The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure

The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure

Safety and Efficacy of DAAs (Daclatasvir+Asunaprevir) in patients with chronic hepatitis C and chronic renal failure will be assessed.

Inclusion Criteria:

• HCV RNA Positive and Genotype 1b
• No history or signs or symptoms of decompensated liver disease or hepatocellular carcinoma within 6 months
• A patient who is on dialysis, or if not MDRD eGFR<30ml/min
• HCV treatment history: HCV treatment-naive participants, defined as never having received HCV treatment with any approved or investigational drug (including vaccines); OR HCV treatment-experienced, defined as having received previous HCV treatment with any (pegylated) interferon ([Peg]IFN)-based drug regimen (with or without ribavirin [RBV] and not including a direct-acting antiviral agent [DAA]). Last dose in this previous HCV treatment course should have occurred at least 2 months prior to screening
• No baseline mutation NS5A polymorphism including L31F/I/M/V and Y93H

Exclusion Criteria:

• A patient who having received Daclatasvir or Asunaprevir
• Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study
• Evidence of a medical condition contributing to chronic liver disease other than HCV or seropositive for HIV
• Diagnosed or suspected hepatocellular carcinoma or other malignancies
• Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage)
• Received solid organ or bone marrow transplant
• Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance
• Significant renal, cardiovascular, pulmonary, or neurological disease and uncontrolled diabetes or hypertension in the opinion of the investigator
• Known hypersensitivity to study drugs, metabolites, or formulation excipients
• Who has taken investigational drugs within 2 months.