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Copyright ©2014 Baishideng Publishing Group Inc.
World J Gastroenterol. Jun 21, 2014; 20(23): 7169-7180
Published online Jun 21, 2014. doi: 10.3748/wjg.v20.i23.7169
Table 1 Baseline characteristics of patients included in entecavir studies[21]
Characteristic, n (%)1ETV-022ETV-027OrienteVirgilKing’s College CohortItalian cohortArgentineancohortHong KongcohortJapan cohortChina cohortChina cohort 2Taiwan cohortTaiwan cohort 2United States cohortUnited States cohort 2Australia
Ref.[7][8][22][23][24][25[[29][32][33][34][35][36][37][38][39][40]
n354325190243154418169222474230176898248169136163
Age, yr (mean ± SD or range)35 ± 13244 ± 11244 (35-54)343 ± 14242358 (18-82)451 ± 13247 (21-77)447 (17-82)442 ± 12236 (16-70)448 ± 13239 (17-77)439 ± 12239 ± 12252 (24-86)4
Male274 (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)
RaceNRNRNRNRNRNRNR
White140 (40)193 (59)60 (84)114 (47)143 (85)7(4)10 (7)
Asian204 (58)122 (38)18 (9)70 (29)26 (15)1768 (100)162 (96)126 (93)
Other2 (< 1)2 (< 1)6 (3)59 (24)
RegionEurope 24%, North America 13%, South America 14%, Australia and Asia 49%Europe 48%, North America 9%, South America 11%, Australia and Asia 33%EuropeEuropeEuropeEuropeSouth AmericaAsiaAsiaAsiaAsiaAsiaNorth AmericaNorth AmericaOceania
GenotypeNRNRNRNRNRNRNRNR
A94 (27)33 (10)40 (22)12 (3)0
B68 (19)46 (14)14 (8)67 (16)-61-57
C111 (31)57 (18)25 (14)336 (81)-39-41
D37 (10)157 (48)91 (50)84 (90)0 (0)0
HBeAg negative6 (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/mL19.62 (2.01)257.6 (1.8)255.94 (4.64-7.39)36.2 ± 1.734.6 (0.2)66.0 (1.5–9)46.88 (1.81)27.1 (4.0-> 8.8)46.7 (2.6-> 9.0)46.3 ± 1.436.74 (1.04-9.69)46.0 ± 1.537.6 (2.2-13.1)47.58 (3.77-9.70)47.48 (3.8-9.9)4NR
ALT, IU/L1140.5 (114.3)2141 (114.7)271.5 (44-108)3NRNR92 (11-2241)4139 (231)292 (17-2168)470 (8-2121)468(3-2631)4NR138 (21-4190)4201 (27-2415)462 (14-839)467 (14-1077)4NR
Cirrhosis26/329 (8)15/303 (5)0757 (24)52 (34)202 (49)38 (23)0102 (22)74 (32)NR13 (14)39 (16)NRNR26(16)
Table 2 Summary of efficacy results from real-life studies of entecavir in nucleos(t)ide analogue-naïve patients n (%)[21]
StudyMedian follow-up (range)Patients(n)Cut-off (assaylimit) (IU/mL)HBV DNA undetectable1HBeAg seroconversion12HBsAg loss1
ORIENTE[22]52 wk (46-53 wk)19050115 (82)12 (21)2 (1)
VIRGIL[23]19 mo (3-45 mo)24380126 (74)13 (15)3 (1)
King’s College cohort[24]28 mo (NR)15412NRNRNR
Italian cohort[25]58 mo (2-80 mo)4181293 (99)527 (31 patients)337 (15 patients)
Argentinean cohort[29]181 wk (108-248 wk)169634 (100)71 (68)23 (14)
Hong Kong cohort[32]3 yr (12-60 mo)2221251 (90)16 (53)1 (0.5)3
Japan cohort[33]2.37 yr (0.5-7.2 yr)4731270 (96)93 (42)1 (0.2)
China cohort[34]27.5 mo (3-73 mo)230100NR17 (15)1 (0.4)
China cohort 2[35]191 wk (1-233 wk)1768501327 (83)NRNR
Taiwan cohort[36]144 wk98NR93 (95)5 (12)0
Taiwan cohort 2[37]25.3 mo (12-69 mo)248633 (82)64 (28)NR
United States cohort[38]25 mo (6-68 mo)16910075 (44)12 (8)NR
United States cohort 2[39]36 mo136100115 (85)41 (30)0
Australia cohort[40]26 mo (3-46)16312134 (82)66 (43)1 (0.6)
Table 3 Baseline characteristics of patients included in tenofovir studies n (%)[21]
Characteristic1Study 103Study 102King’s College CohortUnited States cohortEuropean cohortGerman cohort
Reference[14]14[24][38][42][43]
n1762506028302184
Age, yr (mean ± SD or range)34 ± 11244 ± 11240336 ± 9255 (19-80)44 ± 142
Male119 (68)193 (77)30 (50)16 (58)222 (74)127 (69)
RaceNRNR
White92 (52)161 (64)1 (4)140 (76)
Asian64 (36)63 (25)27 (96)
Other20 (11)26 (10)
RegionEurope 55%, North America 27%, Australia and Asia 18%Europe 63%, North America 21%, Australia and Asia 16%4EuropeNorth AmericaEuropeEurope
GenotypeNRNRNR
A94 (27)33 (10)
B68 (19)46 (14)18 (65)
C111 (31)57 (18)10 (35)
D55/173 (32)156/243 (64)
HBeAg negative0 (0)250 (100)46 (77)0 (0)241 (80)127 (69)
HBV DNA, log10 IU/mL18.64 (1.076)256.86 (1.31)254.2 (0.3)67.74 (3.34-8.66)35.9 (1.4 -> 9)36.9
ALT, IU/L1142 (102.81)2127.5 (101.21)2NR52.5 (8-468)388 (11-3733)3
Cirrhosis34/172 (20)47/250 (19)14 (23)NR105 (35)20 (11)
Table 4 Summary of efficacy results from real-life studies of tenofovir in nucleos(t)ide analogue-naïve patients n (%)
StudyMedian follow-up (range)Patients(n)Cut-off (assay limit) (IU/mL)HBV DNA undetectable1HBeAg seroconversion12HBsAg loss1
King’s College cohort[24]12 mo601233 (76)2 (7)0
United States cohort[38]12 mo (6-23 mo)2810023 (82)7 (5)0
European cohort[42]33 mo (0-66 mo)3021291 (97)18 (36)38 (13)
German cohort[43]24 mo18469170 (92)NRNR