Clinical Trial to eLiminate HCV-infection in Treatment-naïve, Renally Impaired EgyptiAn Patients on Renal Dialysis, With Chronic Hepatitis C Genotype 4

Exclusion Criteria

• •1. Patients didn't sign informed consent or under age of legal consent
• •2. Pregnant or breastfeeding woman
• •3. Has HCV genotypes other than G4
• •4. On peritoneal dialysis for management of kidney disease
• •5. Co-Infection with HIV and/or HBV (with positive HBsAg)
• •6. Evidence of hepatocellular carcinoma (HCC)
• •7. Evidence of hepatic decompensation as evidenced by presence or history of ascites, esophaegal or gastric bleeding, hepatic encelopathy or other signs of or symptoms of advanced liver disease, or cirrhotic subjects with Child-Pugh B or C, or who have a Purgh-Turcotte (CPT) score \>6
• •8. Active or suspected non-hepatic malignancy or history of any malignancy except for cured basal cell or squamous cell skin cancer or in situ cervical cancer
• •9. Organ transplant (including hematopoietic stem cell transplant) other than kidney, cornea, and hair
• •10. Conditions requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
• •11. Uncontrolled or poorly controlled hypertension
• •12. Pregnant, breast-feeding, expecting to conceive or donate eggs, or donate sperm from Day 1 through 14 days after the last study dose.
• •13. Significant cardiovascular disorder (e.g. myocardial infarction or unstable angina) or interventional cardiovascular procedure within 3 months prior to signing informed consent
• •14. Recent (within 3 months prior to signing informed consent) episode or recurrence of stroke, transient ischemic attack (TIA) or neurological disorder, including but not limited to seizures
• •15. ALT or AST \> 10-fold the upper limit of normal
• •16. Evidence of liver disease due to causes other than chronic HCV infection
• •17. Evidence of poorly controlled diabetes (defined as HbA1c \> 8%)
• •18. History of alcohol or drug abuse within the last 12 months
• •19. Serum albumin level \< 3.0 g/dL
• •20. INR \> 1.3 N
• •21. Total Bilirubin levels \> 2.0 mg/dL unless explained by Gilbert's disease
• •22. Platelets Count \<75,000/µL
• •23. White blood cell count \< 1500 µL (mm3)
• •24. Clinically significant TSH and T4 level poorly controlled thyroid function
• •25. Patients with any abnormality on physical examination, vital signs (sitting systolic blood pressure greater than 150 mmHg, sitting diastolic blood pressure greater than 90 mmHg and pulse greater than 90 bpm) and ECG, unless these abnormalities are judged to be not clinically significant by the Investigator
• •26. Body Mass Index \< 18.5 or \> 35 kg/m2
• •27. Use of other investigational drugs/treatments within the previous 3 months
• •28. Known hypersensitivity to any of the test materials or related compounds.
• •29. Active autoimmune disease.
• •30. History of moderate, severe or uncontrolled psychiatric disease, especially severe depression and prior suicidal attempt.
• •31. Unable to comply with research study visits.
• •32. Poor venous access not allowing screening laboratory collection.
• •33. Any other condition that, in the opinion of the Investigator, may be a contraindication to study participation or jeopardize the study conduct according to the protocol.