Ribavirin Levels and Haemoglobin Decline in Early Virological Responders and Non-Responders to Hepatitis C Virus Combination Therapy

Vol. 76, No. 3, 2006

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Original Paper

Ribavirin Levels and Haemoglobin Decline in Early Virological Responders and Non-Responders to Hepatitis C Virus Combination Therapy
Josef Donnerer^a, Maja Grahovac^b, Evelyn Stelzl^b, Harald H. Kessler^b, Csilla Bankuti^c, Vanessa Stadlbauer^c, Rudolf E. Stauber^c

Institutes of
^aExperimental and Clinical Pharmacology and
^bHygiene and
^cDepartment of Internal Medicine, Division of Gastroenterology and Hepatology, Medical University Graz, Graz, Austria

Address of Corresponding Author

Pharmacology 2006;76:136-140 (DOI: 10.1159/000090942)

Key Words

Ribavirin serum levels
Haemoglobin
Chronic hepatitis C

Abstract

Therapeutic drug monitoring of ribavirin has been claimed to predict virological response and/or haematological side effects in patients with chronic hepatitis C undergoing peginterferon/ribavirin combination treatment. In the present study, steady-state ribavirin levels were retrospectively analyzed in serum samples from patients at week 12 of combination therapy with peginterferon alpha-2a or alpha-2b and ribavirin. Patients were classified as early virological responders on the basis of undetectable HCV-RNA or HCV-RNA drop 2 log from baseline at week 12. The mean ribavirin level was not different between early virological responders (2.3 ± 0.1 µg/ml, n = 45) and early virological non-responders (2.0 ± 0.2 µg/ml, n = 10). There was no correlation between ribavirin levels at week 12 and early virological response. In patients with early virological response, haemoglobin (Hb) levels were found to be decreased by 18% on average from the basal values; however, in only 2 patients Hb levels declined below 100 g/l. There was a moderate negative correlation between ribavirin levels and Hb levels at week 12 (R = -0.50, p < 0.001); however, ribavirin levels did not correlate with relative or absolute decline in Hb as compared to basal levels or with ribavirin dose per kilogram body weight. In addition, a significant negative correlation between ribavirin levels and glomerular filtration rate was found (R = -0.31, p < 0.05). Based on our results, monitoring of ribavirin serum levels at week 12 of HCV combination therapy does not appear to predict early virological response or reductions in Hb levels. Further research is needed to assess their diagnostic value at other time points of peginterferon/ribavirin combination treatment and/or in patients with renal insufficiency.

Author Contacts

Josef Donnerer
Experimental and Clinical Pharmacology
Medical University Graz
AT-8010 Graz (Austria)
Tel. +43 316 380 4509, Fax +43 316 380 9645, E-Mail josef.donnerer@meduni-graz.at

Article Information

Received: November 16, 2005
Accepted: November 16, 2005
Published online: January 12, 2006
Number of Print Pages : 5
Number of Figures : 6, Number of Tables : 1, Number of References : 16

Medline Abstract (ID 16410679)

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