Boceprevir Treatment in Liver Pre-transplant HCV Patients
Status:
Unknown status
Trial end date:
2017-02-01
Target enrollment:
Participant gender:
Summary
End-stage liver disease due to hepatitis C virus (HCV) is the most common indication for
liver transplantation(LT) worldwide (30~40%). Within 5 years, about 25-30% of liver
transplant recipients with recurrent hepatitis C would progress to liver cirrhosis (Ponziani
et. Al, 2011), it also accounts for 2/3 of graft failure and deaths after liver
transplantation.(Bzowej et al., 2011)
Kaohsiung Chang Gung Memorial Hospital continue to have at least 45 HCV-related liver disease
patients awaiting for liver transplantation annually. If the HCV viral load can be
significantly reduced or sustained virologic response (SVR) can be achieved by triple therapy
with Pegylated interferon alfa(PEG)/Ribavirin(RBV)/Boceprevir(BOC) treatment before liver
transplantation(LT), the graft re-infection of HCV can be prevented. By this way, we can
reduce the risk of early fibrosis progression in the liver graft, and hopefully, improving
graft and patient survival after liver transplantation.(Toniutto, 2008)(Ponziani et al,
2011).
We aim to conduct an prospective, open label, single arm study. This study design is single
arm to treat HCV patients with Pegylated interferon alfa(PEG)/Ribavirin(RBV)/Boceprevir(BOC)
triple therapies before liver transplantation for patients with detectable HCV RNA. The total
number of patients would be around 20 cases included in the study and all of them will take
Pegylated interferon alfa(PEG)/Ribavirin(RBV)/Boceprevir(BOC) triple therapy. The
experimental regimen contains 4 week lead-in therapy with Peg-Interferon α-2b plus Ribavirin.
Then after, triple therapy with Boceprevir + Peg-Interferon α-2b + Ribavirin will be used for
at least 16 weeks or maximal 44 weeks before transplantation. Normal practice based on the
treatment protocol of the Kaohsiung Chang Gung Memorial Hospital liver transplant center will
be done before enrollment. Patients will be monitored for all the efficacy and safety
endpoints during the treatment period. HCV RNA will be checked at time of transplant.
Finally, patients will received regular monitoring of HCV RNA 1, 3, 6, 9, 12 months after
liver transplantation.