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A Randomized Controlled Trial of Double Versus Triple Therapy with Amantadine for Genotype 1 Chronic Hepatitis C in Latino Patients

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An Erratum to this article was published on 16 January 2010

Abstract

Background

With only a third of Latinos achieving sustained virologic response (SVR), there is a need for enhanced HCV treatment. Amantadine has been proposed to improve response rates in addition to standard therapy with peginterferon α and ribavirin. Our objective is to evaluate whether triple therapy with amantadine improves SVR rates in this special population.

Method

Treatment-naïve Latino subjects with HCV genotype 1 infection were randomized to receive peginterferon α-2a plus weight-based ribavirin for 48 weeks (double therapy) or the same regimen plus amantadine 200 mg daily (triple therapy). The primary endpoint was SVR. Predictors of liver fibrosis using APRI and Forns indices were also evaluated.

Results

We enrolled 124 patients with chronic hepatitis C genotype 1. Sixty-three received conventional therapy and 61 patients had triple therapy with amantadine. SVR at week 72 was achieved in 25 patients (39.7%) vs. 26 patients (42.6%) in the double and triple regimen, respectively (p = 0.561). After multivariate analysis, advanced fibrosis, obesity, and low pretreatment ALT levels were associated with non-response in both groups (p = 0.0234, p = 0.0012, p = 0.0249, respectively). APRI values delimited an area under the ROC curve (AUROC) of 0.724 and Forns index with AUROC of 0.733. There was no difference between both indices in predicting significant fibrosis (Knodell index: F3–F4).

Conclusion

Our study demonstrates that the addition of amantadine to standard treatment of chronic HCV does not improve SVR rates in Latino patients with genotype 1. Further research to improve response rates in this special population is needed.

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Abbreviations

HCV:

Hepatitis C virus

SVR:

Sustained virological response

EVR:

Early virological response

EOTR:

End of treatment response

ULN:

Upper limit of normal

ALT:

Alanine aminotransferase

AST:

Aspartate aminotransferase

APRI:

Aspartate aminotransferase-to-platelet ratio index

ROC:

Receiver operating characteristics

CI:

Confidence interval

AUROC:

Area under receiver operating curves

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Acknowledgments

This study was performed in part with unrestricted support by Roche-Syntex SA. de CV, Mexico. We appreciate the great help of Nurse Leticia Casillas in the patients’ management advocacy and her work in the database. We value the full participation of Dr. Jesus A. Juarez in this project.

Conflict of Interest Statement

Jorge Mendez-Navarro has a research scholarship from Instituto Mexicano del Seguro Social, (IMSS). Kathleen E. Corey has received research support from Bristol Myers Squibb, USA. Raymond T. Chung has received research support from Roche Labs, USA. Margarita Dehesa-Violante, Emmanuel C. Gorospe, Ruby A. Chirino, Segundo Morán and Hui Zheng have nothing to disclose.

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Authors and Affiliations

  1. Departamento de Gastroenterología, Hospital de Especialidades, Centro Médico Nacional Siglo XXI, IMSS, Av. Cuauhtemoc 330, Col. Doctores, 06725, Mexico, DF, Mexico

    Jorge Méndez-Navarro, Ruby A. Chirino, Segundo Morán & Margarita Dehesa-Violante

  2. Gastrointestinal Unit, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Warren 1007, Boston, MA, 02114, USA

    Jorge Méndez-Navarro, Kathleen E. Corey & Raymond T. Chung

  3. Department of Medicine, John Hopkins University School of Medicine, Baltimore, MD, USA

    Emmanuel C. Gorospe

  4. MGH Biostatistics Center, Harvard Medical School, Boston, MA, USA

    Hui Zheng

Authors
  1. Jorge Méndez-Navarro
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  2. Ruby A. Chirino
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  8. Margarita Dehesa-Violante
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Corresponding authors

Correspondence to Jorge Méndez-Navarro or Raymond T. Chung.

Additional information

An erratum to this article can be found at http://dx.doi.org/10.1007/s10620-009-1114-8

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Méndez-Navarro, J., Chirino, R.A., Corey, K.E. et al. A Randomized Controlled Trial of Double Versus Triple Therapy with Amantadine for Genotype 1 Chronic Hepatitis C in Latino Patients. Dig Dis Sci 55, 2629–2635 (2010). https://doi.org/10.1007/s10620-009-1062-3

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  • DOI: https://doi.org/10.1007/s10620-009-1062-3

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