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JAC Advance Access originally published online on January 31, 2008
Journal of Antimicrobial Chemotherapy 2008 61(4):919-924; doi:10.1093/jac/dkn013
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© The Author 2008. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Original research

The use of trough ribavirin concentration to predict sustained virological response and haematological toxicity in HIV/HCV-co-infected patients treated with ribavirin and pegylated interferon

D. Aguilar Marucco*, D. Gonzalez de Requena, S. Bonora, C. Tettoni, M. Bonasso, T. De Blasi, A. D'Avolio, M. Sciandra, M. Siccardi, L. Baietto, L. Trentini, A. Sinicco, G. Cariti and G. Di Perri

Department of Infectious Diseases, University of Turin, Turin, Italy

Received 7 September 2007; returned 22 October 2007; revised 21 December 2007; accepted 2 January 2008

* Corresponding author. Clinica Universitaria, Ospedale Amedeo di Savoia, Corso Svizzera 164, 10149 Torino, Italy. Tel: +39-011-4393980; Fax: +39-011-4393882; E-mail: diego.agui{at}libero.it

Objectives: To study the association between trough ribavirin concentration (Ctrough) with sustained virological response (SVR) and haemoglobin (Hb) decrease in HIV/hepatitis C virus (HCV)-co-infected (HIV+/HCV+) patients treated with anti-HCV therapy.

Methods: HIV+/HCV+ patients treated with ribavirin and pegylated interferon were prospectively evaluated. Qualitative and quantitative HCV-RNA, Hb levels and ribavirin Ctrough were measured at baseline and weeks 2, 4, 12, 24, 36 and 48 during therapy. HCV-RNA was also measured at 24 weeks after the end of therapy. Efficacy analysis was performed on patients with a definitive virological outcome (SVR, relapser and non-responder), whereas for toxicity analysis, dropouts were considered until the last available observation.

Results: Fifty-two patients (54.7% with genotype 1 or 4) were included. Overall, no correlation between ribavirin Ctrough and early virological response (EVR) nor SVR was found. However, in patients with genotype 1 or 4, ribavirin Ctrough was independently associated with EVR (P = 0.036) and SVR (P = 0.046). A ribavirin Ctrough cut-off of 1600 ng/mL was found to be associated with both EVR ({chi}2 = 5.69, P = 0.028) and SVR ({chi}2=4.2, P = 0.04). Higher ribavirin Ctrough correlated with Hb decrease (R = –0.361, P = 0.009) and was independently associated with an Hb decrease of >4 g/dL (P = 0.009). Receiver operating characteristic (ROC) analysis indicated that a ribavirin Ctrough of >2300 ng/mL was associated with an Hb decrease of >4 g/dL ({chi}2 = 8.08, P = 0.01).

Conclusions: Our study confirmed a relationship between ribavirin exposure and both efficacy and toxicity. Moreover, we found ribavirin Ctrough cut-offs for both SVR in genotypes 1 and 4 and overall haematological toxicity. These findings deserve further clinical evaluation.

Keywords: anti-HCV therapy , therapeutic drug monitoring , cut-off values


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