Histological outcome for chronic hepatitis B patients treated with entecavir vs lamivudine-based therapy

Table 1 Demographic data and liver biopsy results for chronic hepatitis B patients in both entecavir and lamivudine arms at baseline

	ETV	LAM ± ADV	P-value
n	19	23
Male gender, n (%)	14 (73.7)	16 (69.6)	0.7687
Age (mean ± SD), yr	43.2 ± 9.8	43.7 ± 9.9	0.8721
log10 HBV DNA (mean ± SD), IU/mL	6.6 ± 1.5	6.2 ± 1.4	0.4019
ALT (mean ± SD), U/L	107 ± 84	96 ± 112	0.2450
HBeAg positive, n (%)	13 (68.42)	14 (60.87)	0.6112
Median grade (range)	11 (0-16)	9 (3-12)	0.0749
Median stage (range)	4 (2-6)	5 (2-6)	0.7381
Duration of treatment (mean ± SD), mo	39 ± 11	42 ± 15	0.6951

ETV: Entecavir; LAM: Lamivudine; ADV: Adefovir; HBV: Hepatitis B virus; ALT: Alanine aminotransferase; HBeAg: Hepatitis B e antigen.

Table 2 Virological, biochemical and serologic outcomes after long-term treatment in both entecavir and lamivudine arms n (%)

	ETV	LAM ± ADV	P-value
n	19	23
HBV DNA < 1000 IU/mL	18 (94.74)	22 (95.65)	0.8897
HBV DNA < 60 IU/mL	10/13 (76.92)	11/16 (68.75)	0.6243
ALT ≤ 1 × upper limit of normal	18 (94.74)	17 (73.91)	0.0715
HBeAg loss/HBeAg positive at baseline	6/13 (46.15)	10/14 (71.43)	0.1817
HBe seroconversion/HBeAg positivity at baseline	5/13 (38.46)	6/14 (42.86)	0.8163
HBsAg loss	0 (0)	0 (0)	-

ETV: Entecavir; LAM: Lamivudine; ADV: Adefovir; HBV: Hepatitis B virus; ALT: Alanine aminotransferase; HBeAg: Hepatitis B e antigen; HBsAg: Hepatitis B surface antigen.

Table 3 Comparison of liver histology at baseline and after long-term treatment in both entecavir and lamivudine arms n (%)

	ETV (n = 19)	LAM ± ADV (n = 23)
Change in necroinflammation
Median grade (range)	11 (0-16)1 to 0 (0-4)1	9 (3-12)2 to 3 (0-12)2
Improved	18 (94.74)	19 (82.61)
No change	1 (5.26)	4 (17.39)
Worsened	0 (0)	0 (0)
Change in fibrosis
Median stage (range)	4 (2-6)3 to 3 (0-5)3	5 (2-6) 4 to 3 (0-6)4
Improved	13 (68.42)	11 (47.83)
No change	5 (26.32)	9 (39.13)
Worsened	1 (5.26)	3 (13.04)

¹Comparison of change in necroinflammation at baseline and after long-term treatment in ETV arm, P = 0.0002;

²Comparison of change in necroinflammation at baseline and after long-term treatment in LAM arm, P < 0.0001;

³Comparison of change in fibrosis at baseline and after long-term treatment in ETV arm, P = 0.0019;

⁴Comparison of change in fibrosis at baseline and after long-term treatment in LAM arm, P = 0.0205. ETV: Entecavir; LAM: Lamivudine; ADV: Adefovir.

Table 4 Comparison of baseline characteristics between patients with and without improvement in fibrosis after long-term antiviral treatment

	With improvement in fibrosis	Without improvement in fibrosis	P-value
n	24	18
Male gender, n (%)	17 (70.83)	13 (72.22)	0.9215
Age (mean ± SD), yr	43.8 ± 9.9	42.9 ± 9.8	0.7596
log10 HBV DNA (mean ± SD), IU/mL	6.7 ± 1.2	5.9 ± 1.5	0.0602
ALT (mean ± SD), U/L	102 ± 82	99 ± 121	0.6473
HBeAg positivity, n (%)	17 (70.83)	10 (55.56)	0.3065
Median grade (range)	10 (3-16)	9 (0-13)	0.1713
Median stage (range)	5 (3-6)	3.5 (2-5)	0.0230
Treated with ETV, n (%)	13 (54.17)	6 (33.33)	0.1795
Treatment duration ≥ 24 mo, n (%)	24 (100)	13 (72.22)	0.0101

HBV: Hepatitis B virus; ALT: Alanine aminotransferase; HBeAg: Hepatitis B e antigen; ETV: Entecavir.

Table 5 Comparison of baseline characteristics between patients with significant or without improvement in fibrosis after long-term antiviral therapy

	With significant improvement1	Without improvement	P-value
n	9	18
Male gender, n (%)	6 (66.7)	13 (72.2)	0.7657
Age (mean ± SD), yr	42.1 ± 11.6	42.9 ± 9.8	0.8557
log10 HBV DNA (mean ± SD), IU/mL	7.3 ± 1.0	5.9 ± 1.5	0.0175
ALT (mean ± SD), U/L	140 ± 72	99 ± 121	0.0270
HBeAg positivity, n (%)	7 (77.8)	10 (55.6)	0.2597
Median grade (range)	11(3-14)	9 (0-13)	0.2778
Median stage (range)	5 (3-6)	3.5 (2-5)	0.2717
Duration of treatment (mean ± SD), mo	44 ± 11	41 ± 18	0.3956

¹Significant improvement in fibrosis was defined as an Ishak fibrosis score of 0 or 1 post-treatment. HBV: Hepatitis B virus; ALT: Alanine aminotransferase; HBeAg: Hepatitis B e antigen.