Abstract
Purpose: Standard therapy for chronic HCV infection is interferon (IFN) in combination with RBV. Previous studies have demonstrated significant rates of depression with this therapy-sometimes necessitating dose reduction or cessation of treatment. Our objective was to evaluate rates of depression and quality of life in subjects who were randomized to CIFN 15 mcg three times a week and RBV or weekly Peg IFN/RBV (150 mcg/0.5 ml). Methods: This was a prospective, multicenter, randomized trial. All subjects were diagnosed with chronic HCV genotype 1 and were naive to treatment. Three scales were used to measure depression and quality of life: the Beck Depression Inventory-II (BDI-II), the Center for Epidemiological Studies Depression Scale (CES-D), and the Hepatitis Quality of Life Questionnaire (HQLQ). All questionnaires were administered at baseline and at treatment weeks 12, and 24 and 24 weeks after cessation of treatment. Results: A total of 96 patients (47 CIFN/RBV and 49 Peg IFN/RBV) were enrolled in the study. Complete data was analyzed in 26 pts in the CIFN/RBV group and 33 pts in the Peg IFN/RBV groups. The two groups were similar in baseline demographics and clinical variables. The BDI-II and CES-D scores significantly increased from baseline in both treatment groups at weeks 12 and 24 (P < 0.001) but returned to baseline 24 weeks after cessation of therapy. HQLQ analysis significantly decreased (P < 0.001) from baseline in both groups at weeks 12 and 24 but returned to baseline after cessation of therapy. Compared to the CIFN/RBV group, patients in the Peg IFN/RBV group had a greater decrease in quality of life during treatment (P= 0.029). Conclusion: The antiviral response in both groups was similar (37% and 42% for CIFN/RBV and Peg IFN/RBV respectively). There was a statistically significant increase in depression scores and decrease in quality of life in both groups during therapy.Table
Published Version
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