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Retreatment of Hepatitis C with Consensus Interferon and Ribavirin After Nonresponse or Relapse to Pegylated Interferon and Ribavirin: A National VA Clinical Practice Study

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Abstract

Background

Studies of the retreatment with consensus interferon (CIFN) and ribavirin (RBV) of hepatitis C virus (HCV)-infected patients who failed prior pegylated interferon alfa/ribavirin (PEG-IFN/RBV) have found quite variable efficacy and tolerability of this therapy. As such, CIFN/RBV use and efficacy in clinical practice were evaluated within the Department of Veterans Affairs (VA), the largest national, integrated system for HCV care.

Aims

The purpose of this study was to determine rates of sustained virologic response (SVR) and patterns of CIFN/RBV use in the VA. Methods included retrospective review of national VA data in HCV-infected patients who had previously failed ≥12 weeks of PEG-IFN/RBV and were prescribed CIFN/RBV between October 1, 2003 and September 30, 2006.

Results

A total of 597 patients met the study criteria. CIFN was primarily dosed as 15 mcg subcutaneously daily combined with standard doses of RBV. Mean treatment duration was 21 weeks; CIFN was discontinued within 4 weeks in 24%. Hematological growth factors were used in 49%. Post-treatment viral loads were available in 385 patients. SVR to CIFN/RBV was achieved in 11%, and was significantly higher in prior PEG-IFN/RBV relapsers compared with nonresponders (31% vs. 6%, respectively; P < 0.0001). A 2-log10 or greater drop in HCV RNA after 24 weeks of PEG-IFN/RBV was a predictor of subsequent SVR to CIFN/RBV.

Conclusions

CIFN/RBV was used frequently in clinical practice for retreatment of PEG-IFN/RBV. In this setting, early treatment discontinuation was common. Overall SVR was low, although response was significantly better in prior PEG-IFN/RBV relapsers and those who had a 2-log10 or greater decline than in nonresponders.

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Abbreviations

CIFN:

Consensus interferon

DIRECT:

Daily-dose consensus interferon and ribavirin: Efficacy of combined therapy

HCV:

Hepatitis C virus

PEG-IFN:

Pegylated interferon alfa

IFN:

Interferon

PBM:

Pharmacy Benefits Management

RBV:

Ribavirin

SVR:

Sustained virologic response

HCV RNA:

Hepatitis C virus ribonucleic acid level

VA:

Veterans Affairs

ICD-9:

International classification of diseases, ninth revision

NPF:

National Patient Files

CPT-4:

Coding for procedures performed, fourth revision

HIV:

Human immunodeficiency virus

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Acknowledgments

This study was performed with support from the Department of Veterans Affairs Hepatitis C Resource Center Program, VA Merit grant I01 CX000295, and an unrestricted grant from Valeant Pharmaceuticals International. The concept, study design, study preparation, data gathering, data analysis, and manuscript preparation were performed exclusively by the investigators. The authors would like to thank Daniel Tracy, Teresa L. Wright, and James C. Ryan for their assistance in the preparation of the manuscript.

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Correspondence to Alexander Monto.

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Yee, H.S., Currie, S.L., Tortorice, K. et al. Retreatment of Hepatitis C with Consensus Interferon and Ribavirin After Nonresponse or Relapse to Pegylated Interferon and Ribavirin: A National VA Clinical Practice Study. Dig Dis Sci 56, 2439–2448 (2011). https://doi.org/10.1007/s10620-011-1746-3

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