End-of-treatment virologic response does not predict relapse after lamivudine treatment for chronic hepatitis B

Table 1 Baseline characteristics of HBeAg-negative and -posi-tive patients

	HBeAg-negative	HBeAg-positive	P value
Case number	12	14	-
Male-number (%)	10 (83)	13 (93)	0.58
Age (yr)	45.2 ± 15.3	35.3 ± 11.2	0.08
ALT (IU/L)	227 (80-2410)	281 (84-1298)	0.92
Serum total bilirubin	2.9 (0.9-18.6)	1.1 (0.6-11.7)	0.24
(mg/dL)
Serum HBV DNA	272 (3-3121)	863 (7-3376)	0.65
level (pg/mL)
HBV genotype	9/3 (75/25)	10/4 (71/29)	1.00
B/C-number (%)
Duration of lamivudine	12.3 ± 1.9	14.2 ± 4.9	0.23
treatmen-mo

Continuous values are expressed as mean ± SD or median (range). HBV DNA levels were determined by a branched DNA assay (Bayer Corporation).

Table 2 Characteristics of relapsers and non-relapsers in 12 patients negative for HBeAg before lamivudine treatment

	Relapsers	Non-relapsers	P value
Case number	6	6	-
Male-number (%)	6 (100)	4 (66.7)	0.13
Age (yr)	50.7 ± 10.1	39.7 ± 18.5	0.24
ALT (IU/L)	227 (80-452)	320 (98-2410)	0.24
Serum total bilirubin	1.2 (0.8-6.5)	2.9 (0.6-18.6)	0.21
(mg/dL)
Serum HBV DNA level	287 (16-2489)	117 (3-3121)	0.41
(pg/mL)
Duration of lamivudine	12.5 ± 2.6	12.2 ± 1.2	0.78
treatment (mo)
HBV genotype	6/0 (100/0)	3/3 (50/50)	0.18
B/C-number (%)

Values are expressed as mean ± SD or median (range). HBV DNA levels were determined by a branched DNA assay (Bayer Corporation).

Table 3 Characteristics of relapsers and non-relapsers in 14 patients positive for HBeAg before lamivudine treatment

	Relapsers	Non-relapsers	P value
Case number	6	8	-
Male-number (%)	5 (83.3)	8 (100)	0.43
Age (yr)	32.5 ± 12.6	37.4 ± 10.4	0.44
ALT (IU/L)	281 (84-1298)	306 (97-868)	0.34
Serum total bilirubin (mg/dL)	1.1 (0.7-11.1)	1.2 (0.7-3.3)	0.28
Serum HBV DNA level at baseline (pg/mL)	310 (7-1590)	280 (20-3376)	0.34
Duration of lamivudine treatment (mo)	15.5 ± 6.5	13.3 ± 3.5	0.47
HBeAg seroconversion-number (%)	2 (33.3)	5 (62.5)	0.30
Duration of additional lamivudine treatment after HBeAg seroconversion (mo)	12.4	6.0 ± 4.7	0.75
HBV genotype B/C -number (%)	5/1 (83.3/16.7)	5/3 (62.5/37.5)	0.58

Values are expressed as mean ± SD or median (range). HBV DNA levels were determined by a branched DNA assay (Bayer Corporation).

Table 4 Relation between virologic response and relapse after cessation of lamivudine treatment

HBV DNA level(copies/mL)	Total (n = 26)		HBeAg-positive				HBeAg-negative
			HBeAg seroconverters		HBeAg non-seroconverters
	Relapser	Non-relapser	Relapser	Non-relapser	Relapser	Non-relapser	Relapser	Non-relapser
	n = 12	n = 14	n = 2	n = 5	n = 4	n = 3	n=6	n=6
< 1000 copies/mL	4 (67)	2 (33)	1 (50)	1 (50)	2 (67)	1 (33)	2 (67)	1 (33)
-number (%)
≥ 1000 copies/mL	8 (40)	12 (60)	1 (20)	4 (80)	2 (50)	2 (50)	4 (44)	5 (56)
-number (%)	P1 = 0.37		P = 1.00		P = 1.00		P = 1.00

Virologic response was determined at the end of lamivudine treatment. HBV DNA levels were determined by the real-time PCR assay.

¹Two-sided.