8- Versus 12-week of Sofosbuvir-ravidasvir Treatment of Chronic Hepatitis C

Exclusion Criteria

• •1. Has evidence of liver cirrhosis in which, liver cirrhosis is determined by;
• •1. APRI score of ≥ 1.5,
• •2. In case where APRI score is \>1.0 but \<1.5,
• •* Perform fibroscan\* (where TE ≥12.5 kPa indicates liver cirrhosis) or
• •* Calculate FIB-4 index (where ≥3.25 indicates liver cirrhosis) \*Depending on availability at facility
• •3. Current/past history of decompensation including ascites, variceal bleeding, bacterial peritonitis, or hepatic encephalopathy.
• •1. Direct bilirubin \>3x ULN
• •2. AST, ALT \>10x ULN
• •3. Low neutrophil count (≤599 cells/mm3), haemoglobin (\<9.0 g/dL), platelets (\<150000 cells/mm3).
• •3. Patients with serum creatinine \>1.5 ULN or end-stage renal disease.2
• •4. Hepatitis B co-infection (HBsAg positive).
• •5. Pregnancy, as documented by positive pregnancy tests at screening and baseline assessment.
• •6. Breastfeeding.
• •7. Subjects currently receiving or unable to stop the use for at least 1 week prior to receiving the first dose of study drug any medications or herbal supplements known to be potent inhibitors or moderate inducers of cytochrome P450 (CYP) 3A4 and potent inducers of P-glycoprotein. This includes subjects who are on amiodarone or other contraindicated drugs. Refer to www.hep\_druginteractions.org, the investigator manual and the investigator's brochure for detailed information.
• •8. Participation in other clinical trials within 3 months.
• •9. Any clinically significant findings or unstable condition during the screening, medical history or physical examination that, in the investigator's opinion, would compromise participation in this study. This could include patients with poorly controlled hypertension, asthma, diabetes, or other life-threatening conditions.
• •10. Current or history of use within the preceding 6 months of immunosuppressive or immune-modulating agents. Corticosteroid used to treat any medical condition are allowed if systemic for not more than 2 weeks or if topical.
• •11. History of solid organ or bone marrow transplantation.
• •12. Any prior DAA use or NS5A inhibitors therapy.
• •13. Patients with significant cardiovascular conditions including myocardial infarction within the previous 6 months or heart failure NYHA class III or IV; history of Torsade de pointes
• •14. HIV/HCV co-infected patients who are yet to receive stable antiretroviral therapy or for whom ART treatment initiation maybe scheduled during the study period.