A Prospective Cohort Study to Improve HCV Care in Dialysis Patients
Status:
Withdrawn
Trial end date:
2019-06-30
Target enrollment:
Participant gender:
Summary
Hepatitis C virus (HCV) infects an estimated 185 million individuals worldwide and 3.4
million to 4.4 million people in the United States. Approximately 80% of acutely infected HCV
patients progress to chronic infection, 20% of whom develop cirrhosis within 25 years, with
25% of patients with cirrhosis developing hepatocellular carcinoma and/or decompensated liver
disease. Hepatitis C virus is the primary cause of liver transplantation in the United
States.
There are 6 known genotypes of HCV. The most common genotypes in the United States are
genotype 1 (subtypes 1a and 1b), 2, and 3, which together comprise 97% of all infections.
In chronic kidney disease (CKD) patients, the prevalence of HCV infection is higher than in
the general population. Patients with impaired kidney function have limited therapeutic
options. The US Food and Drug Administration (FDA) recently approved Elbasvir/Grazopevir for
treatment of genotype 1 and 4 infection in CKD patients including those on hemodialysis.
At our institution, the Multidisciplinary Approach to the Treatment of Chronic Hepatitis C
(MATCH) Initiative is a program which was first implemented to increase screening, diagnosis
and treatment of HCV by actively incorporating primary care providers (PCP) at every step of
the HCV care process. Following implementation of MATCH, early data indicates, marked
increase in screening high risk and baby-boomer cohorts, as well as safe and effective
treatment of HCV cases at the primary provider setting. The initiative proved that active
participation of PCPs in the care of HCV reduced the treatment lag by 71% compared to
traditional care of referring HCV cases to specialized care (Gastroenterology or Hepatology)
while keeping similar SVR. We intend to expand the program to improve quality of care for HCV
patients in dialysis center. We propose active involvement of dialysis clinical staff
including nephrologist, to increase HCV screening rate, promote timely diagnosis and
treatment of CHC in patient with end-stage renal disease.
This study is being conducted to evaluate real-world effectiveness of HCV DAA therapy in CHC
hemodialysis patients when the DAA-treatment is managed and monitored by the clinical staff
of hemodialysis center.
Primary objective: To determine sustained virologic response (SVR) rates attained with
open-label Zepatier administered through hemodialysis center under the supervision of a
nephrologist in chronic hepatitis C infected (CHC) patient currently on hemodialysis.
Secondary objective:
1. To estimate prevalence of HCV infection, severity of fibrosis (using non-invasive
measures), and HCV detection rate in patients with End stage renal disease on
hemodialysis.
2. To calculate the average treatment-lag time (time from HCV diagnosis to submission of
treatment approval).
Phase:
Phase 4
Details
Lead Sponsor:
Albert Einstein Healthcare Network
Collaborators:
DaVita Davita Clinical Research Merck Sharp & Dohme Corp.