A Prospective Cohort Study to Improve HCV Care in Dialysis Patients

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).

Conditions

• Hepatitis C

Interventions

DRUG

Zepatier

Patients screened as HCV positive will receive Zepatier for 12 weeks.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Davita Clinical Research

  collaborator INDUSTRY

• Albert Einstein Healthcare Network

  lead OTHER

Principal Investigators

• Eyob Feyssa, MD · Albert Einstein Healthcare Network

• Eyob Feyssa, MD · Albert Einstein Healthcare Network

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-01

Primary Completion

2019-06-30

Completion

2019-06-30

FDA Drug

Yes