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 Update Ascoine et.al

Ascione et al: investigator-initiated, randomized, controlled study Follow-up PEG-INF α-2b 1.5 µg/kg plus RBV 1000/1200 mg PEGASYS ® 180 µg plus RBV 1000/1200 mg Study Weeks 024/48 * 48/72 Randomization (1:1) CHC, naïve, 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 p=0.008p=0.04p= % +37% +18%

Ascione et al - Results (ITT) Ascione et al, EASL 2008, late-breaker, oral p=0.008p=0.0009p= % +35%

Ascione et al – Results (ITT) Ascione et al, EASL 2008, late-breaker, oral p=0.008p= % +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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