Source: Stroke  |  Posted 4 years ago

By Jill Stein

BARCELONA, SPAIN -- April 16, 2007 -- Low-dose peginterferon-alfa-2a is effective in patients with chronic hepatitis C virus (HCV) infection who are undergoing haemodialysis for end-stage renal disease (ESRD), according to the interim results of an ongoing trial.

Markus Peck-Radosavljevic, professor, division of gastroenterology and hepatology, University of Vienna, Vienna, Austria, presented these results here on April 14[^]th[] at the 42[^]nd[] Annual Meeting of the European Association for the Study of the Liver (EASL).

"Patients with ESTD and chronic HCV are at increased risk of disease progression and decreased graft survival after transplantation," Dr. Peck-Radosavljevic explained.

The preliminary results were from 80 non-cirrhotic, interferon-na?ve patients with chronic HCV and ESRD who were undergoing dialysis and were randomised to peginterferon alfa-2a (40KD) 135 mcg/week or 90 mcg/week for a total of 48 weeks of treatment.

The primary endpoint was sustained virological response, defined as undetectable serum HCV RNA (<50 IU/mL) 24 weeks after the end of treatment.

The 2 treatment groups were similar with respect to gender, mean age, mean body weight, mean level of alanine aminotransferase (ALT), ALT quotient, HCV genotype, mean HCV RNA and mean number of dialysis sessions per week.

Results at 12 weeks showed that in patients receiving peginterferon alfa-2a 135 mcg/week, there were significantly more virological responders at week 12 than in the group receiving 90 mcg/week (61% vs 37%, respectively). However, a significant difference was not observed at week 24.

Only in the difficult-to-treat patients with high viral loads was a clinically relevant difference still present between the 2 dose groups at week 24 (45% vs 25%).

The frequency of adverse events and laboratory abnormalities was similar in the 2 treatment arms.

"These interim results show that treatment with peginterferon-alfa 2a (40 KD) is effective and has acceptable tolerability in chronic HCV patients who have ESRD and are undergoing haemodialysis," Dr. Peck-Radosavljevic said.

The study was supported by Roche.

[Presentation title: Use of Low-Dose Peginterferon Alfa-2a (40KD) (Pegasys) to Treat Hepatitis C-Infected, End-Stage Renal Disease Patients undergoing Hemodialysis: Interim Results from a Randomized Study. Abstract 628]