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When, how and which patient to treat with HBV infection.
David MutimerQueen Elizabeth Hospital
Birmingham, England.
BSG Post-graduate CourseMarch 20th 2006.
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WHO Global Burden of Disease 2000
Cirrhosis (all causes)
• 785,000 deaths per annum from liver failure (cirrhosis, all causes) HBV 40% HCV 25% Other causes 35%
• 600,000 deaths per annum from HCC HBV 57% HCV18% Other causes 25%
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WHO Global Burden of Disease 2000
Mortality from HBV & HCV
• 1 million deaths per annum
including deaths from cirrhosis and/or liver cancer
• HBV causes 644,000 deaths per annum
• HCV causes 325,000 deaths per annum
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When , how and which patient to treat with HBV infection.
David MutimerQueen Elizabeth Hospital
Birmingham, England.
BSG Post-graduate CourseMarch 20th 2006.
= who?
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Where do carriers come from?
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Where do carriers come from?
Acute infection
Chronic infection“carrier”
<5% risk
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Acute HBV infectionn=2,876
Resolution & immunityn=2,660
Chronic infectionn=216
Transmission of HBV in England & WalesHahné et al J Clin Virol 2004;29:211-220.
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To E & W From E & WNet
migration
Migrants 300,820 210,600 90,220
Migrants with chronic
HBV9,922 3,351 6,571
Transmission of HBV in England & WalesHahné et al J Clin Virol 2004;29:211-220.
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New chronic infections in England & Wales (per annum)
• Arising in E & W n = 216 (3%)
• Coming from abroad n = 6,571 (97%)
Transmission of HBV in England & WalesHahné et al J Clin Virol 2004;29:211-220.
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Where do carriers come from?
Acute infection
Chronic infection“carrier”
<5% risk
“carrier” from abroad
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Where do carriers come from?
Acute infection
Chronic infection“carrier”
<5% risk
“carrier” from abroad
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HBV Notifications in England & Wales
0
100
200
300
400
500
600
700
800
1990 1992 1994 1996 1998 2000 2002 2004
year
notif
icat
ions
male female
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HBV Notifications in England & Wales (1990 to 2003)
0
500
1000
1500
2000
2500
3000
3500
4000
notif
icat
ions
<1 1 to 4 5 to 9 10 to14
15 to24
25 to34
35 to44
45 to54
55 to64
> 64
age group
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0 20 40 50
HBeAg+ve HIGH-LEVEL REPLICATION
LOW-LEVEL REPLICATION
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0 20 40 50
HBeAg+ve
HBeAg-ve
HIGH-LEVEL REPLICATION
LOW-LEVEL REPLICATION
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HIGH-LEVEL REPLICATION
LOW-LEVEL REPLICATION
0 20 40 50
HBeAg+ve
HBeAg-ve
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0 20 40 50
HBeAg+ve
HBeAg-ve
HIGH-LEVEL REPLICATION
LOW-LEVEL REPLICATION
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0 20 40 50
HBeAg+ve
HBeAg-ve
HIGH-LEVEL REPLICATION
LOW-LEVEL REPLICATION
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HBV DEATH
0 20 40 50
HBeAg+ve
HBeAg-ve
HIGH-LEVEL REPLICATION
LOW-LEVEL REPLICATION
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0
20
40
60
80
100
120
0 to 10
11 to 20
21 to 30
31 to 40
41 to 50
51 to 60
61 to 70
> 70
num
ber
tran
spla
nted
male female
Liver Transplantation for Chronic HBV
UK Transplant data : 1990-2003
Male:female297:47 (6:1)
Median age 50
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When , how and which patient to treat with HBV infection.
David MutimerQueen Elizabeth Hospital
Birmingham, England.
BSG Post-graduate CourseMarch 20th 2006.
= who?
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When , how and which patient to treat with HBV infection.
David MutimerQueen Elizabeth Hospital
Birmingham, England.
BSG Post-graduate CourseMarch 20th 2006.
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0 20 40 50
HBeAg+ve
Aim of Treatment• HBeAg seroconversionChoice of treatment• Interferon• Lamivudine• AdefovirBut!• High rate of spontaneous seroconversion• Little increase with treatment• A lot of females!
HIGH-LEVEL REPLICATION
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0 20 40 50
HBeAg+ve
Aim of Treatment• HBeAg seroconversionChoice of treatment• Interferon• Lamivudine• AdefovirBut!• High rate of spontaneous seroconversion• Little increase with treatment• A lot of females!
HIGH-LEVEL REPLICATION
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0 20 40 50
HBeAg+ve
Aim of Treatment• HBeAg seroconversionChoice of treatment• Interferon• Lamivudine• AdefovirBut!• High rate of spontaneous seroconversion• Little increase with treatment• A lot of females!
HIGH-LEVEL REPLICATION
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Spontaneous HBeAg SeroconversionItalian children
Bortolotti et al J Hep 1998168 HBeAg +veMedian age 5 at entry
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HBeAg seroconversion @ 8% per annum
Spontaneous HBeAg SeroconversionItalian children
Bortolotti et al J Hep 1998168 HBeAg +veMedian age 5 at entry
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Case 1
• 20 year old Asian lady
• HBeAg-positive
• ALT 50, other LFT’s normal
• ? liver biopsy
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Case 1
• 20 year old Asian lady
• HBeAg-positive
• ALT 50, other LFT’s normal
• ? liver biopsy – I wouldn’t
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Case 1
• 20 year old Asian lady
• HBeAg-positive
• ALT 50, other LFT’s normal
• ? liver biopsy – I wouldn’t
• ? antiviral treatment
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Case 1
• 20 year old Asian lady
• HBeAg-positive
• ALT 50, other LFT’s normal
• ? liver biopsy – I wouldn’t
• ? antiviral treatment – I wouldn’t
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Case 1
• 20 year old Asian lady
• HBeAg-positive
• ALT 50, other LFT’s normal
• ? liver biopsy – I wouldn’t
• ? antiviral treatment – I wouldn’t
• what happened next?
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Case 1
• 20 year old Asian lady
• HBeAg-positive
• ALT 50, other LFT’s normal
• ? liver biopsy – I wouldn’t
• ? antiviral treatment – I wouldn’t
• what happened next? annual review spontaneous HBeAg seroconversion
2 years later
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HBV DEATH
0 20 40 50
HBeAg+ve
HBeAg-ve
Replication after 40• Death wish• Always treat!Aim of treatment• HBV suppression• (HBeAg seroconversion)Choice of treatment• Lamivudine• Adefovir• (Interferon)
HIGH-LEVEL REPLICATION
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HBV DEATH
0 20 40 50
HBeAg+ve
HBeAg-ve
Replication after 40• Death wish• Always treat!Aim of treatment• HBV suppression• (HBeAg seroconversion)Choice of treatment• Lamivudine• Adefovir• (Interferon)
HIGH-LEVEL REPLICATION
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HBV DEATH
0 20 40 50
HBeAg+ve
HBeAg-ve
Replication after 40• Death wish• Always treat!Aim of treatment• HBV suppression• (HBeAg seroconversion)Choice of treatment• Lamivudine• Adefovir• (Interferon)
HIGH-LEVEL REPLICATION
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Case 2
• 47 year old Chinese male
• HBeAg-negative
• ALT 55
• what else?
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Case 2
• 47 year old Chinese male
• HBeAg-negative
• ALT 55
• what else? HBV DNA 500,000 copies/ml US heterogeneous liver liver biopsy
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Case 2
• 47 year old Chinese male
• HBeAg-negative
• ALT 55
• what else? HBV DNA 500,000 copies/ml US heterogeneous liver liver biopsy
• antiviral treatment?
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Case 2
• 47 year old Chinese male
• HBeAg-negative
• ALT 55
• what else? HBV DNA 500,000 copies/ml US heterogeneous liver liver biopsy
• antiviral treatment? definitely – with nucleosides
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0 20 40 50
Treat?• High risk population• Lowest risk have “self-sorted”• Males > females• 30’s > 20’s• Suppression prevents fibrosis• Indefinite suppression possible!
Observe?• Further spontaneous selection likely• Females > males• 20’s > 30’s • Reduces costs (indefinite duration of treatment)• Reduces toxicity (cumulative)• Family planning• Fibrosis is reversible!
HBeAg+ve
HBeAg-ve
HIGH-LEVEL REPLICATION
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0 20 40 50
Treat?• High risk population• Lowest risk have “self-sorted”• Males > females• 30’s > 20’s• Suppression prevents fibrosis• Indefinite suppression possible!
Observe?• Further spontaneous selection likely• Females > males• 20’s > 30’s • Reduces costs (indefinite duration of treatment)• Reduces toxicity (cumulative)• Family planning• Fibrosis is reversible!
HBeAg+ve
HBeAg-ve
HIGH-LEVEL REPLICATION
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0 20 40 50
Treat?• High risk population• Lowest risk have “self-sorted”• Males > females• 30’s > 20’s• Suppression prevents fibrosis• Indefinite suppression possible!
Observe?• Further spontaneous selection likely• Females > males• 20’s > 30’s • Reduces costs (indefinite duration of treatment)• Reduces toxicity (cumulative)• Family planning• Fibrosis is reversible!
HBeAg+ve
HBeAg-ve
HIGH-LEVEL REPLICATION
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0 20 40 50
Treat?• High risk population• Lowest risk have “self-sorted”• Males > females• 30’s > 20’s• Suppression prevents fibrosis• Indefinite suppression possible?
Observe?• Further spontaneous selection likely• Females > males• 20’s > 30’s • Fibrosis is reversible? • Reduces costs (indefinite duration of treatment)• Reduces toxicity (cumulative)• Family planning
HBeAg+ve
HBeAg-ve
HIGH-LEVEL REPLICATION
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0 20 40 50
Treat?• High risk population• Lowest risk have “self-sorted”• Males > females• 30’s > 20’s• Suppression prevents fibrosis• Indefinite suppression possible!
Observe?• Further spontaneous selection likely• Females > males• 20’s > 30’s • Fibrosis is reversible! • Reduces costs (indefinite duration of treatment)• Reduces toxicity (cumulative)• Family planning
HBeAg+ve
HBeAg-ve
HIGH-LEVEL REPLICATION
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0 20 40 50
Treat?• High risk population• Lowest risk have “self-sorted”• Males > females• 30’s > 20’s• Suppression prevents fibrosis• Indefinite suppression possible!
Observe?• Further spontaneous selection likely• Females > males• 20’s > 30’s • Fibrosis is reversible! • Reduces costs (indefinite duration of treatment)• Reduces toxicity (cumulative)• Family planning
LIVER BIOPSY!
HBeAg+ve
HBeAg-ve
HIGH-LEVEL REPLICATION
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IFN or Lamivudine or Adefovir?IFN Lamivudine Adefovir
HBeAg seroconversion
superiorbut prolonged treatment associated with
ongoing HBeAg loss
HBsAg seroconversion
superiorreports of HBsAg loss (genotype dependent)
prolonged suppression
inferioruntil resistance
(20% per annum)superior
(resistance <5% pa)
tolerability inferior superior superior
safetysupervision
autoimmunityexcellent excellent
cost expensive inexpensive expensive
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IFN or Lamivudine or Adefovir?IFN Lamivudine Adefovir
HBeAg seroconversion
superiorbut prolonged treatment associated with
ongoing HBeAg loss
HBsAg seroconversion
superiorreports of HBsAg loss (genotype dependent)
prolonged suppression
inferioruntil resistance
(20% per annum)superior
(resistance <5% pa)
tolerability inferior superior superior
safetysupervision
autoimmunityexcellent excellent
cost expensive inexpensive expensive
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HBeAg SeroconversionSpontaneous vs Nucleosides vs Interferon
0%
5%
10%
15%
20%
25%
30%
HB
eAg
seoc
onve
rsio
n
spontaneous nucleosides interferon
spontaneous
nucleosides
interferon
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Incidence
Incidence of HBeAg Seroconversion in Patients Treated with Adefovir or Lamivudine
0%
10%
20%
30%
40%
50%
60%
% s
eroc
onve
rsio
n
6 12 18 24 36 48
months
ADV
LAM (published)
LAM (B'ham data)
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IFN or Lamivudine or Adefovir?IFN Lamivudine Adefovir
HBeAg seroconversion
superiorbut prolonged treatment associated with
ongoing HBeAg loss
HBsAg seroconversion
superiorreports of HBsAg loss (genotype dependent)
prolonged suppression
inferioruntil resistance
(20% per annum)superior
(resistance <5% pa)
tolerability inferior superior superior
safetysupervision
autoimmunityexcellent excellent
cost expensive inexpensive expensive
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IFN or Lamivudine or Adefovir?IFN Lamivudine Adefovir
HBeAg seroconversion
superiorbut prolonged treatment associated with
ongoing HBeAg loss
HBsAg seroconversion
superiorreports of HBsAg loss (genotype dependent)
prolonged suppression
inferioruntil resistance
(20% per annum)superior
(resistance <5% pa)
tolerability inferior superior superior
safetysupervision
autoimmunityexcellent excellent
cost expensive inexpensive expensive
![Page 59: When, how and which patient to treat with HBV infection. David Mutimer Queen Elizabeth Hospital Birmingham, England. BSG Post-graduate Course March 20](https://reader035.vdocuments.net/reader035/viewer/2022062423/56649c735503460f94925f35/html5/thumbnails/59.jpg)
Incidence
Incidence of Resistance in Patients Treated with Adefovir, Lamivudine, Entecavir, FTC, LdT
0%
24%
0%
13%
5% 2%
42%
0%
18%
14% 4%
53%
15%
70%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
year 1 year 2 year 3 year 4
ADV
LAM
ENT
FTC
LdT
Incidence of resistance
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IFN or Lamivudine or Adefovir?IFN Lamivudine Adefovir
HBeAg seroconversion
superiorbut prolonged treatment associated with
ongoing HBeAg loss
HBsAg seroconversion
superiorreports of HBsAg loss (genotype dependent)
prolonged suppression
inferioruntil resistance
(20% per annum)superior
(resistance <5% pa)
tolerability inferior superior superior
safetysupervision
autoimmunityexcellent excellent
cost expensive inexpensive expensive
![Page 61: When, how and which patient to treat with HBV infection. David Mutimer Queen Elizabeth Hospital Birmingham, England. BSG Post-graduate Course March 20](https://reader035.vdocuments.net/reader035/viewer/2022062423/56649c735503460f94925f35/html5/thumbnails/61.jpg)
IFN or Lamivudine or Adefovir?IFN Lamivudine Adefovir
HBeAg seroconversion
superiorbut prolonged treatment associated with
ongoing HBeAg loss
HBsAg seroconversion
superiorreports of HBsAg loss (genotype dependent)
prolonged suppression
inferioruntil resistance
(20% per annum)superior
(resistance <5% pa)
tolerability inferior superior superior
safetysupervision
autoimmunityexcellent excellent
cost expensive inexpensive expensive
![Page 62: When, how and which patient to treat with HBV infection. David Mutimer Queen Elizabeth Hospital Birmingham, England. BSG Post-graduate Course March 20](https://reader035.vdocuments.net/reader035/viewer/2022062423/56649c735503460f94925f35/html5/thumbnails/62.jpg)
IFN or Lamivudine or Adefovir?IFN Lamivudine Adefovir
HBeAg seroconversion
superiorbut prolonged treatment associated with
ongoing HBeAg loss
HBsAg seroconversion
superiorreports of HBsAg loss (genotype dependent)
prolonged suppression
inferioruntil resistance
(20% per annum)superior
(resistance <5% pa)
tolerability inferior superior superior
safetysupervision
autoimmunityexcellent excellent
cost expensive inexpensive expensive
![Page 63: When, how and which patient to treat with HBV infection. David Mutimer Queen Elizabeth Hospital Birmingham, England. BSG Post-graduate Course March 20](https://reader035.vdocuments.net/reader035/viewer/2022062423/56649c735503460f94925f35/html5/thumbnails/63.jpg)
HBV TreatmentLicensed options 2006
Non-cirrhotic CirrhoticPost-transplant
HIV co-infected
HBeAg-positive
HBeAg-negative
![Page 64: When, how and which patient to treat with HBV infection. David Mutimer Queen Elizabeth Hospital Birmingham, England. BSG Post-graduate Course March 20](https://reader035.vdocuments.net/reader035/viewer/2022062423/56649c735503460f94925f35/html5/thumbnails/64.jpg)
HBV TreatmentLicensed options 2006
Non-cirrhotic CirrhoticPost-transplant
HIV co-infected
HBeAg-positive
IFN
Nucleosides
HBeAg-negative
Nucleosides
IFN
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HBV TreatmentLicensed options 2006
Non-cirrhotic CirrhoticPost-transplant
HIV co-infected
HBeAg-positive
IFN
NucleosidesNucleosides
HBeAg-negative
Nucleosides
IFNNucleosides
![Page 66: When, how and which patient to treat with HBV infection. David Mutimer Queen Elizabeth Hospital Birmingham, England. BSG Post-graduate Course March 20](https://reader035.vdocuments.net/reader035/viewer/2022062423/56649c735503460f94925f35/html5/thumbnails/66.jpg)
HBV TreatmentLicensed options 2006
Non-cirrhotic CirrhoticPost-transplant
HIV co-infected
HBeAg-positive
IFN
NucleosidesNucleosides Nucleosides
HBeAg-negative
Nucleosides
IFNNucleosides Nucleosides
![Page 67: When, how and which patient to treat with HBV infection. David Mutimer Queen Elizabeth Hospital Birmingham, England. BSG Post-graduate Course March 20](https://reader035.vdocuments.net/reader035/viewer/2022062423/56649c735503460f94925f35/html5/thumbnails/67.jpg)
Who and how to treat HBV?
• The patient with likely progressive liver damage requires viral replication over prolonged period easier to identify as (s)he gets older liver biopsy is useful
• Expert clinical guidelines rely heavily on published clinical trials which cannot assess strategy of prolonged
inhibition of viral replication which rely on analysis after brief post-treatment
follow-up IFN or nucleosides?