Accuracy of International Guidelines for Identifying Significant Fibrosis in Hepatitis B e Antigen-Negative Patients With Chronic Hepatitis
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文摘
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Background & Aims

Differing threshold levels of hepatitis B virus (HBV) DNA and alanine aminotransferase (ALT) are recommended by international guidelines for commencement of antiviral therapy. These guidelines advocate therapy for patients with significant fibrosis (METAVIR score ¡ÝF2); we assessed the accuracy of these guideline-defined thresholds in identifying patients with ¡ÝF2 fibrosis.

Methods

We applied the European (European Association for the Study of the Liver [EASL] 2012), Asian-Pacific (Asian-Pacific Association for the Study of the Liver [APASL] 2012), American (American Association for the Study of Liver Diseases [AASLD] 2009), and United States Panel Algorithm (USPA 2008) criteria to 366 consecutive hepatitis B e antigen-negative patients with liver biopsy samples: EASL, ALT >laboratory-defined upper limit of normal (ULN) and HBV DNA ¡Ý2000 IU/mL (n?= 171); APASL, ALT >2-fold laboratory-defined ULN and HBV DNA ¡Ý2000 IU/mL (n?= 87); AASLD, ALT >2-fold the updated ULN (0.5-fold ULN [corresponding to ¡Ü19 U/L] for women and 0.75-fold the ULN [corresponding to ¡Ü30 U/L] for men) and HBV DNA ¡Ý20,000 IU/mL (n?= 53); and USPA, ALT >updated ULN (>0.5-fold ULN for women and >0.75-fold ULN for men) and HBV DNA ¡Ý2000 IU/mL (n?= 173).

Results

Overall, 113 patients (30.9 % ) had ¡ÝF2 fibrosis, which was more frequent among patients who?fulfilled any guideline criteria (45.7 % vs 17.9 % for those who did not fulfill any criteria, P?< .0001). In applying the EASL, AASLD, APASL, and USPA criteria, sensitivity and specificity values for detection of ¡ÝF2 fibrosis were 45.6 % , 58.5 % , 56.3 % , and 45.7 % (P?= .145) and?82.1 % , 73.8 % , 77.1 % , and 82.4 % (P?= .366), respectively. The EASL criteria (area under the?receiver operating characteristic [AUROC] curve, 0.66; 95 % confidence interval [CI], 0.61-0.71) and USPA criteria (AUROC, 0.66; 95 % CI, 0.58-0.73) performed better than APASL (AUROC, 0.64; 95 % CI, 0.59-0.69; P?= .421) and significantly better than the AASLD criteria (AUROC, 0.59; 95 % CI, 0.54-0.64; P?= .013).

Conclusions

In hepatitis B e antigen-negative patients with chronic hepatitis, the EASL, AASLD, APASL, and USPA criteria identify patients with ¡ÝF2 fibrosis with low levels of accuracy. However, the EASL and USPA criteria are the most accurate for identification of these patients.

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