Sofosbuvir Plus Daclatasvir With or Without Ribavirin and Chronic HCV Genotype (GT) 4

Efficacy and Safety of Sofosbuvir Plus Daclatasvir With or Without Ribavirin: Large Real-life Results of Patients With Chronic Hepatitis C Genotype 4

This study aims to evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian participants infected with HCV GT4.

Egyptian participants infected with HCV GT4 were classified into two groups: group 1 (easy to treat) was treated with a dual therapy of SOF/DCV daily for 12 weeks and group 2 (difficult to treat) was treated with a triple therapy of SOF/DCV/RBV daily for 12 weeks.

SOF dose was 400 mg/day given orally DCV was given in a dose of 60 mg/day, orally. RBV was given as oral tablets in the morning and in the evening based on patient's weight and tolerability (starting dose 600 mg/day to reach 1200 mg/day.

Inclusion Criteria:

• Non-cirrhotic treatment-naïve participants
• FIB-4 < 3.25
• albumin > 3.5
• total bilirubin < 1.2 mg/dl
• international normalized ratio (INR) < 1.2
• platelet count > 150,000 mm3.
• experienced participants who had previously failed treatment with peg-IFN-α-/RBV, SOF/peg-IFN-α +RBV, or SOF/SMV
• Naïve cirrhotic participants were confirmed by ultrasonographic features of cirrhosis

Exclusion Criteria:

• liver disease of non-HCV etiology
• hepatitis B or human immune-deficiency virus (HIV) infection
• poorly controlled diabetic (HbA1C > 9) participants
• hepatocellular carcinoma
• a history of extra-hepatic malignancy within 5 years prior to the study
• pregnant or breast feeding
• renal disease; serum creatinine > 2.5 mg/dl or eGFR < 30 ml/min
• evidence of hepatic decompensation; INR > 1.7, serum albumin < 2.8 g/dl, total bilirubin > 3 mg/dl
• blood picture abnormalities such as anemia (hemoglobin concentration of 10 g/dl or less) and thrombocytopenia (platelet count < 50,000 cells/mm3)
• major severe illnesses such as congestive heart failure and respiratory failure.