A Study for G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir

Phase 4

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Subjects aged 20 years or older.
Patients positive for HCV RNA for over 6 months and infected with genotype 1b chronic hepatitis C, including compensated cirrhosis.
Patients without co-infection of hepatitis B virus.
Patients without co-infection of human immunodeficiency virus
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

Patients with decompensated cirrhosis (Child Pugh B and C)
Patients with albumin <3.0 g/dL and platelets <75,000 /μL
Patients with autoimmune hepatitis
Constant heavy alcohol drinkers (converted to ethanol ≥60 g/day)
Patients who have a history of hypersensitivity to grazoprevir and elbasvir
Patients who are pregnant females, or females who may become pregnant, or females who are breastfeeding
Patients with heart disease that is hard to control (e.g., very recent cardiac infarction, severe heart failure, unstable arrhythmia)
Patients who are under medication with drugs listed as contraindication in a package insert of grazoprevir plus elbasvir treatment
Patients judged (by the physician in charge of research) to be inappropriate as subjects for the study for any other reasons.

Arm && Interventions

Group	Intervention	Description
Grazoprevir plus Elbasvir	Grazoprevir plus Elbasvir	Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change of Serum Endostatin Level (ng/mL) From Baseline to 3 Months	3 months	We evaluated the serum endostatin at baseline and 3 months after the treatment initiation.
Change of eGFR Level (mL/Min/1.73m^2) From Baseline to 3 Months	3 months	We evaluated eGFR level at baseline and 3 months after the treatment initiation.

Secondary Outcome Measures

Name	Time	Method
Change of Serum Alanine Aminotransferase (ALT) Level (U/L) From Baseline to 3 Months	3 months	We evaluated the serum ALT levels at baseline and 3 months after the treatment initiation.
Change of Serum Alpha-fetoprotein Level (ng/mL) From Baseline to 3 Months	3 months	We evaluated the serum alpha-fetoprotein levels at baseline and 3 months after the treatment initiation.
Count of Participants With NS3/4A or NS5A Muttations Who Achieved SVR12	3 months	We identified the NS3/4A or NS5A muttations by direct sequencing at baseline. Among participants who had mutations, we calcualted the rate of SVR12.
Sustained Virological Response-12 (SVR12)	3 months	SVR12 was defined as undetectable HCV RNA at week 12 after the end of treatment.