Treatment of chronic hepatitis C in patients who failed interferon monotherapy: Effects of higher doses of interferon and ribavirin combination therapy

Mitchell L. Shiffman, Charlotte M. Hofmann, Joubin Gabbay, Velimir A. Luketic, Richard K. Sterling, Arun J. Sanyal, Melissa J. Contos, Michael J. Ryan, Cynthia Yoshida, Vinod Rustgi

Research output: Contribution to journalArticlepeer-review

43 Scopus citations

Abstract

OBJECTIVE: The present study was designed to evaluate the effectiveness of interferon-ribavirin combination therapy for treatment of chronic hepatitis C virus (HCV) in patients who failed previous treatment with interferon monotherapy. METHODS: A total of 140 patients with well-documented chronic HCV who failed to achieve a virological (if HCV-RNA was assessed) or biochemical response (if HCV-RNA was not assessed) to interferon monotherapy, 3 mU three times weekly (TIW) for 3-18 months, were randomly assigned to one of three treatment groups. Group A patients were treated with 5 mU interferon TIW for 6 months. Ribavirin (1000-1200 mg daily) was added in those patients HCV-RNA positive at month 3. Group B patients were treated with 3 mU interferon TIW plus ribavirin (1000-1200 mg daily) for 6 months. The dose of interferon was increased to 5 mU TIW in those patients HCV-RNA positive at month 3. Group C patients were treated with 5 mU interferon TIW plus ribavirin (1000-1200 mg daily) for 6 months. Serum ALT and HCV-RNA were monitored during and after treatment for a total of 15 months. RESULTS: Seventeen percent of patients in group A became HCV-RNA negative by treatment month 3. Adding ribavirin resulted in one additional patient becoming HCV-RNA negative. However, none of the patients in this group achieved sustained virological response. Twenty-six percent of patients in group B became HCV-RNA negative by treatment month 3. Increasing the dose of interferon from 3 to 5 mU TIW increased virological response to 30%. However, sustained virological response was observed in only 14%. Thirty percent of patients in group C became HCV-RNA negative, but sustained virological response was observed in only 12%. Sustained virological response was found to be significantly greater in patients with a nontype 1 HCV genotype (p < 0.002) and in patients who had a decline in HCV-RNA titer to a value <100,000 copies/ml during their previous course of interferon monotherapy (p < 0.0001). None of the 12 sustained responders were African Americans (p < 0.013). CONCLUSIONS: Retreatment of nonresponders with interferon-ribavirin combination therapy results in limited benefit; only 13% of patients achieved sustained virological response. Response was extremely poor in African Americans and those with HCV genotype 1. (C) 2000 by Am. Coll. of Gastroenterology.

Original languageEnglish (US)
Pages (from-to)2928-2935
Number of pages8
JournalAmerican Journal of Gastroenterology
Volume95
Issue number10
DOIs
StatePublished - 2000
Externally publishedYes

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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