Safety profile of boceprevir and telaprevir in chronic hepatitis C

Real world experience from HCV-TARGET

Stuart C. Gordon, Andrew J. Muir, Joseph K. Lim, Brian Pearlman, Curtis K. Argo, Ananthakrishnan Ramani, Benedict Maliakkal, Imtiaz Alam, Thomas G. Stewart, Monika Vainorius, Joy Peter, David R. Nelson, Michael W. Fried, K. Rajender Reddy

Research output: Contribution to journalArticle

65 Citations (Scopus)

Abstract

Background & Aims: The safety profiles of boceprevir and telaprevir in the treatment of chronic hepatitis C, administered in academic and community centres across the United States, were evaluated. Methods: In 90 medical centres, patients with chronic HCV received pegylated interferon, ribavirin, and either telaprevir or boceprevir per local standard of care. Demographic, adverse event, clinical, and virological data were collected during treatment and follow-up. Results: A total of 2084 patients (97% HCV genotype 1) received at least one dose of a protease inhibitor. At baseline, 38% of patients had cirrhosis, and 57% had received at least one prior treatment for hepatitis C. Serious adverse events occurred in 12% of patients receiving protease inhibitor therapy. Overall, 66% of patients experienced anaemia, leading to frequent ribavirin dose reductions (42%) and erythropoietin use (37%); 11% received blood transfusion. More than 90% of patients had adverse events that led to a prescription, treatment, or dosage change, and 39% of patients discontinued treatment early, most commonly because of adverse events (18%) or lack of efficacy (16%). Hepatic decompensation events occurred in 3% of all patients. Age, female gender, cirrhosis, HCV genotype 1 subtype, creatinine clearance, platelet levels, albumin levels and haemoglobin levels were independent predictors of anaemia. Five deaths occurred. Overall, 52% of all patients achieved a sustained virologic response. Conclusions: In academic and community centres, where chronic hepatitis C patients commonly have advanced liver disease, triple therapy was associated with a high rate of adverse events and involved frequent treatment modifications and adverse event management.

Original languageEnglish (US)
Pages (from-to)286-293
Number of pages8
JournalJournal of Hepatology
Volume62
Issue number2
DOIs
StatePublished - Jan 1 2015

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Chronic Hepatitis C
Safety
Ribavirin
Therapeutics
Protease Inhibitors
Anemia
Fibrosis
Genotype
N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide
telaprevir
Standard of Care
Hepatitis C
Erythropoietin
Blood Transfusion
Interferons
Prescriptions
Liver Diseases
Albumins
Creatinine
Hemoglobins

Keywords

  • Anaemia
  • Boceprevir
  • Cirrhosis
  • Hepatic decompensation
  • Hepatitis C
  • Telaprevir

ASJC Scopus subject areas

  • Hepatology

Cite this

Gordon, S. C., Muir, A. J., Lim, J. K., Pearlman, B., Argo, C. K., Ramani, A., ... Reddy, K. R. (2015). Safety profile of boceprevir and telaprevir in chronic hepatitis C: Real world experience from HCV-TARGET. Journal of Hepatology, 62(2), 286-293. https://doi.org/10.1016/j.jhep.2014.08.052

Safety profile of boceprevir and telaprevir in chronic hepatitis C : Real world experience from HCV-TARGET. / Gordon, Stuart C.; Muir, Andrew J.; Lim, Joseph K.; Pearlman, Brian; Argo, Curtis K.; Ramani, Ananthakrishnan; Maliakkal, Benedict; Alam, Imtiaz; Stewart, Thomas G.; Vainorius, Monika; Peter, Joy; Nelson, David R.; Fried, Michael W.; Reddy, K. Rajender.

In: Journal of Hepatology, Vol. 62, No. 2, 01.01.2015, p. 286-293.

Research output: Contribution to journalArticle

Gordon, SC, Muir, AJ, Lim, JK, Pearlman, B, Argo, CK, Ramani, A, Maliakkal, B, Alam, I, Stewart, TG, Vainorius, M, Peter, J, Nelson, DR, Fried, MW & Reddy, KR 2015, 'Safety profile of boceprevir and telaprevir in chronic hepatitis C: Real world experience from HCV-TARGET', Journal of Hepatology, vol. 62, no. 2, pp. 286-293. https://doi.org/10.1016/j.jhep.2014.08.052
Gordon, Stuart C. ; Muir, Andrew J. ; Lim, Joseph K. ; Pearlman, Brian ; Argo, Curtis K. ; Ramani, Ananthakrishnan ; Maliakkal, Benedict ; Alam, Imtiaz ; Stewart, Thomas G. ; Vainorius, Monika ; Peter, Joy ; Nelson, David R. ; Fried, Michael W. ; Reddy, K. Rajender. / Safety profile of boceprevir and telaprevir in chronic hepatitis C : Real world experience from HCV-TARGET. In: Journal of Hepatology. 2015 ; Vol. 62, No. 2. pp. 286-293.
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