Durability of viral response after off-treatment in HBeAg positive chronic hepatitis B

Table 1 Baseline characteristics of the study population

Baseline characteristics	Total (n = 48)
Age, yr (mean ± SD)	42.1 ± 12.9
Sex (male/female)	29/19
Pretreatment ALT level (IU/L)	198 (11-374)
Pretreatment HBV DNA level (log10 copies/mL)	8.5 (5.0-10)
Time to undetectable HBV (mo)	7.7 (1.3-39.4)
Time to HBeAg seroconversion (mo)	13.4 (0.8-39.4)
Consolidation treatment duration (mo)	10.3 (6-37.9)
Total treatment duration (mo)	26.1 (9.4-47.4)
Antiviral agent (entecavir/clevudine)	31/17
Previous NUC treatment (naïve/lamivudine)	41/7

ALT: Alanine aminotransferase; HBV: Hepatitis B virus; HBeAg: Hepatitis B e antigen; NUC: Nucleos(t)ide analogues.

Table 2 Summary of patients who showed serologic and virological recurrence

Patient No.	Age (yr)	Sex	Serologic recurrence (HBeAg reversion)	Virological recurrence (copies/L)	ALT level at relapse (U/L)
1	28	Female	Yes	97 600	139
2	24	Female	Yes	645 000 000	236
3	42	Male	Yes	120 759	71
4	46	Male	Yes	980 000	45
5	47	Male	Yes	254 251 078	89
6	48	Female	Yes	320 630	287
7	46	Male	No	42 900	42
8	32	Female	No	20 916	32
9	67	Male	No	10 083	38
10	42	Male	No	41 982	65
11	46	Male	No	86 000	40
12	66	Female	No	4 521 266	131
13	38	Male	No	587 000	43
14	67	Female	No	10 032	31
15	62	Female	No	637 898	28
16	50	Male	No	43 719	98
17	51	Female	No	32 033	101
18	42	Male	No	86 6197	243
19	53	Male	No	6 158 288	54
20	37	Female	No	116 000 000	436

ALT: Alanine aminotransferase; HBeAg: Hepatitis B e antigen.

Table 3 Clinical characteristics in virological recurrence and non-recurrence

	Virological recurrence(n = 20)	Virological non-recurrence(n = 28)	P value
Age, yr (mean ± SD)	46.7 ± 12.1	38.8 ± 12.7	0.022
Sex (male/female)	11/9	29/19	0.561
Pretreatment ALT level (IU/L)	199 (40-374)	189 (11-364)	0.491
Pretreatment HBV DNA level (log10 copies/mL)	7.7 (5.1-10)	7 (5.0-9.1)	0.125
Time to undetectable HBV (mo)	6.7 (2.3-39.4)	9.1 (1.3-25.0)	0.490
Time to HBeAg seroconversion (mo)	13.9 (0.8-39.4)	12.7 (1.4-31.2)	0.744
Consolidation treatment duration (mo)	10.3 (6-23.9)	11.7 (6-37.9)	0.517
Total treatment duration (mo)	25.6 (9.6-47.4)	27.0 (9.4-43.3)	0.358
Antiviral agent (entecavir/clevudine)	15/5	16/12	0.236

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

Table 4 Multivariate analysis on predictive factors of virological recurrence after withdrawal of antiviral treatment

	Regression coefficent	Standard error	P value	RR (95% CI)
Age ( ≤ 40 yr vs > 40 yr)	-1.17	0.596	0.049	0.310 (0.096-0.998)
Sex (male vs female)	-0.938	0.527	0.075	0.391 (0.139-1.099)
Pretreatment ALT level (< 2 × ULN vs≥ 2 × ULN)	-2.11	1.135	0.063	0.121 (0.013-1.121)
Pretreatment HBV DNA level (< 108 vs≥ 108)	-0.27	0.533	0.612	0.763 (0.268-2.170)
Time to undetectable HBV (< 6 mo vs≥ 6 mo)	-0.237	0.635	0.709	0.789 (0.227-2.739)
Time to HBeAg seroconversion (< 12 mo vs≥ 12 mo)	1.417	0.846	0.094	4.126 (0.786-21.66)
Consolidation treatment (< 15 mo vs≥ 15 mo)	2.425	0.87	0.005	11.299 (2.054-65.12)
Total treatment duration (< 24 mo vs≥ 24 mo)	0.001	0.732	0.999	1.001 (0.238-4.207)
Antiviral agent (entecavir vs clevudine)	-1.529	0.861	0.076	0.217 (0.040-1.172)

HBV: Hepatitis B virus; HBeAg: Hepatitis B e antigen; ULN: Upper limit of normal; ALT: Alanine aminotransferase; RR: Relative risk.