Development Of Algorithms Based On Serum Mark And Transient Elastography For Detecting Signific Fibrosis And Cirrhosis In Chronic Hepatitis B Patien Significant Reduction In Liver Biopsy

Background Liver biopsy has been considered as gold standard for detecting liver fibrosis for many years,some limitations of it such as costly,invasive,bleeding lead to the development for non‐invasive modes for identifying liver fibrosis,such as Fibro Scan(FS),FIB‐4(fibrosis index based on the four factors)and APRI(aspartate aminotransferase‐to‐platelet ratio index).Step‐wise algorithms combining individual non‐invasive modes applied to HCV patients in detecting liver fibrosis have been reported,but few studies show combined algorithm in HBV patients.Since significant fibrosis is an indication of antiviral therapy,which can reduce the development to cirrhosis and hepatocellular carcinoma(HCC),it is important to detect significant fibrosis correctly for CHB patients.This study is to develop algorithms for detecting significant fibrosis and cirrhosis in chronic hepatitis B(CHB)patients with the aim of reducing unwarranted liver biopsy.Methods For 307 CHB patients,the aspartate aminotransferase‐ to‐platelet ratio index(APRI),the fibrosis index based on four factors(FIB‐4),and the result of transient elastography with Fibro Scan(FS)were obtained when a liver biopsy was carried out.Cut‐off values of APRI,FIB‐4,and FS were adopted from published reports.Cut‐off values of APRI,FIB‐4,and FS for predicting the presence of significant fibrosis were 0.25,1.45,and 9.4,respectively.Cut‐off values of APRI,FIB‐4,and FS for predicting the absence of cirrhosis were 0.25,2.9,and 9.4respectively.We develop step‐wise algorithms by using FIB‐4 or APRI as initial step,and then followed by FS.Patients with APRI > 0.25(FIB‐4 > 1.45)were detected as significant fibrosis,with regard to APRI < 0.25(FIB‐4 < 1.45),patients were detected as significant fibrosis with FS > 9.4.Patients undetermined were considered to liver biopsy needed.Results Algorithm implementation found that APRI + FS significantly lowered the requirement for liver biopsy for the detection of significant fibrosis compared to either individual APRI or FS screening(65.1% vs 75.9% or 78.5%,P=0.003 or<0.001,respectively).The combination of FIB‐4 + FS significantly reduced the need for liver biopsy compared to single FIB‐4 or FS(58.3% vs 67.4% or 78.5%,P=0.019 or <0.001,respectively).The FIB‐4 + FS algorithm also reduced the need for liver biopsy for detection of significant fibrosis in patients ≥50 years old compared to APRI + FS(22.6% vs 56.5%,P< 0.001),with a relatively lower accuracy(83.9% vs98.4%,P = 0.004).Only 3.6% or 1.3% of patients needed liver biopsy for diagnosis of cirrhosis after screening with APRI + FS or FIB‐4 + FS,respectively.Conclusion The APRI + FS and FIB‐4 + FS algorithms could significantly reduce the need for liver biopsy with high accuracy,sensitivity,and positive predictive value for diagnosis of significant fibrosis and cirrhosis in CHB patients.