A Study for G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir
Condition: Hepatitis C Viral; Chronic Kidney Disease stage3
MeSH terms: Hepatitis C; Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Grazoprevir plus Elbasvir
Intervention description: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.
Intervention MeSH terms: Grazoprevir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Direct Acting Antivirals; Grazoprevir; Elbasvir

Summary:

      The regimen using grazoprevir plus elbasvir treatment is promising in Japan, because it may
      safely be used for the elderly patients with renal dysfunction. Grazoprevir and elbasvir are
      metabolized in the liver and do not require dose-adjustment for patients with renal
      dysfunction. However, no data related to efficacy and safety of the grazoprevir plus elbasvir
      treatment for Japanese elderly patients with renal dysfunction (eGFR<60 mL/min/1.73m2) have
      been reported. Therefore, physicians are at a loss whether or not to treat the patients with
      renal dysfunction due to no evidence.

      The aim of this study is to investigate the improvement of serum endostatin level of Japanese
      patients with CKD stage 3 after grazoprevir (NS3/4A protease inhibitor) plus elbasvir (NS5A
      replication complex inhibitor) treatment by a prospective, multicenter cohort study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects aged 20 years or older.

          2. Patients positive for HCV RNA for over 6 months and infected with genotype 1b chronic
             hepatitis C, including compensated cirrhosis.

          3. Patients without co-infection of hepatitis B virus.

          4. Patients without co-infection of human immunodeficiency virus

          5. Patients with moderate chronic kidney disease (CKD stage 3) (eGFR: 30-59
             mL/min/1.73m2). A diagnosis of CKD is only confirmed if repeated eGFR tests for at
             least 90 days.

        Exclusion Criteria:

          1. Patients with decompensated cirrhosis (Child Pugh B and C)

          2. Patients with albumin <3.0 g/dL and platelets <75,000 /μL

          3. Patients with autoimmune hepatitis

          4. Constant heavy alcohol drinkers (converted to ethanol ≥60 g/day)

          5. Patients who have a history of hypersensitivity to grazoprevir and elbasvir

          6. Patients who are pregnant females, or females who may become pregnant, or females who
             are breastfeeding

          7. Patients with heart disease that is hard to control (e.g., very recent cardiac
             infarction, severe heart failure, unstable arrhythmia)

          8. Patients who are under medication with drugs listed as contraindication in a package
             insert of grazoprevir plus elbasvir treatment

          9. Patients judged (by the physician in charge of research) to be inappropriate as
             subjects for the study for any other reasons.