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Predictors of consent to pharmacogenomics testing in the IDEAL study.

Publication ,  Conference
Jazwinski, AB; Clark, PJ; Thompson, AJ; Gordon, SC; Lawitz, EJ; Noviello, S; Brass, CA; Pedicone, LD; Albrecht, JK; Sulkowski, MS; Muir, AJ
Published in: Pharmacogenet Genomics
November 2013

INTRODUCTION: Pharmacogenomic testing is important in developing individualized therapeutic approaches. In the phase 3 IDEAL (Individualized Dosing to Assess Optimal Pegylated Interferon Therapy) clinical trial, a subset of patients receiving peginterferon and ribavirin for treatment of chronic hepatitis C agreed to provide blood samples for genetic testing. Genome-wide association studies subsequently identified associations between IL28B polymorphism and sustained virologic response, and ITPA polymorphism and ribavirin-associated anemia. OBJECTIVE: To characterize the groups of patients who accepted or declined pharmacogenomic testing in the IDEAL study. METHODS: Clinical and demographic factors and treatment outcomes were compared at all sites that had approved pharmacogenomic testing. Differences between patients who consented to and declined pharmacogenomic testing were analyzed using Student's t-test and χ²-test. RESULTS: In total, 109 of 118 sites participated in the pharmacogenomic substudy, and 1674 of 2949 (57%) patients enrolled at these sites consented to pharmacogenomic testing. More patients treated in academic medical centers than in community centers (60 vs. 52%, P<0.001) provided consent. More men than women (58 vs. 54%, P=0.04) consented to pharmacogenomic testing. There was no significant difference in pharmacogenomic participation between patients from different racial groups, including whites and African Americans (58 vs. 54%, P=0.07). Treatment outcomes were also similar according to pharmacogenomic participation. CONCLUSION: In the IDEAL study, patient consent to pharmacogenomic testing did not introduce selection bias. Treatment at an academic center and male sex were associated with higher rates of pharmacogenomic testing consent. Efficacy and safety outcomes were similar in patients who accepted and declined pharmacogenomic testing.

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Published In

Pharmacogenet Genomics

DOI

EISSN

1744-6880

Publication Date

November 2013

Volume

23

Issue

11

Start / End Page

619 / 623

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Sex Characteristics
  • Ribavirin
  • Recombinant Proteins
  • Racial Groups
  • Pyrophosphatases
  • Precision Medicine
  • Polymorphism, Genetic
  • Polyethylene Glycols
 

Citation

APA
Chicago
ICMJE
MLA
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Jazwinski, A. B., Clark, P. J., Thompson, A. J., Gordon, S. C., Lawitz, E. J., Noviello, S., … Muir, A. J. (2013). Predictors of consent to pharmacogenomics testing in the IDEAL study. In Pharmacogenet Genomics (Vol. 23, pp. 619–623). United States. https://doi.org/10.1097/FPC.0000000000000002
Jazwinski, Alison B., Paul J. Clark, Alexander J. Thompson, Stuart C. Gordon, Eric J. Lawitz, Stephanie Noviello, Clifford A. Brass, et al. “Predictors of consent to pharmacogenomics testing in the IDEAL study.” In Pharmacogenet Genomics, 23:619–23, 2013. https://doi.org/10.1097/FPC.0000000000000002.
Jazwinski AB, Clark PJ, Thompson AJ, Gordon SC, Lawitz EJ, Noviello S, et al. Predictors of consent to pharmacogenomics testing in the IDEAL study. In: Pharmacogenet Genomics. 2013. p. 619–23.
Jazwinski, Alison B., et al. “Predictors of consent to pharmacogenomics testing in the IDEAL study.Pharmacogenet Genomics, vol. 23, no. 11, 2013, pp. 619–23. Pubmed, doi:10.1097/FPC.0000000000000002.
Jazwinski AB, Clark PJ, Thompson AJ, Gordon SC, Lawitz EJ, Noviello S, Brass CA, Pedicone LD, Albrecht JK, Sulkowski MS, Muir AJ. Predictors of consent to pharmacogenomics testing in the IDEAL study. Pharmacogenet Genomics. 2013. p. 619–623.

Published In

Pharmacogenet Genomics

DOI

EISSN

1744-6880

Publication Date

November 2013

Volume

23

Issue

11

Start / End Page

619 / 623

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Sex Characteristics
  • Ribavirin
  • Recombinant Proteins
  • Racial Groups
  • Pyrophosphatases
  • Precision Medicine
  • Polymorphism, Genetic
  • Polyethylene Glycols