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

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http://www.cghjournal.org/article/PIIS1542356510010839/abstract?rss=yes

Low-Dose Peginterferon Alfa-2a Is Safe and Produces a Sustained Virologic

Response in Patients With Chronic Hepatitis C and End-Stage Renal Disease

Markus Peck¨CRadosavljevic, Boletis, Fatih Besisik, L¨²cia Ferraz,

t Alric, Didier , Diethelm Messinger, s Tietz, Hugo Cheinquer

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 ¦Ìg/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 ¦Ìg/wk group and 34.9% (15/43) in the 90 ¦Ìg/wk

group (odds ratio, 1.22; 95% confidence interval, 0.49¨C3.06; P = .67). Among

patients with undetectable HCV RNA at week 12, 60.9% (14/23) of those in the 135

¦Ìg/wk group and 87.5% (14/16) of those in the 90 ¦Ìg/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%¨C40% of patients with chronic hepatitis C and

ESRD on hemodialysis.

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Conflicts of interest The authors disclose the following: Dr Peck¨CRadosavljevic

has received grant support from and has served as an investigator, speaker, and

consultant for Roche. D. Messinger is employed by Roche to provide statistical

consultancy and analysis. Dr Tietz is an employee of Roche. Dr Cheinquer has

received research support from Bristol-Myers Squibb and from Roche and has acted

as a consultant for Bristol-Myers Squibb and for Roche. The remaining authors

disclose no conflicts.

Funding The study was sponsored by Roche, Basel, Switzerland.