Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients: A randomized trial

✍ Scribed by Ira M. Jacobson; Robert S. Brown Jr; Bradley Freilich; Nezam Afdhal; Paul Y. Kwo; John Santoro; Scott Becker; Adil E. Wakil; David Pound; Eliot Godofsky; Robert Strauss; David Bernstein; Steven Flamm; Mary Pat Pauly; Pabak Mukhopadhyay; Louis H. Griffel; Clifford A. Brass

• Publisher: John Wiley and Sons
• Year: 2007
• Tongue: English
• Weight: 339 KB
• Volume: 46
• Category: Article
• ISSN: 0270-9139
• DOI: 10.1002/hep.21932

✦ Synopsis

Clifford A. Brass, 15 and the WIN-R Study Group This prospective, multicenter, community-based and academic-based, open-label, investigator-initiated, U.S. study evaluated efficacy and safety of pegylated interferon (PEG-IFN) alfa-2b plus a flat or weight-based dose of ribavirin (RBV) in adults with chronic hepatitis C. Patients (n ‫؍‬ 5027) were randomly assigned to receive PEG-IFN alfa-2b 1.5 g/kg/week plus flat-dose (800 mg/day) or weight-based (800-1400 mg/day) RBV for 48 weeks (patients with genotype 1, 4, 5, or 6) and for 24 or 48 weeks (genotype 2/3 patients). Primary end point was sustained virologic response (undetectable [<125 IU/mL] serum hepatitis C virus RNA at 24-week follow-up). Sustained virologic response, but not end-of-treatment, rates were significantly higher with weight-based than with flat-dose RBV (44.2% versus 40.5%; P ‫؍‬ 0.008). Sustained virologic response rates by intention-to-treat analysis were 34.0% and 28.9%, respectively, in genotype 1 patients (P ‫؍‬ 0.005) and 31.2% and 26.7%, respectively, in genotype 1 patients with high baseline viral load (P ‫؍‬ 0.056). In genotype 2/3 patients, rates were not significantly different (61.8% and 59.5%, respectively) regardless of treatment duration. Besides greater hemoglobin reductions with weight-based RBV, safety profiles were similar across RBV dosing groups, including the 1400-mg/day group. Conclusion: PEG-IFN alfa-2b plus weight-based RBV is more effective than flat-dose RBV, particularly in genotype 1 patients, providing equivalent efficacy across all weight groups. RBV 1400 mg/day is appropriate for patients 105 to 125 kg. For genotype 2/3 patients, 24 weeks of treatment with flat-dose RBV is adequate; no evidence of additional benefit of extending treatment to 48 weeks was demonstrated. (HEPATOLOGY 2007;46:971-981.