Clinical milestones for the prediction of severe anemia by chronic hepatitis C patients receiving telaprevir-based triple therapy

J Hepatol. 2013 Oct;59(4):667-74. doi: 10.1016/j.jhep.2013.05.017. Epub 2013 May 23.

Ogawa E, Furusyo N, Nakamuta M, Kajiwara E, Nomura H, Dohmen K, Takahashi K, Satoh T, Azuma K, Kawano A, Tanabe Y, Kotoh K, Shimoda S, Hayashi J; Kyushu University Liver Disease Study (KULDS) Group.

Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan.

Abstract

BACKGROUND & AIMS: Anemia is a common adverse effect of telaprevir (TVR) in combination with pegylated interferon (PegIFN)α and ribavirin (RBV) therapy. It occurs at a higher incidence with the TVR relative to PegIFNα and RBV alone. We herein evaluate the baseline and on-treatment predictors of the development of severe anemia by chronic hepatitis C virus (HCV) patients receiving TVR-based triple therapy.

METHODS: This prospective, multicenter study consisted of 292 patients (median age: 62years) infected with HCV genotype 1. All received 12weeks of TVR in combination with 24weeks of PegIFNα2b and RBV. The definition of severe anemia during antiviral treatment is hemoglobin (Hb)<85g/L.

RESULTS: 101 (34.6%) patients developed severe anemia during the treatment period. Multivariable logistic regression analysis of possible pretreatment predictors of the development of severe anemia extracted baseline Hb<135g/L (Hazard ratio [HR], 2.53; p=0.0013), estimated glomerular filtration rate <80ml/min/1.73m(2) (HR, 1.83; p=0.0265), and inosine triphosphatase (ITPA) CC genotype (rs1127354) (HR, 2.91; p=0.0024). For patients with ITPA CC (n=227), multivariable logistic regression analysis of possible pretreatment and on-treatment predictors of the development of severe anemia extracted Hb level at week 2 (HR, 0.96; p=0.0085) and the initial four weeks of weight-adjusted TVR (HR, 1.05; p=0.0281).

CONCLUSIONS: Anemia remains a risk for all patients treated with TVR-based triple therapy. However, ITPA polymorphism (rs1127354) is useful for predicting the development of severe anemia and will be helpful in the management of treatment.

Copyright © 2013 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

KEYWORDS: AUROC, Anemia, CI, HCV, HR, Hb, Hepatitis C virus, ITPA, Inosine triphosohatase, PegIFN, Pegylated interferon, RBV, RVR, Ribavirin, SNP, SVR, TVR, Telaprevir, area under the receiver operating characteristic curve, confidence interval, eGFR, estimated glomerular filtration rate, hazard ratio, hemoglobin, hepatitis C virus, inosine triphosphatase, pegylated interferon, rapid virological response, ribavirin, single nucleotide polymorphism, sustained virological response, telaprevir

PMID: 23707372 [PubMed - in process]

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