title: Tailoring interferon dose and monitoring viral load in hepatitis C virus genotype 1b infected patients: a pilot study.
abstract: OBJECTIVE
  Complete [biochemical and virological) primary response remains the first goal of any antiviral therapy and its early assessment could be particularly useful in the management of the high viral load, genotype 1b infected patients, who have the worst chance of response. We evaluated whether tailoring interferon dose according to pre-treatment viral load and early monitoring of quantitative HCV-RNA could either improve or predict the results of recombinant alpha-2a interferon treatment in these patients.
  
  
  METHODS
  Fifty-three consecutive genotype 1b HCV-infected patients, stratified in two groups by viral load (cut off 6 MEq/ml), received randomly 6 or 9 MU of recombinant alpha-2a interferon thrice weekly for 6 months, followed by 6 MU for another 6 months.
  
  
  METHODS
  HCV-RNA was measured [b-DNA] assay) two months apart prior to therapy, at baseline, after 2 weeks of therapy and monthly thereafter.
  
  
  RESULTS
  In the high viraemic group, complete primary response was observed in 80% of patients treated with high dose recombinant alpha 2a interferon and only in 14.3% of low dose treated patients [p<0.03]. In low viraemic patients, complete primary response was 53. 8% in low dose patients and 80% (8 out of 10) in the high dose group. Sustained response was 60% in high viraemic patients treated with high dose and absent in those treated with low dose [p<0.05]. One log viral load decrease at 2 or 4 weeks showed 0.87 and 0.80 positive predictive values, 0.95 and 1.0 negative predictive values with 96% and 100% sensitivities and 83% and 70% specificities.
  
  
  CONCLUSIONS
  6 MU recombinant alpha-2a interferon thrice weekly schedules were completely ineffective in the large majority (85.7%) of patients with viral load above 6 million HCV-RNA copies/ml and the treatment failure could be predicted by lack of one log viral load decrease after 2-4 weeks of treatment.
authors.affiliation: Gastroenterology and Hepatology Unit, Spedali Riuniti Santa Chiara, Azienda Ospedaliera Pisana, Cisanello Hospital, Pisa, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Colombatto
authors.forename: M
authors.initials: M
authors.lastname: Baldi
authors.forename: F
authors.initials: F
authors.lastname: Oliveri
authors.forename: A
authors.initials: A
authors.lastname: Randone
authors.forename: F
authors.initials: F
authors.lastname: Bonino
authors.forename: M R
authors.initials: MR
authors.lastname: Brunetto
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D005260:Female; D016174:Hepacivirus / Q000235:genetics / Q000276:immunology; D018937:Hepatitis C Antibodies / Q000032:analysis*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011379:Prognosis; D012367:RNA, Viral / Q000032:analysis*; D011994:Recombinant Proteins; D019562:Viral Load / Q000379:methods*; D014766:Viremia / Q000188:drug therapy / Q000821:virology
chemical_list: D000998:Antiviral Agents; D018937:Hepatitis C Antibodies; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins