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PEGINTERFERON ALPHA-2A PLUS RIBAVIRIN VERSUS PEGINTERFERON ALPHA-2B PLUS RIBAVIRIN IN NAIVE PATIENTS WITH CHRONIC HEPATITIS C VIRUS INFECTION: RESULTS OF A PROSPECTIVE RANDOMISED TRIAL
EASL 2008 - Update
Ascoine et.al
Ascione et al: investigator-initiated, randomized, controlled study
Follow-up
Follow-upPEG-INF α-2b 1.5 µg/kg plus
RBV 1000/1200 mg
PEGASYS® 180 µg plus RBV 1000/1200 mg
Study Weeks0 24/48 * 48/72
Randomization (1:1)
CH
C,
naï
ve,
all
G,
n=
320
* G1/4 was treated for 48 weeks, G2/3 was treated for 24 weeks
Ascione et al, EASL 2008, late-breaker, oral
Ascione et al – Results (ITT)
Ascione et al, EASL 2008, late-breaker, oral
54.8%
88.1%
54.4%
39.8%
74.6%68.7%
0%
20%
40%
60%
80%
100%
Overall G1/4 G2/3
SV
R [
%]
PEGASYS plus RBV PEG-INF alfa-2b plus RBV
p=0.008 p=0.04 p=0.046
+26% +37% +18%
Ascione et al - Results (ITT)
75.6%
42.4%
54.4% 56.0%
46.2%
68.7%
0%
20%
40%
60%
80%
100%
Overall Non-cirrhotics Cirrhotics
SV
R [
%]
PEGASYS plus RBV PEG-INF alfa-2b plus RBV
Ascione et al, EASL 2008, late-breaker, oral
p=0.008 p=0.0009 p=0.7
+26% +35%
Ascione et al – Results (ITT)
69.0%
54.4%46.2%
68.7%
0%
20%
40%
60%
80%
100%
Overall HCV RNA >500,000 IU/mL
SV
R [
%]
PEGASYS plus RBV PEG-INF alfa-2b plus RBV
Ascione et al, EASL 2008, late-breaker, oral
p=0.008 p=0.002
+26% +49%
Ascione et al – Results and Conclusion
Results:
• At multivariate analysis the variables independently associated with SVR were male sex; absence of cirrhosis; G2/3; treatment with PEGASYS®
• Side effects were similar, although there were more withdrawals for side effects in the group treated with PEG-INF α-2b.
Ascione et al, EASL 2008, late-breaker, oral
Conclusions
Pegasys has been shown to be superior over PEG-INF alfa-2b in a high standard comparative study
Pegasys has been shown to be superior in the broadest range of patients:
• All genotypes (1-4)
• Majority of patients (non-cirrhotic)
• High viral load (>500,000 IU)
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