Long-term lamivudine treatment for chronic hepatitis B in Japanese patients: A project of Kyushu University Liver Disease Study

Table 1 Baseline characteristics of 318 patients with chronic HBV infection treated with lamivudine (mean± SD)

Characteristics	Cirrhosis		P
	No	Yes
	n = 216	n = 102
Number of men (%)	154 (71.3)	77 (75.5)	0.5168
Age (yr)	45.0 ± 11.1	53.7 ± 9.7	< 0.0001
Number with 35 yr old and over (%)	173 (80.1)	98 (96.1)	0.0003
ALT (IU/L)	320.9 ± 503.3	101.5 ± 95.4	< 0.0001
Total bilirubin (mg/dL)	1.2 ± 1.3	1.4 ± 1.3	0.188
Albumin (g/dL)	4.0 ± 0.4	3.5 ± 0.6	< 0.0001
Platelet count (mean ± SD) (x104/μL)	16.2 ± 5.3	9.8 ± 4.4	< 0.0001
Number of HBeAg positivity (%)	119 (55.1)	54 (52.9)	0.8112
HBV-DNA1	6.8 ± 1.3	6.6 ± 1.2	0.1344
Lamivudine treatment (mo)	20.2 ± 8.9	21.8 ± 9.7	0.1429

ALT, alanine aminotransferase; HBeAg, hepatitis B e antigen; SD, standard deviation ¹Logarithmic transformed copies/mL.

Table 2 Virological response of 318 patients with chronic HBV infection treated with lamivudine (mean± SD)

Characteristics	Virological response		P
	No	Yes
	n = 288	n = 30
Number of men (%)	207 (71.9)	24 (80.0)	0.4624
Age (yr)	47.9 ± 11.4	46.9 (22-73)	0.6453
Number of cirrhosis (%)	90 (31.2)	12 (40.0)	0.4403
Baseline laboratory data
Total bilirubin (mg/dL)	1.3 ± 1.5	1.1 ± 0.6	0.6895
Albumin (g/dL)	3.9 ± 0.6	3.8 ± 0.6	0.2381
Platelet count (x 104/μL)	14.3 ± 5.9	13.2 ± 5.8	0.2624
Number of HBeAg positivity (%)	147 (51.0)	26 (86.7)	0.0004
HBV-DNA1	6.6 ± 1.2	7.7 ± 0.7	< 0.0001

ALT, alanine aminotransferase; HBeAg, hepatitis B e antigen; SD, standard deviation ¹Logarithmic transformed copies/mL

Table 3 Forward stepwise logistic regression analysis for all independent factors contributing to virological response

Factors	Odds ratio	95% CI	P
(At baseline)
HBV DNA less than 6.81	434.7	104.1 - 2000	<  0.0001
HBeAg negativity	7.142	2.136 - 238.0	< 0.0001
Platelet count more than 10 0x 109/L	4.625	1.242 - 17.22	0.0224
(During treatment)
Decline of HBV-DNA more than 3.21	51.13	11.21 - 233.0	< 0.0001
within 3 mo of the start of treatment

HBV, hepatitis B virus; HBeAg, hepatitis B e antigen; CI, confidence interval of odds ratios ¹Logarithmic transformed copies/mL.

Table 4 Forward stepwise logistic regression analysis for all independent factors contributing to virological breakthrough

Factors	Odds ratio	95% CI	P
(At baseline)
Cirrhosis	3.527	1.687 - 7.371	0.0008
HBeAg positivity	2.512	1.265 - 4.989	0.0085
Platelet counts less than 100 x 109/L	2.386	1.003 - 5.676	0.0491
(During treatment)
Decline of HBV-DNA less than 3.91	2.358	1.246 - 4.464	0.0084
within 6 mo of the start of treatment

HBV, hepatitis B virus; HBeAg, hepatitis B e antigen; CI, confidence interval of odds ratios ¹Logarithmic transformed copies/mL.