title: Randomized, controlled trial with IFN-alpha combined with ribavirin with and without amantadine sulphate in non-responders with chronic hepatitis C.
abstract: OBJECTIVE
  Efficacy and safety of interferon-alpha (IFN-alpha)/ribavirin retreatment with or without amantadine sulphate were evaluated in non-responders with chronic hepatitis C.
  
  
  METHODS
  Two hundred twenty five consecutive non-responders to previous antiviral treatment(s) with IFN-alpha alone or in combination with ribavirin or amantadine were treated with IFN-alpha 2b 5 MU daily for 4 weeks, 5 MU tiw for 20 weeks, followed by 3 MU tiw for additional 24 weeks combined with ribavirin 1000-1200 mg/d. One hundred fifteen of 225 patients were randomized to receive amantadine sulphate 100 mg bid for 48 weeks. Treatment was discontinued in patients with detectable serum hepatitis C virus (HCV)-RNA at treatment week 24.
  
  
  RESULTS
  An overall sustained virologic response with undectable serum HCV-RNA levels was observed in 49/225 patients (22%). Patients infected with HCV-genotype non-1 (P<0.001), low viremia (P=0.011) and only one previous antiviral treatment (P=0.032) were more likely to respond to antiviral retreatment. There was a trend towards higher sustained virologic response rates in patients receiving triple retreatment compared with those treated with IFN-alpha/ribavirin alone (25 versus 18%, P=0.172).
  
  
  CONCLUSIONS
  The addition of amantadine was well tolerated and led to an improvement of sustained virologic responses compared with retreatment with IFN-alpha/ribavirin alone, in particular in patients with low baseline viremia.
authors.affiliation: Medizinische Klinik II, Klinikum der Johann Wolfgang Goethe-Universität, Theodor-Stern Kai 7, D-60590 Frankfurt/M, Germany. gerlinde.teuber@em.uni-frankfurt.de
authors.forename: Gerlinde
authors.initials: G
authors.lastname: Teuber
authors.forename: M
authors.initials: M
authors.lastname: Pascu
authors.forename: T
authors.initials: T
authors.lastname: Berg
authors.forename: M
authors.initials: M
authors.lastname: Lafrenz
authors.forename: J
authors.initials: J
authors.lastname: Pausch
authors.forename: F
authors.initials: F
authors.lastname: Kullmann
authors.forename: G
authors.initials: G
authors.lastname: Ramadori
authors.forename: R
authors.initials: R
authors.lastname: Arnold
authors.forename: H
authors.initials: H
authors.lastname: Weidenbach
authors.forename: E
authors.initials: E
authors.lastname: Musch
authors.forename: U
authors.initials: U
authors.lastname: Junge
authors.forename: K H
authors.initials: KH
authors.lastname: Wiedmann
authors.forename: E
authors.initials: E
authors.lastname: Herrmann
authors.forename: M
authors.initials: M
authors.lastname: Zankel
authors.forename: S
authors.initials: S
authors.lastname: Zeuzem
mesh_terms: D000328:Adult; D000368:Aged; D000547:Amantadine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004352:Drug Resistance, Microbial; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000187:drug effects*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; 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; D012254:Ribavirin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D012254:Ribavirin; D000547:Amantadine