Low-Dose Peginterferon Alfa-2a Is Safe and Produces a Sustained Virologic Response in Patients With Chronic Hepatitis C and End-Stage Renal Disease

Clinical Gastroenterology and Hepatology
Volume 9, Issue 3 , Pages 242-248, March 2011

Markus Peck–Radosavljevic, John Boletis, Fatih Besisik, Maria Lúcia Ferraz, Laurent Alric, Didier Samuel, Diethelm Messinger, Andreas Tietz, Hugo Cheinquer

published online 09 November 2010.

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 (40 kDa) in patients with chronic hepatitis C and ESRD on hemodialysis.

Methods
We performed a randomized, multicenter, 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 (40 kDa) at dosages of 135 or 90 μg/wk for 48 weeks.

Results
The incidences of overall sustained virologic responses (SVRs) (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/wk group and 34.9% (15/43) in the 90 μg/wk group (odds ratio, 1.22; 95% confidence interval, 0.49–3.06; P = .67). Among patients with undetectable HCV RNA at week 12, 60.9% (14/23) of those in the 135 μg/wk group and 87.5% (14/16) of those in the 90 μg/wk 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 (40 kDa) is safe and produces an SVR in 35%–40% of patients with chronic hepatitis C and ESRD on hemodialysis.

Keywords: Chronic Hepatitis C, End-Stage Renal Disease, Hemodialysis, Hepatitis C Virus, Peginterferon, Sustained Virologic Response

Source