PEGINTERFERON ALPHA2 A PLUS RIBAVIRIN VERSUS PEGINTERFERON ALPHA2

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PEGINTERFERON ALPHA-2 A PLUS RIBAVIRIN VERSUS PEGINTERFERON ALPHA-2 B PLUS RIBAVIRIN IN NAIVE PATIENTS

PEGINTERFERON ALPHA-2 A PLUS RIBAVIRIN VERSUS PEGINTERFERON ALPHA-2 B PLUS RIBAVIRIN IN NAIVE PATIENTS WITH CHRONIC HEPATITIS C VIRUS INFECTION: RESULTS OF A PROSPECTIVE RANDOMISED TRIAL Ascoine et. al EASL 2008 - Update

CHC, naïve, all G, n=320 Ascione et al: investigator-initiated, randomized, controlled study PEG-INF α-2

CHC, naïve, all G, n=320 Ascione et al: investigator-initiated, randomized, controlled study PEG-INF α-2 b 1. 5 µg/kg plus RBV 1000/1200 mg Follow-up PEGASYS® 180 µg plus RBV 1000/1200 mg Follow-up 0 Study Weeks 24/48 * Randomization (1: 1) * G 1/4 was treated for 48 weeks, G 2/3 was treated for 24 weeks Ascione et al, EASL 2008, late-breaker, oral 48/72

Ascione et al – Results (ITT) p=0. 008 p=0. 04 +26% +37% Ascione et

Ascione et al – Results (ITT) p=0. 008 p=0. 04 +26% +37% Ascione et al, EASL 2008, late-breaker, oral p=0. 046 +18%

Ascione et al - Results (ITT) p=0. 008 +26% Ascione et al, EASL 2008,

Ascione et al - Results (ITT) p=0. 008 +26% Ascione et al, EASL 2008, late-breaker, oral p=0. 0009 +35% p=0. 7

Ascione et al – Results (ITT) p=0. 008 p=0. 002 +26% +49% Ascione et

Ascione et al – Results (ITT) p=0. 008 p=0. 002 +26% +49% Ascione et al, EASL 2008, late-breaker, oral

Ascione et al – Results and Conclusion } Results: • At multivariate analysis the

Ascione et al – Results and Conclusion } Results: • At multivariate analysis the variables independently associated with SVR were male sex; absence of cirrhosis; G 2/3; treatment with PEGASYS® • Side effects were similar, although there were more withdrawals for side effects in the group treated with PEG-INF α-2 b. Ascione et al, EASL 2008, late-breaker, oral

Conclusions } Pegasys has been shown to be superior over PEG-INF alfa-2 b in

Conclusions } Pegasys has been shown to be superior over PEG-INF alfa-2 b 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)