Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin for Treatment-Naïve Hemodialysis Patients With Chronic Hepatitis C
Status:
Completed
Trial end date:
2013-09-01
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. In dialysis patients, treatment with conventional or pegylated
interferon has also received much attention recently. 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%. In this study, treatment with
pegylated IFN alfa-2a plus low dose ribavirin achieved a higher SVR rate that that with
pegylated IFN alfa-2b plus low dose ribavirin (100% vs. 25%).
Based on the long-term favorable outcome in dialysis patients who eradicate HCV, and the
superior response of pegylated IFN alfa-2a plus low dose ribavirin to pegylated IFN alfa-2b
plus low dose ribavirin in treating dialysis patients with chronic hepatitis C, the aim of
the study is to evaluate the efficacy and safety of pegylated IFN alfa-2a plus low dose
ribavirin versus pegylated interferon alfa-2a alone in treatment naïve dialysis patients with
chronic hepatitis C.
Phase:
Phase 4
Details
Lead Sponsor:
National Taiwan University Hospital
Collaborators:
Department of Health, Executive Yuan, R.O.C. (Taiwan) National Science Council, Taiwan