A small percentage of patients with hepatitis C receive triple therapy with boceprevir or telaprevir

Emerson Y. Chen, Seth N. Sclair, Frank Czul, Betty Apica, Perry Dubin, Paul Martin, William M. Lee

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

Background and aims: Protease inhibitor triple therapy for hepatitis C virus (HCV) infection (boceprevir or telaprevir with pegylated interferon and ribavirin) has been shown to increase rates of sustained virologic response in phase 3 trials. We investigated the proportion of patients who began therapy with this regimen in the 12 months after the Food and Drug Administration approval of boceprevir and telaprevir in the United States. METHODS: We performed a retrospective cross-sectional study of 487 patients with HCV genotype 1 infection (396 did not receive triple therapy, and 91 had begun triple therapy with boceprevir or telaprevir), who were seen at hepatology practices in Dallas and Miami from June 2011 through February 2012. The subjects were predominantly middle-aged, non-Hispanic white, and privately insured; 50% were treatment-naive, and most had advanced fibrosis. We compared features of patients who initiated triple therapy with those who deferred it. Treated patients were followed to determine the discontinuation rate in the first 12 weeks of treatment. RESULTS: Of patients assessed, only 18.7% began triple therapy, the same percentage as those receiving dual therapy (pegylated interferon and ribavirin) before boceprevir or telaprevir was approved for treatment of HCV infection in the United States. Reasons for deferring treatment included relative contraindications (50.5%), patient choice (22.5%), and less advanced liver disease (17.4%). Among treated patients, 15% discontinued prematurely because of serious adverse events. On the basis of multivariate analysis, factors associated with initiation of triple therapy included prior treatment relapse (odds ratio [OR], 4.6; 95%confidence interval [CI], 2.1-9.9) and liver fibrosis of stage 3 (OR, 9.1; 95% CI, 3.1-27) or stage 4 (OR, 9.0; 95% CI, 3.3-25) but not hepatic decompensation. CONCLUSIONS: Only 18.7% of patients with HCV genotype 1 infection received triple therapy in the 12 months after Food and Drug Administration approval of boceprevir and telaprevir. This low percentage might result from concerns of side effects and recognition that more effective medications could be available in the future.

Original languageEnglish
Pages (from-to)1014-1020
Number of pages7
JournalClinical Gastroenterology and Hepatology
Volume11
Issue number8
DOIs
StatePublished - Aug 1 2013

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Hepatitis C
Hepacivirus
Therapeutics
Drug Approval
Ribavirin
Odds Ratio
Virus Diseases
Confidence Intervals
United States Food and Drug Administration
telaprevir
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
Interferons
Genotype
Gastroenterology
Infection
Protease Inhibitors
Liver Cirrhosis
Liver Diseases
Fibrosis
Multivariate Analysis

ASJC Scopus subject areas

  • Gastroenterology
  • Hepatology

Cite this

A small percentage of patients with hepatitis C receive triple therapy with boceprevir or telaprevir. / Chen, Emerson Y.; Sclair, Seth N.; Czul, Frank; Apica, Betty; Dubin, Perry; Martin, Paul; Lee, William M.

In: Clinical Gastroenterology and Hepatology, Vol. 11, No. 8, 01.08.2013, p. 1014-1020.

Research output: Contribution to journalArticle

Chen, Emerson Y. ; Sclair, Seth N. ; Czul, Frank ; Apica, Betty ; Dubin, Perry ; Martin, Paul ; Lee, William M. / A small percentage of patients with hepatitis C receive triple therapy with boceprevir or telaprevir. In: Clinical Gastroenterology and Hepatology. 2013 ; Vol. 11, No. 8. pp. 1014-1020.
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abstract = "Background and aims: Protease inhibitor triple therapy for hepatitis C virus (HCV) infection (boceprevir or telaprevir with pegylated interferon and ribavirin) has been shown to increase rates of sustained virologic response in phase 3 trials. We investigated the proportion of patients who began therapy with this regimen in the 12 months after the Food and Drug Administration approval of boceprevir and telaprevir in the United States. METHODS: We performed a retrospective cross-sectional study of 487 patients with HCV genotype 1 infection (396 did not receive triple therapy, and 91 had begun triple therapy with boceprevir or telaprevir), who were seen at hepatology practices in Dallas and Miami from June 2011 through February 2012. The subjects were predominantly middle-aged, non-Hispanic white, and privately insured; 50{\%} were treatment-naive, and most had advanced fibrosis. We compared features of patients who initiated triple therapy with those who deferred it. Treated patients were followed to determine the discontinuation rate in the first 12 weeks of treatment. RESULTS: Of patients assessed, only 18.7{\%} began triple therapy, the same percentage as those receiving dual therapy (pegylated interferon and ribavirin) before boceprevir or telaprevir was approved for treatment of HCV infection in the United States. Reasons for deferring treatment included relative contraindications (50.5{\%}), patient choice (22.5{\%}), and less advanced liver disease (17.4{\%}). Among treated patients, 15{\%} discontinued prematurely because of serious adverse events. On the basis of multivariate analysis, factors associated with initiation of triple therapy included prior treatment relapse (odds ratio [OR], 4.6; 95{\%}confidence interval [CI], 2.1-9.9) and liver fibrosis of stage 3 (OR, 9.1; 95{\%} CI, 3.1-27) or stage 4 (OR, 9.0; 95{\%} CI, 3.3-25) but not hepatic decompensation. CONCLUSIONS: Only 18.7{\%} of patients with HCV genotype 1 infection received triple therapy in the 12 months after Food and Drug Administration approval of boceprevir and telaprevir. This low percentage might result from concerns of side effects and recognition that more effective medications could be available in the future.",
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AU - Martin, Paul

AU - Lee, William M.

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N2 - Background and aims: Protease inhibitor triple therapy for hepatitis C virus (HCV) infection (boceprevir or telaprevir with pegylated interferon and ribavirin) has been shown to increase rates of sustained virologic response in phase 3 trials. We investigated the proportion of patients who began therapy with this regimen in the 12 months after the Food and Drug Administration approval of boceprevir and telaprevir in the United States. METHODS: We performed a retrospective cross-sectional study of 487 patients with HCV genotype 1 infection (396 did not receive triple therapy, and 91 had begun triple therapy with boceprevir or telaprevir), who were seen at hepatology practices in Dallas and Miami from June 2011 through February 2012. The subjects were predominantly middle-aged, non-Hispanic white, and privately insured; 50% were treatment-naive, and most had advanced fibrosis. We compared features of patients who initiated triple therapy with those who deferred it. Treated patients were followed to determine the discontinuation rate in the first 12 weeks of treatment. RESULTS: Of patients assessed, only 18.7% began triple therapy, the same percentage as those receiving dual therapy (pegylated interferon and ribavirin) before boceprevir or telaprevir was approved for treatment of HCV infection in the United States. Reasons for deferring treatment included relative contraindications (50.5%), patient choice (22.5%), and less advanced liver disease (17.4%). Among treated patients, 15% discontinued prematurely because of serious adverse events. On the basis of multivariate analysis, factors associated with initiation of triple therapy included prior treatment relapse (odds ratio [OR], 4.6; 95%confidence interval [CI], 2.1-9.9) and liver fibrosis of stage 3 (OR, 9.1; 95% CI, 3.1-27) or stage 4 (OR, 9.0; 95% CI, 3.3-25) but not hepatic decompensation. CONCLUSIONS: Only 18.7% of patients with HCV genotype 1 infection received triple therapy in the 12 months after Food and Drug Administration approval of boceprevir and telaprevir. This low percentage might result from concerns of side effects and recognition that more effective medications could be available in the future.

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