Effect of fibrosis on adverse events in patients with hepatitis C treated with telaprevir

K. Bichoupan, Jonathan M. Schwartz, V. Martel-Laferriere, E. R. Giannattasio, K. Marfo, J. A. Odin, L. U. Liu, T. D. Schiano, P. Perumalswami, M. Bansal, P. J. Gaglio, Harmit S. Kalia, D. T. Dieterich, A. D. Branch, John F. Reinus

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)209-216
Number of pages8
JournalAlimentary Pharmacology and Therapeutics
Volume39
Issue number2
DOIs
StatePublished - Jan 2014

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Hepatitis C
Fibrosis
Therapeutics
telaprevir
Blood Platelets
Ribavirin
Creatinine
Hemoglobins
History
Biopsy

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Effect of fibrosis on adverse events in patients with hepatitis C treated with telaprevir. / Bichoupan, K.; Schwartz, Jonathan M.; Martel-Laferriere, V.; Giannattasio, E. R.; Marfo, K.; Odin, J. A.; Liu, L. U.; Schiano, T. D.; Perumalswami, P.; Bansal, M.; Gaglio, P. J.; Kalia, Harmit S.; Dieterich, D. T.; Branch, A. D.; Reinus, John F.

In: Alimentary Pharmacology and Therapeutics, Vol. 39, No. 2, 01.2014, p. 209-216.

Research output: Contribution to journalArticle

Bichoupan, K, Schwartz, JM, Martel-Laferriere, V, Giannattasio, ER, Marfo, K, Odin, JA, Liu, LU, Schiano, TD, Perumalswami, P, Bansal, M, Gaglio, PJ, Kalia, HS, Dieterich, DT, Branch, AD & Reinus, JF 2014, 'Effect of fibrosis on adverse events in patients with hepatitis C treated with telaprevir', Alimentary Pharmacology and Therapeutics, vol. 39, no. 2, pp. 209-216. https://doi.org/10.1111/apt.12560
Bichoupan, K. ; Schwartz, Jonathan M. ; Martel-Laferriere, V. ; Giannattasio, E. R. ; Marfo, K. ; Odin, J. A. ; Liu, L. U. ; Schiano, T. D. ; Perumalswami, P. ; Bansal, M. ; Gaglio, P. J. ; Kalia, Harmit S. ; Dieterich, D. T. ; Branch, A. D. ; Reinus, John F. / Effect of fibrosis on adverse events in patients with hepatitis C treated with telaprevir. In: Alimentary Pharmacology and Therapeutics. 2014 ; Vol. 39, No. 2. pp. 209-216.
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abstract = "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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T1 - Effect of fibrosis on adverse events in patients with hepatitis C treated with telaprevir

AU - Bichoupan, K.

AU - Schwartz, Jonathan M.

AU - Martel-Laferriere, V.

AU - Giannattasio, E. R.

AU - Marfo, K.

AU - Odin, J. A.

AU - Liu, L. U.

AU - Schiano, T. D.

AU - Perumalswami, P.

AU - Bansal, M.

AU - Gaglio, P. J.

AU - Kalia, Harmit S.

AU - Dieterich, D. T.

AU - Branch, A. D.

AU - Reinus, John F.

PY - 2014/1

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N2 - 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.

AB - 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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