title: Peginterferon alpha-2a and ribavirin in patients with hepatitis C virus genotype 1 infection with persistently normal alanine aminotransferase levels.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of peginterferon α-2a plus ribavirin at standard doses in patients with hepatitis C virus (HVC) genotype 1 infection with persistently normal alanine aminotransferase (ALT) levels.
  
  
  METHODS
  Patients aged 18 to 65 years were included in this observational, prospective study if they had evidence of a HCV genotype 1 infection. The serum HCV RNA concentration was determined at baseline and week 12. A qualitative HCV RNA test was performed at baseline and at weeks 48 and 72. Liver function tests were performed at each study visit. The primary efficacy measure was the sustained virological response in the intention-to-treat population. Logistic regression analyses were also performed to explore predictors of virological response.
  
  
  RESULTS
  A sustained virological response was observed in 100 of the 175 patients (57%). An early virological response and end-of-treatment response were seen in 159 patients (91%) and 133 patients (76%), respectively. Thirty-seven of the 122 evaluable patients for this outcome (30%) showed a rapid virological response. A higher viral load was a significant predictor for a lack of rapid virological response and lack of sustained virological response. There were not any unexpected safety or tolerability findings.
  
  
  CONCLUSIONS
  Our study suggests that the efficacy of the combination of peginterferon α-2a and ribavirin in patients with HCV genotype 1 infection and normal ALT levels is at least similar to that reported in patients with elevated ALT levels.
authors: Department of Gastroenterology and Hepatology, University Hospital Puerta de Hierro Mahadahonda Madrid, Spain. joseluis.calleja@uam.es
authors: José-Luis
authors: JL
authors: Calleja
authors: Javier
authors: J
authors: García-Samaniego
authors: Belén
authors: B
authors: Ruiz-Antorán
authors: María
authors: M
authors: Trapero
authors: Rosa
authors: R
authors: Morillas
authors: Juan
authors: J
authors: de la Revilla
authors: José Carlos
authors: JC
authors: Erdozaín
authors: María-Dolores
authors: MD
authors: Espinosa
authors: Dolores
authors: D
authors: Suárez
authors: Ricard
authors: R
authors: Solá
authors: Manuel
authors: M
authors: Romero-Gómez
authors: Fernando
authors: F
authors: Baños
authors: Marco-Antonio
authors: MA
authors: Alvarez
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood*; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D016174:Hepacivirus / Q000235:genetics*; D006526:Hepatitis C / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; D000410:Alanine Transaminase; C100416:peginterferon alfa-2a