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![Page 1: Stefan ZEUZEM. What is the optimal treatment of naive patients with chronic hepatitis C ? 2 nd Paris Hepatitis Conference Palais des Congrès, Paris, 22-23.](https://reader035.fdocuments.in/reader035/viewer/2022062321/56649dc95503460f94abf866/html5/thumbnails/1.jpg)
Stefan ZEUZEM
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What is the optimal treatment of naive patients
with chronic hepatitis C ?
2nd Paris Hepatitis Conference Palais des Congrès, Paris, 22-23 January 2007
Stefan ZeuzemJ.W. Goethe University Hospital
Frankfurt, Germany
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Peginterferon alfa-2a/2b + Ribavirin for treatment of chronic hepatitis C
37
61
46
76
0
20
40
60
80
100
IFN + RBV PEG-IFNalfa-2a +
RBV
33
79
42
82
0
20
40
60
80
100
IFN + RBV PEG-IFNalfa-2b +
RBV
HCV-1
HCV-2,3
Su
sta
ine
d vi
rolo
gic
S
ust
ain
ed
viro
log
ic
resp
ons
e (
%)
resp
ons
e (
%)
Manns et al., Lancet 2001;358:958-965
Fried et al., N Engl J Med 2002; 347:975-982
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PEG-IFN alfa-2a + RBV (LD vs SD) for treatment of chronic hepatitis C
29
42 41
52
0
20
40
60
80
100
24 wks 48 wks
84 81 79 80
0
20
40
60
80
100
24 wks 48 wks
Su
sta
ine
d vi
rolo
gic
S
ust
ain
ed
viro
log
ic
resp
ons
e (
%)
resp
ons
e (
%)
Hadziyannis et al., Ann Intern Med 2004;40:346-355
HCV-1 HCV-2,3
RBV 800 mg/d RBV 1000-1200 mg/d
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HCV genotyping
HCV-1 (4,5,6)HCV RNA quant.
HCV-2,3
Combination treatment800 mg Ribavirin
for 24 weeks
Combination treatment1000-1200 mg Ribavirin
HCV RNA quant. at week 12
< 2log decline 2log declineHCV RNA +
stop treatmentor
continue withPEG-IFN alone
for inhibition of fibrosis
progression
continue txuntil week 24
if HCV RNA -continue tx
until week 48
2log declineHCV RNA -
continue txuntil week 48
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Individualisation according to HCV genotype:
Shorter treatment in HCV-1?
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Virologic response in patients with HCV-1 and HCV RNA < 600,000 IU/mL
0
10
20
30
40
50
60
70
80
90
All patients Week 4 Week 12 Week 24/EOT
SVR
Relapse
Time to first negative HCV RNAPEG-IFN -2b + RBVZeuzem et al., J Hepatol 2006
Pat
ient
s (%
)
(47%) (26%) (10%)
50%
37%
89%
25%17%
8%
75%80%
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Patients with HCV-1 and HCV RNA < 600,000 IU/mL
Investigator HCV-1patients
HCV-1 & LVL
Quantification assay
Data source
Manns et al. 1034 290 (28.1%)
qPCR (NGI) Lancet 2001
Jacobson et al.
2710 989(36.5%)
SP TaqMan SPRI data base
Fried et al. 725 253(34.9%)
Cobas Amplicor HCV Monitor 2.0
NEJM 2002
Hadziyannis et al.
740 267(36.1%)
Cobas Amplicor HCV Monitor 2.0
Ann Intern Med 2004
Total 5209 1799(34.5%)
Zeuzem, Zeuzem, J HepatolJ Hepatol 2006 2006
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Early identification of HCV 1 patients responding to 24 wks PEG-IFN alfa-2a/RBV
89 88
73
91
1623
3544
0
20
40
60
80
100
HCV RNA < 50IU/mL at week 4
HCV RNA > 50IU/mL at week 4
24-LD
24-SD
48-LD
48-SD
Jensen et al., Jensen et al., HepatologyHepatology 2006;43:954-60
Sus
tain
ed v
irolo
gic
Sus
tain
ed v
irolo
gic
resp
onse
(%
)re
spon
se (
%)
18 33 40 55 81 84 208 210
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*Logit scale5.6 log10 IU/mL ~400 x103 IU/mL
GAM analysisEffect of pre-treatment HCV RNA on SVR
Pro
bab
ility
of
SV
R*
Baseline HCV RNA (log10 IU/ml)
3 4 6 75
0.5
0.88
0.98
0.9985.6 log10 IU/mL
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Individualisation according to HCV genotype:
Longer treatment in HCV-1 ?
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Extended treatment duration for HCV 1: 48 vs 72 weeks of PEG-IFN alfa-2a + RBV
80 76
17
29
0
10
20
30
40
50
60
70
80
HCV RNA < 50 IU/mL at week 12
HCV RNA ≥ 50 IU/mL at week 12
48 wks
72 wks
Sus
tain
ed v
irolo
gic
resp
onse
rat
e (%
)
Berg, et al. Gastroenterology 2006;130:1086-1097
104/130 90/119 17/100 31/106
P=0.040
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Virologic relapse rates in patients with rapid virologic response
7
16 1512
0
5
10
15
20
25
30
< 50 IU/mL < 50 IU/mL
48 wks
72 wks
Berg, et al. Gastroenterology 2006;130:1086-1097
Viro
logi
c re
laps
e ra
te (
%)
Week 4 Week 12
19/123 12/1013/46 5/32
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Virologic relapse rates in patients with slow virologic response
37
23
64
40
0
10
20
30
40
50
60
70
> 50 IU/mL > 50 IU/mL
48 wks
72 wks
Berg, et al. Gastroenterology 2006;130:1086-1097
Viro
logi
c re
laps
e ra
te (
%)
Week 4 Week 12
30/47 21/5246/124 28/122
P=0.016 P=0.021
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Peginterferon alfa-2a plus ribavirin for 48 vs. 72 weeks in patients with detectable
HCV RNA at week 4 of treatment
0
10
20
30
40
50
60
HCV-1 HCV-1 / <800,000 IU/mL
HCV-1 / >800,000 IU/mL
48 wks
72 wks
Sanchez-Tapias et al., Gastroenterology 2006;131:451-460
Sus
tain
ed v
irolo
gic
resp
onse
rat
e (%
)
28%
44%
27% 28%
51%
37%
P=0.003 P=0.002 P=0.35
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Peginterferon alfa-2a plus ribavirin for 48 vs. 72 weeks in patients with detectable
HCV RNA at week 4 of treatment
0
10
20
30
40
50
60
HCV-1 HCV-1 / <800,000 IU/mL
HCV-1 / >800,000 IU/mL
48 wks
72 wks
Sanchez-Tapias et al., Gastroenterology 2006;131:451-460
Viro
logi
c re
laps
e ra
te (
%)
17%
53%
27%23%
55%50%
P=0.002 P=0.007 P=0.15
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Individualisation according to HCV genotype:
Shorter treatment in HCV-2 and HCV-3 ?
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PEG-IFN-2b + RBV for treatment of chronic HCV-2 and -3 infection (ITT)
0%
20%
40%
60%
80%
100%
all patients 14 wks tx 24 wks tx
SVR
Relapse
NR
Pat
ient
s (%
)
82%
10%14%
90%
56%
26%
Dalgard et al., Hepatology 2004;40:1260-65
4% 0%
19%
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End-of-treatment (ETR) and sustained virologic response (SVR)
- HCV genotypes 2 and 3 combined -
0%
20%
40%
60%
80%
100%
Group A Group B Group C
ETR
SVR
Viro
logi
c re
spon
se (
%) 94%
81%
67/71
SVR B vs C: SVR B vs C: PP = 0.003 = 0.003
(16 weeks)(16 weeks) (24 weeks)(24 weeks)
82% 86%
69%
39%
(24 weeks)(24 weeks)
58/71 59/69 56/69 9/13 5/13
v. Wagner et al, Gastroenterology 2005
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Sustained virologic response (SVR) according to HCV genotype
0%
20%
40%
60%
80%
100%
Group A Group B Group C
HCV-2
HCV-3
SV
R (
%)
76% 77%
40/53
(24 weeks)(24 weeks) (12 weeks)(12 weeks)
76%87%
72%
41%
(24 weeks)(24 weeks)
13/17 89/102 24/31 42/58 9/22
Mangia et al, N Engl J Med 2005
Tx: PEG-IFN alfa-2b 1.0 µg/kg + RBV 1000-1200 mg
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Treatment of chronic HCV-2 infection with PEG-IFN alfa-2a + RBV for 16 vs. 24 weeks
0%
20%
40%
60%
80%
100%
RVR SVR
16 weeks 24 weeks
Viro
logi
c re
spon
se (
%)
86%94%
43/50
87%95%
87/100 47/50 95/100
M-L Yu et al, GUT 2006
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PEG-IFN alfa-2a + RBV for 16 or 24 weeks in HCV-2 and -3 (ACCELERATE Study)
65% 62%
76%70%
0%
20%
40%
60%
80%
100%
Standard Analysis Intent-to-treat
16 weeks PEG-IFN alfa-2a 180 ug + RBV 800 mg24 weeks PEG-IFN alfa-2a 180 ug + RBV 800 mg
P <.0001P <.0001 P =.0004P =.0004
N=679 N=732 N=731N=630
Shiffman et al., Late-Breaker Abstract EASL 2006Shiffman et al., Late-Breaker Abstract EASL 2006
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84%
61%
83%
59%
89%80% 85%
66%
0%
20%
40%
60%
80%
100%
≤400,000 IU/mL >400,000 IU/mL ≤400,000 IU/mL >400,000 IU/mL
16 weeks PEG-IFN alfa-2a 180 ug + Ribavirin 800 mg24 weeks PEG-IFN alfa-2a 180 ug + Ribavirin 800 mg
SV
R (
%)
SV
R (
%)
Standard population; VR = HCV RNA < 50 IU/mLStandard population; VR = HCV RNA < 50 IU/mL
Genotype 2Genotype 2 Genotype 3Genotype 3
N=61 N=46 N=285 N=92 N=84 N=241 N=243N=257
74%74%
94%94%
80%80%
98%98%
56%56%
67%67%75%75%
85%85%90%90%
70%70%
92%92%
77%77%
52%52%
65%65%
72%72%
60%60%
Shiffman et al., Late-Breaker Abstract EASL 2006Shiffman et al., Late-Breaker Abstract EASL 2006
PEG-IFN alfa-2a + RBV for 16 or 24 weeks in HCV-2 and -3 (ACCELERATE Study)
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PEG-IFN alfa-2a 180 µg qw Ribavirin 800 mg qd
PEG-IFN α-2a 180 µg qwRibavirin
800-1200 mg qd
PEG-IFN α-2b 1.0 µg/kg qw
Ribavirin 1000-1200 mg qd
PEG-IFN α-2b 1.5 µg/kg qw
Ribavirin 800-1400 mg qd
No Yes Yes Yes
1221531469
(993 US)273
Global Italy Germany Norway
~0.6 x 106 50%<0.6 x 106~1 x 1065.6 x 106
46 46.6-49.7 38-42 37 (median)
81.5 69.5 74-80 76 (median)
50% 78% 25% 19%
RegimenRegimen
% GT 2% GT 2
NumberNumber
RegionRegion
Mean baseline Mean baseline viral load viral load IU/mlIU/ml
Mean Age (yrs)Mean Age (yrs)
Treatment Treatment duration based duration based on RVR?on RVR?
Mean body Mean body weight (kg)weight (kg)
ACCELERATEACCELERATE VON WAGNERVON WAGNERMANGIAMANGIA DALGARDDALGARD
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Individualisation according to HCV genotype:
Longer treatment in HCV-3 (HVL) ?
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Relapse rate by HCV genotype and baseline viral load in patients treated for
24 weeks (Peg-IFN alfa-2b + RBV)
0
5
10
15
20
25
< 600,000IU/mL
> 600,000IU/mL
< 600,000IU/mL
> 600,000IU/mL
Rel
apse
(%
)
HCV-2 HCV-3
5%9% 8%
23%
Zeuzem et al., J Hepatol 2004
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Individualisation according to HCV genotype:
Treatment duration for HCV-4 ?
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PEG-IFN-2a + ribavirin for treatment of patients with chronic HCV-4 infection
0
10
20
30
40
50
60
70
80
24 weeks 48 weeks
800 mg RBV
1000/1200 mg RBV
sust
aine
d vi
rolo
gic
resp
onse
(%
)
0%
67%63%
79%
M Diago et al., Ann Intern Med 2004;140:72-73
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Sustained virologic response (SVR) in patients infected with HCV-4
0%
20%
40%
60%
80%
100%
24 weeks 36 weeks 48 weeks
SV
R (
%)
66%
29%
69%
Kamal et al, GUT 2005
Tx: PEG-IFN alfa-2b 1.5 µg/kg + RBV 1000-1200 mg
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Sustained virologic response (SVR) in patients infected with HCV-4 (HVL)
0%
20%
40%
60%
80%
100%
24 weeks 36 weeks 48 weeks
SV
R (
%)
35%
0%
65%
Kamal et al, GUT 2005
Tx: PEG-IFN alfa-2b 1.5 µg/kg + RBV 1000-1200 mg
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Future individualization of therapy
0 1 2 31
2
3
4
5
6
7
7 14 21 28
Limit of detection
days
Se
rum
HC
V R
NA
(lo
g)
FPR (0.0 < 0,05)
RVR( 0.35)
NR (c < 0,2)
HCV-2, HCV-3 (LVL) 12-16 WochenDelgaard et al. 2005; v. Wagner et al. 2005Mangia et al. 2005, Shiffman et al. 2006
HCV-2 (HVL) 24 WeeksShiffman et al. 2006
HCV-3 (HVL), HCV-4 (LVL)36-48 (?) Wochenv. Wagner et al. 2005, Kamal et al. 2006
HCV-1 (LVL, RVR) 24 WochenZeuzem et al. 2004, Zeuzem et al. 2005
HCV-1, HCV-4 48 WochenManns et al. 2002, Hadziyannis et al. 2004Kamal et al., 2005
HCV-1 (SPR) 72 WochenButi et al. 2003, Berg et al. 2006
(0.05 < 0.35)SPR
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Conclusions (1)
• Virologic response rates are better in HCV-2 than HCV-3 infected patients
• Certain patients with HCV-2 or HCV-3 infection may be successfully treated with 12-16 weeks of combination therapy
• Patients infected with HCV-3 and high viral load may require longer than 24 weeks of combination therapy
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Conclusions (2)
• Patients infected with HCV-1 and low baseline viral load who respond early (at week 4) may only require 24 weeks of combination therapy
• Slow viral responders infected with HCV-1 benefit from longer than 48 weeks of combination therapy
• Compliance and adherence important
• Future options: small molecules (HCV protease and polymerase inhibitors)
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