Treatment of chronic hepatitis B in clinical practice with entecavir or tenofovir

Table 1 Baseline characteristics of patients included in entecavir studies[21]

Characteristic, n (%)1	ETV-022	ETV-027	Oriente	Virgil	King’s College Cohort	Italian cohort	Argentineancohort	Hong Kongcohort	Japan cohort	China cohort	China cohort 2	Taiwan cohort	Taiwan cohort 2	United States cohort	United States cohort 2	Australia
Ref.	[7]	[8]	[22]	[23]	[24]	[25[	[29]	[32]	[33]	[34]	[35]	[36]	[37]	[38]	[39]	[40]
n	354	325	190	243	154	418	169	222	474	230	1768	98	248	169	136	163
Age, yr (mean ± SD or range)	35 ± 132	44 ± 112	44 (35-54)3	43 ± 142	423	58 (18-82)4	51 ± 132	47 (21-77)4	47 (17-82)4	42 ± 122	36 (16-70)4	48 ± 132	39 (17-77)4	39 ± 122	39 ± 122	52 (24-86)4
Male	274 (77)	248 (76)	139 (73)	177 (73)	122 (79)	316 (76)	113 (77)	157 (71)	321 (67)	196 (85)	1414 (80)	67 (68)	172 (69)	100 (59)	83 (61)	113 (69)
Race					NR	NR		NR	NR	NR		NR				NR
White	140 (40)	193 (59)	60 (84)	114 (47)			143 (85)							7(4)	10 (7)
Asian	204 (58)	122 (38)	18 (9)	70 (29)			26 (15)				1768 (100)			162 (96)	126 (93)
Other	2 (< 1)	2 (< 1)	6 (3)	59 (24)
Region	Europe 24%, North America 13%, South America 14%, Australia and Asia 49%	Europe 48%, North America 9%, South America 11%, Australia and Asia 33%	Europe	Europe	Europe	Europe	South America	Asia	Asia	Asia	Asia	Asia		North America	North America	Oceania
Genotype			NR		NR		NR	NR		NR	NR	NR				NR
A	94 (27)	33 (10)		40 (22)					12 (3)					0
B	68 (19)	46 (14)		14 (8)					67 (16)					-61	-57
C	111 (31)	57 (18)		25 (14)					336 (81)					-39	-41
D	37 (10)	157 (48)		91 (50)		84 (90)			0 (0)					0
HBeAg negative	6 (3)	322 (99)	133 (70)	157 (65)	106 (69)	347 (83)	65 (39)	132 (59)	252 (53)	117 (51)	602 (34)	57 (58)	0 (0)	0 (0)	0 (0)	10 (6.1)
HBV DNA, log10 IU/mL1	9.62 (2.01)25	7.6 (1.8)25	5.94 (4.64-7.39)3	6.2 ± 1.73	4.6 (0.2)6	6.0 (1.5–9)4	6.88 (1.81)2	7.1 (4.0-> 8.8)4	6.7 (2.6-> 9.0)4	6.3 ± 1.43	6.74 (1.04-9.69)4	6.0 ± 1.53	7.6 (2.2-13.1)4	7.58 (3.77-9.70)4	7.48 (3.8-9.9)4	NR
ALT, IU/L1	140.5 (114.3)2	141 (114.7)2	71.5 (44-108)3	NR	NR	92 (11-2241)4	139 (231)2	92 (17-2168)4	70 (8-2121)4	68(3-2631)4	NR	138 (21-4190)4	201 (27-2415)4	62 (14-839)4	67 (14-1077)4	NR
Cirrhosis	26/329 (8)	15/303 (5)	07	57 (24)	52 (34)	202 (49)	38 (23)	0	102 (22)	74 (32)	NR	13 (14)	39 (16)	NR	NR	26(16)

¹Unless otherwise specified;

²Mean ± SD;

³Median (interquartile range);

⁴Median (range);

⁵log10 copies/mL;

⁶Mean ± SE;

⁷Advanced fibrosis in 34%. ALT: Alanine transaminase; NR: Not reported; NUC: Nucleos(t)ide analogue; VIRGIL: Vigilance against viral resistance; ETV: Entecavir.

Table 2 Summary of efficacy results from real-life studies of entecavir in nucleos(t)ide analogue-naïve patients n (%)[21]

Study	Median follow-up (range)	Patients(n)	Cut-off (assaylimit) (IU/mL)	HBV DNA undetectable1	HBeAg seroconversion12	HBsAg loss1
ORIENTE[22]	52 wk (46-53 wk)	190	50	115 (82)	12 (21)	2 (1)
VIRGIL[23]	19 mo (3-45 mo)	243	80	126 (74)	13 (15)	3 (1)
King’s College cohort[24]	28 mo (NR)	154	12	NR	NR	NR
Italian cohort[25]	58 mo (2-80 mo)	418	12	93 (99)	527 (31 patients)	337 (15 patients)
Argentinean cohort[29]	181 wk (108-248 wk)	169	6	34 (100)	71 (68)	23 (14)
Hong Kong cohort[32]	3 yr (12-60 mo)	222	12	51 (90)	16 (53)	1 (0.5)3
Japan cohort[33]	2.37 yr (0.5-7.2 yr)	473	12	70 (96)	93 (42)	1 (0.2)
China cohort[34]	27.5 mo (3-73 mo)	230	100	NR	17 (15)	1 (0.4)
China cohort 2[35]	191 wk (1-233 wk)	1768	50	1327 (83)	NR	NR
Taiwan cohort[36]	144 wk	98	NR	93 (95)	5 (12)	0
Taiwan cohort 2[37]	25.3 mo (12-69 mo)	248	6	33 (82)	64 (28)	NR
United States cohort[38]	25 mo (6-68 mo)	169	100	75 (44)	12 (8)	NR
United States cohort 2[39]	36 mo	136	100	115 (85)	41 (30)	0
Australia cohort[40]	26 mo (3-46)	163	12	134 (82)	66 (43)	1 (0.6)

¹Unless otherwise specified;

²Median (interquartile range);

³Advanced fibrosis in 34%.

Table 3 Baseline characteristics of patients included in tenofovir studies n (%)[21]

Characteristic1	Study 103	Study 102	King’s College Cohort	United States cohort	European cohort	German cohort
Reference	[14]	14	[24]	[38]	[42]	[43]
n	176	250	60	28	302	184
Age, yr (mean ± SD or range)	34 ± 112	44 ± 112	403	36 ± 92	55 (19-80)	44 ± 142
Male	119 (68)	193 (77)	30 (50)	16 (58)	222 (74)	127 (69)
Race			NR		NR
White	92 (52)	161 (64)		1 (4)		140 (76)
Asian	64 (36)	63 (25)		27 (96)
Other	20 (11)	26 (10)
Region	Europe 55%, North America 27%, Australia and Asia 18%	Europe 63%, North America 21%, Australia and Asia 16%4	Europe	North America	Europe	Europe
Genotype			NR		NR	NR
A	94 (27)	33 (10)
B	68 (19)	46 (14)		18 (65)
C	111 (31)	57 (18)		10 (35)
D	55/173 (32)	156/243 (64)
HBeAg negative	0 (0)	250 (100)	46 (77)	0 (0)	241 (80)	127 (69)
HBV DNA, log10 IU/mL1	8.64 (1.076)25	6.86 (1.31)25	4.2 (0.3)6	7.74 (3.34-8.66)3	5.9 (1.4 -> 9)3	6.9
ALT, IU/L1	142 (102.81)2	127.5 (101.21)2	NR	52.5 (8-468)3	88 (11-3733)3
Cirrhosis	34/172 (20)	47/250 (19)	14 (23)	NR	105 (35)	20 (11)

¹Unless otherwise specified;

²mean ± SD;

³median (range);

⁴Australia or New Zealand;

⁵log10 copies/Ml;

⁶mean ± SE. ALT: Alanine transaminase; NR: Not reported; HBeAg: Hepatitis B e antigen.

Table 4 Summary of efficacy results from real-life studies of tenofovir in nucleos(t)ide analogue-naïve patients n (%)

Study	Median follow-up (range)	Patients(n)	Cut-off (assay limit) (IU/mL)	HBV DNA undetectable1	HBeAg seroconversion12	HBsAg loss1
King’s College cohort[24]	12 mo	60	12	33 (76)	2 (7)	0
United States cohort[38]	12 mo (6-23 mo)	28	100	23 (82)	7 (5)	0
European cohort[42]	33 mo (0-66 mo)	302	12	91 (97)	18 (36)3	8 (13)
German cohort[43]	24 mo	184	69	170 (92)	NR	NR

¹Unless stated otherwise;

²among those hepatitis B e antigen (HBeAg) (+) at baseline;

³Kaplan–Meier estimate. NR: Not reported; HBV: Hepatitis B virus; NR: Not reported; NUC: Nucleos(t)ide analogue; HBsAg: Hepatitis B surface antigen.