A Prospective Cohort Study to Improve HCV Care in Dialysis Patients

NCT03791814 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: MATCH-D study
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 2.To calculate the average treatment-lag time (time from HCV diagnosis to submission of treatment approval).

Conditions

Hepatitis C

Keywords

HCV treatment; Zepatier; Dialysis patients

Outcome Measures

Primary Outcomes (1)

• HCV treatment-lag time

  To determine the average treatment-lag time (time from HCV diagnosis to submission of treatment approval) of HCV treatment delivered through hemodialysis centers by nephrologists compared to standard of care via traditional gastroenterology or hepatology centers.

  12 weeks

Secondary Outcomes (2)

• Prevalence rates

  12 weeks

• Sustained virologic response (SVR) rates

  6 months

Study Arms (1)

Zepatier treatment

EXPERIMENTAL

Open-label Zepatier (grazoprevir 100 mg and elbasvir 50 mg) will be administered in this study. Daily treatment of Zepatier for a 12-week duration will be administered.

Drug: Zepatier

Interventions

Zepatier DRUG

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

Zepatier treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18 years of age or older on day of signing the informed consent form.
• Be on long term hemodialysis at any of the selected 4 collaborative hemodialysis centers
• Have positive anti-HCV antibody titers and detectable HCV RNA level before or after the initiation of MATCH-D.
• HCV genotype 1 and 4
• Have an HCV treatment status that is one of the following:
• Treatment naïve: Naive to all anti-HCV treatment
• Prior IFN or PEG-IFN + Ribavirin Treatment failures: Null responders, Partial responders, Relapsers
• P/R Intolerant: Subjects were intolerant to a prior IFN or PEG-IFN
• Ribavirin regimen, Subjects discontinued treatment prematurely and were therefore unable to complete a full course of therapy because of drug-related toxicity.

You may not qualify if:

• Has evidence of decompensated chronic liver disease such as presence of or history of - ascites, gastric or variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease
• Have Child-Pugh B or C cirrhosis (these patients will need to be referred to a hepatologist for HCV therapy)
• Have a likelihood of receiving a renal transplant or liver transplant during the study treatment period.
• Have hepatocellular carcinoma
• Have other liver disease (which require HCV therapy to be delivered under the supervision of a hepatologist)
• A patient with a life expectancy less than 12 months
• Current untreated chronic hepatitis B infection HBsAg+ patients are excluded. Note: Patients with HBcAb+ will not be excluded, but will have HBV DNA levels checked and will be monitored while on DAA therapy and medically managed as considered appropriate by the PI.
• Have HIV and currently not under Antiretroviral Therapy (ART)
• Pregnant or nursing (lactating) women
• Albumin below 3g/dL
• Platelet count below 75,000
• Unable to comply with research study visits
• Poor venous access not allowing screening laboratory collection
• Have any condition that the investigator considers a contraindication to study participation

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead
• Merck Sharp & Dohme LLC: collaborator
• Davita Clinical Research: collaborator

Related Publications (19)

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Interventions

elbasvir-grazoprevir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Eyob Feyssa, MD

  Albert Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

• Eyob Feyssa, MD

  Albert Einstein Healthcare Network

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 31, 2018
• First Posted: January 3, 2019
• Study Start: January 1, 2019
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share