NEW YORK (Reuters Health) – A low-dose regimen of peginterferon, without ribavirin, produces a sustained virologic response in up to 40% of patients with chronic hepatitis C and end-stage renal disease on dialysis, results of an international study indicate.
Hepatitis C virus infection is associated with increased mortality in patients with end-stage renal disease and with poorer outcomes after transplantation, note Dr. Markus Peck–Radosavljevic, at the Medical University of Vienna, Austria, and colleagues in the March issue of Clinical Gastroenterology and Hepatology.
However, while peginterferon plus ribavirin is the standard treatment for chronic hepatitis C, ribavirin is contraindicated in patients with renal dysfunction. Furthermore, interferon is not well tolerated by patients with ESRD.
The researchers therefore conducted a trial of two reduced doses of peginterferon alfa-2a monotherapy in 81 such patients at 22 centers in 8 countries. The participants were randomized to receive subcutaneous peginterferon alfa-2a 135 mcg or 90 mcg once weekly for 48 weeks, administered after hemodialysis sessions.
“Overall SVR (sustained virologic response) rates among patients treated with peginterferon alfa-2a (40 kDa) 135 mcg/wk and 90 mcg/wk, respectively, were 39.5% (15/38) and 34.9% (15/43),” the researchers report.
SVR rates in both groups were higher in those with a low baseline viral load, and lower in those with hepatitis C type 1 given 135 mcg/week, according to the report.
No unexpected safety concerns arose in either group. The most common adverse events were conditions such as anemia or hypertension associated with ESRD and the usual side effects of interferon such as myalgia, fatigue and pyrexia.
Five patients in the 135-mcg/wk group and three in the 90-mcg/wk group withdrew from treatment because of adverse events or laboratory abnormalities.
Dr. Peck–Radosavljevic and colleagues conclude, “These findings support the conclusion that monotherapy with peginterferon alfa-2a (40 kDa) therapy at a dose of 135 mcg/wk or 90 mcg/wk for 48 weeks is an attractive option to improve treatment outcomes in patients with ESRD by means of eradication of HCV before transplantation.”
Clin Gastroenterol Hepatol 2011;9:242-248.