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Pegylated Interferon Alfa-2a Monotherapy Efficacious in Treating Dialysis Patients With Hepatitis C: Presented at AASLD

By Maria Bishop

BOSTON, MA -- November 5, 2007 -- Pegylated interferon (PEG-IFN) alfa-2a monotherapy is effective in dialysis patients with hepatitis C virus (HCV), demonstrating a sustained virological response (SVR) of 36.8% in this hepatologically compromised patient population, researchers reported here at the 58th Annual Scientific Meeting of the American Association for the Study of Liver Disease (AASLD).

PEG IFN alfa-2a, due to its limited excretion (< 10%) appears to be the preferred treatment of haemodialysis patients, despite serious side effects, noted lead author Reinhart Zachoval, MD, Head of Ambulatory Hepatological Care, Medical Clinic 2, Ludwig - Maximilians University (LMU), Grosshadern, Munich, Germany.

Dr. Zachoval led an open, prospective multicentre study of 38 haemodialysis patients (23 male) with chronic hepatitis C to evaluate the rate of SVR after 48 weeks of PEG-IFN alfa-2a monotherapy. Patients received 135 ug of PEF-IFN alfa-2a per week at the end of their dialysis procedures for 24 weeks. If patients achieved a decline of HCV ribonucleic acid (RNA) greater than 2 log, therapy was continued for a total of 48 weeks.

In a subgroup of 11 patients, results from a dose of 180 ug of the therapy were recorded.

SVR was observed in 14 of the 38 patients (36.8%). Seventeen patients were non-responders, and 7 patients showed a relapse of viremia.

Repeated dosing at both dose levels resulted in constant drug levels in patients undergoing haemodialysis.

A high rate of severe side effects was also shown, however, and 8 patients discontinued the trial due to serious adverse events, including death (myocardial infarction), massive retinal arterial embolisation, grand mal seizures, instable angina, pneumonia, and massive diabetic foot syndrome.

While the drug demonstrated good efficacy, the high rate of side effects in this study therefore necessitates meticulous patient selection in these often comorbid individuals, concluded Dr. Zachoval.

This trial was sponsored by Roche Pharma, Grenzach, Germany.


[Presentation title: PEG-IFN alfa-2a Monotherapy in Dialysis Patients Infected With HCV. Abstract 328]

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