Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C
Condition: Hepatitis C; Hemodialysis; Nosocomial Infection
MeSH terms: Infections; Hepatitis A; Hepatitis C; Cross Infection; Hepatitis
Intervention: Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]
Intervention description: Same as described in arm description
Intervention MeSH terms: Ribavirin; Grazoprevir; Elbasvir-grazoprevir drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: An interventional, prospective, non-randomized, non-blinded trial to evaluate real world strategies to identify and treat hepatitis C infected hemodialysis patients with Zepatier
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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