BMC Gastroenterology (Feb 2010)

Short versus standard treatment with pegylated interferon alfa-2A plus ribavirin in patients with hepatitis C virus genotype 2 or 3: the cleo trial

  • Picardi Antonio,
  • Arcuri Pasquale,
  • Nosotti Lorenzo,
  • Bonaventura Maria,
  • Mazzoni Ettore,
  • Barlattani Angelo,
  • Romano Mario,
  • Barbaro Giuseppe,
  • Pellicelli Adriano M,
  • Mecenate Fabrizio,
  • Barbarini Giorgio,
  • D'Ambrosio Cecilia,
  • Paffetti Amerigo,
  • Andreoli Arnaldo,
  • Soccorsi Fabrizio

DOI
https://doi.org/10.1186/1471-230X-10-21
Journal volume & issue
Vol. 10, no. 1
p. 21

Abstract

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Abstract Background In patients with chronic hepatitis C virus (HCV) genotype 2 or 3, 24 weeks' treatment with pegylated interferon alfa (PEG-IFN-alpha) and ribavirin induces a sustained virological response (SVR) in almost 80% of cases. Evidence suggests that a similar response rate may be obtained with shorter treatment periods, especially in patients with a rapid virological response (RVR). The aim of this study was to compare the efficacy of 12 or 24 weeks of treatment in patients with chronic HCV genotype 2 or 3 and to identify patients suitable for 12 weeks treatment. Methods Two hundred and ten patients received PEG-IFN-alpha-2a (180 ug/week) and ribavirin (800-1200 mg/day) for 4 weeks. Patients with a RVR (HCV RNA not detectable) were randomized (1:1) to either 12 (group A1) or 24 (group A2) weeks of combination therapy. Patients without a RVR continued with 24-weeks' combination therapy (group B). HCV RNA was monitored at weeks 4, 8, 12, and 24, and at week 24 post-treatment. Results At study end, end of treatment response (ETR) was observed in 62 (86%) patients of group A1 and in 55 (77%) patients of group A2 (p Conclusion In HCV patients with genotype 2 or 3, 12-week combination therapy is as efficacious as 24-week therapy and several independent covariates were predictive of SVR. Trial registration Trial number ISRCTN29259563