PrOD for Non-Cirrhotic Patients With HCV-1b Receiving Hemodialysis (PIVOTAL)
Hepatitis Viruses

About this trial
This is an interventional treatment trial for Hepatitis Viruses focused on measuring Hepatitis C virus, Hemodialysis, Direct acting antiviral agents
Eligibility Criteria
Inclusion Criteria:
- Ages of 20 to 70 yeas
- 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 enzyme-linked immunosorbent assay [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 Gesellschaft mit beschränkter Haftung [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 GT-1b infection (Abbott RealTime HCV genotyping 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
Absence of cirrhosis with documented results of one of the following criteria:
- Liver biopsy within 24 months prior to or during screening demonstration the absence of cirrhosis, e.g. METAVIR score ≤ 3 or Ishak score ≤ 4.
- A screening transient elastography (Fibroscan) result of < 12.5 kilopascal (kPa)
- A screening Fibrosis Index Based on 4 markers (FIB-4) of ≤ 1.45 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) of ≤ 2
- Subjects with non-qualifying FIB-4/APRI or Fibroscan result may only be enrolled if they have a qualifying liver biopsy within 24 months prior to or during screening
- Estimated glomerular filtration (eGFR) rate < 15 mL/min/1.73m2 as assessed by modified of diet in renal disease (MDRD) equation, and receiving regular hemodialysis
Exclusion Criteria:
- HCV infection other than HCV GT-1b
- Hepatitis B virus (HBV) or HIV co-infection
- Presence of cirrhosis (Child-Puge class A, B or C)
Any primary cause of liver disease other than chronic HCV infection, including but not limited to the following
- Hemochromatosis
- Alfa-1 antitrypsin deficiency
- Wilson's disease
- Autoimmune hepatitis
- Alcoholic liver disease
- Drug-induced hepatitis
Screening laboratory analyses showing any of the following results
- Hemoglobin (Hb) level < 10 g/dL
- Absolute neutrophil count (ANC) < 1,500 cells/μL
- Platelet count < 60,000 cells/mm3
- International normalized ratio (INR) > 2.0
- Albumin (Alb) < 2.8 g/dL
- Bilirubin (Bil) > 3.0 mg/dL
- Alanine aminotransferase (ALT) > 5X upper limit of normal (ULN)
- Aspartate aminotransferase (AST) > 5X 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 [12] Unwilling to provide informed consent
Sites / Locations
- Ditmanson Medical Foundation Chia-Yi Christian Hospital
- National Taiwan University Hospital, Yun-Lin Branch
- China Medical University Hospital
- Taichung Veterans General Hospital
- National Cheng Kung University Hospital
- National Taiwan University Hospital
- Taipei City Hospital, Ren-Ai Branch
- Tri-Service General Hospital, National Defense Medical Center
Arms of the Study
Arm 1
Experimental
PTV/r/OBV/DSV
Paritaprevir/ritonavir/ombitasvir (PTV/r/OBV, 75mg/50mg/12.5mg per tablet, Viekirax): 2 tablets per os per day Dasabuvir (DSV, 250 mg per tablet, Exviera): 1 tablet per os twice per day Treatment duration: 12 weeks