title: Danazol improves thrombocytopenia in HCV patients treated with peginterferon and ribavirin.
abstract: BACKGROUND
  Thrombocytopenia is a common hematologic disorder observed in patients with chronic hepatitis C virus (HCV) infection. Combined peginterferon (PEG-INF) and ribavirin treatment may exacerbate thrombocytopenia in patients with HCV.
  
  
  OBJECTIVE
  The aim of this pilot clinical trial was to assess the efficacy, tolerability and safety of Danazol in thrombocytopenia associated with PEG-INF and ribavirin treatment in patients with HCV.
  
  
  METHODS
  We included patients whose platelets were < 90,000/mm³ and who were undergoing antiviral treatment. Danazol (300-600 mg/day) was administered during and until the end of antiviral therapy [7.6 months (2 to 11 months)]. The monitoring was performed through platelet analysis and liver function tests. A viral load test was done at the beginning and end of treatment. Fortynine patients receiving a combined therapy of PEG-INF, ribavirin and Danazol increased their platelet levels to 121,081/mm³ (46,000-216,000/mm³); 10.6% of patients gained > 100,000 platelets/mm³, and 71% of patients maintained their initial platelet levels. Sustained viral response (SVR) was achieved in 63% of patients. SVR rates were high in patients with genotype non 1 (78.7%) and decreased in patients with genotype 1 (60.1%). The increase in platelet levels was associated to an increase in fibrinogen levels and a decrease in the activity of ALT. By contrast, patients without SVR presented a delayed response to increased platelet levels and showed no significant improvement in liver function when they received Danazol.
  
  
  CONCLUSIONS
  Danazol can be used along with PEG-INF and ribavirin to treat thrombocytopenia in patients with HCV.
authors.affiliation: Departamento de Gastroenterología y Hepatología, Hospital General Regional UMF No. 1, Instituto Mexicano del Seguro Social. Cuernavaca, Morelos, México.
authors.forename: Guillermo Cabrera
authors.initials: GC
authors.lastname: Alvarez
authors.forename: Diana
authors.initials: D
authors.lastname: Gómez-Galicia
authors.forename: Lourdes
authors.initials: L
authors.lastname: Rodríguez-Fragoso
authors.forename: Vicente Madrid
authors.initials: VM
authors.lastname: Marina
authors.forename: Luis Cañedo
authors.initials: LC
authors.lastname: Dorantes
authors.forename: Miguel
authors.initials: M
authors.lastname: Sánchez-Alemán
authors.forename: Nahum
authors.initials: N
authors.lastname: Méndez-Sánchez
authors.forename: Jorge Reyes
authors.initials: JR
authors.lastname: Esparza
mesh_terms: D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000009:adverse effects*; D015415:Biomarkers / Q000097:blood; D003613:Danazol / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005340:Fibrinogen / Q000378:metabolism; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000009:adverse effects*; D008297:Male; D008800:Mexico; D008875:Middle Aged; D016017:Odds Ratio; D010865:Pilot Projects; D010976:Platelet Count; D011092:Polyethylene Glycols / Q000009:adverse effects*; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000009:adverse effects; D012254:Ribavirin / Q000009:adverse effects*; D013921:Thrombocytopenia / Q000097:blood / Q000139:chemically induced / Q000188:drug therapy* / Q000821:virology; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; D005340:Fibrinogen; D000410:Alanine Transaminase; D003613:Danazol; C100416:peginterferon alfa-2a