title: The anti-viral effect of sorafenib in hepatitis C-related hepatocellular carcinoma.
abstract: BACKGROUND
  Sorafenib is currently the only approved systemic therapy shown to have efficacy in the treatment of advanced hepatocellular carcinoma (HCC). Recent studies suggest that hepatitis C (HCV)-related HCC patients derive more clinical benefit from sorafenib than other subgroups, but the mechanism for this effect is unknown. In vitro data suggest that sorafenib may exert anti-viral properties, and thus our aim in this study was to evaluate potential anti-viral activity of sorafenib in patients with HCV-related HCC.
  
  
  OBJECTIVE
  To evaluate potential anti-viral activity of sorafenib in patients with HCV-related HCC.
  
  
  METHODS
  We prospectively enrolled patients with HCV-related HCC treated with sorafenib for up to 6 months. Baseline clinical, viral and oncologic data were collected. Patients' HCV viral loads were obtained at various time points, and compared with their baseline viral levels. No patients received any known anti-viral therapy during this time.
  
  
  RESULTS
  Thirty-three patients were identified with baseline and subsequent HCV levels available for analysis. Six patients completed 6 months of full dose sorafenib, and comparisons of their HCV viral loads showed no significant change at week 24 (difference of means = 0.3500, CI: -0.1799-0.8799, P = 0.150), or the interim time points. Similarly, the HCV viral loads of all patients who received sorafenib and the viral loads of those patients who had tumour response to sorafenib showed no significant changes at any time point.
  
  
  CONCLUSIONS
  Despite preclinical data and previous subgroup analyses suggesting that sorafenib has an anti-viral effect against HCV, this study suggests that sorafenib lacks significant anti-viral activity in HCV patients with HCC.
authors.affiliation: Division of Gastroenterology, Hepatology and Nutrition, University of Florida College of Medicine, Gainesville, USA. Roniel.Cabrera@medicine.uﬂ.edu
authors.forename: R
authors.initials: R
authors.lastname: Cabrera
authors.forename: A R
authors.initials: AR
authors.lastname: Limaye
authors.forename: P
authors.initials: P
authors.lastname: Horne
authors.forename: R
authors.initials: R
authors.lastname: Mills
authors.forename: C
authors.initials: C
authors.lastname: Soldevila-Pico
authors.forename: V
authors.initials: V
authors.lastname: Clark
authors.forename: G
authors.initials: G
authors.lastname: Morelli
authors.forename: R
authors.initials: R
authors.lastname: Firpi
authors.forename: D R
authors.initials: DR
authors.lastname: Nelson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000821:virology; D015331:Cohort Studies; D005260:Female; D006526:Hepatitis C / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000821:virology; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000627:therapeutic use*; D000077157:Sorafenib; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib