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


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 × 10(6) (n = 49) and 8 × 10(6) 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.
Department of Cardiology, Campus Benjamin Franklin, Charite-Universitätsmedizin Berlin, Berlin, Germany. heinz-peter.schultheiss@charite.de.|Institute for Cardiac Diagnostics and Therapy (IKDT), Moltkestr. 31, 12203, Berlin, Germany. heinz-peter.schultheiss@charite.de.
Heinz-Peter
HP
Schultheiss
Kardiologische Klinik, Herz- und Diabetes Zentrum NRW, Bad Oeynhausen, Germany.
Cornelia
C
Piper
Bayer Health Care AG, Berlin, Germany.
Olaf
O
Sowade
Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
Finn
F
Waagstein
Bayer Health Care AG, Berlin, Germany.
Joachim-Friedrich
JF
Kapp
Institut für Biometrie und Epidemiologie, Universitätsklinikum Hamburg Eppendorf, Hamburg, Germany.
Karl
K
Wegscheider
Bayer Health Care AG, Berlin, Germany.
Georg
G
Groetzbach
Department of Cardiology, Campus Benjamin Franklin, Charite-Universitätsmedizin Berlin, Berlin, Germany.|Department of Cardiology, Universitätsklinik der Paracelsus Medizinischen Privatuniversität, Nuremberg, Germany.
Matthias
M
Pauschinger
Department of Cardiology, Campus Benjamin Franklin, Charite-Universitätsmedizin Berlin, Berlin, Germany.|Institute for Cardiac Diagnostics and Therapy (IKDT), Moltkestr. 31, 12203, Berlin, Germany.
Felicitas
F
Escher
Centre for Inherited Cardiovascular Diseases and Transplant Research Area, IRCCS Foundation Policlinico San Matteo, Univ di Pavia, Pavia, Italy.
Eloisa
E
Arbustini
Bayer Health Care AG, Berlin, Germany.
Harald
H
Siedentop
Department of Cardiology, Campus Benjamin Franklin, Charite-Universitätsmedizin Berlin, Berlin, Germany.|Institute for Cardiac Diagnostics and Therapy (IKDT), Moltkestr. 31, 12203, Berlin, Germany.
Uwe
U
Kuehl
D000257:Adenoviridae Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000821:virology; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001706:Biopsy; D009202:Cardiomyopathies / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000821:virology; D002908:Chronic Disease; D004311:Double-Blind Method; D004769:Enterovirus Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000821:virology; D016731:Erythema Infectiosum / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000821:virology; D005060:Europe; D005260:Female; D006801:Humans; D000068576:Interferon beta-1b / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D020127:Recovery of Function; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
D000998:Antiviral Agents; D000068576:Interferon beta-1b
Antiviral therapy, myocardial biopsies; Chronic viral cardiomyopathy; Interferon beta