Retreatment of Dialysis Patients With Chronic Hepatitis C With Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin
Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
Participant gender:
Summary
Chronic hepatitis C virus (HCV) infection is common in dialysis patients. Interferon
(IFN)-based treatment for chronic hepatitis C has been the mainstay therapy in
immunocompetent patients. Two meta-analyses evaluating the efficacy and safety of
conventional IFN alfa monotherapy showed that the sustained virologic response (SVR) rates
were 37% and 33%, respectively; and the corresponding dropout rates were 17% and 29.6%,
respectively. The efficacy and safety of pegylated IFN alfa-2a and 2b in treating dialysis
patients showed conflicting results, with a more favorable outcome of patients treated with
pegylated IFN alfa-2a (135-180 μg/week: SVR 33-75%, well tolerated) than those treated with
pegylated IFN alfa-2b (0.5-1.0 μg/week: SVR 12.5%, poorly tolerated), Currently, IFN-based
therapy to treatment HCV infection should be initiated in dialysis stages, because the use of
IFN in RT patients harbors high risks of acute graft rejection,and have low response rates
under the concomitant use of immunosuppressive agents.
Ribavirin, which has been used in combination with IFN to treat chronic hepatitis C in the
general patients and achieve a higher SVR rate than IFN monotherapy, is considered
contraindicated in dialysis patients with chronic hepatitis C due to the risk of severe
hemolytic anemia. However, some pilot studies evaluating combined conventional IFN alfa plus
low dose ribavirin (170-300 mg/day) showed SVR rates of 17%-66% after 24-48 weeks of
treatment.In addition, a recent study including 6 patients with combination of pegylated IFN
alfa plus low dose ribavirin also showed a SVR rate of 50%.
Although dialysis patients have a higher SVR rate to conventional IFN or pegylated IFN
monotherapy than patients with normal renal function for HCV therapy. More than half of these
patients are relapsers or non-responders to IFN monotherapy. Retreatment of HCV-patients with
normal renal function by combined pegylated IFN alfa plus ribavirin who fail to response to
IFN monotherapy has achieved a SVR rate of 28%. Based on the long-term favorable outcome in
dialysis patients who eradicate HCV, the aim of the study is to evaluate the efficacy and
safety of retreatment by pegylated IFN alfa-2a plus low dose ribavirin in dialysis patients
who fail to achieve HCV eradication by conventional or pegylated IFN alfa.
Phase:
Phase 4
Details
Lead Sponsor:
National Taiwan University Hospital
Collaborators:
Department of Health, Executive Yuan, R.O.C. (Taiwan) National Science Council, Taiwan