title: Low dose ribavirin for treatment of hepatitis C virus infected thalassemia major patients; new indications for combination therapy.
abstract: BACKGROUND
  Treatment guidelines contraindicate ribavirin for treatment of hepatitis C virus (HCV) infection in thalassemia major patients. Nevertheless, the current evidence suggests that ribavirin might be tolerated by these patients.
  
  
  OBJECTIVE
  Despite this evidence, low dose ribavirin combination therapy has not been compared with peginterferon monotherapy in these patients so far.
  
  
  METHODS
  Two hundred eighty thalassemia patients with detectable HCV-RNA PCR (≥ 50 IU/mL) and liver histology consistent with chronic HCV infection were self-assigned to receive peginterferon alfa-2a (n = 81) monotherapy or its combination therapy with ribavirin, 600-800 mg QD, according to hemoglobin levels (n = 199). Treatment experienced patients were eligible for this study.
  
  
  RESULTS
  Sustained virological response (SVR) was significantly higher in patients who received ribavirin (51 % vs. 38 % P = 0.02). In multivariate regression, OR of ribavirin for prediction of SVR was 2.2 (95 % CI 1.24-3.91). The SVR was significantly higher in the ribavirin group in subgroups of patients with more than 24 years of age, elevated ALT, ferritin < 2006 ng/mL, previous treatment failure, genotype 1, positive history of splenectomy, fibrosis score of 0-4 HAI and viral load < 600,000 IU/mL. Treatment discontinuations due to the safety concerns were comparable between the treatment groups (6.5 and 8 %). Furthermore, transfusion intervals were almost halved in patients who received low dose ribavirin.
  
  
  CONCLUSIONS
  According to the present study, adult thalassemia patients with HCV infection can be treated successfully with low dose ribavirin. Hence, we strongly advise combination therapy in thalassemia patients with aforementioned clinical characteristics. Moreover, ribavirin does not seem to be beneficial in thalassemia patients below 18 years of age.
authors.affiliation: Baqiyatallah Research Center for Gastroenterology and Liver Disease, Baqiyatallah University of Medical Sciences, Tehran, IR Iran.
authors.forename: Seyed Vahid
authors.initials: SV
authors.lastname: Tabatabaei
authors.forename: Seyed Moayed
authors.initials: SM
authors.lastname: Alavian
authors.forename: Maryam
authors.initials: M
authors.lastname: Keshvari
authors.forename: Bita
authors.initials: B
authors.lastname: Behnava
authors.forename: Seyyed Mohammad
authors.initials: SM
authors.lastname: Miri
authors.forename: Pegah
authors.initials: P
authors.lastname: Karimi Elizee
authors.forename: Farhad
authors.initials: F
authors.lastname: Zamani
authors.forename: Sedigheh
authors.initials: S
authors.lastname: Amini Kafiabad
authors.forename: Ahmad
authors.initials: A
authors.lastname: Gharehbaghian
authors.forename: Bashir
authors.initials: B
authors.lastname: Hajibeigy
authors.forename: Kamran Bagheri
authors.initials: KB
authors.lastname: Lankarani