, California; McGill University Health Centre, Montreal, Québec, Canada; Atlanta VA Medical Center and Emory University School of Medicine, Atlanta, Georgia; Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, Texas; University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; Sheikh Khalifa Medical City, Abu Dhabi, United Arab Emirates; Washington DC VA Medical Center and George Washington University Medical Center, Washington, DC; James J. Peters VA Medical Center and Mount Sinai School of Medicine, New York, New York; and Rutgers University, Newark, New Jersey.

Presented in part at the 19th International AIDS Conference, Washington, DC, 22–27 July 2012, and the 20th Conference on Retroviruses and Opportunistic Infections, Atlanta, Georgia, 3–6 March 2013.

Disclaimer: The contents of this article do not represent the views of the Department of Veterans Affairs or the U.S. Government.

Acknowledgment: The authors thank the VA Central Cancer Registry for permitting them to link the VACS-VC database with the VA Central Cancer Registry database and for providing the data set containing the linked records.

Grant Support: By National Institute of Allergy and Infectious Diseases research grant K01 AI070001 (Dr. Lo Re), National Institute on Alcohol Abuse and Alcoholism research grant U01 AA13566 (Dr. Justice), and National Institute of Mental Health research grant T32 MH020031 (Ms. Park).

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-1829.

Reproducible Research Statement: Study protocol and statistical code: Available from Dr. Lo Re (e-mail, vincentl@mail.med.upenn.edu). Data set: The data in the Veterans Aging Cohort Study are available to VA researchers only and can be requested from www.vacohort.org/groups/RequestingData.aspx.

Requests for Single Reprints: Vincent Lo Re III, MD, MSCE, Division of Infectious Diseases, Department of Medicine, Penn Center for AIDS Research, Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, 836 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104.

Current Author Addresses: Dr. Lo Re: Division of Infectious Diseases, Department of Medicine, Penn Center for AIDS Research, Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, 836 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104.

Mr. Kallan: Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, 523 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104.

Dr. Tate: VA Connecticut Health Systems, 950 Campbell Avenue, West Haven, CT 06516.

Dr. Localio: Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, 606 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104.

Dr. Lim: Yale Digestive Diseases, Temple Medical Center, 40 Temple Street, Suite 1A, New Haven, CT 06510.

Dr. Goetz: VA Greater Los Angeles Healthcare System, Infectious Diseases Section (111-F), Veterans Affairs Greater Los Angeles Healthcare System, 11301 Wilshire Boulevard, Los Angeles, CA 90073.

Dr. Klein: Montreal Chest Institute, 3650 Saint Urbain Street, Montreal, Québec H2X 2P4, Canada.

Dr. Rimland: Atlanta VA Medical Center, Medical Service (111-RIM), 1670 Clairmont Road, Decatur, GA 30033.

Dr. Rodriguez-Barradas: Michael E. DeBakey VA Medical Center, 2002 Holcombe Boulevard, 111-G, Houston, TX 77030.

Dr. Butt: University of Pittsburgh School of Medicine, 3520 Fifth Avenue, Suite 510, Pittsburgh, PA 15213.

Dr. Gibert: Washington DC VA Medical Center, Section of Infectious Diseases, 50 Irving Street, Northwest, Washington, DC 20422.

Dr. Brown: James J. Peters VA Medical Center, 130 West Kingsbridge Road, 111F, Bronx, NY 10468.

Ms. Park: Yale School of Medicine, 950 Campbell Avenue, Building 35A, West Haven, CT 06516.

Dr. Dubrow: Yale School of Public Health, PO Box 208034, New Haven, CT 06520.

Dr. Reddy: Hospital of the University of Pennsylvania, Division of Gastroenterology, 2 Dulles, Philadelphia, PA 19104.

Dr. Kostman: Penn Presbyterian Medical Center, Division of Infectious Diseases, 3910 Powelton Avenue, 4th Floor, Philadelphia, PA 19104.

Dr. Strom: Chancellor, Rutgers Biomedical & Health Sciences, Rutgers, The State University of New Jersey, Suite 1535, Stanley S. Bergen Building, Newark, NJ 07103.

Dr. Justice: Veterans Affairs Connecticut Healthcare System, Building 35a, Room 2-212, 950 Campbell Avenue, West Haven, CT 06516.

Author Contributions: Conception and design: V. Lo Re, J.P. Tate, A.R. Localio, J.K. Lim, M.B. Klein, D. Rimland, M.C. Rodriguez-Barradas, A.A. Butt, C.L. Gibert, J.R. Kostman, B.L. Strom.

Analysis and interpretation of the data: V. Lo Re, M.J. Kallan, J.P. Tate, A.R. Localio, J.K. Lim, M.B. Goetz, M.B. Klein, D. Rimland, M.C. Rodriguez-Barradas, A.A. Butt, C.L. Gibert, S.T. Brown, L. Park, A.C. Justice.

Drafting of the article: V. Lo Re, M.J. Kallan, A.R. Localio, J.K. Lim, M.B. Klein, A.A. Butt, J.R. Kostman.

Critical revision of the article for important intellectual content: V. Lo Re, M.J. Kallan, J.P. Tate, A.R. Localio, J.K. Lim, M.B. Goetz, M.B. Klein, D. Rimland, M.C. Rodriguez-Barradas, A.A. Butt, C.L. Gibert, S.T. Brown, R. Dubrow, K.R. Reddy, J.R. Kostman, B.L. Strom, A.C. Justice.

Final approval of the article: V. Lo Re, M.J. Kallan, J.P. Tate, A.R. Localio, J.K. Lim, M.B. Goetz, M.B. Klein, D. Rimland, M.C. Rodriguez-Barradas, A.A. Butt, C.L. Gibert, S.T. Brown, L. Park, R. Dubrow, K.R. Reddy, J.R. Kostman, B.L. Strom, A.C. Justice.

Provision of study materials or patients: D. Rimland, S.T. Brown, A.C. Justice.

Statistical expertise: M.J. Kallan, J.P. Tate, A.R. Localio, M.B. Klein, R. Dubrow, A.C. Justice.

Obtaining of funding: V. Lo Re, B.L. Strom, A.C. Justice.

Administrative, technical, or logistic support: V. Lo Re, M.B. Klein, D. Rimland, R. Dubrow, B.L. Strom, A.C. Justice.

Collection and assembly of data: M.J. Kallan, J.P. Tate, M.B. Klein, D. Rimland, S.T. Brown, L. Park, A.C. Justice.


Ann Intern Med. 2014;160(6):369-379. doi:10.7326/M13-1829
Text Size: A A A

Background: The incidence and determinants of hepatic decompensation have been incompletely examined among patients co-infected with HIV and hepatitis C virus (HCV) in the antiretroviral therapy (ART) era, and few studies have compared outcome rates with those of patients with chronic HCV alone.

Objective: To compare the incidence of hepatic decompensation between antiretroviral-treated patients co-infected with HIV and HCV and HCV-monoinfected patients and to evaluate factors associated with decompensation among co-infected patients receiving ART.

Design: Retrospective cohort study.

Setting: Veterans Health Administration.

Patients: 4280 co-infected patients who initiated ART and 6079 HCV-monoinfected patients receiving care between 1997 and 2010. All patients had detectable HCV RNA and were HCV treatment–naive.

Measurements: Incident hepatic decompensation, determined by diagnoses of ascites, spontaneous bacterial peritonitis, or esophageal variceal hemorrhage.

Results: The incidence of hepatic decompensation was greater among co-infected than monoinfected patients (7.4% vs. 4.8% at 10 years; P < 0.001). Compared with HCV-monoinfected patients, co-infected patients had a higher rate of hepatic decompensation (hazard ratio [HR] accounting for competing risks, 1.56 [95% CI, 1.31 to 1.86]). Co-infected patients who maintained HIV RNA levels less than 1000 copies/mL still had higher rates of decompensation than HCV-monoinfected patients (HR, 1.44 [CI, 1.05 to 1.99]). Baseline advanced hepatic fibrosis (FIB-4 score >3.25) (HR, 5.45 [CI, 3.79 to 7.84]), baseline hemoglobin level less than 100 g/L (HR, 2.24 [CI, 1.20 to 4.20]), diabetes mellitus (HR, 1.88 [CI, 1.38 to 2.56]), and nonblack race (HR, 2.12 [CI, 1.65 to 2.72]) were each associated with higher rates of decompensation among co-infected patients.

Limitation: Observational study of predominantly male patients.

Conclusion: Despite receiving ART, patients co-infected with HIV and HCV had higher rates of hepatic decompensation than HCV-monoinfected patients. Rates of decompensation were higher for co-infected patients with advanced liver fibrosis, severe anemia, diabetes, and nonblack race.

Primary Funding Source: National Institutes of Health.

Figures

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Figure 1.

Study flow diagram.

ART = antiretroviral therapy; HCC = hepatocellular carcinoma; HCV = hepatitis C virus; VACS-VC = Veterans Aging Cohort Study Virtual Cohort.

* HIV infection determined by diagnosis codes from the International Classification of Diseases, Ninth Revision.

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Figure 2.

Standardized cumulative incidences of hepatic decompensation, based on competing risk regression analyses.

Top. Antiretroviral-treated patients co-infected with HIV and HCV (solid line) and HCV-monoinfected patients (dotted line). Middle. Co-infected patients with HIV RNA levels ≥1000 copies/mL on any HIV RNA test result during follow-up (dashed line), co-infected patients with HIV RNA levels <1000 copies/mL on all HIV RNA test results throughout follow-up (solid line), and HCV-monoinfected patients (dotted line). Bottom. Co-infected patients with pre-ART CD4 T-lymphocyte counts <0.200 × 109 cells/L (solid line), co-infected patients with pre-ART CD4 T-lymphocyte counts ≥0.200 × 109 cells/L (dashed line), and HCV-monoinfected patients (dotted line). Strata for CD4 counts ≥0.200 × 109 cells/L were collapsed into a single plot because these hazard ratios were indistinguishable (see Table 2). ART = antiretroviral therapy; HCV = hepatitis C virus.

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