Increased plasma concentration of Ribavirin as a result of renal dysfunction in HCV patients treated with telaprevir. Massimo Tempestilli, M.Sc.1, Gianpiero D’Offizi, M.D.1, Raffaella Lionetti, M.D.1, Marzia Montalbano, M.D.1, Andrea Giaffreda, M.Sc1, Simone Fazio, M.Sc1. and Leopoldo P. Pucillo, M.D.1 1

National Institute for Infectious Diseases “L. Spallanzani” I.R.C.C.S., Via Portuense 292, 00149

Rome, Italy.

Keywords: Kidney, anaemia, therapeutic drug monitoring

Corresponding authors: Massimo Tempestilli, National Institute for Infectious Diseases “L. Spallanzani” I.R.C.C.S., Via Portuense 292, 00149 Rome, Italy. Mail to: [email protected] Tel +39 06 55170354. Fax +39 06 5599340.

Potential conflict of interest: None.

Financial disclosure: This study was supported by grants from the Italian Ministry of Health “Ricerca Corrente 2012”.

Word count: 480. This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1002/hep.26978

Hepatology

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2 Abbreviation: HCV, hepatitis C virus RBV, Ribavirin PEG-IFN, pegylated interferon TLV, Telaprevir eGFR, estimated glomerular filtration rate

To the Editor:

Pronounced anaemia is observed in HCV patients treated with a triple therapy containing Ribavirin (RBV), pegylated interferon (PEG-IFN) and Telaprevir (TLV) when compared to patients treated with the dual therapy (RBV and PEG-IFN).[1] Mauss et al.[2] recently suggested in Hepatology that this could be due to accumulation of RBV consequent to impaired renal drug elimination. To confirm this hypothesis, the estimated glomerular filtration rate (eGFR),[3] haemoglobin and RBV plasma concentration in twenty three HCV genotype-1 infected patients treated with fixed doses of the triple therapy for 12 weeks and, successively, with the dual therapy until 48 weeks, were evaluated at weeks 4, 8, 12, 24, 48. eGFR decreased during the period of triple therapy from 100.8 ± 23.6 mL/min pre-therapy to 88.5 ± 16.9 mL/min, 75.7 ± 19.7 mL/min, 83.4 ± 20.7 mL/min at weeks 4, 8, 12, respectively (P

Increased plasma concentration of ribavirin as a result of renal dysfunction in hepatitis C virus patients treated with telaprevir.

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