Baseline characteristics of patients before starting treatment
1. Baseline clinical data of patients Treatment Treatment Test of Sig. crude Adjuste CI naive experienced (p-value) d OD 95% Age in years (Mean ±SD) Gender: n (%) ‒ Male ‒ Female BMI: n (%) ‒ Underweight ‒ Normal ‒ Overweight ‒ Obese ‒ Extremely obese Child Class: n (%) ‒ Class A ‒ Class B ‒ Class C Arrhythmia by ECG: n (%) ‒ Negative ‒ positive Liver by US: n (%) ‒ No cirrhosis ‒ Cirrhosis Spleen by US: n (%) ‒ Normal ‒ Large Ascites by US: n (%) ‒ None 100 % ‒ Mild/moderate ‒ Severe HCC by US: n (%) ‒ Negative 100 % ‒ Positive Esophageal varices by UGITE: n (%) ‒ None ‒ Grade 1 ‒ Grade 2 ‒ Grade 3/4 0% BMI: body mass index, ECG: Electrocardiography, US: ultrasound, HCC: hepatocellular carcinoma, UGITE: Upper Gastro-intestinal Tract Endoscopy 2. Baseline laboratory and viral load data of patients: Treatmen Treatme Test of crude Adjust CI t naive nt Sig. (p- ed OD 95% experienc value) ed Hemoglobin (g/dL) WBC (x103 cells/mm3) ANC (x103 cells/mm3) Platelets (x103 cells/mm3) INR ALT (IU/L) AST (IU/L) Albumin (g/dL) Bilirubin (mg/dL) AFP (IU/L) Urea (mg/dL) Creatinine (mg/dL) Creatinine clearance (mL/min) HCV-RNA Log10 (IU/mL) Data are expressed as mean ± standard deviation, WBC: White blood cells, ANC: Absolute neutrophilic count, INR: international normalized ratio, ALT: alanine transaminase, AST: aspartate transaminase, AFP: alfa-fetoprotein, HCV: hepatitis C virus, RNA: ribonucleic acid II. Follow-up characteristics of patients after 4 weeks of treatment 1. Clinical data of patients after 4 weeks of treatment Treatment Treatment Test of Sig. crude Adjuste CI naive experienced (p-value) d OD 95% Child Class: n (%) ‒ Class A ‒ Class B ‒ Class C Arrhythmia by ECG: n (%) ‒ Negative ‒ positive Ascites by US: n (%) ‒ None 100 % ‒ Mild/moderate ‒ Severe HCC by US: n (%) ‒ Negative 100 % ‒ Positive Esophageal varices by UGITE: n (%) ‒ None ‒ Grade 1 ‒ Grade 2 ‒ Grade 3/4 0% BMI: body mass index, ECG: Electrocardiography, US: ultrasound, HCC: hepatocellular carcinoma, UGITE: Upper Gastro-intestinal Tract Endoscopy 2. Laboratory data of patients after 4 weeks of treatment Treatmen Treatme Test of crude Adjust CI t naive nt Sig. (p- ed OD 95% experienc value) ed Hemoglobin (g/dL) WBC (x103 cells/mm3) ANC (x103 cells/mm3) Platelets (x103 cells/mm3) INR ALT (IU/L) AST (IU/L) Albumin (g/dL) Bilirubin (mg/dL) AFP (IU/L) Urea (mg/dL) Creatinine (mg/dL) Creatinine clearance (mL/min) HCV-RNA Log10 by PCR (IU/mL) Data are expressed as mean ± standard deviation, WBC: White blood cells, ANC: Absolute neutrophilic count, INR: international normalized ratio, ALT: alanine transaminase, AST: aspartate transaminase, AFP: alfa-fetoprotein, HCV: hepatitis C virus, RNA: ribonucleic acid 3. Primary Efficacy and Safety Endpoints after 4 weeks of treatment
Treatment Treatment Test of Sig. crude Adjuste CI
naive experienced (p-value) d OD 95% HCV-RNA by PCR: n (%) ‒ Negative ‒ Positive Anemia: n (%) Arrhythmia: n (%) Hepatotoxicity: n (%) HRS: n (%) HCV: hepatitis C virus, RNA: ribonucleic acid, HRS: Hepatorenal syndrome