Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Tablet Plus Ribavirin Tablet (Part A) Versus Single Dose (2 Tablets) of EHCV Containing Sofosbuvir, Ribavirin, and Natural Anti-hemolytic (B) in Egyptian Adults With Chronic Genotype 4 HCV Infection

Inclusion criteria

Inclusion Criteria for Part A Subjects must meet all of the following inclusion criteria to be eligible for participation in this study. 1. Willing and able to provide written informed consent. 2. Male or female, age ≥ 18 years. 3. HCV RNA ≥ 104 IU/mL at screening. 4. Confirmed chronic HCV infection as documented by either: a. a positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit, or 5. HCV genotype 4 at screening as determined by the Central Laboratory. Any non-definitive results will exclude the subject from study participation. 6. The subject's medical records must be sufficient to categorize prior treatment history as one of the following: i) IFN-intolerant: subject had documented intolerance to IFN during prior IFN therapy of up to 12 weeks duration ii) Non-response: subject did not achieve undetectable HCV RNA levels on treatment iii) Relapse/Breakthrough: subject achieved undetectable HCV RNA levels during treatment or within 4 weeks after treatment and later showed detectable HCV RNA An Absence of cirrhosis is defined as any one of the following: * Liver biopsy within 2 years of Screening showing absence of cirrhosis * Fibroscan with a result of ≤ 12.5 kPa within 6 months of Baseline/Day1 * FibroTest score of ≤ 0.48 AND APRI of ≤ 1 performed during Screening In the absence of a definitive diagnosis of the presence or absence of cirrhosis by the above criteria, a liver biopsy is required. Liver biopsy results supersede the results obtained by Fibroscan or Fibro Test. 7. Body mass index (BMI) ≥ 18 kg/m2. 8. Screening ECG without clinically significant abnormalities. 9. Subjects must have the following laboratory parameters at screening: * ALT ≤ 10 x the upper limit of normal (ULN) * AST ≤ 10 x ULN * Hemoglobin ≥ 12 g/dL for male, ≥ 11 g/dL for female subjects * Platelets \> 50,000 cells/mm3 * INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR * Albumin ≥ 3 g/dL * Direct bilirubin ≤ 1.5 x ULN * HbA1c ≤ 10% * Creatinine clearance (CLcr) ≥ 60 mL/min, as calculated by the Cockcroft-Gault equation 10. Subject has not been treated with any investigational drug or device within 30 days of the screening visit. 11. A female subject is eligible to enter the study if it is confirmed that she is: 1. Not pregnant or nursing 2. Of non-childbearing potential (ie, women who have had a hysterectomy, both ovaries removed or medically documented ovarian failure, or are postmenopausal women \> 50 years of age with cessation \[for 12 months\] of previously occurring menses), or 3. Of childbearing potential (ie, women who have not had a hysterectomy, both ovaries removed, or no medically documented ovarian failure). Women ≤ 50 years of age with amenorrhea will be considered to be of childbearing potential. These women must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the Baseline/Day 1 visit prior to randomization. They must also agree to one of the following from 3 weeks prior to Baseline/Day 1 until 6 months after last dose of RBV: * Complete abstinence from intercourse. Periodic abstinence from intercourse (eg, calendar, ovulation, symptothermal, post-ovulation methods) is not permitted. Or * Consistent and correct use of 1 of the following methods of birth control listed below in addition to a male partner who correctly uses a condom from the date of screening until 6 months after the last dose of RBV. Women of childbearing potential must not rely on hormone-containing contraceptives as a form of birth control during the study. Female subjects using a hormone-containing contraceptive prior to screening may continue their contraceptive regimen in addition to the study specified methods of birth control. * Intrauterine device (IUD) with a failure rate of \< 1% per year * Female barrier method: cervical cap or diaphragm with spermicidal agent * Tubal sterilization * Vasectomy in male partner 12. All male study participants must agree to consistently and correctly use a condom, while their female partner agrees to use either 1 of the non-hormonal methods of birth control listed above or a hormone-containing contraceptive listed below, from the date of screening until 7 months after their last dose of RBV: * Implants of levonorgestrel * Injectable progesterone * Oral contraceptives (either combined or progesterone only) * Contraceptive vaginal ring * Transdermal contraceptive patch 13. Male subjects must agree to refrain from sperm donation for at least 7 months after the last dose of RBV. 14. Subject must be of generally good health as determined by the Investigator. 15. Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments. Inclusion Criteria for Part B Subjects must meet all of the following inclusion criteria to be eligible for participation in this study. 1. Willing and able to provide written informed consent. 2. Male or female, age ≥ 18 years. 3. HCV genotype 4 at screening as determined by the Central Laboratory. Any non-definitive results will exclude the subject from study participation. Historical result from prior participation in this study is acceptable, if applicable. 4. Cohort 1 only: HCV RNA ≥ 104 IU/mL at screening. 5. Chronic HCV infection (≥ 6 months) documented by medical history. 6. Cohort 1 only: HCV treatment naïve, defined as no prior exposure to any IFN, RBV, or other approved or experimental HCV specific direct acting antiviral agent 7. BMI ≥ 18 kg/m2 Absence of cirrhosis is defined as any one of the following: 1. Liver biopsy within 2 years of Screening showing absence of cirrhosis 2. Fibroscan with a result of ≤ 12.5 kPa within 6 months of Baseline/Day1 C- Fibro Test score of ≤ 0.48 AND APRI of ≤ 1 performed during Screening In the absence of a definitive diagnosis of the presence or absence of cirrhosis by the above criteria, a liver biopsy is required. Liver biopsy results supersede the results obtained by Fibroscan or Fibro Test. 8. Screening ECG without clinically significant abnormalities. 9. Subjects must have the following laboratory parameters at screening: * ALT ≤ 10 x the upper limit of normal (ULN) * AST ≤ 10 x ULN * Hemoglobin ≥ 12 g/dL for male, ≥ 11 g/dL for female subjects * Platelets \> 50,000 cells/mm3 * INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR * Albumin ≥ 3 g/dL * Direct bilirubin ≤ 1.5 x ULN * HbA1c ≤ 10% * Creatinine clearance (CLcr) ≥ 60 mL/min, as calculated by the Cockcroft-Gault equation Subjects who received prior treatment in this study and who currently do not fulfill all of the above requirements may be enrolled in Part B Cohort 2 at the request of the Investigator and with the approval of the Medical Monitor or Study Director. 10. Subject has not been treated with any investigational drug or device within 28 days of the Baseline/Day 1 visit. 11. A female subject is eligible to enter the study if it is confirmed that she is: D Not pregnant or nursing e Of non-childbearing potential (ie, women who have had a hysterectomy, both ovaries removed or medically documented ovarian failure, or are postmenopausal women \> 50 years of age with cessation \[for 12 months\] of previously occurring menses), or F Of childbearing potential (ie, women who have not had a hysterectomy, both ovaries removed, or no medically documented ovarian failure). Women ≤ 50 years of age with amenorrhea will be considered to be of childbearing potential. These women must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the Baseline/Day 1 visit prior to randomization. They must also agree to one of the following from 3 weeks prior to Baseline/Day 1 until 30 days after the last dose of LDV/SOF or 6 months after last dose of RBV: • Complete abstinence from intercourse. Periodic abstinence from intercourse (eg, calendar, ovulation, symptothermal, post-ovulation methods) is not permitted. Or * Consistent and correct use of 1 of the following methods of birth control listed below in addition to a male partner who correctly uses a condom from the date of screening until 30 days after the last dose of LDV/SOF or 6 months after the last dose of RBV. * Intrauterine device (IUD) with a failure rate of \< 1% per year * Female barrier method: cervical cap or diaphragm with spermicidal agent * Tubal sterilization * Vasectomy in male partner * Implants of levonorgestrel * Injectable progesterone * Oral contraceptives (either combined or progesterone only) * Contraceptive vaginal ring * Transdermal contraceptive patch 12. All male study participants must agree to consistently and correctly use a condom from Baseline until 90 days after their last dose of LDV/SOF or 7 months after their last dose of RBV. If their female partner is of childbearing potential (as defined above), she must use 1 of the methods of birth control listed above from the date of screening until 90 days after their last dose of LDV/SOF or 7 months after their last dose of RBV. 13. Male subjects must agree to refrain from sperm donation for at least 7 months after the last dose of RBV or 90 days after their last dose of LDV/SOF, as applicable. 14. Subject must be of generally good health as determined by the Investigator. 15. Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.