title: Early addition of ribavirin to interferon in chronic hepatitis C not responsive to interferon monotherapy.
abstract: OBJECTIVE
  Persistence of HCV-RNA in serum early in treatment is a strong predictor of failure of alpha-interferon therapy for chronic hepatitis C. Therefore, we compared the efficacy of ribavirin addition to alpha-interferon with a doubling of the dosage of alpha-interferon in case of lack of early virological response to alpha-interferon therapy.
  
  
  METHODS
  Sixty patients were administered interferon alpha2b at the dosage of 3 million units 3 times a week. After the first 4 weeks of therapy, serum HCV-RNA was evaluated. The patients with negative HCV-RNA test received the same treatment for a further 11 months, while those with detectable HCV-RNA were randomized to receive either the same dosage of alpha-interferon plus ribavirin (1000 mg/day) or double dosage of alpha-interferon (6 million units tiw) for 11 months. We considered sustained response to be the maintenance of normal alanine aminotransferase and negativity at HCV-RNA testing until the end of a 6-month post-treatment follow-up.
  
  
  RESULTS
  After the first 4 weeks of treatment, 12 (20%) patients showed virological response and 48 patients (80%) remained positive on HCV-RNA testing. Sustained response was observed in 5/12 (42%) patients with early virological response, in 10/24 (42%) patients without early virological response who were administered ribavirin and alpha-interferon, and in only 1/24 (4%) patients who were administered the double dosage of alpha-interferon (p=0.006).
  
  
  CONCLUSIONS
  This study shows the efficacy of the addition of ribavirin to alpha-interferon and the lack of efficacy of doubling the dosage of alpha-interferon in patients without clearance of hepatitis C virus early on in treatment.
authors.affiliation: Department of Hepatology, S. Giuseppe Hospital, Niguarda Hospital, Milan, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Bellobuono
authors.forename: L
authors.initials: L
authors.lastname: Mondazzi
authors.forename: S
authors.initials: S
authors.lastname: Tempini
authors.forename: F
authors.initials: F
authors.lastname: Chiodo
authors.forename: E
authors.initials: E
authors.lastname: Magliano
authors.forename: L
authors.initials: L
authors.lastname: Furione
authors.forename: G
authors.initials: G
authors.lastname: Idéo
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000900:Anti-Bacterial Agents; D000998:Antiviral Agents / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004351:Drug Resistance; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012254:Ribavirin / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D012254:Ribavirin; D000410:Alanine Transaminase