Efficacy of 3 years of adefovir monotherapy in chronic hepatitis B patients with lamivudine resistance

Table 1 Baseline demographic and virological data of the study population

Factor	A groupn (range)	B groupn (range)
Sex (M:F)	38:14	18:6
Age (yr)	27.6 (19-60)	25.7 (18-59)
ALT (U/L)	165 (44-1000)	230 (110-640)
HbeAg positive/HBeAg negative	36:16	17:7
HBV DNA (log copies/mL)	7.35 (3.00-9.0)	7.5 (3.0-9.0)
LAM-induced mutation of HBV DNA and rebound	40:12	20:4

Continuous variables were expressed as median (range). M: Male; F: Female; ALT: Alanine aminotransferase; HBV: Hepatitis B virus; HbeAg: Hepatitis B e antigen; LAM: Lamivudine.

Table 2 Control of the therapeutic effect in the two groups

Group	Baseline	n	12 wk		24 wk		52 wk		104 wk		156 wk
	(copies/mL)		VR1	BR2	VR1	BR2	VR1	BR2	VR1	BR2	VR1	BR2
A	103-105	18	16 (88.8)1	16 (88.8)	16 (88.8)1	16 (88.8)	16 (88.8)3	16 (88.8)	16 (88.8)1	16 (88.8)	16 (88.8)1	16 (88.8)
A	≥ 106	34	14 (41.1)	24 (70.5)	15 (44.1)	30 (88.2)	16 (47.0)	22 (64.7)	16 (47.0)	26 (76.4)	16 (47.0)	18 (52.9)
B	103-105	11	9 (81.8)4	9 (81.8)	9 (81.8)4	10 (90.9)	9 (81.8)4	10 (90.9)	8 (72.7)	9 (81.8)	9 (81.8)4	9 (81.8)
B	≥ 106	13	6 (46.1)	10 (76.9)	6 (46.1)	10 (76.9)	6 (46.1)	9 (69.2)	7 (53.8)	9 (69.2)	6 (46.1)	9 (69.2)
A	HBeAg positive	36	18 (50.0)	26 (72.2)	20 (55.5)	30 (83.3)	20 (55.5)	26 (72.2)	22 (61.1)	26 (72.2)	20 (55.5)	22 (61.1)
A	HBeAg negative	16	12 (75.0)	14 (87.5)	14 (87.5)	16 (100.0)	12 (75.0)	12 (75.0)	14 (87.5)	16 (100.0)	12 (75.0)	6 (75.0)
B	HBeAg positive	17	8 (47.8)	12 (70.5)	9 (52.9)	15 (88.2)	9 (52.9)	15 (88.2)	9 (52.9)	13 (76.4 )	10 (58.8)	11 (64.7)
B	HBeAg negative	7	5 (71.4)	6 (85.7)	5 (71.4)	6 (85.7)	6 (85.7)	6 (85.7)	5 (71.4)	6 (85.7)	5 (71.4)	6 (85.7)
A	ALT < 2 × ULN	20	17 (85.0)	18 (90.0)	16 (80.0)	18 (90.0)	14 (70.0)	14 (70.0)	14 (70.0)	18 (90.0)	14 (70.0)	14 (70.0)
A	ALT > 2 × ULN	32	18 (56.2)	22 (68.7)	18 (56.2)	28 (87.5)	18 (56.2)	26 (81.2)	22 (68.7)	24 (75.0)	18 (56.25)	20 (62.5)
B	ALT < 2 × ULN	10	8 (80.00)	9 (90.0)	8 (80.0)	10 (100.0)	8 (80.0)	10 (100.0)	8 (80.0)	10 (100.0)	8 (80.0)	9 (90.0)
B	ALT > 2 × ULN	14	8 (57.1)	10 (71.4)	8 (57.1)	12 (85.7)	10 (71.4)	12 (85.7)	10 (71.4)	12 (85.7)	10 ( (71.4)	12 (85.7)

Group A: Treated with adefovir; Group B: Treated with adefovir and lamivudine;

¹VR: Defined as HBV DNA < lower detection limit;

²BR: Defined as ALT < lower detection limit;

³P < 0.01 (χ² = 4.35-5.4) vs group A with baseline HBV DNA ≥ 10⁶ copies/mL;

⁴P < 0.05 (χ² = 4.1-5.0) vs group B with baseline HBV DNA ≥ 10⁶ copies/mL. VR: Virological response; BR: Biochemical response; HBV: Hepatitis B virus; HBeAg: Hepatitis B e antigen; ALT: Alanine aminotransferase.

Table 3 Response to adefovir salvage therapy n (%)

Project		HBV DNA (copies/mL)			HBeAg positive		rtA181V/S variation
		103	103-106	≥107	HBeAg seroconversion	HBeAg elimination	Change drug
Baseline level	A	12 (23.0)	22 (42.43)	18 (34.6)	36
	B	5 (20.8)	11 (45.8)	8 (33.3)	17
12 wk	A	30 (57.7)1	18 (34.6)	4 (7.6)2	0 (0)	2 (5.5)
	B	14 (58.3)4	8 (33.3)	2 (8.3)5	1 (5.8)	1 (5.8)
24 wk	A	32 (61.5)4	20 (38.4)	0 (0)3	4 (11.1)	2 (5.5)	2 (5.5)
	B	15 (62.5)4	8 (33.3)	1 (4.1)5	2 (11.7)	2 (11.7)	1 (5.8)
52 wk	A	34 (65.4)1	18 (34.6)	0 (0)3	4 (11.1)	2 (5.5)	2 (5.5)
	B	16 (66.6)4	8 (33.3)	0 (0)5	4 (23.5)	2 (11.7)	1 (5.8)
104 wk	A	36 (69.2)1	16 (30.7)	0 (0)3	8 (22.2)	4 (11.1)	2 (5.5)
	B	16 (66.6)4	8 (33.3)	0 (0)5	4 (23.5)	2 (11.7)	1 (5.8)
156 wk	A	34 (65.4)1	16 (30.7)	2 (3.8)3	8 (22.2)	6 (16.6)	4 (11.1)
	B	15 (62.5)4	8 (33.3)	1 (4.1)5	4 (23.5)	2 (11.7)	2 (11.7)

Group A: Treated with adefovir; Group B: Treated with adefovir and lamivudine;

¹P < 0.001 (χ² = 6.4-11.0) vs group A baseline HBV DNA 10³ copies/mL;

²P < 0.05 (χ² = 4.7);

³P < 0.01 (χ² = 7.9-10.8) vs group A baseline HBV DNA 10⁷ copies/mL;

⁴P < 0.001 (χ² = 5.9-11.7) vs group B baseline HBV DNA 10³ copies/mL;

⁵P < 0.01 (χ² = 7.7-11.0) vs group B baseline HBV DNA 10⁶ copies/mL. HBV: Hepatitis B virus; HBeAg: Hepatitis B e antigen.