July 28, 2010

Peginterferon α-2a and ribavirin treatment of patients with haemophilia and hepatitis C virus infection: a single-centre study of 367 cases

Liver International
Early View (Articles online in advance of print)
Published Online: 8 Jul 2010
© 2010 John Wiley & Sons A/S

Seyed-Moayed Alavian 1 , Seyed Vahid Tabatabaei 1 , Maryam Keshvari 2 , Bita Behnava 1 , Seyyed Mohammad Miri 1 , Pegah Karimi Elizee 2 and Kamran Bagheri Lankarani 3

1 Research Center for Gastroenterology and Liver Disease, Baqiyatallah University of Medical Sciences, Tehran, Iran
2 Iranian Blood Transfusion Organization Research Center (IBTO), Tehran, Iran
3 Shiraz University of Medical Sciences, Shiraz, Iran

Correspondence

Seyed-Moayed Alavian, Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Ground floor of Baqiyatallah Hospital, Mollasadra Ave., Vanak Sq. P. O. Box 14155-3651, Tehran, Iran
Tel/Fax: +98 21 88 067 114
e-mail: editor@hepmon.com

KEYWORDS
congenital bleeding disorder • HCV • haemophilia • peginterferon α-2a • ribavirin

ABSTRACT

Background/aims: Chronic hepatitis C virus infection (HCV) is a major comorbidity in patients with haemophilia. Peginterferon alpha and ribavirin is current standard anti-HCV thrapy but there is little information about safety and efficacy of peginterferon α-2a and ribavirin combination therapy in these patients.

Material and methods: In an open-label single-treatment arm cohort study, 367 haemophilia patients seronegative for hepatitis B and human immunodeficiency virus markers and chronically infected with HCV (HCV RNA>50 IU/ml for at least 6 months) received 180 μg of Pegasys® and 800–1200 mg of ribavirin according to body weight. Genotypes 1 and 4, mixed and untypable infections were treated for 48 weeks, while genotypes 2 and 3 were treated for 24 weeks. The efficacy of therapy was expressed as sustained virological response (SVR).

Results: Two hundred and twenty-five subjects [61%, 95% confidence interval (CI) 56–66] achieved SVR, 66 patients relapsed and 30 subjects did not respond and nine patients developed breakthrough during treatment. In a multivariate logistic regression model, age<24 odds ratio (OR)=1.8 (95% CI 1.1–3.1), genotype non-1 OR=1.8 (95% CI 1.1–3.2), BMI<25 OR=2.1 (95% CI 1.3–3.3) and HCV RNA<600 000 IU/ml OR=1.7 (95% CI 1.1–3.2) were independent predictors of SVR. Eight patients discontinued the treatment because of persistent neutropaenia and 22 subjects were dropped out because of intractable side effects. Furthermore, two patients died during treatment and five were lost to follow-up after treatment cessation.

Conclusions: Peginterferon alpha-2a in combination with weight-based ribavirin has SVR rate of 51% for genotype 1 and 71% for genotype non-1 infections in haemophilia patients. Age<24, BMI<25, viral load<600 000 IU/ml and genotype non-1 are the major determinants of SVR achievement in these patients.

Received 9 February 2010
Accepted 24 May 2010

DIGITAL OBJECT IDENTIFIER (DOI)
10.1111/j.1478-3231.2010.02296.x About DOI
 
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