TY - JOUR
T1 - Predicting Clinical and Histologic Outcomes Based on Standard Laboratory Tests in Advanced Chronic Hepatitis C
AU - Ghany, Marc G.
AU - Lok, Anna S F
AU - Everhart, James E.
AU - Everson, Gregory T.
AU - Lee, William M.
AU - Curto, Teresa M.
AU - Wright, Elizabeth C.
AU - Stoddard, Anne M.
AU - Sterling, Richard K.
AU - Di Bisceglie, Adrian M.
AU - Bonkovsky, Herbert L.
AU - Morishima, Chihiro
AU - Morgan, Timothy R.
AU - Dienstag, Jules L.
N1 - Funding Information:
University of California-Irvine, Irvine, California: (contract N01-DK-9-2320, grant M01RR-00827 ) John C. Hoefs, MD; John R. Craig, MD; M. Mazen Jamal, MD, MPH; Muhammad Sheikh, MD, Choon Park, RN.
Funding Information:
University of Colorado School of Medicine, Denver, Colorado: (contract N01-DK-9-2327, grant M01RR-00051 , grant 1 UL1 RR 025780-01 ) S. Russell Nash, MD; Jennifer DeSanto, RN; Carol McKinley, RN.
Funding Information:
Massachusetts General Hospital, Boston, Massachusetts: (contract N01-DK-9-2319, grant M01RR-0106 6; grant 1 UL1 RR025758-01 , Harvard Clinical and Translational Science Center) Raymond T. Chung, MD; Andrea E. Reid, MD; Atul K. Bhan, MD; Wallis A. Molchen, Cara C. Gooch.
Funding Information:
University of Texas Southwestern Medical Center, Dallas, Texas: (contract N01-DK-9-2321, grant M01RR-00633 , grant 1 UL1 RR024982-01 , North and Central Texas Clinical and Translational Science Initiative) Thomas E. Rogers, MD; Janel Shelton, Nicole Crowder, LVN; Rivka Elbein, RN, BSN; Nancy Liston, MPH.
Funding Information:
Funding Supported by the National Institute of Diabetes and Digestive and Kidney Diseases (contract numbers are listed below) and the National Institute of Allergy and Infectious Diseases (NIAID), the National Cancer Institute, the National Center for Minority Health and Health Disparities, and by General Clinical Research Center and Clinical and Translational Science Center grants from the National Center for Research Resources, National Institutes of Health (grant numbers are listed below). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health. Additional funding to conduct this study was supplied by Hoffmann-La Roche, Inc., through a Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health.
PY - 2010/1
Y1 - 2010/1
N2 - Background & Aims: Predictors of clinical outcomes and histologic progression among patients with chronic hepatitis C and advanced fibrosis are poorly defined. We developed statistical models to predict clinical and histologic outcomes in such patients. Methods: Baseline demographic, clinical, and histologic data from Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) Trial participants were subjected to multivariate analyses to determine their ability to predict clinical outcomes (ascites, spontaneous bacterial peritonitis, Child-Turcotte-Pugh score ≥7 on 2 consecutive visits, variceal bleeding, hepatic encephalopathy, and liver-related death) and histologic outcome (≥2-point increase in Ishak fibrosis stage) during the 3.5 years of the trial. Results: Of 1050 randomized patients, 135 had 1 or more clinical outcomes a median of 23 (range, 1-45) months after randomization. Factors associated with a clinical outcome in multivariate analyses were higher aspartate aminotransferase/alanine aminotransferase ratio, lower albumin, lower platelet count, higher total bilirubin, and more advanced Ishak fibrosis score (P < .0001). The cumulative 3.5-year incidence of a clinical outcome was 2% in the lowest and 65% in the highest risk group. Of 547 patients without cirrhosis at baseline and at least 1 follow-up biopsy, 152 had a histologic outcome. Independent variables associated with a histologic outcome were higher body mass index, lower platelet count, and greater hepatic steatosis (P < .0001). Conclusions: In patients with chronic hepatitis C and advanced fibrosis, risk of clinical complications and fibrosis progression during 3.5 years can be predicted using baseline laboratory tests and histologic data. Our models may be useful in counseling patients and determining the frequency of monitoring.
AB - Background & Aims: Predictors of clinical outcomes and histologic progression among patients with chronic hepatitis C and advanced fibrosis are poorly defined. We developed statistical models to predict clinical and histologic outcomes in such patients. Methods: Baseline demographic, clinical, and histologic data from Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) Trial participants were subjected to multivariate analyses to determine their ability to predict clinical outcomes (ascites, spontaneous bacterial peritonitis, Child-Turcotte-Pugh score ≥7 on 2 consecutive visits, variceal bleeding, hepatic encephalopathy, and liver-related death) and histologic outcome (≥2-point increase in Ishak fibrosis stage) during the 3.5 years of the trial. Results: Of 1050 randomized patients, 135 had 1 or more clinical outcomes a median of 23 (range, 1-45) months after randomization. Factors associated with a clinical outcome in multivariate analyses were higher aspartate aminotransferase/alanine aminotransferase ratio, lower albumin, lower platelet count, higher total bilirubin, and more advanced Ishak fibrosis score (P < .0001). The cumulative 3.5-year incidence of a clinical outcome was 2% in the lowest and 65% in the highest risk group. Of 547 patients without cirrhosis at baseline and at least 1 follow-up biopsy, 152 had a histologic outcome. Independent variables associated with a histologic outcome were higher body mass index, lower platelet count, and greater hepatic steatosis (P < .0001). Conclusions: In patients with chronic hepatitis C and advanced fibrosis, risk of clinical complications and fibrosis progression during 3.5 years can be predicted using baseline laboratory tests and histologic data. Our models may be useful in counseling patients and determining the frequency of monitoring.
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U2 - 10.1053/j.gastro.2009.09.007
DO - 10.1053/j.gastro.2009.09.007
M3 - Article
C2 - 19766643
AN - SCOPUS:72549110673
SN - 0016-5085
VL - 138
SP - 136
EP - 146
JO - Gastroenterology
JF - Gastroenterology
IS - 1
ER -