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

• Status: Completed
• Trial end date: 2017-05-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beni-Suef University
• Treatments: Sofosbuvir

Criteria

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.