Absolute and relative contraindications to pegylated-interferon or ribavirin in the US general patient population with chronic hepatitis C: results from a US database of over 45 000 HCV-infected, evaluated patients
Article first published online: 7 JAN 2013
© 2013 Blackwell Publishing Ltd
Alimentary Pharmacology & Therapeutics
Volume 37, Issue 4, pages 473–481, February 2013
How to Cite
Talal, A. H., LaFleur, J., Hoop, R., Pandya, P., Martin, P., Jacobson, I., Han, J. and Korner, E. J. (2013), Absolute and relative contraindications to pegylated-interferon or ribavirin in the US general patient population with chronic hepatitis C: results from a US database of over 45 000 HCV-infected, evaluated patients. Alimentary Pharmacology & Therapeutics, 37: 473–481. doi: 10.1111/apt.12200
- Issue published online: 22 JAN 2013
- Article first published online: 7 JAN 2013
- Manuscript Accepted: 11 DEC 2012
- Manuscript Revised: 6 DEC 2012
- Manuscript Revised: 1 NOV 2012
- Manuscript Received: 5 OCT 2012
- Genentech, Inc
Chronic hepatitis C (HCV) treatment with pegylated-interferon (PEG-IFN)/ribavirin (RBV) is often limited by preexisting medical, psychiatric and psychosocial contraindications. However, limited data exist in general patient populations.
To evaluate the percentage of HCV-infected patients in the general US population who may have contraindications to PEG-IFN/RBV.
The General Electric (GE) Centricity dataset was used to screen the US population between 2004 and 2009 for HCV infection and contraindications to PEG-IFN/RBV. HCV diagnosis and contraindications were identified using ICD-9-CM codes or laboratory values. Only patients with an encounter 180 days prior to HCV diagnosis were included. Demographic differences were calculated using Pearson's chi-squared test. Frequencies and percentages for absolute and relative contraindications to PEG-IFN and/or RBV were determined and proportions and rates/1000 person-months were calculated.
A total of 15 561 021 patients were screened, and 45 690 (0.3%) were HCV-positive and were evaluated. Those with contraindications were significantly younger, female, White, not currently married and receiving Medicare or Medicaid coverage (all P < 0.0001). 17.3% had at least one contraindication to PEG-IFN/RBV (5.5 events/1000 person-months); bipolar disorder (6.5%), anaemia (Hgb < 10 g/dL; 5.9%), pregnancy (1.9%) and neutropenia (neutrophils <750 cells/mm3; 1.2%) were most frequently cited.
Approximately, 17% of HCV-infected patients in the general US population had at least one contraindication to PEG-IFN/RBV. Most contraindications were relative and potentially modifiable. Clinical assessment of contraindications as relative and/or modifiable should be considered and used to determine if patients could benefit from current PEG-IFN–containing triple therapy or future PEG-IFN– or RBV-free regimens.