Reuters Health Information (2011-03-10): Low-dose interferon safe, effective for dialysis patients with hepatitis C
Drug & Device Development
Low-dose interferon safe, effective for dialysis patients with hepatitis C
Last Updated: 2011-03-10 10:55:12 -0400 (Reuters Health)
NEW YORK (Reuters Health) - A low-dose regimen of peginterferon, without ribavirin, produces a sustained virologic response in up to 40% of dialysis patients with chronic hepatitis C, an international study indicates.
"This is the first large prospective trial to show the efficacy and safety of pegylated interferon monotherapy in patients undergoing hemodialysis," lead investigator Dr. Markus Peck-Radosavljevic told Reuters Health via email.
"This is important since this group of patients is fraught with a particularly high rate of HCV infection, especially outside the US and EU."
Hepatitis C virus infection is associated with increased mortality in patients with end-stage renal disease and with poorer outcomes after transplantation, notes Dr. Peck-Radosavljevic, at the Medical University of Vienna, Austria, and colleagues in the March issue of Clinical Gastroenterology and Hepatology.
Peginterferon plus ribavirin is the standard treatment for chronic hepatitis C, but ribavirin is contraindicated in renal dysfunction. Furthermore, interferon is not well tolerated by patients with end stage renal disease.
The researchers therefore tested two reduced doses of peginterferon alfa-2a monotherapy, in a trial involving 81 patients 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. The standard dose for non-hemodialysis patients is 180 mcg/week, Dr. Peck-Radosavljevic said.
"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."
The study was sponsored by Roche Switzerland.
Clin Gastroenterol Hepatol 2011.