title: Short versus standard treatment with pegylated interferon alfa-2A plus ribavirin in patients with hepatitis C virus genotype 2 or 3: the cleo trial.
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 < 0.05) Relapse rate was 3% each in groups A1 and A2, and 6% in group B. Among patients with a HCVRNA test 24 weeks after the end of treatment, SVR was observed in 60 (83%) of group A1 patients and in 53 (75%) of group A2 patients. Rapid virological response, low baseline HCV RNA levels, elevated alanine aminotransferase levels and low fibrosis score, were the strongest covariates associated with SVR, independent of HCV genotype. No baseline characteristic was associated with relapse.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Trial number ISRCTN29259563.
authors.affiliation: Liver Unit San Camillo Forlanini Hospital, Rome, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Mecenate
authors.forename: Adriano M
authors.initials: AM
authors.lastname: Pellicelli
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Barbaro
authors.forename: Mario
authors.initials: M
authors.lastname: Romano
authors.forename: Angelo
authors.initials: A
authors.lastname: Barlattani
authors.forename: Ettore
authors.initials: E
authors.lastname: Mazzoni
authors.forename: Maria Elena
authors.initials: ME
authors.lastname: Bonaventura
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Nosotti
authors.forename: Pasquale
authors.initials: P
authors.lastname: Arcuri
authors.forename: Antonio
authors.initials: A
authors.lastname: Picardi
authors.forename: Giorgio
authors.initials: G
authors.lastname: Barbarini
authors.forename: Cecilia
authors.initials: C
authors.lastname: D'Ambrosio
authors.forename: Amerigo
authors.initials: A
authors.lastname: Paffetti
authors.forename: Arnaldo
authors.initials: A
authors.lastname: Andreoli
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Soccorsi
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011994:Recombinant Proteins; D012008:Recurrence; D012254:Ribavirin / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a