Independent prospective multicenter validation of biochemical markers (fibrotest-actitest) for the prediction of liver fibrosis and activity in patients with chronic hepatitis C: the fibropaca study.
OBJECTIVE
Fibrotest (FT) and Actitest (AT) are biochemical markers of fibrosis and activity for use as a non-invasive alternative to liver biopsy in patients with chronic hepatitis C virus (HCV). The aim of this study was to perform an external validation of FT and AT and to study the discordances between FT/AT and liver biopsy in patients with chronic hepatitis C.


METHODS
A total of 519 consecutive patients with chronic HCV were prospectively included in five centers, with liver biopsy and biochemical markers taken at the same day. Fifteen patients were excluded because their biopsies could not be interpreted. Diagnostic accuracies were assessed by receiver operating characteristic (ROC) curve analysis.


RESULTS
Median biopsy size was 15 mm (range: 2-58), with 9 portal tracts (1-37) and 1 fragment (1-12). 46% (230/504) were classified F2-F4 in fibrosis and 39% A2-A3 in activity. FT area under ROC curve for diagnosis of activity (A2-A3), significant fibrosis (F2-F4), and severe fibrosis (F3-F4) were 0.73 [0.69-0.77], 0.79 [0.75-0.82], and 0.80 [0.76-0.83], respectively. Among the 92 patients (18%) with 2 fibrosis stages of discordance between FT and biopsy, the discordance was attributable to FT in 5% of cases, to biopsy in 4%, and undetermined in 9%.


CONCLUSIONS
This prospective independent and multicenter study confirms the diagnostic value of FT and AT found in the princeps study and suggests that FT and AT can be an alternative to biopsy in most patients with chronic HCV.
Department of Virology, Alphabio Laboratory, 23 Street of Friedland, 13006 Marseille, France.
Philippe
P
Halfon
Marc
M
Bourliere
Romaric
R
Deydier
Danielle
D
Botta-Fridlund
Christophe
C
Renou
Albert
A
Tran
Isabelle
I
Portal
Isabelle
I
Allemand
Jean Jacques
JJ
Bertrand
Alessandra
A
Rosenthal-Allieri
Michel
M
Rotily
Christophe
C
Sattonet
Thierry
T
Benderitter
Marie Christine
MC
Saint Paul
Henry Pierre
HP
Bonnot
Guillaume
G
Penaranda
Claude
C
Degott
Marie France
MF
Masseyeff
Denis
D
Ouzan
D000293:Adolescent; D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D016632:Apolipoprotein A-I / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D015415:Biomarkers / Q000097:blood*; D001706:Biopsy; D003430:Cross-Sectional Studies; D005260:Female; D006242:Haptoglobins / Q000378:metabolism; D019698:Hepatitis C, Chronic / Q000175:diagnosis* / Q000453:epidemiology / Q000473:pathology; D006801:Humans; D008099:Liver / Q000473:pathology; D008103:Liver Cirrhosis / Q000175:diagnosis* / Q000453:epidemiology / Q000473:pathology; D008111:Liver Function Tests / Q000379:methods*; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D011237:Predictive Value of Tests; D011446:Prospective Studies; D013223:Statistics as Topic; D000511:alpha-Macroglobulins / Q000378:metabolism
D016632:Apolipoprotein A-I; D015415:Biomarkers; D006242:Haptoglobins; D000511:alpha-Macroglobulins; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase