Effect of liver inflammation on accuracy of FibroScan device in assessing liver fibrosis stage in patients with chronic hepatitis B virus infection

Table 1 Demographic characteristics and clinical features of our patient cohort

	All (n = 416)	Concordance group (n = 274)	Discordance group (n = 142)	P value
Age (yr)	38.67 ± 10.47	38.41 ± 10.63	39.18 ± 10.18	0.467
Male, n	305 (73.3)	209 (76.3)	96 (67.6)	0.058
BMI (kg/m2)	22.90 ± 2.64	22.88 ± 2.49	22.94 ± 2.92	0.833
TBIL (μmoL/L)	17.11 ± 21.56	17.70 ± 23.30	15.98 ± 17.73	0.402
Albumin (g/L)	42.50 ± 5.02	42.57 ± 5.05	42.37 ± 5.00	0.706
ALT (IU/L)	95.25 ± 52.0	78.90 ± 99.89	126.10 ± 118.46	< 0.001
AST (IU/L)	58.46± 108.85	49.05 ± 55.44	76.61 ± 62.80	< 0.001
PLT (109/L)	187.46 ± 56.53	186.36 ± 56.86	189.59 ± 56.04	0.916
HBsAg (Log IU/mL)	3.42 ± 0.97	3.38 ± 1.04	3.50 ± 0.80	0.258
HBeAg positive (%)	237 (57.0)	155 (56.6)	82 (57.7)	0.818
HBV-DNA (Log IU/mL)	4.98 ± 2.18	4.95 ± 2.16	5.05 ± 2.23	0.641
PT (s)	12.20 ± 0.98	12.17 ± 1.03	12.25 ± 0.88	0.387
AFP (ng/mL)	11.37 ± 34.59	11.98 ± 36.80	10.20 ± 29.95	0.597
LSM (kPa)	9.83 ± 7.70	9.75 ± 7.21	9.97 ± 5.14	0.751
Fibrosis stage1, n				< 0.001
F0-1	175 (42.1)	143 (52.2)	32 (22.5)
F2	106 (25.5)	49 (17.9)	57 (40.1)
F3	67 (16.1)	23 (8.4)	44 (31.0)
F4	68 (16.3)	59 (21.5)	9 (6.3)
Inflammation grade1, n				< 0.001
A0	17 (4.1)	15 (5.5)	2 (1.4)
A1	236 (56.7)	187 (68.2)	49 (34.5)
A2	119 (28.6)	49 (17.9)	70 (49.3)
A3	44 (10.6)	23 (8.4)	21 (14.8)

¹According to METAVIR system, the liver fibrosis stage ranged from 0 to 4, and liver inflammation grade ranged from 0 to 3. BMI: Body mass index; TBIL: Total bilirubin; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; PLT: Platelet count; HBV: Hepatitis B virus; PT: Prothrombin time; AFP: Alpha fetoprotein; LSM: Liver stiffness measurements; HBsAg: Hepatitis B surface antigen; HBeAg: Hepatitis B envelope antigen.

Table 2 Accuracy of liver stiffness measurement values by transient elastography in diagnosing ≥ F2, ≥ F3, and F4, as measured by area under the receiver operating characteristic curve (n = 416)

Fibrosis stage	AUC (95%CI)	Sensitivity (%)	Specificity (%)	PPV (%)	NPV (%)	Cut-off point
≥ F2	0.863 (0.826-0.895)	83.40	81.71	86.01	78.49	≥ 7.3
≥ F3	0.911 (0.880-0.937)	80.74	87.19	76.59	89.72	≥ 9.7
F4	0.918 (0.887-0.942)	86.76	89.08	61.47	97.10	≥ 11.3

AUC: Area under the receiver operating characteristic curve; NPV: Negative predictive value; PPV: Positive predictive value; ≥ F2: Significant fibrosis; ≥ F3: Advanced fibrosis; F4: Cirrhosis.

Table 3 Univariate and multivariate regression analyses of risk of misdiagnosis of fibrosis stage by transient elastography in all patients

Variables	Univariate analyses		Multivariate analyses
	OR (95%CI)	P value	OR (95%CI)	P value
Age (yr)	1.00 (0.99-1.03)	0.472
Male, n	0.65 (0.42-1.02)	0.059
BMI (kg/m2)	1.01 (0.93-1.09)	0.832
TBIL > 2 ULN (μmoL/L)	0.68 (0.24-1.92)	0.464
Albumin (g/L)	0.99 (0.95-1.03)	0.707
ALT1 (IU/L)
< 2 ULN	Reference	Reference	Reference	Reference
2-5 ULN	2.16 (1.31-3.56)	0.003	1.00 (0.52-1.93)	0.996
≥ 5 ULN	4.93 (2.66-9.12)	< 0.001	1.11 (0.44-2.76)	0.996
AST1 ≥ 2 ULN (IU/L)	4.42 (2.73-7.16)	< 0.001	2.05 (0.97-4.34)	0.059
PLT (109/L)	1.00 (0.99-1.01)	0.580
HBsAg (Log IU/mL)	1.13 (0.91-1.40)	0.258
HBeAg positive	1.05 (0.70-1.58)	0.818
HBV-DNA (Log IU/mL)	1.02 (0.93-1.12)	0.636
PT (s)	1.09 (0.89-1.34)	0.408
AFP (ng/mL)	1.00 (0.99-1.01)	0.622
Inflammation activity2
A < 2	Reference	Reference	Reference	Reference
A ≥ 2	5.01 (3.24-7.74)	< 0.001	3.53 (2.11-5.92)	< 0.001

¹Normal alanine aminotransferase and aspartate aminotransferase levels are 40 U/L for women and men.

²Inflammation activity was calculated as a range of 0-3 according to the METAVIR system. BMI: Body mass index; TBIL: Total bilirubin; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; PLT: Platelet count; HBV: Hepatitis B virus; PT: Prothrombin time; AFP: Alpha fetoprotein; ULN: Upper limit of normal; HBsAg: Hepatitis B surface antigen; HBeAg: Hepatitis B envelope antigen.