The document presents baseline characteristics and follow-up data from patients undergoing treatment for hepatitis C. Baseline data includes demographics, medical history, laboratory results, and viral load. Follow-up data after 4 weeks of treatment includes updated clinical exams, laboratory results, viral load, and safety outcomes. Comparisons are made between treatment naive and experienced groups, with adjustments made for covariates. The data will help evaluate patient outcomes and safety of treatment approaches.
Original Description:
Original Title
Baseline characteristics of patients before starting treatment
The document presents baseline characteristics and follow-up data from patients undergoing treatment for hepatitis C. Baseline data includes demographics, medical history, laboratory results, and viral load. Follow-up data after 4 weeks of treatment includes updated clinical exams, laboratory results, viral load, and safety outcomes. Comparisons are made between treatment naive and experienced groups, with adjustments made for covariates. The data will help evaluate patient outcomes and safety of treatment approaches.
The document presents baseline characteristics and follow-up data from patients undergoing treatment for hepatitis C. Baseline data includes demographics, medical history, laboratory results, and viral load. Follow-up data after 4 weeks of treatment includes updated clinical exams, laboratory results, viral load, and safety outcomes. Comparisons are made between treatment naive and experienced groups, with adjustments made for covariates. The data will help evaluate patient outcomes and safety of treatment approaches.
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 32.7% 34.02% 1.5(.46) .45(.5) .58(.35) .19-1.9 ‒ Class B 65.02% 61.82% ‒ Class C 4.16% 4.16% Arrhythmia by ECG: n (%) ‒ Negative ‒ positive Ascites by US: n (%) ‒ None 100 % ‒ Mild/moderate ‒ Severe HCC by US: n (%) ‒ Negative 48 % 50.2% .23(.63) .9(.58) .92(.67) .64-1.3 ‒ Positive 52% 49.8% Esophageal varices by UGITE: n (%) ‒ None 100% 100% ‒ Grade 1 ‒ Grade 2 ‒ Grade 3/4 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 Treatme Treatme Test of crude Adjust CI nt naive nt Sig. (p- ed OD 95 experienc value) % ed Hemoglobin (g/dL) 9.4(.88) 9.45(.85) 1.07(.5 1.07(.5 .9- 5) 5) 1.3 WBC (x103 8.5(.89) 8.4(.85) .85(.11 .86(.17 cells/mm )3 ) ) 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