title: Safety and Efficacy of Adding Ribavirin to Interferon or Peginterferon in Treatment of Hepatitis C Infection in Patients With Thalassemia: A Systematic Review on Randomized Controlled Trials.
abstract: BACKGROUND
  Hepatitis C virus (HCV) infection is a major cause of liver-morbidity and mortality among patients with thalassemia. Peginterferon plus ribavirin is currently the recommended therapy for hepatitis C infection in patients do not have thalassemia, but using ribavirin in patients with thalassemia is restricted due to its hemolytic effect. To evaluate the efficacy and safety of adding ribavirin to peginterferon or interferon, authors performed a systematic review on the available literatures.
  
  
  METHODS
  Trials were identified through electronic database, manual searches of journals and bibliographies and approaching authors of trials. Randomized trials that enrolled patients with a diagnosis of thalassemia and chronic hepatitis C infection treated with interferon or peginterferon with or without ribavirin were included. Two investigators independently evaluated the trials for inclusion criteria, risk of bias and data extraction. The primary outcomes were sustained virological response (SVR), liver-related morbidity, mortality and adverse events. The odds ratios from each trial were calculated individually and in the subgroup analysis of trials. Data were analyzed with fixed-effect model.
  
  
  RESULTS
  Three randomized clinical trials with 92 patients were included. All three trials had unclear risk of bias. Compared with peginterferon monotherapy, adding ribavirin to peginterferon had significant beneficial effect on sustained virological response (OR = 3.44, 95% CI: 1.18 - 10.06). There was no significant difference between combination therapy and monotherapy in the end of treatment achievement response. Other than about 30% increase in blood transfusion due to anemia that returned to normal level 2 - 3 months after treatment, there was no significant increase in side effects followed by adding ribavirin to pegylated interferon (Peg-IFN). Data were insufficient to determine the impact of genotype, viral load and age on the response to treatment.
  
  
  CONCLUSIONS
  Compared with monotherapy, adding ribavirin to treatment is more effective in removing hepatitis C virus from the bloodstream in patients with thalassemia, it is also more effective in reducing the relapse rate after treatment. Except the increase in blood transfusion, there was no significant increase in side effects followed by adding ribavirin.
authors.affiliation: Department of Gastroenterology, Tehran University of Medical Sciences, Tehran, IR Iran; Department of Health Management and Economics, School of Public Health, Tehran University of Medical Sciences, Tehran, IR Iran.
authors.forename: Ehsan
authors.initials: E
authors.lastname: Aminizadeh
authors.affiliation: Research Center for Gastroenterology and Liver Disease, Baqiyatallah University of Medical Sciences, Tehran, IR Iran.
authors.forename: Seyed Moayyed
authors.initials: SM
authors.lastname: Alavian
authors.affiliation: Department of Health Management and Economics, School of Public Health, Tehran University of Medical Sciences, Tehran, IR Iran.
authors.forename: Ali
authors.initials: A
authors.lastname: Akbari Sari
authors.affiliation: Department of Gastroenterology, Tehran University of Medical Sciences, Tehran, IR Iran.
authors.forename: Nasser
authors.initials: N
authors.lastname: Ebrahimi Daryani
authors.affiliation: Research Center for Gastroenterology and Liver Disease, Baqiyatallah University of Medical Sciences, Tehran, IR Iran.
authors.forename: Bita
authors.initials: B
authors.lastname: Behnava
keywords: Hepatitis C Virus; Interferon; Pegylated Interferon; Response; Ribavirin; Thalassemia; Treatment