This study will assess the effect of treatment for hepatitis C virus (HCV) on cardiovascular disease risk. The study will enroll men and women who are infected with HCV and have underlying metabolic disease. All participants will receive a 12-week course of an HCV treatment (elbasvir/grazoprevir). Cardiovascular disease risk will be evaluated at baseline, week 4 on treatment, 12 weeks post-treatment, and 52 weeks post-treatment through noninvasive measurements of endothelial function, insulin resistance, liver fibrosis and steatosis, and circulating blood biomarkers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Daily fixed-dose combination (FDC) elbasvir (EBR) (50 mg)/grazoprevir (GZR) (100 mg) for 12 weeks
UCLA CARE Center
Los Angeles, California, United States
Change in reactive hyperemia index (RHI) by peripheral arterial tonometry (PAT)
Time frame: Baseline to 12 weeks after end of EBR/GZR treatment.
Change in insulin resistance by HOMA-IR
Time frame: Baseline to 12 weeks after end of treatment
Change in reactive hyperemia index (RHI) by PAT
Time frame: Baseline to week 4 on treatment
Change in reactive hyperemia index (RHI) by PAT
Time frame: Baseline to 52 weeks after end of treatment
Change in insulin resistance by HOMA-IR
Time frame: Baseline to week 4 on treatment
Change in insulin resistance by HOMA-IR
Time frame: Baseline to 52 weeks after end of treatment
Change in hemoglobin A1c
Time frame: Baseline to week 4, baseline to 12 weeks after end of treatment, and baseline to 52 weeks after end of treatment
Change in total and LDL cholesterol levels
Time frame: Baseline to week 4, baseline to 12 weeks after end of treatment, and baseline to 52 weeks after end of treatment
Change in levels of each soluble biomarker (sCD163, sCD14, sICAM-1, PAI-1, sE-selectin, oxidized LDL, Lp-PLA2, and lipoprotein particle quantification)
Time frame: Baseline to week 4, baseline to 12 weeks after end of treatment, and baseline to 52 weeks after end of treatment
Cross-sectional levels of each soluble biomarker (sCD163, sCD14, sICAM-1, PAI-1, sE-selectin, oxidized LDL, Lp-PLA2, and lipoprotein particle quantification) at each time point for correlation with RHI
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Time frame: Baseline, week 4, post-treatment weeks 12 and 52
Cross-sectional fibrosis score in kPa by transient elastography (TE) for correlation with RHI and soluble biomarkers
Time frame: Baseline and 12 and 52 weeks after end of treatment
Cross-sectional steatosis score in dB/m by CAP for correlation with RHI and soluble biomarkers at the same time points
Time frame: Baseline and 12 and 52 weeks after end of treatment
Change in fibrosis score by transient elastography
Time frame: Baseline to 52 weeks after end of treatment
Change in hepatic steatosis score by CAP
Time frame: Baseline to 52 weeks after end of treatment