Similar efficacy and safety of tenofovir in Asians and non-Asians with chronic hepatitis B

Table 1 Patient characteristics at baseline n (%)

	HBeAg-negative		HBeAg-positive
	Asian	Non-Asian	Asian	Non-Asian
	n = 102	n = 186	n = 115	n = 113
Male	71 (70)	144 (77)	60 (52)b	84 (73)
Age (yr, mean ± SD)	44 ± 9.4	44 ± 10.9	34 ± 9.7	33 ± 11.9
BMI (kg/m2, mean ± SD)	24.1 ± 3.1b	26.4 ± 4.5	23.0 ± 3.5b	25.1 ± 5.5
HBV DNA (log10 copies/mL, mean ± SD)	6.5 ± 1.4a	6.9 ± 1.3	8.4 ± 1.1b	8.9 ± 1.0
Median ALT, U/L (Q1, Q3)	73 (45, 115)	103 (67, 140)	90 (56, 144)	118 (88, 196)
Normal ALT1	17 (17)b	12 (6.5)	10 (9)	5 (4)

¹Normal ALT ≤ 34 U/L for females; ≤ 43 U/L for males.

^aP≤ 0.05,

^bP≤ 0.01, vs non-Asian patients. ALT: Alanine aminotransferase; BMI: Body mass index; HBeAg: Hepatitis B e antigen; HBV: Hepatitis B virus; Q1: Quartile 1; Q3: Quartile 3.

Table 2 Mean ± SD change in hepatitis B virus DNA levels from baseline (log₁₀ copies/mL)

Weeks from baseline	HBeAg-negative		HBeAg-positive
	Asians	Non-Asian	Asians	Non-Asian
	n = 102	n = 186	n = 115	n = 113
Week 4	-2.9 ± 0.82	-2.9 ± 0.80	-3.1 ± 0.76	-2.9 ± 0.77
Week 8	-3.4 ± 1.04	-3.5 ± 0.85	-4.0 ± 1.07	-3.8 ± 0.88

HBeAg: Hepatitis B e antigen.

Table 3 Change in liver histology n (%)

	Asian	Non-Asian
Histology improvement1	95 (77.2)	213 (71.5)
Knodell necroinflammatory score
Improvement	99 (80.5)	227 (76.2)
No change	9 (7.3)	38 (12.8)
Worsening	2 (1.6)	11 (3.7)
Missing	13 (10.6)	22 (7.4)
Knodell fibrosis score
Improvement	3 (2.4)	15 (5.0)
No change	89 (72.4)	227 (76.2)
Worsening	18 (14.6)	33 (11.1)
Missing	13 (10.6)	23 (7.7)

¹Defined as at least a two-point reduction in the Knodell necroinflammatory score and no worsening in the Knodell fibrosis score.