title: 12 weeks of interferon-based therapy is feasible in patients with hepatitis C-related cirrhosis and thrombocytopenia: A post hoc analysis of eltrombopag studies.
abstract: BACKGROUND
  A 24-48-week course of interferon-based therapy poorly tolerated in hepatitis C virus (HCV) cirrhosis patients with thrombocytopenia. Aim of the study was to identify patients at low-risk of liver-related complications over a 12-week course of interferon-based therapy.
  
  
  METHODS
  We assessed the rate of complications and death during the first 12 weeks of interferon-based therapy in HCV cirrhotics with thrombocytopenia (platelets ≤75×10(9)/L) enrolled in the ENABLE-1 and -2 phase 3 randomised controlled trials.
  
  
  RESULTS
  Overall, among 1441 patients, 89 complications (6.9%) and 10 deaths (0.7%) were observed within the first 12 weeks of therapy. At univariate analysis baseline albumin levels and Model for End Stage Liver Disease (MELD) score (≤35 g /L, p<0.001, and ≥10, p<0.001, respectively) were the only predictors associated with occurrence of complications and death. Of the 1026 patients with serum albumin >35 g/L (71.2%), one patient died (0.1%) and 17 experienced liver-related complications (1.7%). Among 667 patients with serum albumin >35 g/L and MELD score <10, no deaths occurred and 4 experienced liver-related complications (0.6%).
  
  
  CONCLUSIONS
  Among HCV cirrhotic patients with thrombocytopenia, albumin levels and MELD score can identify patients who may safely receive a 12-week course of interferon-based therapy with a low risk of complications.
authors.affiliation: Department of Internal Medicine, Humanitas University Medicine, Rozzano (Milano), Italy. Electronic address: brunosavino2@gmail.com.
authors.forename: Savino
authors.initials: S
authors.lastname: Bruno
authors.affiliation: Haematology, Oncology Centre of Excellence GlaxoSmithKline, London, United Kingdom.
authors.forename: Paresh
authors.initials: P
authors.lastname: Sewpaul
authors.affiliation: Department of Internal Medicine, Humanitas University Medicine, Rozzano (Milano), Italy.
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Russo
authors.affiliation: Department of Internal Medicine, Humanitas University Medicine, Rozzano (Milano), Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Boccaccio
authors.affiliation: Gastroenterology & Hepatology Unit, Di.Bi.MI.S. University of Palermo, Italy.
authors.forename: Piero Luigi
authors.initials: PL
authors.lastname: Almasio
authors.affiliation: University of Genova, Genova, Italy.
authors.forename: Edoardo G
authors.initials: EG
authors.lastname: Giannini
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000418:Albumins / Q000032:analysis; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D001565:Benzoates / Q000627:therapeutic use; D005260:Female; D016174:Hepacivirus; D019698:Hepatitis C, Chronic / Q000150:complications*; D006801:Humans; D006834:Hydrazines / Q000627:therapeutic use; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000150:complications* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011720:Pyrazoles / Q000627:therapeutic use; D012254:Ribavirin / Q000627:therapeutic use; D012307:Risk Factors; D012720:Severity of Illness Index; D013921:Thrombocytopenia / Q000097:blood*; D016896:Treatment Outcome
chemical_list: D000418:Albumins; D000998:Antiviral Agents; D001565:Benzoates; D006834:Hydrazines; D016898:Interferon-alpha; D011720:Pyrazoles; D012254:Ribavirin; C520809:eltrombopag
keywords: Albumin level; Liver-related complication; Liver-related mortality; MELD score