Background
Methods
Patients
HBV RNA quantification
Evaluation of HBV-SAT performance
Serum HBsAg quantification
HBV DNA measurement
Statistical analysis
Results
Baseline characteristics
Parameters | Chronic HBV infection | |||||||
---|---|---|---|---|---|---|---|---|
Total (n = 291) | HBeAg positive | HBeAg negative | P# value | |||||
Total (n = 156) | Immune tolerant, IT (n = 35) | HBeAg positive immune active hepatitis, EPIA (n = 121) | Total (n = 135) | Inactive chronic hepatitis B, ICH (n = 77) | HBeAg negative reactive hepatitis, ENH (n = 58) | |||
Age, years median(IQR) | 37(30,46) | 33(28,41) | 30(27.5,34.0) | 34.0 (28.0,42.0) | 41(33,52) | 40.0 (31.0,50.0) | 42.0(35.0,53.0) | 0.000 |
Gender, M/F | 206/85 | 114/42 | 25/10 | 89/32 | 92/43 | 45/32 | 47/11 | 0.028 |
Disease category(CH/LC/HCC) | 240/51/0 | 125/31/0 | 30/0/0 | 90/31/0 | 115/20/0 | 74/3/0 | 41/17/0 | / |
Child-Pugh class(A/B/C) | 31/11/9 | 23/4/4 | na | 23/4/4 | 8/7/5 | 1/1/1 | 7/6/4 | / |
HBsAg, log IU/mL, median(IQR) | 3.49(2.91,4.12) | 3.92(3.27,4.56) | 4.56(4.13,4.71) | 3.71(3.22,4.31) | 2.98(2.38,3.58) | 2.94(2.32,3.54) | 3.00(2.48,3.66) | 0.000 |
HBeAg, log S/CO median(IQR) | na | 2.81(1.67,3.11) | 3.01(3.07,3.17) | 2.58(1.46,3.03) | na | na | na | 0.005 |
HBV DNA,log copies/mL, median(IQR) | 5.94(3.63,8.14) | 7.65(5.87,8.43) | 8.44(8.15,8.43) | 7.11(5.39,8.44) | 3.61(2.74,5.20) | 2.74(2.74,3.82) | 5.48(4.09,6.65) | 0.000 |
HBV RNA,log copies/mL median(IQR) | 5.50(2.57,7.16) | 6.82(5.57,7.98) | 7.87(6.08,8.30) | 6.67(5.433,7.80) | 2.40(2.00,5.23) | 2.00(2.00,3.04) | 5.31(3.57,6.37) | 0.000 |
ALT,IU/L median(IQR) | 59(30,191) | 88.5(42.5261.0) | 34(28.5,43.5) | 153(66.50,348.50) | 36(20,100.50) | 24(18,34) | 131(67,309) | 0.000 |
AST,IU/L median(IQR) | 41(23,102) | 58.5(31,116) | 27(23,31.5) | 76.5(44,157) | 27(21,56) | 21(19,26) | 89.5(39,188) | 0.000 |
Distribution of serum HBV RNA levels in various phases of chronic HBV infection
Serum HBV RNA level was positively correlated with serum HBV DNA and HBsAg level in chronic HBV-infected individuals
Value of serum HBV RNA in monitoring chronic HBV infection
Variables | HBV RNA >2.11(log copies/mL) | HBV DNA >3.39(log copies/mL) | HBsAg>2.74(log IU/mL) | HBV RNA >2.11(log copies/mL) & HBsAg>2.74(log IU/mL) | HBV DNA >3.39(log copies/mL) & HBsAg>2.74(log IU/mL) |
---|---|---|---|---|---|
Sensitivity(%) | 84.21 | 75.4 | 70.17 | 59.64 | 56.14 |
Specificity(%) | 73.68 | 80.26 | 42.11 | 81.58 | 86.84 |
PPV(%) | 70.59 | 74.13 | 47.62 | 70.83 | 76.19 |
NPV(%) | 86.15 | 81.33 | 65.31 | 72.94 | 72.52 |
Diagnostic accuracy(%) | 78.19 | 78.19 | 54.13 | 72.18 | 73.68 |
P value* | χ2 = 1.362 P = 0.243 | χ2 = 3.189 P = 0.074 | χ2 = 8.515 P = 0.004 | χ2 = 10.729 P = 0.001 | |
P value# | χ2 = 0.928 P = 0.335 | χ2 = 15.545 P = 0.000 | χ2 = 1.364 P = 0.243 | χ2 = 4.153 P = 0.042 |
Correlation between serum HBV RNA and clinical parameters
IT (n = 35) | EPIA (n = 121) | ICH (n = 77) | ENH (n = 58) | |||||
---|---|---|---|---|---|---|---|---|
r | P value | r | P value | r | P value | r | P value | |
Age(year) | −0.019 | 0.916 | −0.205 | 0.024 | −0.136 | 0.240 | −0.054 | 0.689 |
ALT(U/L) | 0.051 | 0.773 | 0.220 | 0.015 | 0.123 | 0.286 | 0.489 | 0.000 |
AST(U/L) | 0.286 | 0.096 | 0.231 | 0.011 | 0.336 | 0.003 | 0.546 | 0.000 |
HBeAg(S/CO) | −0.215 | 0.214 | 0.291 | 0.001 | / | / | / | / |