title: Peginterferon alfa-2b therapy in acute hepatitis C: impact of onset of therapy on sustained virologic response.
abstract: OBJECTIVE
  Pegylated interferon therapy has not been adequately evaluated in acute hepatitis C virus (HCV) infection. This randomized trial assessed the efficacy, safety, and timing of pegylated interferon alfa-2b for treatment of acute hepatitis C.
  
  
  METHODS
  One hundred seventy-five patients acutely infected with HCV were screened. Patients whose infection did not spontaneously resolve by week 8 were randomized to once weekly peginterferon alfa-2b monotherapy (1.5 microg/kg per week) started at weeks 8, 12, or 20 for a duration of 12 weeks. The primary endpoint was undetectable HCV RNA 24 weeks after the end of treatment (sustained virologic response [SVR]). All patients were followed for 48 weeks after cessation of therapy.
  
  
  RESULTS
  One hundred twenty-nine subjects started treatment at week 8 (group A, n = 43), week 12 (group B, n = 43), or week 20 (group C, n = 43). By using an intent-to-treat analysis, the overall SVR rate was 87%. The SVR rates were 95%, 92%, and 76% with treatment onset at 8, 12, and 20 weeks, respectively. Overall, SVR rates were better for patients infected with genotypes 2, 3, and 4 than those infected with genotype 1. Earlier initiation of therapy improved SVR rates for patients infected with genotype 1 with high viral load. Peginterferon alfa-2b was well tolerated. Subjects with SVR maintained undetectable HCV RNA 48 weeks after therapy.
  
  
  CONCLUSIONS
  Peginterferon alfa-2b monotherapy in acute hepatitis C induces high sustained virologic response rates, prevents chronic evolution, and is well tolerated. Initiation of treatment at week 8 or 12 results in higher sustained virologic rates than initiation at week 20.
authors.affiliation: Division of Gastroenterology and Liver Disease Center, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
authors.forename: Sanaa M
authors.initials: SM
authors.lastname: Kamal
authors.forename: Amr E
authors.initials: AE
authors.lastname: Fouly
authors.forename: Refaat R
authors.initials: RR
authors.lastname: Kamel
authors.forename: Bridgette
authors.initials: B
authors.lastname: Hockenjos
authors.forename: Ahmed
authors.initials: A
authors.lastname: Al Tawil
authors.forename: Khalifa E
authors.initials: KE
authors.lastname: Khalifa
authors.forename: Qi
authors.initials: Q
authors.lastname: He
authors.forename: Margaret J
authors.initials: MJ
authors.lastname: Koziel
authors.forename: Khairy M
authors.initials: KM
authors.lastname: El Naggar
authors.forename: Jens
authors.initials: J
authors.lastname: Rasenack
authors.forename: Nezam H
authors.initials: NH
authors.lastname: Afdhal
mesh_terms: D000208:Acute Disease; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D005260:Female; D006526:Hepatitis C / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C417083:peginterferon alfa-2b