Phase 4 N=40 Treatment

EBR/GZR for HCV-1b Patients Receiving Hemodialysis

Hepatitis C

Bottom Line

View on ClinicalTrials.gov: NCT03420300 ↗

Enrolled (actual)

Serious AEs

12.5%

Results posted

Mar 2020

Primary outcome: Primary: Sustained Virologic Response (SVR12) Rate — 38 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: EBR/GZR (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: National Taiwan University Hospital
Primary completion: Nov 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Sustained Virologic Response (SVR12) Rate	38	—
SECONDARY Treatment-emergent Adverse Event (AE)-Related Withdrawal Rate	—	—
SECONDARY Sustained Virologic Response (SVR24) Rate	38	—
SECONDARY Rapid Virologic Response (RVR) Rate	39	—
SECONDARY End-of-treatment Virological Response (EOTVR) Rate	40	—
SECONDARY Week 12 Virologic Response (W12VR)	39	—

Summary

Hepatitis C virus (HCV) infection is common in patients receiving hemodialysis. The uptake of antiviral therapy for these patients is limited in the era of interferon (IFN) plus ribavirin (RBV), probably because the sustained virologic response (SVR) rates are low and the risk of treatment-related adverse events (AEs) are high. In the era of IFN-free direct acting antiviral agents (DAAs), several studies have indicated high rates of SVR and excellent safety profiles to treat patients with severe renal impairment. With regard to elbasvir/grazoprevir (EBR/GZR) treatment, a phase 3 study (C-SURFER) study has shown 99% of SVR in HCV-1 patients with chronic kidney disease (CKD) stage 4 or 5. Furthermore, most patients tolerated the treatment well. Although the data confirmed the excellent safety and efficacy in HCV-1 patients with severe renal impairment, data regarding the safety and efficacy for Asian HCV-1b patients receiving hemodialysis is lacking. Therefore, we aim to evaluated the safety and efficacy of EBR/GZR for 12 weeks in treatment-naive and treatment-experienced HCV-1b patients receiving hemodialysis.

Eligibility Criteria

Inclusion Criteria

20 yeas or more
Male or female
Body mass index (BMI) 18.5-35.0 kg/m2
Chronic HCV infection, defined as patients who meet as least one of the two following criteria:
Anti-HCV antibody (Abbott HCV EIA 2.0, Abbott Laboratories, Abbott Park, Illinois, USA) or HCV RNA > 1,000 IU/mL for at least 6 months before screening
Positive HCV RNA > 1, 0000 IU/mL (Cobas TaqMan HCV Test v2.0, Roche Diagnostics GmbH, Mannheim, Germany, low limit of quantification (LLOQ): 25 IU/mL) at the time of screening with a liver biopsy consistent with chronic HCV infection
HCV genotype 1 (HCV GT-1b) infection (Abbott RealTime HCV genotype II, Abbott Molecular Inc. Illinois, USA)
Treatment-naïve or treatment-experienced (including patients who relapsed, who had virological breakthrough, or who were null-responsive to IFN-based therapies)
HCV RNA > 10, 000 IU/mL at screening
Estimated glomerular filtration (eGFR) rate 2.0
Albumin (Alb) 2.0 mg/dL
Alanine aminotransferase (ALT) > 10X upper limit of normal (ULN)
Aspartate aminotransferase (AST) > 10X upper limit of normal (ULN)
Serum alfa-fetoprotein (AFP) > 100 ng/mL
Presence of hepatocellular carcinoma (HCC) on imaging studies such as computed tomography (CT) scan or magnetic resonance imaging (MRI)
History of malignancy (except cutaneous melanoma) within 5 years at the screening
Organ transplantation other than cornea and hair (prior renal transplantation with graft failure not included)
Prior exposure to investigational agents for HCV (direct acting antiviral agents, host-targeting agents, or therapeutic vaccines)
Pregnancy
Unwilling to have contraception during the study period
Unwilling to provide informed consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03420300). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.