Long-term effects of lamivudine treatment in Japanese chronic hepatitis B patients

Table 1 Comparison of patients with and without the emergence of YMDD mutants during treatment, median (range)

Characteristics	Mutant- or mixed mutant-type (n = 56)	Not detected or wild-type (n = 5)	P-value
No. of men (%)	42 (75.0)	3 (80.0)	NS
Age (yr)	50 (28-69)	52 (34-55)	NS
ALT level (U/L)	79 (15-1593)	63 (44-108)	NS
Albumin (g/dL)	4.1 (2.9-5.0)	4.3 (4.0-4.3)	NS
Platelet count (× 104/mL)	13.1 (3.3-43.3)	17.8 (15.2-26.0)	NS
HBeAg positivity (%)	23 (41.1)	2 (40.0)	NS
HBV-DNA level (log copies/mL)	6.5 (2.7-8.7)	7.0 (5.4-8.7)	NS
Cirrhosis (%)	22 (39.3)	1 (20.0)	NS
History of HCC (%)	8 (14.3)	1 (20.0)	NS
Virological breakthrough (%)	26 (46.4)	0	< 0.0001
Patients with hepatitis flare-ups (%)	20 (35.7)	0	< 0.0001

Between group comparison was done of whether or not YMDD mutant was detected at each observation point. ALT: Alanine aminotransferase; HBeAg: Hepatitis B e antigen; HBV: Hepatitis B virus; HCC: Hepatocellular carcinoma; NS: Not significant.

Table 2 Comparison of the emergence of YMDD mutants during treatment by hepatitis B e antigen status of patients, median (range)

Characteristics	HBeAg negative (n = 36)	HBeAg positive (n = 25)	P-value
No. of men (%)	28 (78)	17 (68)	NS
Age (yr)	50 (29-69)	50 (28-60)	NS
HBV DNA level (log copies/mL)	5.8 (2.7-7.6)	7.6 (4.1-8.7)	< 0.0001
Patients with YMDD mutants (%)	33 (92)	23 (92)	NS
Virological breakthrough (%)	12 (33)	14 (56)	NS
Patients with flare-ups of hepatitis (%)	9 (25)	11 (44)	NS

HBeAg: Hepatitis B e antigen; HBV: Hepatitis B virus; NS: Not significant.

Table 3 Characteristics of the patients with flare-ups of hepatitis

Patient	Age (yr)	Sex	Cirrhosis	HBeAg	Change of HBV DNA level after treatment (log copies/mL)			Mutant type
					Pre-treatment	Nadir	Virological breakthrough with hepatitis flare-ups
1	54	F	+	+	8.7	4.7	7.6	YIDD/YVDD
2	56	M	+	+	8.1	4.1	7.9	Mixed
3	59	M	+	-	6.6	< 2.6	6.8	YIDD
4	60	M	+	+	7.9	< 2.6	8	Mixed
5	65	M	+	+	6.5	< 2.6	6.7	Mixed
6	49	M	+	+	7.9	3.9	7	YIDD
7	58	M	-	+	8.7	3.9	7.2	YVDD
8	51	M	-	+	7.8	3.8	7.6	YIDD/YVDD
9	58	M	-	+	8.7	4.3	7.9	Mixed
10	61	M	+	-	6	< 2.6	6.6	Mixed
11	51	F	-	+	7.2	< 2.6	5.9	YIDD
12	62	F	-	+	7.7	< 2.6	6.6	Mixed
13	44	M	+	+	6.7	< 2.6	5.9	YVDD
14	56	M	-	+	8.7	5	7	YVDD
15	50	F	-	+	7.6	5.6	6.2	YIDD
16	47	M	+	+	7.9	3.9	6.4	YIDD
17	59	F	+	-	6.9	< 2.6	6.1	YVDD
18	45	M	-	-	6.9	< 2.6	6.1	Mixed
19	61	M	-	-	6.7	< 2.6	5.9	Mixed
20	56	M	+	-	6.6	< 2.6	5.7	YVDD

HBV: Hepatitis B virus; HBeAg: Hepatitis B e antigen.