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Safety, efficacy of interferon beta-1b for virus elimination in chronic viral cardiomyopathy confirmed in new trial

Sunday, November 16 2008 | Comments
Evidence Grade 7 What's This?
By Patrice La Vigne

Patients with chronic viral cardiomyopathy may receive clinical benefits safely from interferon beta-1b therapy, according to new findings.

Study researcher Dr. Heinz-Peter Schultheiss from Charite-Universitatsmedizin in Berlin, Germany, noted that the current guidelines do not recommend biopsy for patients with chronic viral cardiomyopathy, but recent molecular diagnostic techniques have proven greater ability to detect viral genomes. Therefore, he and his research team aimed to test the effect of antiviral treatment in patients with viral persistence and persistent viral cardiomyopathy.

The Phase II double-blind, randomized controlled, European trial included 143 patients with chronic viral cardiomyopathy (left ventricular ejection fraction [LVEF]  >25%) who were randomized to receive either 4 international units (IU) of subcutaneous interferon beta-1b (n=49), 8 IU of interferon beta-1b (n=46), or placebo (n=48) for 24 weeks. 

Dr. Schultheiss said the outcomes were evaluated according to strata. In the first stratum, patients' biopsies showed enterovirus, adenovirus, and/or parvovirus B19. In the second stratum, patients' biopsies only showed parvovirus B19. Neither of these stratums individually revealed a statistically significant effect from interferon beta-1b treatment. However, when both strata were considered together, there was a statistically significant increase in viral elimination or reduction of virus load, as assessed by independent physicians (P=.048).

Evaluation of the secondary endpoint revealed an improvement in patients' New York Heart Association functional classification and quality of life scores, as measured by the Minnesota Living with Heart Failure Questionnaire. There were no other noteworthy changes in other secondary endpoints, such as LVEF measurement or 6-minute walking test.

According to Dr. Schultheiss, there were some adverse events that resulted from interferon beta-1b use, but none were serious and there was a low discontinuation rate overall.

"These data implicate for the first time a biopsy-based specific and casual therapy for chronic cardiomyopathy," Dr. Schultheiss said, stressing the need to move into Phase III testing. (Abstract Oral Session 3322.)

Bayer HealthCare sponsored the study.

This information concerns a use that has not been approved by the Food and Drug Administration.

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