Efficacy of switching to telbivudine plus adefovir in suboptimal responders to lamivudine plus adefovir

Table 1 Baseline characteristics of patients n (%)

Variables	Total (n = 106)	LdT + ADV (n = 53)	LAM + ADV (n = 53)	P value
Mean age, yr	46.3 (22-76)	49.0 (23-76)	43.7 (22-73)	0.053
Male	79 (74.5)	42 (79.2)	37 (69.8)	0.265
Liver cirrhosis	24 (22.6)	13 (24.5)	11 (20.8)	0.647
Laboratory results
AST (IU/L)	29 (7-119)	33 (7-119)	28 (10-92)	0.125
ALT (IU/L)	28 (13-125)	26 (15-84)	29 (13-125)	0.098
Total bilirubin (mg/dL)	0.7 (0.3-1.8)	0.7 (0.3-1.8)	0.8 (0.3-1.6)	0.382
Albumin (g/dL)	4.5 (0.7-5.4)	4.4 (3.4-5.4)	4.6 (0.7-5.1)	0.777
Prothrombin time	1.01 (0.91-1.42)	1.00 (0.91-1.42)	1.02 (0.93-1.24)	0.917
Platelet count (× 109/L)	175 (45-293)	175 (67-290)	174 (45-293)	0.610
AFP (ng/mL)	2.87 (0.86-57.54)	2.61 (1.57-11.66)	2.98 (0.86-57.54)	0.030
Mean prior LAM period, mo (range)	32.2 (8-139)	31.5 (8-77)	33.5 (11-139)	0.695
Mean prior LAM + ADV period, mo (range)	17.1 (6-45)	18.3 (6-45)	14.9 (6-39)	0.131
YMDD mutation	106 (100)	53 (100)	53 (100.0)	-
rtM204I alone	27 (25.5)	13 (24.5)	14 (26.4)	0.643
rtM204I + rtM204V	1 (0.9)	1 (1.9)
rtM204I + rtL180M	28 (26.4)	15 (28.4)	13 (24.5)
rtM204V + rtL180M	28 (26.4)	12 (22.6)	16 (30.2)	0.501
rtM204I + rtM204V + rtL180M	22 (20.8)	12 (22.6)	10 (18.9)	0.514
eGFR (mL/min per 1.73 m2)	89.1 (56.1-131.6)	89.8 (59.8-131.6)	85.7 (56.1-123.3)	0.437
Serum HBV DNA (log10 IU/mL)				0.729
Mean (SD)	3.71 (1.46)	3.66 (1.65)	3.76 (1.25)
Median (range)	3.63 (1.32-8.10)	3.34 (1.32-8.10)	3.78 (1.41-5.94)

Data expressed as mean (SD), mean (range) or median (range). ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; LAM: Lamivudine; ADV: Adefovire; HBV: High hepatitis B virus; eGFR: Estimated glomerular filtration rate; LdT: Telbivudine.

Table 2 Virologic, serologic and biochemical responses during study periods n (%)

Variables	Week 12		P value	Week 24		P value	Week 48		P value
	LdT + ADV	LAM + ADV		LdT + ADV	LAM + ADV		LdT + ADV	LAM + ADV
Serum HBV DNA, mean (SD) (log10 IU/mL)	3.05 (1.51)	3.84 (1.35)	0.011	2.79 (1.52)	3.65 (1.44)	0.003	2.85 (1.73)	3.29 (1.49)	0.168
Reductions in HBV DNA1, mean (SD) (log10 IU/mL)	-0.68 (0.83)	0.07 (0.60)	< 0.001	-0.88 (1.06)	-0.11 (0.85)	< 0.001	-0.81 (1.43)	-0.47 (1.04)	0.167
HBV DNA undetectable2	8 (15.1)	1 (1.9)	0.030	12 (22.6)	2 (3.8)	0.004	16 (30.2)	6 (11.5)	0.019
Virologic nonresponders3	-	-	-	33 (62.3)	48 (90.6)	0.001	-	-	-
HBsAg loss	0 (0)	0 (0)	-	0 (0)	0 (0)	-	0 (0)	0 (0)	-
HBeAg negativity,	0 (0)	0 (0)	-	2 (3.8)	0 (0)	-	3 (5.7)	2 (3.8)	0.648
Normal range of ALT4	39 (73.6)	38 (71.7)	0.828	37 (69.8)	40 (75.5)	0.513	40 (75.5)	38 (71.7)	0.768
ALT normalization5	2/14 (14.3)	6/14 (42.9)	0.209	6/14 (42.9)	5/14 (35.7)	0.704	8/14 (57.1)	3/14 (21.4)	0.053

¹Reduction of hepatitis B virus (HBV) DNA from baseline;

²Defined serum HBV DNA of < 12 IU/mL;

³Defined as a < 1 log₁₀ IU/mL reduction in serum HBV DNA level from baseline at 24 wk;

⁴Upper normal limit of ALT, 40 IU/L;

⁵Among patients who have elevated ALT levels at baseline. ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; LAM: Lamivudine; ADV: Adefovir. HBsAg: Hepatitis B surface antigen; HBeAg: Hepatitis Be antigen.