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Safety profile of boceprevir and telaprevir in chronic hepatitis C: real world experience from HCV-TARGET.

Publication ,  Journal Article
Gordon, SC; Muir, AJ; Lim, JK; Pearlman, B; Argo, CK; Ramani, A; Maliakkal, B; Alam, I; Stewart, TG; Vainorius, M; Peter, J; Nelson, DR ...
Published in: J Hepatol
February 2015

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.

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Published In

J Hepatol

DOI

EISSN

1600-0641

Publication Date

February 2015

Volume

62

Issue

2

Start / End Page

286 / 293

Location

Netherlands

Related Subject Headings

  • Young Adult
  • Viral Load
  • Treatment Outcome
  • Retrospective Studies
  • Proline
  • Oligopeptides
  • Middle Aged
  • Male
  • Humans
  • Hepatitis C, Chronic
 

Citation

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Gordon, S. C., Muir, A. J., Lim, J. K., Pearlman, B., Argo, C. K., Ramani, A., … HCV-TARGET study group. (2015). Safety profile of boceprevir and telaprevir in chronic hepatitis C: real world experience from HCV-TARGET. J Hepatol, 62(2), 286–293. https://doi.org/10.1016/j.jhep.2014.08.052
Gordon, Stuart C., Andrew J. Muir, Joseph K. Lim, Brian Pearlman, Curtis K. Argo, Ananthakrishnan Ramani, Benedict Maliakkal, et al. “Safety profile of boceprevir and telaprevir in chronic hepatitis C: real world experience from HCV-TARGET.J Hepatol 62, no. 2 (February 2015): 286–93. https://doi.org/10.1016/j.jhep.2014.08.052.
Gordon SC, Muir AJ, Lim JK, Pearlman B, Argo CK, Ramani A, et al. Safety profile of boceprevir and telaprevir in chronic hepatitis C: real world experience from HCV-TARGET. J Hepatol. 2015 Feb;62(2):286–93.
Gordon, Stuart C., et al. “Safety profile of boceprevir and telaprevir in chronic hepatitis C: real world experience from HCV-TARGET.J Hepatol, vol. 62, no. 2, Feb. 2015, pp. 286–93. Pubmed, doi:10.1016/j.jhep.2014.08.052.
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, HCV-TARGET study group. Safety profile of boceprevir and telaprevir in chronic hepatitis C: real world experience from HCV-TARGET. J Hepatol. 2015 Feb;62(2):286–293.
Journal cover image

Published In

J Hepatol

DOI

EISSN

1600-0641

Publication Date

February 2015

Volume

62

Issue

2

Start / End Page

286 / 293

Location

Netherlands

Related Subject Headings

  • Young Adult
  • Viral Load
  • Treatment Outcome
  • Retrospective Studies
  • Proline
  • Oligopeptides
  • Middle Aged
  • Male
  • Humans
  • Hepatitis C, Chronic