Tenofovir disoproxil fumarate in Chinese chronic hepatitis B patients: Results of a multicenter, double-blind, double-dummy, clinical trial at 96 weeks

Table 1 Baseline demographic and clinical characteristics of the nucleoside-naive chronic hepatitis B Chinese patients

Demographic and clinical characteristics	Group A (n = 161)	Group B (n = 169)	P value
Age, yr
mean ± SD	35.16 ± 9.34	34.91 ± 9.79	0.8082
Range	19.00-62.00	19.00-64.00
Male, n (%)	116 (72.05)	134 (79.29)	0.1248
HBV DNA, log10 IU/mL	6.86 ± 1.13	6.91 ± 1.05	0. 6761
HBeAg positive
mean ± SD	7.27 ± 0.81	7.29 ± 0.71	0.8126
Range	5.00-8.66	5.02-8.47
HBeAg negative
mean ± SD	5.87 ± 1.20	6.03 ± 1.17	0.5144
Range	3.42-8.01	3.33-8.16
HBeAg status, n (%)
HBeAg negative	114 (70.81)	118 (69.82)	0.8448
HBeAg positive	47 (29.19)	51 (30.18)
Baseline HBsAg, log10 IU/mL	161 (100)	169 (100)	0.4979
HBeAb status, n (%)
HBeAg positive
HBeAb negative	12 (10.53)	16 (13.56)	0.4776
HBeAb positive	102 (89.47)	102 (86.44)
HBeAg negative
HBeAb negative	46 (97.87)	51 (100.00)	0.2236
HBeAb positive	1 (2.13)	0 (0.00)
Duration of positivity for HBV, yr
mean ± SD	10.39 ± 8.03	9.76 ± 7.22	0.4575
Range	0.00-40.00	0.50-34.00
Baseline ALT, U/L, mean ± SD	175.47 ± 92.17	180.05 ± 96.05	0.6592

HBV: Hepatitis B virus; HBeAg: Hepatitis B e antigen; HBeAb: Hepatitis B e antibody; ALT: Alanine transaminase; HBsAg: Hepatitis B surface antigen.

Table 2 Hepatitis B virus DNA levels in trial participants in the two groups (log10 IU/mL)

	HBeAg-positive CHB			HBeAg-negative CHB
Group	n	72 wk (mean ± SD)	96 wk (mean ± SD)	n	72 wk (mean ± SD)	96 wk (mean ± SD)
A	114	1.55 ± 0.73	1.50 ± 0.70	47	1.38 ± 0.30	1.41 ± 0.36
B	118	1.54 ± 0.61	1.56 ± 0.84	51	1.36 ± 0.25	1.32 ± 0.10
P value		0.8570	0.5579		0.7215	0.1177

HBeAg: Hepatitis B e antigen; CHB: Chronic hepatitis B.

Table 3 Reductions in hepatitis B virus DNA level in trial participants in the two groups (log10 IU/mL)

	HBeAg-positive CHB			HBeAg-negative CHB
Group	n	72 wk (mean ± SD)	96 wk (mean ± SD)	n	72 wk (mean ± SD)	96 wk (mean ± SD)
A	114	5.72 ± 1.01	5.77 ± 0.99	47	4.49 ± 1.19	4.46 ± 1.19
B	118	5.75 ± 0.84	5.73 ± 1.01	51	4.67 ± 1.22	4.70 ± 1.18
P value		0.8514	0.6843		0.5528	0.3644

HBeAg: Hepatitis B e antigen; CHB: Chronic hepatitis B.

Table 4 Proportions of participants with undetectable levels of hepatitis B virus DNA (< 20 IU/mL) in the two groups

	HBeAg-positive CHB			HBeAg-negative CHB
Group	n	72 wk	96 wk	n	72 wk	96 wk
A	114	74 (64.91)	81 (71.05)	47	40 (85.11)	41 (87.23)
B	118	81 (68.64)	92 (77.97)	51	48 (94.12)	48 (94.12)
P value		0.5788	0.2326		0.1877	0.3046

Values are presented as n (%). HBeAg: Hepatitis B e antigen; CHB: Chronic hepatitis B.

Table 5 Rates of hepatitis B e antigen loss and hepatitis B e antigen seroconversion in participants with hepatitis B e antigen-positive chronic hepatitis B at week 96

	Group	Number of observations	Number of cases	Incidence	P value
HBeAg loss	A	100	31	31.00	0.6482
	B	110	30	27.27
HBeAg seroconversion	A	89	18	20.22	0.4491
	B	95	15	15.79

HBeAg: Hepatitis B e antigen.

Table 6 Number of participants who exhibited alanine aminotransferase normalization in the two groups

	Group	Number of observations	Number of cases	P value
72 wk	A	145	120	1.0000
	B	162	133
96 wk	A	141	113	0.3637
	B	162	137

Table 7 Estimated glomerular filtration rate values in participants in the two groups

	Group	The median of eGFR	P value
Baseline	A	113.25 ± 19.11	0.651
	B	115.54 ± 18.68
48 wk	A	111.87 ± 19.22	0.808
	B	115.35 ± 15.54
96 wk	A	110.00 ± 17.90	0.164
	B	110.49 ± 16.921

¹In group B, there was a significant difference in estimated glomerular filtration rate between the baseline value and the value at 96 wk (P < 0.05). eGFR: Estimated glomerular filtration rate.

Table 8 Urine neutrophil gelatinase-associated lipocalin levels in trial participants at baseline and at week 96

	Urine NGAL	Z	P value
Baseline	1.69 ± 2.38	3.79	< 0.01
96 wk	3.73 ± 11.48

NGAL: Neutrophil gelatinase-associated lipocalin.