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s 2072
Optimizing the Use of APRI and FIB-4 to Rule
out Cirrhosis in Patients with Chronic Hepatitis
B: Results from the Sonic-B Study
Milan J. Sonneveld1, Willem Pieter Brouwer2, Henry Lik Yuen
Chan3, Teerha Piratvisuth4, Jidong Jia5, Stefan Zeuzem6,
Yun-Fan Liaw7, Bettina E. Hansen8, Hannah S.J. Choi9,
Cynthia Wat10, Qing Xie11, Maria Buti12, Robert J. De Knegt13
and Harry L. A. Janssen8, (1)Erasmus University Medical
Center, (2)Gastroenterology and Hepatology, Erasmus
University Medical Center, (3)Institute of Digestive Disease,
Department of Medicine and Therapeutics, and State Key
Laboratory of Digestive Disease, The Chinese University of
Hong Kong, Hong Kong, (4)Nkc Institute of Gastroenterology
and Hepatology, (5)Liver Research Center, Beijing Friendship
Hospital, Capital Medical University, Beijing Key Laboratory
of Translational Medicine in Liver Cirrhosis, National Clinical
Research Center of Digestive Diseases, Beijing, China;,
(6)Universitätsklinikum Frankfurt, (7)Liver Research Unit,
Chang Gung Memorial Hospital, (8)Toronto Centre for Liver
Disease, University Health Network, (9)University of Toronto,
(10)Roche Products Limited, Roche Products Ltd, (11)
Department of Infectious Diseases, Ruijin Hospital, Shanghai
Jiao Tong University School of Medicine, Shanghai, China,
(12)Hospital Universitari Vall d’Hebron, Barcelona, Spain, (13)
Gastroenterology and Hepatology, Erasmus Medical Centre
Background: Ruling out the presence of cirrhosis is
important for the management of chronic hepatitis B (CHB).
We aimed to study and optimize the performance of 2 noninvasive
indices for ruling out cirrhosis: the AST-platelet ratio
index (APRI) and FIB-4. Methods: We enrolled patients
from 8 global randomized trials that required baseline liver
biopsy and all consecutive biopsied patients from 2 tertiary
referral hospitals in the Netherlands and Canada. We applied
conventional cut-offs to rule in (APRI >2.00; FIB-4 >3.25) or
rule out (APRI <1.00; FIB-4 <1.45) cirrhosis and subsequently
identified and externally validated new cut-offs aiming for a
sensitivity of >90% and a negative predictive value (NPV) of
>95%. Results: We enrolled 3960 patients of whom 1034
were assigned to the validation dataset. In the derivation
dataset (n=2926), 59.8% was Asian and 35.4% Caucasian.
Cirrhosis was detected in 340 (11.6%). Application of
conventional cut-offs for APRI yielded unclassifiable
results in 24.1%, and 45% of patients with cirrhosis were
misclassified as having no cirrhosis. Application of FIB-4
yielded similar results: 23.4% of patients were unclassifiable
and 40.9% of patients with cirrhosis were misclassified as
having no cirrhosis. An APRI <0.45 had an NPV of 95% and
showed 8.5% misclassification in the derivation dataset, but
performance was reduced in the validation set. A FIB-4 score
<0.70 identified ~32% of patients in both the derivation and
validation datasets, with excellent NPVs (>96%) and low
rates of misclassification (5.8% in validation dataset) (table 1).
Conclusion: Conventional cut-offs for APRI and FIB-4 should
not be used to guide management of CHB patients due to
high rates misclassification. A newly identified and externally
validated cut-off for FIB-4 (<0.70) can be used to confidently
exclude cirrhosis. |
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