Clin Gastroenterol Hepatol. 2010 Nov 4. [Epub ahead of print]
Peck-Radosavljevic M, Boletis J, Besisik F, Ferraz ML, Alric L, Samuel D, Messinger D, Tietz A, Cheinquer H.
University of Vienna, Vienna, Austria.
Abstract
BACKGROUND & AIMS: Chronic hepatitis C increases mortality of patients with end-stage renal disease (ESRD). Ribavirin is not recommended for patients with renal dysfunction; peginterferon monotherapy is the most appropriate treatment for chronic hepatitis C in such patients. We evaluated the efficacy and safety of 2 dosages of peginterferon alfa-2a (40KD) in patients with chronic hepatitis C and ESRD on hemodialysis.
METHODS: We performed a randomized, multi-centre, open-label clinical study of 85 patients with chronic hepatitis C and ESRD who were receiving hemodialysis at specialist outpatient hepatology clinics. Patients were treated with subcutaneous peginterferon alfa-2a (40KD) at dosages of 135 or 90 μg/week for 48 weeks.
RESULTS: The incidence of overall sustained virologic responses (SVR, undetectable hepatitis C virus [HCV] RNA [<50 IU/mL] after 24 weeks of untreated follow-up) were 39.5% (15/38) in the 135 μg/week group and 34.9% (15/43) in the 90 μg/week group (odds ratio: 1.22; 95% confidence interval: 0.49-3.06; P=0.6746). Among patients with undetectable HCV RNA at week 12, 60.9% (14/23) of those in the 135 μg/week and 87.5% (14/16) of those in the 90 μg/week group achieved an SVR. Therapy was well tolerated with no new safety concerns. The most common adverse events (>10% of patients in at least 1 treatment group) included conditions associated with ESRD (anemia and hypertension) and with interferon treatment.
CONCLUSIONS: Forty-eight weeks of treatment with low-dose peginterferon alfa-2a (40KD) is safe and produces an SVR in 35%-40% of patients with chronic hepatitis C and ESRD on hemodialysis.
Copyright © 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.
PMID: 21056689 [PubMed - as supplied by publisher]
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