title: Interferon-alpha-2B and ribavirin in combination for chronic hepatitis C patients not responding to interferon-alpha alone: an Italian multicenter, randomized, controlled, clinical study.
abstract: OBJECTIVE
  The aim of the study was to assess the efficacy of interferon (IFN)-alpha-2b and ribavirin in combination in the treatment of chronic hepatitis C (CHC) patients unresponsive to a previous treatment with IFN-alpha-2b alone.
  
  
  METHODS
  We conducted a randomized study in 303 CHC patients. One hundred fifty-two patients received subcutaneous administration of recombinant IFN-alpha-2b (3 MU thrice weekly) and ribavirin (1000-1200 mg/daily per os), whereas 151 received IFN-alpha-2b alone (6 MU thrice weekly). Both ribavirin and IFN-alpha-2b were given for 24 wk, regardless of treatment response. Alanine aminotransferase (ALT) levels and HCV RNA titer were checked during the treatment period and for a further 24 wk.
  
  
  RESULTS
  Normal ALT levels were observed in 64.5% of the patients treated with IFN-alpha and ribavirin and in 22.6% of the patients treated with IFN-alpha alone. In the group of patients receiving IFN-alpha and ribavirin HCV RNA was not detectable in 40% of patients responders and remained undetectable in 44.2% of sustained responders. In the group of patients receiving IFN-alpha alone HCV RNA was not detectable in 24.2% of patients responders and remained not detectable in 33.3% of sustained responders.
  
  
  CONCLUSIONS
  A 24-wk treatment course with IFN-alpha and ribavirin given to patients with a previous lack of response to IFN-alpha alone offers a chance of a sustained biochemical and virological response, at least in a subset of such patients. The role of long-term therapy in inducing prolonged remission still remains to be explored.
authors.affiliation: Department of Emergency Medicine, University La Sapienza, Rome, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Barbaro
authors.forename: G
authors.initials: G
authors.lastname: Di Lorenzo
authors.forename: M
authors.initials: M
authors.lastname: Soldini
authors.forename: G
authors.initials: G
authors.lastname: Giancaspro
authors.forename: G
authors.initials: G
authors.lastname: Bellomo
authors.forename: G
authors.initials: G
authors.lastname: Belloni
authors.forename: B
authors.initials: B
authors.lastname: Grisorio
authors.forename: M
authors.initials: M
authors.lastname: Annese
authors.forename: D
authors.initials: D
authors.lastname: Bacca
authors.forename: R
authors.initials: R
authors.lastname: Francavilla
authors.forename: G
authors.initials: G
authors.lastname: Rizzo
authors.forename: G
authors.initials: G
authors.lastname: Barbarini
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D019233:Retreatment; D012254:Ribavirin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D004338:Drug Combinations; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D012254:Ribavirin