End Stage Renal Disease Clinical Trial
Official title:
Prospective, Single-Center, Open Label, Pilot Study of Safety and Efficacy of Triple Anti-Viral Therapy With Pegylated Interferon, Ribavirin, and Boceprevir in Patients With Genotype 1 Chronic HCV With End Stage Renal Disease
The purpose of the study is to assess the safety and efficacy of triple therapy with pegylated interferon (P-IFN), ribavirin and boceprevir in patients with genotype 1 chronic Hepatitis C Virus (HCV) infection and end stage renal disease (ESRD) on hemodialysis (HD).
Hepatitis C (HCV) remains the most common chronic infection in the United States with about
3 million people chronically infected. The majority of these patients in the U.S. have
genotype 1 HCV infection, which has been the most difficult genotype to treat with the
traditional regimen of pegylated-interferon (P-IFN) and ribavirin, leading to sustained
virologic response (SVR) in less than 50% of cases. HCV is also an established risk factor
for chronic kidney disease (CKD) and end-stage renal disease (ESRD) and unfortunately the
treatment is even less successful in these patients mainly limited by increased medication
toxicity.
In spring of 2011, the FDA approved two new direct acting antivirals (DAA) for the treatment
of chronic genotype 1 HCV, boceprevir and telaprevir, to be used in combination with Peg-IFN
and ribavirin. This 'triple therapy' approach has significantly increased the response rate
(increased SVR rates to about 80% in those patients who had never been previously treated)
representing a significant advance in the field. In addition, several response-guided
therapy approaches were tested to determine if treatment duration could be shortened based
upon the virologic response on treatment.
To date, there have been no studies evaluating the safety and efficacy of triple therapy in
patients with ESRD. However, a single dose pharmacokinetic study of boceprevir in subjects
with ESRD on hemodialysis demonstrated that the mean maximum concentration achieved by
boceprevir (Cmax) and bioavailability (AUC) were comparable in patients with ESRD and in
healthy subjects. Mean t½, median Tmax and mean apparent oral total clearance (CL/F) values
were also similar in healthy subjects and patients with ESRD. Boceprevir exposure was also
similar on dialysis and non-dialysis days. These data suggest that boceprevir does not need
to be adjusted in patients with ESRD on dialysis, and that it is not removed by
hemodialysis. To date, there are no studies of telaprevir in ESRD patients.
The investigators therefore aim to study the safety and efficacy of triple therapy using
boceprevir in combination with P-IFN and ribavirin in patients with stage 5 CKD (defined as
glomerular filtration rate (GFR) < 15 mL.min.1.73m2 on permanent hemodialysis for stage 5).
In addition, given the significant toxicity of treatment in this particular patient
population, the investigators aim to study the efficacy of response guided therapy in those
patients who are eligible for response-guided therapy based on prior studies (treatment
naïve patients, and well documented history of relapse with prior treatment with P-IFN and
ribavirin).
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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