Low Dose Ribavirin for Treatment of Hepatitis C Virus Infected Thalassemia Major Patients; New Indications for Combination Therapy

authors:

avatar Seyed Vahid Tabatabaei 1 , avatar Seyed Moayed Alavian 2 , * , avatar Maryam Keshvari 1 , avatar Bita Behnava 1 , avatar Seyyed Mohammad Miri 1 , avatar Pegah Karimi Elizee 1 , avatar Farhad Zamani 1 , avatar Sedigheh Amini Kafiabad 1 , avatar Ahmad Gharehbaghian 1 , avatar Bashir Hajibeigy 1 , avatar Kamran Bagheri Lankarani 3

Baqiyatallah Research Center for Gastroenterology and Liver Disease, Baqiyatallah University of Medical Sciences, IR Iran
Baqiyatallah Research Center for Gastroenterology and Liver Disease, Baqiyatallah University of Medical Sciences, editor@hepatmon.com, IR Iran
Shiraz University of Medical Sciences, IR Iran
Hepatitis Monthly: Vol.12, issue 6; 372-381
article type: Research Article
received: May 10, 2012
accepted: May 30, 2012
DOI: https://doi.org/10.5812/hepatmon.6592

how to cite: Tabatabaei S, Alavian S, Keshvari M, Behnava B, Miri S, et al. Low Dose Ribavirin for Treatment of Hepatitis C Virus Infected Thalassemia Major Patients; New Indications for Combination Therapy. Hepat Mon. 2012;12(6): 372-381. https://doi.org/10.5812/hepatmon.6592.

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.
Objectives: Despite this evidence, low dose ribavirin combination therapy has not been compared with peg interferon monotherapy in these patients so far.
Patients and 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 peg interferon 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.

Implication for health policy/practice/research/medical education:
new treatment methods in special patients with thalassemia could be a challenge among clinicians especially internists. This topic is not discussed in other studies and originated form a national trial.
Please cite this paper as:
Tabatabaei SV, Alavian SM, Keshvari M, Behnava B, Miri SM, Karimi Elizee P, et al. Low Dose Ribavirin for Treatment of Hepatitis C Virus Infected Thalassemia Major Patients; new Indications for Combination Therapy. Hepat Mon. 2012;12(6): 372-81. DoI: 10.5812/hepatmon.6592

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