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Updates in HBV Management
CCO Independent Conference Coverage of the 2006 Annual Meeting
of the European Association for the Study of the Liver*
April 26-30, 2006
Vienna, Austria
*CCO is an independent medical education company that
provides state-of-the-art medical information to healthcare
professionals through conference coverage and other
educational programs.
This program is supported by an educational grant from
Updates in HBV Management
About These Slides





These slides accompany CCO’s comprehensive online Independent
Conference Coverage of the 2006 Annual Meeting of the European
Association for the Study of the Liver
The full program is available on the Clinical Care Options for Hepatitis Web
site: clinicaloptions.com/vienna2006
Users are encouraged to use these slides in their own presentations, but we
ask that content and attribution not be changed. Users are asked to honor
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Clinical Care Options
We are grateful to Stephanos J. Hadziyannis, MD, Henry Dunant Hospital,
Athens, Greece, who aided in the content creation of these slides
Disclaimer
The materials published on the Clinical Care Options Web site reflect the views of the authors, not those of Clinical
Care Options, LLC, the CME providers, or the companies providing educational grants. The materials may discuss uses
and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration.
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clinicaloptions.com/hep
Chronic Hepatitis B Treatment:
Investigational Agents
Updates in HBV Management
Pradefovir for Chronic Hepatitis B:
Week 48 Analysis

Phase II randomized, open-label, multicenter trial of adefovir-naive patients
(N = 244)
– Patients received adefovir 10 mg/day or pradefovir 5, 10, 20, or 30 mg/day for 48
weeks
– Mean baseline HBV DNA: 7.9-8.2 log10 copies/mL
– Mean baseline ALT: 2.6-3.3 x ULN
– Genotype C: 67%
– Asian: 100%
– HBeAg(+): 70%
Pradefovir
Week 48 Outcome
5 mg/day
(n = 47)
10 mg/day
(n = 49)
20 mg/day
(n = 48)
30 mg/day
(n = 48)
Adefovir
(n = 50)
HBV DNA < 400 copies/mL, %
45
63
56
71
36
ALT normalized
 HBeAg-positive patients
 HBeAg-negative patients
64
57
64
81
65
65
69
67
64
79
HBeAg seroconversion, %
18
12
10
19
17
Lee KS, et al. EASL 2006. Abstract 741.
clinicaloptions.com/hep
Updates in HBV Management
Mean (SE) Change in
HBV DNA From Baseline
(log10 copies/mL)
Pradefovir for Chronic Hepatitis B:
Week 48 Analysis
0
Pradefovir 5 mg/day (n = 47)
Pradefovir 10 mg/day (n = 49)
Pradefovir 20 mg/day (n = 48)
Pradefovir 30 mg/day (n = 48)
Adefovir 10 mg/day (n = 50)
-1
-2
-3
-4
-5
-6
0
4
12
18
24
36
-4.09 (P = .827 vs ADV)
-4.19
-4.84 (P = .007 vs ADV)
-4.89 (P = .007 vs ADV)
-5.54 (P = .001 vs ADV)
48
Week
Mean Change in HBV DNA
from Baseline, log10 copies/mL
HBeAg Positive Patients
HBeAg Negative Patients
Lee KS, et al. EASL 2006. Abstract 741.
5 mg/day
-4.19
(n = 33)
-3.86
(n = 14)
Pradefovir
10 mg/day 20 mg/day
-4.97
-5.14
(n = 33)
(n = 31)
-4.58
-4.42
(n = 16)
(n = 17)
30 mg/day
-5.67
(n = 36)
-5.14
(n = 12)
Adefovir
10 mg/day
-4.10
(n = 36)
-4.41
(n = 14)
clinicaloptions.com/hep
Updates in HBV Management
GLOBE: Predictors of Response to
Telbivudine
 Retrospective subanalysis of GLOBE trial: international, randomized
phase III trial
Factors Associated With Undetectable Viral Load at Year 1 (Stepwise Logistic Regression)
Odds Ratio for Undetectable HBV DNA
Factor
HBeAg Positive
HBeAg Negative
(n = 921)
(n = 446)
Telbivudine treatment
2.78
3.44
High ALT
2.08
1.89
Prior interferon use
2.16
NS
High Knodell score (> median)
2.22
NS
Asian race vs other
Asian vs white race
Asia region vs other
Asia region vs North America
HBV DNA, middle vs highest tertile
HBV DNA, lowest vs highest tertile
3.33
NS
2.63
2.70
2.08
6.43
3.33
2.44
NS
NS
2.03
3.13
Thongsawat S. EASL 2006. Abstract 110.
clinicaloptions.com/hep
Updates in HBV Management
Telbivudine vs Adefovir in HBeAgPositive Patients: Week 24 Analysis
 Randomized, multicenter open-label study
– Serum HBV DNA: > 105 copies/mL
– ALT: 1.3-10.0 x ULN
Week 52
Preliminary Analysis
Week 24
HBeAg-positive,
treatment-naive chronic
hepatitis B patients with
compensated liver disease
Telbivudine 600 mg/day
(n = 45)
Telbivudine 600 mg/day
(n = 45)
Adefovir 10 mg/day
(n = 45)
Adefovir 10 mg/day
(n = 45)
Adefovir 10 mg/day
(n = 45)
Telbivudine 600 mg/day
(n = 45)
(N = 135)
Chan HLY, et al. EASL 2006. Abstract 52.
clinicaloptions.com/hep
Updates in HBV Management
Telbivudine vs Adefovir in HBeAgPositive Patients: Week 24 Analysis
Mean Serum HBV DNA
Change From Baseline
(log10 copies/mL)
0
4
8
Weeks
12
16
20
24
0
-1
-2
-3
-4
-5
-6
-7
Telbivudine (n = 45)
Adefovir (n = 90)
Week 24 Outcome
Telbivudine, %
(n = 45)
Adefovir, %
(n = 90)
P Value
Serum HBV DNA, copies/mL
 < 300
 300 - 3 log10
 3-4 log10
 > 4 log10
ALT normalization
HBeAg loss
NS, not significant.
39
11
18
32
61
16
12
10
17
61
63
10
< .01
NS
NS
< .01
Chan HLY, et al. EASL 2006. Abstract 52.
clinicaloptions.com/hep
Updates in HBV Management
ANA380 (LB80380) in HBeAg-Positive
Patients With Lamivudine Resistance

Phase III, multicenter, doseescalating study (N = 65)

HBeAg-positive Asian patients
– HBV DNA > 106 copies/mL

ALT normalization: 12 of
36 individuals in 90, 150, or 240
mg/day arms by Week 12

Significant viral suppression
– ALT 1.5-10.0 x ULN
ANA380 Dosing Group, mg/day
– Confirmed YMDD mutations
5 dose escalation groups
– ANA380 (30, 60, 90, 150, or 240
mg/day) + lamivudine for 4 weeks
followed by 8 weeks ANA380
monotherapy
Lai CL, et al. EASL 2006. Abstract 6.
Reduction in HBV DNA by
Week 12, log10 copies/mL

30
60
90
150
240
(n = 13) (n = 14) (n = 14) (n = 12) (n = 12)
0
-1
-2
-3
-2.8
-3.2
-4
-3.9
-3.9
-4.1
-5
clinicaloptions.com/hep
Updates in HBV Management
Open-Label, Phase III Study of
Clevudine: Year 1 results

Clevudine 30 mg/day for 24 weeks, then 10 mg/day through Week 48, then 12 weeks
follow-up off treatment (N = 55)
–
–

Median baseline HBV DNA for HBeAg(+) patients (n = 40): 8.10 log10 copies/mL
Median baseline HBV DNA for HBeAg(-) patients (n = 15): 4.91 log10 copies/mL
All patients with HBV DNA < 300 copies/mL at Week 24 had sustained virologic,
biochemical responses through Week 48
100 100
100
Percentage With
Normal Serum ALT
Treatment End (Week 48)
89 86
80
60
40
27
25
20
0
HBeAg-Positive
Patients (n = 40)
HBeAg-Negative
Patients (n = 15)
Chung YH, et al. EASL 2006. Abstract 53.
Percentage With
HBV DNA < 300 copies/mL
Baseline (Week 0)
Follow-up (Week 60)
100 100
100
80
68
60
40
23
20
0
0
HBeAg-Positive
Patients (n = 40)
0
HBeAg-Negative
Patients (n = 15)
clinicaloptions.com/hep
Chronic Hepatitis B Treatment:
Adefovir
Updates in HBV Management
Adefovir Resistance Analysis
 Incidence of HBV RT resistance mutations evaluated in 29 HBeAg(-)
patients treated with ADV for 5 years
Virologic Resistance (VR) Analysis in HBeAg(-) Patients With
ADV Resistance Mutations by Year 5
Cumulative Probability
of Outcome, Year
Genotypic
Resistance, %
Genotypic
Resistance + VR, %
Genotypic Resistance +
VR + ALT Elevation, %
1
0
0
0
2
3
3
2
3
11
8
6
4
18
13
10
5
29
16
11

Majority of patients with adefovir resistance acquired N236T mutation
– Mutation frequency by Year 5
– N236T > A181V > A181V/N236T > A181T/N236T
Borroto-Esoda K, et al. EASL 2006. Abstract 483.
clinicaloptions.com/hep
Updates in HBV Management
Adefovir vs Adefovir + Lamivudine in
Patients With Lamivudine Resistance


Multicenter prospective/retrospective analysis of patients in Italian
Expanded Access Program (N = 738)
Factors associated with lower risk of virologic rebound in multivariate
analysis at mean follow-up of 24 months
– Receiving ADV plus LAM vs ADV alone
– HR: 0.34 (95% CI: 0.15-0.71; P = .009)
– Achieving HBV DNA negativity by Week 24
– HR: 0.05 (95% CI: 0.01-0.35; P = .003)
Outcome
Virologic rebound*
Virologic Rebound and Adefovir Resistance
Adefovir, % (n = 277)
Adefovir + Lamivudine, % (n = 294)
P Value
15
4
< .001
Adefovir resistance†
8
0
< .001
*HBV DNA increase > 1 log10 vs nadir.
†Evidence of resistance: N236T (n = 9), A181T/V (n = 9), N236T + A181V (n = 3), ALT increase
(n = 30; 57%).
Lampertico P, et al. EASL 2006. Abstract 116.
clinicaloptions.com/hep
Updates in HBV Management
Adefovir Therapy in Genotype C
Patients

Single-arm study: 96 HBV genotype C patients treated for > 12 months
Outcome
Months After Starting Adefovir
3
6
9
12
15
18
Median change in serum HBV
DNA, log10 copies/mL
-2.5
-3.0
-3.4
-3.5
-4.4
-4.0
HBV DNA < 100 copies/mL, %
4
7
21
18
28
16
ALT normalization, %
48
58
71
78
73
65
HBeAg loss, %
7
17
18
22
29
33

Cumulative rates of viral resistance
– Defined as HBV DNA level elevated > 10-fold in ≥ 2 consecutive visits
– Month 12: 23%
– Month 24: 31%
Lee YS, et al. EASL 2006. Abstract 500.
clinicaloptions.com/hep
Chronic Hepatitis B Treatment:
Entecavir
Updates in HBV Management
ETV-027: Entecavir in NucleosideNaive HBeAg(-) Patients: Week 96
Week 48* Week 52: Management Decision
Entecavir
(n = 325)
Responders
(n = 275; 85%)
Virologic-only
responders
(n = 34; 10%)
Continue to Yr 2†
(n = 26; 76%)
Nonresponders
(n = 3; 1%)
Lamivudine
(n = 313)
Responders
(n = 245; 78%)
Virologic-only
responders
(n = 34; 11%)
Nonresponders
(n = 18; 6%)
Continue to Yr 2†
(n = 28; 82%)
Week 96
Responders
(n = 11; 42%)
Virologic-only
responders
(n = 15; 58%)
Nonresponders
(n = 0; 0%)
Responders
(n = 8; 29%)
Virologic-only
responders
(n = 15; 54%)
Nonresponders
(n = 5; 18%)
*Data missing at Week 48 for 13 entecavir- and 6 lamivudine-treated individuals.
†Those responding after Week 48 and those not responding could discontinue before Week 96.
Nonresponse, HBV DNA ≥ 0.7 MEq/mL by bDNA; Response, HBV DNA < 0.7 MEq/mL by bDNA and ALT <
1.25 x ULN; Virologic Response, HBV DNA < 0.7 MEq/mL by bDNA but ALT > 1.25 x ULN.
Shouval D, et al. EASL 2006. Abstract 45.
clinicaloptions.com/hep
Updates in HBV Management
ETV-027: Entecavir in NucleosideNaive HBeAg(-) Patients: Week 96

Cumulative response outcomes superior with entecavir
– Cumulative confirmed response defined as 2 sequential measurements of success
Cumulative Response Outcomes
P < .0001
Percentage of Patients
100
80
P < .0001
90
72
94
77
P = .045
78
71
P = .05
89
84
Entecavir
Lamivudine
60
40
20
0
Wk 48
Wk 96
HBV DNA
< 300 copies/mL
Shouval D, et al. EASL 2006. Abstract 45.
Wk 48
Wk 96
ALT ≤ 1 x ULN
clinicaloptions.com/hep
Updates in HBV Management
ETV-026: Entecavir in LAM-Refractory
HBeAg(+) Patients: Week 96
Week 48* Week 52: Management Decision
Responders
(n = 13; 9%)
Entecavir
(n = 145)
Lamivudine
(n = 141)
Virologic-only
responders
(n = 80; 55%)
Continue to Yr
(n = 77; 96%)
2†
Week 96
Responders
(n = 9; 12%)
Nonresponders
(n = 40; 28%)
Virologic-only
responders
(n = 57; 74%)
Nonresponders
(n = 11; 14%)
Responders
(n = 1; < 1%)
Responders
(n = 0; 0%)
Virologic-only
responders
(n = 7; 5%)
Nonresponders
(n = 121; 86%)
Continue to Yr 2†
(n = 3; 43%)
Virologic-only
responders
(n = 0; 0%)
Nonresponders
(n = 3; 100%)
*Data missing for 8 entecavir- and 16 lamivudine-treated individuals at Week 48.
†Those responding after Week 48 and those not responding could discontinue before Week 96.
Response, HBV DNA < 0.7 MEq/mL by bDNA and HBeAg loss; Virologic Response, HBV DNA < 0.7 MEq/mL
by bDNA but HBeAg positive; Nonresponse, HBV DNA ≥ 0.7 MEq/mL by bDNA.
Yurdaydin C, et al. EASL 2006. Abstract 80.
clinicaloptions.com/hep
Updates in HBV Management
ETV-026: Entecavir in LAM-Refractory
HBeAg(+) Patients: Week 96
Outcome, Week 96
LVD, n (%)
(n = 145)
ETV, n (%)
(n = 141)
P Value
Cumulative confirmed undetectable HBV DNA*
1 (< 1)
42 (30)
< .0001
(< 300 copies/mL)
Cumulative confirmed normal ALT*
42 (29)
120 (85)
< .0001
(≤ 1 x ULN)
HBeAg seroconversion
8 (6)
24 (17)
.0011
ALT flare†
16 (11)
1(1)
NA
ETV, entecavir; LVD, lamivudine; NA, not available.
*Cumulative percentage of patients achieving treatment endpoint for 2 sequential time points or at last
observation.
†ALT > 2 x baseline and > 10 x ULN while on treatment.
 Safety profile similar for entecavir, lamivudine
 Entecavir superior to lamivudine across subgroups
 ALT levels ≥ 2 x ULN at baseline associated with higher rates of
histologic improvement in entecavir patients
Yurdaydin C, et al. EASL 2006. Abstract 80. Yurdaydin C, et al. EASL 2006. Abstract 512.
clinicaloptions.com/hep
Updates in HBV Management
Entecavir Treatment in Advanced
Fibrosis Patients: Week 48
Entecavir randomized phase III trials: ETV-022, ETV-027, ETV-026
Nucleoside-Naive Patients With
Advanced Fibrosis or Cirrhosis
Missing data
Percentage of Patients
HBeAg Positive
100
8
17
80
35
6
28
60
40
57
49
Lamivudine-Refractory Patients With
Advanced Fibrosis or Cirrhosis
Worsening
No change
HBeAg Negative
8
24
2
31
5
18
59
53
20
0
ETV
LAM
(n = 46) (n = 47)
ETV
LAM
(n = 51) (n = 57)
Percentage of Patients

Improvement
100
80
22
0
60
35
0
19
29
40
20
19
43
33
ETV
LAM
(n = 23) (n = 21)
Advanced fibrosis, Ishak fibrosis score of 4, 5 or 6; fibrosis improvement, ≥ 1 point decline in Ishak
fibrosis score from baseline; fibrosis worsening, ≥ 1 point increase in Ishak fibrosis score from baseline.
Simsek H, et al. EASL 2006. Abstract 513.
clinicaloptions.com/hep
Updates in HBV Management
Analysis of Entecavir Resistance:
Nucleoside-Naive Individuals
 No evidence of ETV resistance mutations (substitutions decreasing
ETV susceptibility > 3-fold) in any ETV-treated patients with
– Virologic rebound (n = 18) at Year 1 or Year 2
– Suboptimal responses (HBV DNA > 105 copies/mL at Week 48; n = 5)
– HBV DNA > 300 copies/mL at Week 96 or end of dosing (n = 33)
 ETV susceptibility similar at baseline and at time of rebound or
suboptimal responses in 23 evaluated patients
– No patients with virologic rebound had substitutions decreasing ETV
susceptibility
 90 substitutions at 76 residues of the RT gene emerged on ETV
– None resulted in reduced susceptibility to ETV > 3-fold
Colonno R, et al. EASL 2006. Abstract 490.
clinicaloptions.com/hep
Chronic Hepatitis B Treatment:
Peginterferon
Updates in HBV Management
Sustained Responses in HBeAg(-)
Patients Treated With Peginterferon
 Long-term follow-up of a phase III, randomized trial
– Only sustained biochemical responders at 6 months in PEG
monotherapy group evaluated (n = 116)
Randomization
Month 12
Months 36*
Lamivudine 100 mg/day
(n = 181)
HBeAg-negative
patients with
chronic HBV infection
(N = 537)
Peginterferon alfa-2a 180 µg/week
+
Placebo once daily
(n = 177)
Follow-up
Peginterferon alfa-2a 180 µg/week
+
Lamivudine 100 mg/day
(n = 179)
*Current analysis.
Marcellin P, et al. EASL 2006. Abstract 743.
clinicaloptions.com/hep
Updates in HBV Management
Sustained Responses in HBeAg(-)
Patients Treated With Peginterferon

66% of patients from original study eligible for follow-up study

Biochemical response defined as ALT < 50 IU/L
–
Complete response: ALT normal at all time points
–
Partial response: ALT at times elevated but never > 50 IU/L
Sustained Response Outcomes at 24 Months Off-Treatment Follow-up
Response Criteria
Peginterferon Alfa-2a Responders, n (%)
(N = 116)
Biochemical response
69 (59)
Complete biochemical response
44 (38)
Partial biochemical response
25 (22)
Combination response (biochemical + HBV DNA
levels < 100 x 103 copies/mL)
47 (41)
HBsAg loss
11 (9)*
HBsAg seroconversion†
6 (5)
*4 patients reverted to HBsAg positivity.
†Development of anti-HBs antibody.
Marcellin P, et al. EASL 2006. Abstract 743.
clinicaloptions.com/hep
Updates in HBV Management
Sustained Responses in HBeAg(+)
Patients Treated With Peginterferon
172 Patients Treated With Peginterferon alfa-2a Monotherapy for 48 Weeks
NO
60% (n = 103)
Outcome at Month 12
Off Treatment?
Durability of HBeAg Seroconversion,
Development of HBeAg Seroconversion,
Month 12 Posttreatment
Months 6-12
100
100
91%
HBeAg
85
Maintained
seroconversion
80
80
Lost
No HBeAg
60
60
seroconversion
40
40
20
9%
0
Lau GK, et al. EASL 2006. Abstract 50.
Percentage of
Patients (n = 103)
Percentage of
Patients (n = 69)
YES
40% (n = 69)
HBeAg Seroconversion by
Month 6 Off Treatment?
20
15
0
clinicaloptions.com/hep
Hepatitis B Treatment:
Predictors of Response
Updates in HBV Management
Early Virologic Suppression as a
Predictor of Year 1 Response

Retrospective analysis of GLOBE trial (N = 1367)
– Data from lamivudine- and telbivudine-treated patients pooled
Proportion of Patients With Normalized
ALT at Week 52
Proportion of Patients With Undetectable
Viral Load at Week 52
100
91 94
80
69 67
60
40
40
30
20
5
0
< 300
300-3 log 3-4 log
10
> 4 log
Viral Load at Week 24 (copies/mL)
Zeuzem S, et al. EASL 2006. Abstract 51.
HBeAg negative
Percentage of Patients
Percentage of Patients
HBeAg positive
100
90
83
80
89
74
80
63
60
54
36
40
20
0
< 300
300-3 log 3-4 log
> 4 log
Viral Load at Week 24 (copies/mL)
clinicaloptions.com/hep
Updates in HBV Management
Early Virologic Suppression as a
Predictor of Year 1 Response
Week 24 Viral Load, %
Outcomes at Week 52*
< 300
copies/mL
300-1000
copies/mL
1000-10,000
copies/mL
> 10,000
copies/mL
Virologic breakthrough
 HBeAg-positive patients
 HBeAg-negative patients
1
0
4
7
9
17
14
44
HBeAg seroconversion
(HBeAg-positive patients)
41
26
13
4
*Pooled data from telbivudine- and lamivudine-treated individuals.

HBV DNA < 300 copies/mL at Week 24 had high positive predictive value
(PPV) for maintained suppression at Week 52 with telbivudine
– PPV lower with lamivudine
Zeuzem S, et al. EASL 2006. Abstract 51.
clinicaloptions.com/hep
Transplantation
Updates in HBV Management
Adefovir in Lamivudine-Resistant
Hepatitis B Transplant Patients


Adefovir ± ongoing lamivudine
(N = 57)
– HBIG administration posttransplant
(n = 34)
– Median adefovir treatment
– Week 48: 0%
– Week 96: 2%
– Prior to transplant: 15 wks
– Posttransplant: 36 wks
– Week 144: 2%
Detection of HBV Markers Posttransplant
Marker
HBIG,
n (%)
(n = 34)
No HBIG,
n (%)
(n = 23)

7% discontinued due to adverse
event (not ADV related)

Highest serum creatinine
posttransplant
– Normal/grade 1: 84%
Serum HBV DNA
> 1000 copies/mL
 Confirmed
 Single positive test
2 (6)
4 (12)
0 (0)
3 (13)
HBsAg positive
 Confirmed
 First test was only positive
0 (0)
2 (6)
0 (0)
2 (9)
Schiff E, et al. EASL 2006. Abstract 2.
Cumulative probability of
ADV resistance measured from
annual rates in larger study
– Grade 2: 7%
– Grade 3: 7%
– Grade 4: 2%
clinicaloptions.com/hep
Updates in HBV Management
LAM ± HBIG for Preventing HBV
Recurrence After Transplant: Year 5

29 liver transplant patients
– HBsAg positive, HBeAg positive, or anti-HBe positive
– HBV DNA negative on lamivudine or spontaneously

HBIG + Lamivudine
(n = 15)
HBIG + Lamivudine
(n = 9)
Lamivudine
(n = 14)
Lamivudine
(n = 20)
No recurrence
Recurrence (n = 4)
HBsAg positive and
HBV DNA positive
Recurrence at Months 23, 24, 44, and 48 posttransplant
– 3 of 4 individuals did not receive lamivudine pretransplant
– Additional 5 patients HBV DNA positive but not HBsAg positive
– 3/5 received lamivudine + HBIG for entire treatment duration

5-year survival rate: 90%
Buti M, et al. EASL 2006. Abstract 129.
clinicaloptions.com/hep
Updates in HBV Management
Nonliver Transplantation From antiHBc–Positive Organ Donors

Virologic and serologic outcomes of anti-HBc(-) patients who received
transplants from anti-HBc(+), HBsAg(-) donors assessed (N = 60)

5/7 who developed anti-HBc antibodies were anti-HBs negative at time of
transplant
Transplanted Organ
Anti-HBc Positive After Transplant, n (%)
Lung (n = 17)
 Anti-HBs < 100 IU/L at transplant (n = 11)
 Anti-HBs > 100 IU/L at transplant (n = 6)
4 (24)
3 (27)
1 (17)
Kidney (n = 43)
 Anti-HBs < 100 IU/L at transplant (n = 20)
 Anti-HBs > 100 IU/L at transplant (n = 23)
3 (7)
2 (10)
1 (4)

No patients became HBsAg positive following transplant

HBV DNA undetectable in 10 of 43 kidney patients with negative or low antiHBs titers
Fytili P, et al. EASL 2006. Abstract 140.
clinicaloptions.com/hep
HBV Vaccination
Updates in HBV Management
Relationship Between HBV
Vaccination and HCC Incidence

3,855,485 newborns vaccinated in Taiwan (1984-2000)
–

43,134,217 person-years of follow-up
158 cases of newly diagnosed HCC during follow-up
HCC Incidence/
100,000 Person-Years
–
–
Rates higher in girls vs boys
Receiving 4 vs 1-2 doses increased preventive effects against HCC
1.0
Girls (n = 2,009,182)
Boys (n = 1,846,303)
0.74
0.8
0.6
0.4
(n = 15)
0.44
0.43
(n = 98)
(n = 8)
0.29
0.51
(n = 49)
0.37
(n = 33)
(n = 60)
0.31
(n = 34)
0.19
(n = 19)
0.2
0
All Participants, n
1-2 Vaccine Doses, n
3 Vaccine Doses, n
4 Vaccine Doses, n
Girls
2,009,182
217,768
1,061,759
729,655
Boys
1,846,303
197,921
979,213
669,169
Chien YC, et al. EASL 2006. Abstract 247.
clinicaloptions.com/hep
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