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Betaferon in chronic viral cardiomyopathy (BICC) trial: Effects of interferon-β treatment in patients with chronic viral cardiomyopathy

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Abstract

Background

Chronic viral infections of the heart are considered one antecedent event leading to progressive dysfunction of the myocardium, often with an impaired prognosis due to a virus- or immune-mediated myocardial injury. Symptomatic treatment does not influence the viral cause of heart failure, and the effect of antiviral treatment has not been determined, yet.

Methods and results

In this phase II study 143 patients with symptoms of heart failure and biopsy-based confirmation of the enterovirus (EV), adenovirus, and/or parvovirus B19 genomes in their myocardial tissue were randomly assigned to double-blind treatment, and received either placebo (n = 48) or 4 × 106 (n = 49) and 8 × 106 IU (n = 46) interferon beta-1b (IFN-β-1b) for 24 weeks, in addition to standard heart failure treatment. Patients with active myocarditis or other specific causes of heart failure were excluded. Compared to placebo, virus elimination and/or virus load reduction was higher in the IFN-β-1b groups (odds ratio 2.33, p = 0.048), similarly in both interferon groups and both strata. IFN-β-1b treatment was associated with favourable effects on NYHA functional class (p = 0.013 at follow-up week 12), improvement in quality of life (Minnesota Heart Failure score; p = 0.032 at follow-up week 24) and patient global assessment (follow-up week 12 to follow-up week 24; p = 0.039). The frequency of adverse cardiac events was not higher in the IFN-β-1b groups compared to the placebo group.

Conclusions

Immunomodulatory IFN-β-1b treatment is a well-tolerated and safe treatment option, leading to effective virus clearance or reduction of the virus load in patients with chronic viral cardiomyopathy. Favourable clinical effects assess quality of life, NYHA functional class, and patient global assessment.

ClinicalTrials.gov identifier: NCT001185250

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Acknowledgments

This study was supported by a grant from Bayer Health Care, Berlin, Germany and applied diagnostic procedures developed with the support of the German Research Foundation (DFG), Transregional Collaborative Research Centre “Inflammatory Cardiomyopathy, Molecular Pathogenesis and Therapy” (SFB TR 19).

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Authors and Affiliations

  1. Department of Cardiology, Campus Benjamin Franklin, Charite-Universitätsmedizin Berlin, Berlin, Germany

    Heinz-Peter Schultheiss, Matthias Pauschinger, Felicitas Escher & Uwe Kuehl

  2. Institute for Cardiac Diagnostics and Therapy (IKDT), Moltkestr. 31, 12203, Berlin, Germany

    Heinz-Peter Schultheiss, Felicitas Escher & Uwe Kuehl

  3. Kardiologische Klinik, Herz- und Diabetes Zentrum NRW, Bad Oeynhausen, Germany

    Cornelia Piper

  4. Bayer Health Care AG, Berlin, Germany

    Olaf Sowade, Joachim-Friedrich Kapp, Georg Groetzbach & Harald Siedentop

  5. Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden

    Finn Waagstein

  6. Institut für Biometrie und Epidemiologie, Universitätsklinikum Hamburg Eppendorf, Hamburg, Germany

    Karl Wegscheider

  7. Department of Cardiology, Universitätsklinik der Paracelsus Medizinischen Privatuniversität, Nuremberg, Germany

    Matthias Pauschinger

  8. Centre for Inherited Cardiovascular Diseases and Transplant Research Area, IRCCS Foundation Policlinico San Matteo, Univ di Pavia, Pavia, Italy

    Eloisa Arbustini

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  1. Heinz-Peter Schultheiss
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Correspondence to Heinz-Peter Schultheiss.

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Schultheiss, HP., Piper, C., Sowade, O. et al. Betaferon in chronic viral cardiomyopathy (BICC) trial: Effects of interferon-β treatment in patients with chronic viral cardiomyopathy. Clin Res Cardiol 105, 763–773 (2016). https://doi.org/10.1007/s00392-016-0986-9

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  • DOI: https://doi.org/10.1007/s00392-016-0986-9

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