November 26, 2013

Alimentary Pharmacology & Therapeutics

Early View (Online Version of Record published before inclusion in an issue)

Original Article

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K. Bichoupan1,*, J. M. Schwartz2, V. Martel-Laferriere1, E. R. Giannattasio2, K. Marfo2,  J. A. Odin1, L. U. Liu1, T. D. Schiano1, P. Perumalswami1, M. Bansal1, P. J. Gaglio2, H. Kalia2, D. T. Dieterich1, A. D. Branch1, J. F. Reinus2

Article first published online: 24 NOV 2013

DOI: 10.1111/apt.12560

© 2013 John Wiley & Sons Ltd

Summary

Background

Data about adverse events are needed to optimise telaprevir-based therapy in a broad spectrum of patients.

Aim

To investigate adverse events of telaprevir-based therapy in patients with and without advanced fibrosis or cirrhosis in a real-world setting.

Methods

Data on 174 hepatitis C-infected patients initiating telaprevir-based therapy at Mount Sinai and Montefiore medical centres were collected. Biopsy data and FIB-4 scores identified patients with advanced fibrosis. Multivariable fully adjusted models were built to assess the effect of advanced fibrosis on specific adverse events and discontinuation of treatment due to an adverse event.

Results

Patients with (n = 71) and without (n = 103) advanced fibrosis were similar in BMI, ribavirin exposure, gender, prior treatment history, haemoglobin and creatinine, but differed in race. Overall, 47% of patients completed treatment and 40% of patients achieved SVR. Treated patients with and without advanced fibrosis or cirrhosis had similar rates of adverse events; advanced fibrosis, however, was independently associated with ano-rectal discomfort (P = 0.03). Three patients decompensated and had advanced fibrosis. The discontinuation of all treatment medications due to an adverse event was significantly associated with older age (P = 0.01), female gender (P = 0.01) and lower platelets (P = 0.03).

Conclusions

Adverse events were common, but were not significantly related to the presence of advanced fibrosis or cirrhosis. More critical monitoring in older and female patients with low platelets throughout treatment may reduce adverse event-related discontinuations.

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