title: Extended treatment duration for hepatitis C virus type 1: comparing 48 versus 72 weeks of peginterferon-alfa-2a plus ribavirin.
abstract: OBJECTIVE
  The treatment of patients infected with hepatitis C virus (HCV) type 1 remains a challenge necessitating innovative strategies to improve treatment outcome. The extension of treatment duration beyond 48 weeks is one possible strategy to address this problem.
  
  
  METHODS
  The efficacy and safety of 48 weeks (group A, N = 230) vs 72 weeks (group B, N = 225) of treatment with pegylated-interferon-alfa-2a (180 microg/wk) plus ribavirin (800 mg/day) were studied in treatment-naive patients with HCV type 1 infection. On-treatment and sustained virologic response (SVR) 24 weeks after stopping treatment was assessed by qualitative reverse-transcription polymerase chain reaction (sensitivity 50 IU/mL).
  
  
  RESULTS
  Overall, no significant differences could be observed in the treatment outcome between both groups. End-of-treatment and SVR rates in groups A and B were 71% vs 63% and 53% vs 54%, respectively. Patients with undetectable HCV-RNA levels already at weeks 4 and 12 had excellent SVR rates ranging from 76% to 84% regardless of treatment group, whereas patients shown to be still HCV-RNA positive at week 12 achieved significantly higher SVR rates when treated for 72 instead of 48 weeks (29% vs 17%, P = .040). A particular benefit from extended treatment duration was seen in patients with low-level viremia (<6000 IU/mL) at week 12. The frequency and intensity of adverse events was similar between the 2 groups.
  
  
  CONCLUSIONS
  Extended treatment duration generally is not recommended in HCV type 1 infection and should be reserved only for patients with slow virologic response defined as HCV-RNA positive at week 12 but negative at week 24.
authors.affiliation: Universitätsklinikum Charité, Campus Virchow-Klinikum, Universitätsmedizin Berlin, Germany. thomas.berg@charite.de
authors.forename: Thomas
authors.initials: T
authors.lastname: Berg
authors.forename: Michael
authors.initials: M
authors.lastname: von Wagner
authors.forename: Samer
authors.initials: S
authors.lastname: Nasser
authors.forename: Christoph
authors.initials: C
authors.lastname: Sarrazin
authors.forename: Tobias
authors.initials: T
authors.lastname: Heintges
authors.forename: Tilman
authors.initials: T
authors.lastname: Gerlach
authors.forename: Peter
authors.initials: P
authors.lastname: Buggisch
authors.forename: Tobias
authors.initials: T
authors.lastname: Goeser
authors.forename: Jens
authors.initials: J
authors.lastname: Rasenack
authors.forename: Gerd R
authors.initials: GR
authors.lastname: Pape
authors.forename: Wolfgang E
authors.initials: WE
authors.lastname: Schmidt
authors.forename: Birgit
authors.initials: B
authors.lastname: Kallinowski
authors.forename: Hartwig
authors.initials: H
authors.lastname: Klinker
authors.forename: Ulrich
authors.initials: U
authors.lastname: Spengler
authors.forename: Peter
authors.initials: P
authors.lastname: Martus
authors.forename: Ulrich
authors.initials: U
authors.lastname: Alshuth
authors.forename: Stefan
authors.initials: S
authors.lastname: Zeuzem
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D016174:Hepacivirus / Q000145:classification* / 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; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012008:Recurrence; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D014766:Viremia / Q000188:drug therapy
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a