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Wiley InterScience | ||
  The American Journal of GastroenterologyVolume 100 Issue 11, Pages 2453 - 2462 Published Online: 28 Oct 2005 © 2008 American College of Gastroenterology/Blackwell Publishing Official publication of the American College of Gastroenterology
Abstract | References | Full Text: HTML, PDF (Size: 143K) | Related Articles | Citation Tracking  A Randomized Trial of Pegylated Interferon α-2b Plus Ribavirin in the Retreatment of Chronic Hepatitis C Dr. Jacobson is a consultant and member of the Speakers Bureau for Schering-Plough, which supported this trial. Copyright 2005 by the American College of Gastroenterology (Am J Gastroenterol 2005;100:2453–2462) ABSTRACTOBJECTIVES: The efficacy of combination therapy with pegylated interferon (PEG IFN) α plus ribavirin (RBV) in the retreatment of chronic hepatitis C (CHC) in patients who previously failed combination standard IFN plus RBV or IFN monotherapy has not been well established. METHODS: Three hundred and twenty-one CHC patients including virologic nonresponders to combination IFN plus RBV (n = 219) or IFN monotherapy (n = 47), and relapsers to combination therapy (n = 55) were randomized to receive PEG IFN α-2b 1.5 μg/kg per wk plus RBV 800 mg per day (Regimen A, n = 160) or PEG IFN α-2b 1.0 μg/kg per wk plus RBV 1,000–1,200 mg per day (Regimen B, n = 161) for 48 wks. RESULTS: Sustained virologic response (SVR) occurred in 16% of the overall study population (Regimen A vs B, 18%vs 13%, p= 0.21), in 8% of the combination therapy nonresponders (10%vs 6%, p= 0.35), in 21% of the IFN monotherapy nonresponders (16%vs 27%, p= 0.35), and in 42% of the combination therapy relapsers (50%vs 32%, p= 0.18). In nonresponders to prior combination therapy, HCV ribonucleic acid levels <100,000 copies/mL at the end of the prior treatment course were associated with an increased SVR compared with levels ≥100,000 copies/mL (21%vs 5%, p= 0.002). In the overall study population, genotype 1 patients had lower SVR rates than others (14%vs 33%, p= 0.01), and African Americans had lower SVR than Caucasians (4%vs 18%, p= 0.01). CONCLUSION: Combination therapy with PEG IFN α-2b plus RBV is more effective in patients who relapsed after combination standard IFN plus RBV than in nonresponders to either combination therapy or IFN monotherapy. There was no significant effect of dosing regimen. Received March 3, 2005; accepted June 14, 2005. |  |
