title: Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection.
abstract: BACKGROUND
  Treatment guidelines recommend the use of peginterferon alfa-2b or peginterferon alfa-2a in combination with ribavirin for chronic hepatitis C virus (HCV) infection. However, these regimens have not been adequately compared.
  
  
  METHODS
  At 118 sites, patients who had HCV genotype 1 infection and who had not previously been treated were randomly assigned to undergo 48 weeks of treatment with one of three regimens: peginterferon alfa-2b at a standard dose of 1.5 microg per kilogram of body weight per week or a low dose of 1.0 microg per kilogram per week, plus ribavirin at a dose of 800 to 1400 mg per day, or peginterferon alfa-2a at a dose of 180 microg per week plus ribavirin at a dose of 1000 to 1200 mg per day. We compared the rate of sustained virologic response and the safety and adverse-event profiles between the peginterferon alfa-2b regimens and between the standard-dose peginterferon alfa-2b regimen and the peginterferon alfa-2a regimen.
  
  
  RESULTS
  Among 3070 patients, rates of sustained virologic response were similar among the regimens: 39.8% with standard-dose peginterferon alfa-2b, 38.0% with low-dose peginterferon alfa-2b, and 40.9% with peginterferon alfa-2a (P=0.20 for standard-dose vs. low-dose peginterferon alfa-2b; P=0.57 for standard-dose peginterferon alfa-2b vs. peginterferon alfa-2a). Estimated differences in response rates were 1.8% (95% confidence interval [CI], -2.3 to 6.0) between standard-dose and low-dose peginterferon alfa-2b and -1.1% (95% CI, -5.3 to 3.0) between standard-dose peginterferon alfa-2b and peginterferon alfa-2a. Relapse rates were 23.5% (95% CI, 19.9 to 27.2) for standard-dose peginterferon alfa-2b, 20.0% (95% CI, 16.4 to 23.6) for low-dose peginterferon alfa-2b, and 31.5% (95% CI, 27.9 to 35.2) for peginterferon alfa-2a. The safety profile was similar among the three groups; serious adverse events were observed in 8.6 to 11.7% of patients. Among the patients with undetectable HCV RNA levels at treatment weeks 4 and 12, a sustained virologic response was achieved in 86.2% and 78.7%, respectively.
  
  
  CONCLUSIONS
  In patients infected with HCV genotype 1, the rates of sustained virologic response and tolerability did not differ significantly between the two available peginterferon-ribavirin regimens or between the two doses of peginterferon alfa-2b. (ClinicalTrials.gov number, NCT00081770.)
authors.affiliation: Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27715, USA. mchut001@mc.duke.edu
authors.forename: John G
authors.initials: JG
authors.lastname: McHutchison
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Lawitz
authors.forename: Mitchell L
authors.initials: ML
authors.lastname: Shiffman
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Muir
authors.forename: Greg W
authors.initials: GW
authors.lastname: Galler
authors.forename: Jonathan
authors.initials: J
authors.lastname: McCone
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Nyberg
authors.forename: William M
authors.initials: WM
authors.lastname: Lee
authors.forename: Reem H
authors.initials: RH
authors.lastname: Ghalib
authors.forename: Eugene R
authors.initials: ER
authors.lastname: Schiff
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Galati
authors.forename: Bruce R
authors.initials: BR
authors.lastname: Bacon
authors.forename: Mitchell N
authors.initials: MN
authors.lastname: Davis
authors.forename: Pabak
authors.initials: P
authors.lastname: Mukhopadhyay
authors.forename: Kenneth
authors.initials: K
authors.lastname: Koury
authors.forename: Stephanie
authors.initials: S
authors.lastname: Noviello
authors.forename: Lisa D
authors.initials: LD
authors.lastname: Pedicone
authors.forename: Clifford A
authors.initials: CA
authors.lastname: Brass
authors.forename: Janice K
authors.initials: JK
authors.lastname: Albrecht
authors.forename: Mark S
authors.initials: MS
authors.lastname: Sulkowski
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D012254:Ribavirin