title: A randomized trial of pegylated interferon alpha-2b plus ribavirin in the retreatment of chronic hepatitis C.
abstract: OBJECTIVE
  The efficacy of combination therapy with pegylated interferon (PEG IFN) alpha plus ribavirin (RBV) in the retreatment of chronic hepatitis C (CHC) in patients who previously failed combination standard IFN plus RBV or IFN monotherapy has not been well established.
  
  
  METHODS
  Three hundred and twenty-one CHC patients including virologic nonresponders to combination IFN plus RBV (n = 219) or IFN monotherapy (n = 47), and relapsers to combination therapy (n = 55) were randomized to receive PEG IFN alpha-2b 1.5 microg/kg per wk plus RBV 800 mg per day (Regimen A, n = 160) or PEG IFN alpha-2b 1.0 microg/kg per wk plus RBV 1,000-1,200 mg per day (Regimen B, n = 161) for 48 wks.
  
  
  RESULTS
  Sustained virologic response (SVR) occurred in 16% of the overall study population (Regimen A vs B, 18%vs 13%, p= 0.21), in 8% of the combination therapy nonresponders (10%vs 6%, p= 0.35), in 21% of the IFN monotherapy nonresponders (16%vs 27%, p= 0.35), and in 42% of the combination therapy relapsers (50%vs 32%, p= 0.18). In nonresponders to prior combination therapy, HCV ribonucleic acid levels <100,000 copies/mL at the end of the prior treatment course were associated with an increased SVR compared with levels >or=100,000 copies/mL (21%vs 5%, p= 0.002). In the overall study population, genotype 1 patients had lower SVR rates than others (14%vs 33%, p= 0.01), and African Americans had lower SVR than Caucasians (4%vs 18%, p= 0.01).
  
  
  CONCLUSIONS
  Combination therapy with PEG IFN alpha-2b plus RBV is more effective in patients who relapsed after combination standard IFN plus RBV than in nonresponders to either combination therapy or IFN monotherapy. There was no significant effect of dosing regimen.
authors.affiliation: Center for the Study of Hepatitis C and Division of Gastroenterology and Hepatology, Weill Medical College of Cornell University, New York, New York 10021, USA.
authors.forename: Ira M
authors.initials: IM
authors.lastname: Jacobson
authors.forename: Stevan A
authors.initials: SA
authors.lastname: Gonzalez
authors.forename: Furqaan
authors.initials: F
authors.lastname: Ahmed
authors.forename: Edward
authors.initials: E
authors.lastname: Lebovics
authors.forename: Albert D
authors.initials: AD
authors.lastname: Min
authors.forename: Henry C
authors.initials: HC
authors.lastname: Bodenheimer
authors.forename: Stephen P
authors.initials: SP
authors.lastname: Esposito
authors.forename: Robert S
authors.initials: RS
authors.lastname: Brown
authors.forename: Norbert
authors.initials: N
authors.lastname: Bräu
authors.forename: Franklin M
authors.initials: FM
authors.lastname: Klion
authors.forename: Hillel
authors.initials: H
authors.lastname: Tobias
authors.forename: Edmund J
authors.initials: EJ
authors.lastname: Bini
authors.forename: Neil
authors.initials: N
authors.lastname: Brodsky
authors.forename: Maurice A
authors.initials: MA
authors.lastname: Cerulli
authors.forename: Ayse
authors.initials: A
authors.lastname: Aytaman
authors.forename: Peter W
authors.initials: PW
authors.lastname: Gardner
authors.forename: Jane M
authors.initials: JM
authors.lastname: Geders
authors.forename: Julie E
authors.initials: JE
authors.lastname: Spivack
authors.forename: Michael G
authors.initials: MG
authors.lastname: Rahmin
authors.forename: David H
authors.initials: DH
authors.lastname: Berman
authors.forename: James
authors.initials: J
authors.lastname: Ehrlich
authors.forename: Mark W
authors.initials: MW
authors.lastname: Russo
authors.forename: Maxwell
authors.initials: M
authors.lastname: Chait
authors.forename: Deborah
authors.initials: D
authors.lastname: Rovner
authors.forename: Brian R
authors.initials: BR
authors.lastname: Edlin
mesh_terms: D001741:Black or African American; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004337:Drug Carriers; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics; 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; D011092:Polyethylene Glycols; D012367:RNA, Viral / Q000032:analysis; D011994:Recombinant Proteins; D012008:Recurrence; D019233:Retreatment; D012254:Ribavirin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load; D044465:White People
chemical_list: D000998:Antiviral Agents; D004337:Drug Carriers; D004338:Drug Combinations; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b