Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C

• Status: Completed
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to define strategies for Nephrologists to directly supervise and apply direct acting antivirals to cure hepatitis C in hemodialysis patients. Strategies will include identification of candidate patients, application for insurance approval, specifics of direct acting antiviral therapy (Zepatier with or without ribavirin) and laboratory monitoring during and after therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Elbasvir-grazoprevir drug combination; Grazoprevir; Ribavirin

Criteria

Inclusion Criteria:

• Hemodialysis patient

• > age 18 years old

• Hepatitis C antibody positive and Hepatitis C RNA Quantification positive

• Hepatitis C genomes 1a, 1b, or 4

• Prior Interferon , ribavirin treatment failures , partial responders, or intolerance to these treatment allowed to enroll

• Not of reproductive potential - hemodialysis patients must have no menses for 12 months

• Males with partners of reproductive potential as along a 2 reliable forms of contraception are used simultaneously during treatment and for 6 months after completion of treatment

• Ability to understand the study procedures, alternative treatments available, risks of participating in the study, and voluntarily agree to participate

Exclusion Criteria:

• Currently undergoing active treatment for HCV with a direct acting antiviral or have previously successfully been treated with a direct acting antiviral

• Have moderate or severe hepatic disease - Child-Pugh B or C

• Have evidence of decompensated liver disease manifested by ascites, gastric or variceal bleeding, hepatic encephalopathy, or other signs/symptoms of advanced liver disease

• Co-administration of known heaptotoxic drugs including but not limited to : etofoxine, isoniazid, nitrofurantoin, phenytoin

• Use of strong CYP3A/P-gp inhibitors, organic acid transporting polypeptide 1B1/3 inhibitors, strong inducers of cytochrome 450 3A (CYP3A), efavirenz, or other drugs which may interact with elbasvir/grazoprevir as per package insert

• history of substance abuse with alcohol, intravenous drugs, psychotropics, narcotics, cocaine use within 1 year of screening for study

• history of any condition, pre-study lab abnormality, or ECG abnormality or history of any illness which in the opinion of the investigators might confound the results of the study or pose additional risks from the administration of elbasvir/grazoprevir

• Have evidence of history of chronic hepatitis not caused by HCV including but not limited to nonalcoholic steatohepatitis (NASH), drug induced hepatitis, and autoimmune hepatitis