학술논문
Serum Levels of Hepatitis B Surface Antigen Predict Severity of Fibrosis in Patients With E Antigen-Positive Chronic Hepatitis B.
Document Type
Academic Journal
Author
Marcellin P; Centre de Recherche sur l'Inflammation, UMR 1149 Inserm, Université Paris Diderot, Clichy, France; Service d'Hépatologie, AP-HP Hôpital Beaujon, Clichy, France. Electronic address: patrick.marcellin@bjn.aphp.fr.; Martinot-Peignoux M; Centre de Recherche sur l'Inflammation, UMR 1149 Inserm, Université Paris Diderot, Clichy, France; Service d'Hépatologie, AP-HP Hôpital Beaujon, Clichy, France.; Asselah T; Centre de Recherche sur l'Inflammation, UMR 1149 Inserm, Université Paris Diderot, Clichy, France; Service d'Hépatologie, AP-HP Hôpital Beaujon, Clichy, France.; Batrla R; Roche Diagnostics Ltd, Forrenstrasse, 6343 Rotkreuz, Switzerland.; Messinger D; IST GmbH, Mannheim, Germany.; Rothe V; IST GmbH, Mannheim, Germany.; Lau G; Institute of Translational Hepatology, Beijing 302 Hospital, Beijing, China; Humanity and Health Gastroenterology and Liver Clinic, Hong Kong SAR, China.; Liaw YF; Liver Research Unit, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taipei, Taiwan.
Source
Publisher: W.B. Saunders for the American Gastroenterological Association Country of Publication: United States NLM ID: 101160775 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1542-7714 (Electronic) Linking ISSN: 15423565 NLM ISO Abbreviation: Clin Gastroenterol Hepatol Subsets: MEDLINE
Subject
Language
English
Abstract
Background & Aims: Noninvasive techniques are needed to assess hepatic fibrosis in patients with chronic hepatitis B. We developed a scoring system to determine the degree of fibrosis in patients with genotype B or genotype C hepatitis B virus (HBV) infection and positive for the hepatitis B e antigen.
Methods: We performed a retrospective study to identify baseline variables associated with the severity of fibrosis (METAVIR scores, F0-F4) in a large phase 3 clinical trial of predominantly Asian patients (n = 710), using multivariate logistic regression analyses. Significant variables were used to construct predictive models using optimal cut-off values. The final model was validated in similar patients from a large phase 4 clinical trial (n = 465).
Results: We developed 2 prediction scoring systems (PSs). PS1 analyzed data on HBV genotype (B vs. C), patient age (<30 vs. ≥30 y), level of hepatitis B surface antigen (≤17,500 vs. >17,500 IU/mL), and level of alanine aminotransferase (≤3-fold vs. >3-fold the upper limit of normal). PS2 analyzed data on only age and level of hepatitis B surface antigen. PS1 identified patients with F0 to F1 vs. F2 to F4 fibrosis with more than 87% specificity and a positive predictive value greater than 75; it identified patients with F0 to F2 vs. F2 to F4 fibrosis with approximately 95% specificity and a positive predictive value (PPV) of approximately 97%. PS2 identified patients with F0 to F1 fibrosis with less accuracy than PS1, but identified patients with F0 to F2 fibrosis with an almost identical level of sensitivity and PPV.
Conclusions: We developed a simple scoring system to determine the severity of fibrosis in patients with genotypes B or C HBV infection who are hepatitis B e antigen positive. Our system differentiated patients with no or mild fibrosis (F0-F1) from those with marked or severe (F2-F4) fibrosis with a high PPV. The high level of specificity for the identification of nonsevere fibrosis (F0-F2) limits the risk of overlooking patients with severe fibrosis (F3-F4).
(Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.)
Methods: We performed a retrospective study to identify baseline variables associated with the severity of fibrosis (METAVIR scores, F0-F4) in a large phase 3 clinical trial of predominantly Asian patients (n = 710), using multivariate logistic regression analyses. Significant variables were used to construct predictive models using optimal cut-off values. The final model was validated in similar patients from a large phase 4 clinical trial (n = 465).
Results: We developed 2 prediction scoring systems (PSs). PS1 analyzed data on HBV genotype (B vs. C), patient age (<30 vs. ≥30 y), level of hepatitis B surface antigen (≤17,500 vs. >17,500 IU/mL), and level of alanine aminotransferase (≤3-fold vs. >3-fold the upper limit of normal). PS2 analyzed data on only age and level of hepatitis B surface antigen. PS1 identified patients with F0 to F1 vs. F2 to F4 fibrosis with more than 87% specificity and a positive predictive value greater than 75; it identified patients with F0 to F2 vs. F2 to F4 fibrosis with approximately 95% specificity and a positive predictive value (PPV) of approximately 97%. PS2 identified patients with F0 to F1 fibrosis with less accuracy than PS1, but identified patients with F0 to F2 fibrosis with an almost identical level of sensitivity and PPV.
Conclusions: We developed a simple scoring system to determine the severity of fibrosis in patients with genotypes B or C HBV infection who are hepatitis B e antigen positive. Our system differentiated patients with no or mild fibrosis (F0-F1) from those with marked or severe (F2-F4) fibrosis with a high PPV. The high level of specificity for the identification of nonsevere fibrosis (F0-F2) limits the risk of overlooking patients with severe fibrosis (F3-F4).
(Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.)