Precore/basal core promoter mutants and hepatitis B viral DNA levels as predictors for liver deaths and hepatocellular carcinoma

Table 1 Demographic and virologic characteristics of basal core promoter 1762/1764 mutants

Characteristics	Mutant	Wild type	P
Number	124	156
Age (yr) (mean ± SD)	50.9 ± 13.5	46.3 ± 15.9	0.01
Male/Female	93/31	112/44	0.5
Asian/Non-Asian	107/17	121/35	0.06
Genotype, n (%)			< 0.0001
A	12/121 (9.9)	28/147 (19.1)
B	18/121 (14.9)	54/147 (36.7)
C	90/121 (74.4)	62/147 (42.2)
Baseline HBV-DNA level (mean ± SD, copies/mL)	6.7 ± 1.6 Log10	7.3 ± 1.9 Log10	0.003
PC1 1896 mutant, n (%)			0.8
Yes	35/124 (28.2)	46/156 (29.5)
No	89/124 (71.8)	110/156 (70.5)
HBeAg, n (%)			0.07
+	68/124 (54.8)	101/154 (65.6)
−	56/124 (45.2)	53/154 (34.4)

¹Precore.

Table 2 Demographic and virologic characteristics of precore 1896 mutants

Characteristic	Mutant	Wild type	P
Number	112	270
Age (yr) (mean ± SD)	49.7 ± 14.8	47.3 ± 15.1	0.16
Male/Female	77/35	192/78	0.6
Asian/Non-Asian	99/13	201/69	0.002
Genotype, n (%)			< 0.0001
A	2/93 (2.1)	54/227 (23.8)
B	53/93 (56.9)	39/227 (17.2)
C	38/93 (40.9)	128/227 (56.4)
Baseline HBV-DNA level (mean ± SD, copies/mL)	5.5 ± 2.0 Log10	6.5 ± 2.3 Log10	< 0.0001
HBeAg, n (%)			< 0.0001
+	33/109 (30.1)	161/268 (60.1)
−	76/109 (69.7)	107/268 (39.9)

Table 3 Demographic and virologic characteristics of HBV genotypes

Characteristics	Genotype A	Genotype B	Genotype C	P
n	56	92	166
Age (yr) (mean ± SD)	51.0 ± 15.8	46.3 ± 17.7	47.4 ± 14.7	0.2
Male/Female	47/9	64/28	117/49	0.02
Asian/Non-Asian	16/40	84/8	157/9	< 0.0001
HBV-DNA (mean ± SD, copies/mL)	6.68 ± 2.53 Log10	6.12 ± 2.08 Log10	6.94 ± 1.81 Log10L	0.003
HBeAg, n (%)				0.0002
+	37/55 (67.3)	35/91 (38.5)	104/165 (63.0)
-	18/55 (32.7)	56/91 (61.5)	61/165 (37.0)

Table 4 Demographic and virologic characteristics of baseline serum HBV-DNA Levels (mean ± SD, copies/mL)

Characteristics	Mean HBV-DNA levels	P
Sex		0.0007
Male	6.39 ± 2.30 Log10
Female	5.52 ± 2.14 Log10
Race		0.24
Asian	6.05 ± 2.21 Log10
Non-Asian	6.39 ± 2.57 Log10
HBeAg		< 0.0001
+ (n = 194)	7.42 ± 1.97 Log10
− (n = 191)	4.86 ± 1.81 Log10

Table 5 Univariate analysis of factors associated with non-HCC related liver deaths

Factor	Alive	Expired	P
n	326	43	-
Age (yr) (mean ± SD)	45.5 ± 14.7	57.2 ± 12.2	< 0.0001
Male/Female	213/113	41/2	< 0.0001
Asian/Non-Asian	264/62	24/19	0.0005
Cirrhosis			< 0.0001
Yes	77/139	38/139
No1	257/261	4/261
Baseline HBV-DNA level (mean ± SD)	6.0 ± 2.38 Log10 copies/mL	6.92 ± 1.96 Log10 copies/mL	0.02
BCP 1762/1764 mutant			0.07
Yes	86	20
No	132	16
PC 1896 mutant			0.78
Yes	86	12
No	223	30
Genotype			0.43
A	46	8
B	76	8
C	126	19
HBeAg			0.17
+	159	26
−	163	17

¹Four other patients without cirrhosis died of non-liver related deaths.

Table 6 Univariate analysis of factors associated with development of HCC

Factor	HCC	No HCC	P
n	31	369
Age (yr) (mean ± SD)	57.4 ± 2.7	46.9 ± 0.8	0.0002
Male/Female	28/3	254/115	0.006
Asian/Non-Asian	26/5	288/81	0.4
Cirrhosis			< 0.0001
Yes	22/139	117/139
No	9/261	252/261
BCP 1762/1764 mutant			0.007
Yes	18	106
No	6	148
PC 1896 mutant			0.05
Yes	14	98
No	17	253
Genotype			0.2
A	2	54
B	8	84
C	19	147
HBeAg			0.3
+	12	165
-	18	180
Baseline HBV-DNA level (mean ± SD, copies/mL)	6.3 ± 1.4 Log10	6.1 ± 2.3 Log10	0.6