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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.
Kyushu University Hospital
Fukuoka, Japan
Change of Serum Endostatin Level (ng/mL) From Baseline to 3 Months
We evaluated the serum endostatin at baseline and 3 months after the treatment initiation.
Time frame: 3 months
Change of eGFR Level (mL/Min/1.73m^2) From Baseline to 3 Months
We evaluated eGFR level at baseline and 3 months after the treatment initiation.
Time frame: 3 months
Sustained Virological Response-12 (SVR12)
SVR12 was defined as undetectable HCV RNA at week 12 after the end of treatment.
Time frame: 3 months
Change of Serum Alanine Aminotransferase (ALT) Level (U/L) From Baseline to 3 Months
We evaluated the serum ALT levels at baseline and 3 months after the treatment initiation.
Time frame: 3 months
Change of Serum Alpha-fetoprotein Level (ng/mL) From Baseline to 3 Months
We evaluated the serum alpha-fetoprotein levels at baseline and 3 months after the treatment initiation.
Time frame: 3 months
Count of Participants With NS3/4A or NS5A Muttations Who Achieved SVR12
We identified the NS3/4A or NS5A muttations by direct sequencing at baseline. Among participants who had mutations, we calcualted the rate of SVR12.
Time frame: 3 months
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