title: An independent and prospective comparison of two commercial fibrosis marker panels (HCV FibroSURE and FIBROSpect II) during albinterferon alfa-2b combination therapy for chronic hepatitis C.
abstract: Noninvasive markers that accurately follow changes in fibrosis may provide alternatives to liver biopsy for assessment of histological endpoints of antiviral therapy in chronic hepatitis C (CHC). This study compared two commercially available serum marker panels (HCV FibroSURE and FIBROSpect II) during interferon-based therapy. Ninety-five interferon-naïve patients with genotype 1 CHC were enrolled in a phase 2b, active-controlled study of albinterferon alfa-2b/ribavirin for 48 weeks. Proprietary and simple biochemical marker panels were independently evaluated in serum before and during the study. Baseline liver biopsies were evaluated for METAVIR fibrosis by a single pathologist. Index scores were obtained for HCV FibroSURE (n = 84) and FIBROSpect II (n = 95); mean biopsy length: 17.8 +/- 8.0 mm. For detecting fibrosis stages 2-4 (prevalence 23% [22/95] and 21% [18/84]), HCV FibroSURE and FIBROSpect II indicated high sensitivity (1.00 and 0.95, respectively), lower but comparable specificity (0.61 and 0.66, respectively), and a good area under the receiver operating characteristic curve (0.89 and 0.90, respectively). Simple indices had high indeterminate rates (31-40%) at baseline. Patients with a sustained virological response had lower baseline scores than nonresponders, and reduced median percent changes in index scores for HCV FibroSURE (-20.0%vs 2.9%; P = 0.14) and FIBROS Spect II (-6.8%vs 18.4%; P = 0.05). The panels demonstrated comparable performance characteristics for differentiating mild from moderate-severe stage disease in CHC. Lower index scores at baseline that continue to decline likely reflect reduced fibrogenesis activity in patients with successful antiviral responses to therapy.
authors.affiliation: Duke Clinical Research Institute and Duke University Medical Center, Durham, NC 27715, USA. keyur.patel@duke.edu
authors.forename: K
authors.initials: K
authors.lastname: Patel
authors.forename: Y
authors.initials: Y
authors.lastname: Benhamou
authors.forename: E M
authors.initials: EM
authors.lastname: Yoshida
authors.forename: K D
authors.initials: KD
authors.lastname: Kaita
authors.forename: S
authors.initials: S
authors.lastname: Zeuzem
authors.forename: M
authors.initials: M
authors.lastname: Torbenson
authors.forename: E
authors.initials: E
authors.lastname: Pulkstenis
authors.forename: G M
authors.initials: GM
authors.lastname: Subramanian
authors.forename: J G
authors.initials: JG
authors.lastname: McHutchison
mesh_terms: D000328:Adult; D000418:Albumins / Q000008:administration & dosage / Q000627:therapeutic use; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use; D015415:Biomarkers / Q000032:analysis* / Q000097:blood; D001706:Biopsy; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000187:drug effects*; D019698:Hepatitis C, Chronic / Q000188:drug therapy / Q000503:physiopathology* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use; D008099:Liver / Q000473:pathology; D008103:Liver Cirrhosis / Q000188:drug therapy / Q000473:pathology / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged; D011933:Reagent Kits, Diagnostic; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage / Q000627:therapeutic use; D012680:Sensitivity and Specificity; D016896:Treatment Outcome
chemical_list: D000418:Albumins; D000998:Antiviral Agents; D015415:Biomarkers; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011933:Reagent Kits, Diagnostic; D011994:Recombinant Proteins; D012254:Ribavirin; C531108:albinterferon alfa-2b