Relationship between virological response and FIB-4 index in chronic hepatitis B patients with entecavir therapy

Table 1 Baseline characteristics and virological responses at week 48 between groups A and B

	All patients	Group A	Group B	P value
	(n = 231)	(n = 112)	(n = 119)
Age (yr)	32.5 ± 10.1	32.6 ± 9.78	32.5 ± 10.4	0.96
Male (%)	172 (74.4)	83 (74.1)	89 (74.8)	0.99
ALT (IU/L)	113 ± 115	113 ± 117	113 ± 116	0.75
AST (IU/L)	64 ± 74	65 ± 75	62 ± 67	0.74
PLT (× 109/L)	167.7 ± 57.3	170.0 ± 53.9	165.7 ± 60.5	0.56
HBeAg-positive (%)	178 (77.0)	89 (79.5)	89 (74.8)	0.43
HBV DNA at baseline	7.36 ± 1.20	7.38 ± 1.15	7.35 ± 1.25	0.11
(log10 IU/mL)
HBV DNA at week	1.81 ± 0.85	1.74 ± 0.83	1.88 ± 0.87	0.08
48 (log10 IU/mL)
HBV DNA-negative	111 (48.1)	54 (48.2)	56 (47.1)	0.86
(< 20 IU/mL)
HBeAg seroconversion	19 (8.2)	10 (8.9)	9 (7.6)	0.71
in HBeAg-positive patients
ALT normalization	176 (76.2)	85 (75.9)	91 (76.5)	0.91

Group A patients were treated with 0.5 mg/d ETV. Group B patients were treated with 0.5 mg/d ETV maleate. ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; PLT: Platelet; HBV: Hepatitis B virus; HBeAg: Hepatitis B e antigen.

Table 2 Baseline characteristics of all populations with respect to hepatitis B virus DNA response at week 48

	Virological response at week 48
	CVR	PVR	P value
	(n = 119)	(n = 112)
Age (yr)	34.9 ± 10.9	30.2 ± 8.8	< 0.0011
Male (%)	78 (70.3)	94 (80.8)	0.16
ALT (IU/L)	120 ± 130	108 ± 88	0.05
AST (IU/L)	78 ± 87	57 ± 41	0.0011
PLT (× 109/L )	160 ± 55	175 ± 58	0.07
HBeAg-positive (%)	71 (64)	107 (89)	< 0.0012
HBV DNA	6.88 ± 1.23	7.78 ± 0.92	< 0.0012
(log10 IU/mL)
Group A (%)	55 (50)	57 (47.5)	0.75
Genotype			0.77
B	56 (51.4)	53 (48.6)
C	65 (58.5)	57 (47.5)
FIB-4 index	2.01 ± 1.43	1.21 ± 0.76	0.0031

¹This difference was no longer significant after multivariate logistic regression analysis;

²The two groups still showed a significant difference after multivariate logistic regression analysis. ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; PLT: Platelet; HBV: Hepatitis B virus; HBeAg: Hepatitis B e antigen.

Table 3 Baseline characteristics of 178 hepatitis B e antigen-positive and 53 hepatitis B e antigen-negative patients with respect to hepatitis B virus DNA response at week 48

	HBeAg-positive (n = 178)			HBeAg-negative (n = 53)
	CVR	PVR	P value	CVR	PVR	P value
	(n = 71)	(n = 107)		(n = 48)	(n = 5)
Age (yr)	32.1 ± 9.9	29.7 ± 8.7	0.09	39.2 ± 10.3	35.2 ± 11.7	0.22
Male n (%)	49 (69)	88 (82)	0.041	29 (72)	6 (46)	0.08
ALT (IU/L)	121 ± 143	107 ± 90	0.108	118 ± 124	120 ± 74	0.89
AST (IU/L)	82 ± 88	56 ± 42	0.0021	73 ± 76	67 ± 92	0.75
PLT (× 109/L)	158 ± 53	175 ± 58	0.05	163 ± 58	181 ± 75	0.97
HBV DNA	7.26 ± 1.05	7.92 ± 0.89	0.0011	6.32 ± 1.29	6.62 ± 0.87	0.15
(log10 IU/mL)
Group A, n (%)	39 (55)	51 (47)	0.34	19 (39)	4 (80)	0.08
FIB-4 index	1.89 ± 1.43	1.18 ± 0.69	0.0011	2.17 ± 1.44	1.92 ± 1.67	0.84

¹This difference was no longer significant after multivariate logistic regression analysis; ²The two groups still showed a significant difference after multivariate logistic regression analysis. ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; PLT: Platelet; HBV: Hepatitis B virus; HBeAg: Hepatitis B e antigen.

Table 4 Multivariate analysis of factors predicting maintained viral suppression in relation to virological response at week 48 using the Cox proportional hazard model in hepatitis B e antigen-positive patients

	Maintained viral suppression at week 144
	HR	95%CI	P value
Age (yr)	1.008	0.98-1.04	0.54
Sex	0.927	0.694-1.325	0.68
ALT (IU/L)	1.000	0.997-1.004	0.81
AST (IU/L)	1.001	0.994-1.000	0.77
PLT (× 109/L )	0.998	0.994-1.000	0.40
HBeAg-positive	1.326	0.918-1.916	0.13
Baseline HBV DNA	0.781	0.678-0.900	< 0.001
(log10 IU/mL)
HBV DNA at week 48	0.768	0.694-0.993	< 0.001
(log10 IU/mL)
FIB-4 index	0.737	0.452-1.199	0.22

ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; PLT: Platelet; HBV: Hepatitis B virus; HBeAg: Hepatitis B e antigen.

Table 5 Comparison of FIB-4 index between complete virological response and partial virological response groups from baseline to 144 wk

	HBeAg-positive (n = 178)			HBeAg-negative (n = 53)
	CVR (n = 71)	PVR (n value = 107)	P value	CVR (n = 48)	PVR (n = 5)	P value
0 wk	1.89 ± 1.43	1.18 ± 0.69	< 0.001	2.17 ± 1.44	1.92 ± 1.66	0.71
48wk	1.20 ± 0.81	0.94 ± 0.57	0.007	1.50 ± 0.89	1.52 ± 0.82	0.79
144 wk	1.24 ± 0.87	1.02 ± 0.73	0.06	1.49 ± 0.90	1.12 ± 0.44	0.37
48-144 wk	-0.11 ± 0.47	-0.13 ± 0.49	0.71	-0.02 ± 0.34	-0.07 ± 0.38	0.44
0-144 wk	0.64 ± 1.25	0.15 ± 0.72	0.004	0.68 ± 0.95	0.81 ± 1.25	0.79

HBeAg: Hepatitis B e antigen; CVR: Complete virological response; PVR: Partial virological response.

Table 6 Comparison of FIB-4 index between groups a and b from baseline to 144 wk

	Group a (n = 120)	Group b (n = 58)	P value
0 wk	1.56 ± 1.14	1.27 ± 0.99	0.11
144 wk	1.12 ± 0.81	1.10 ± 0.78	0.89
0-144 wk	0.44 ± 0.99	0.17 ± 0.98	0.09

Group a: HBV DNA was undetectable at week 144; Group b: HBV DNA was still detectable at week 144.