Treatment of CKD Patients With HCV

Overview

The goal of this clinical trial is to evaluate the optimal drug therapy of HCV in CKD Patients different stages with or without compensated cirrhosis. The main questions it aims to answer are: outcome measure 1: Efficacy of the treatment by the assessment of sustained virological response (SVR12) following 12 weeks after the last dose HCV RNA drop to undetectable levels. outcome measure 2: Safety of the treatment by comparing the biochemical parameters before and after treatment. If there is a comparison group: Researchers will compare biochemical parameters of the participants before and after treatment to see if there is any decline in the general health. Participants will be divided to two groups according to their kidney status depending on their GFR, Group 1: 25 CKD Patients with eGFR more than 30ml/min with HCV infection and will receive Sofosbuvir and Daclatasvir regimen for 12 weeks, Group 2: 25 CKD Patients with eGFR less than 30ml/min with HCV infection and will receive Paritaprevir, Ombitasvir, Ritonavir and Ribavirin for 12 weeks.

The study will be conducted on HCV patients with CKD in Tanta University Hospitals (Tanta University, Internal Medicine Department, Nephrology and Dialysis Unite and Viral Committee). The duration of the study will be at least 6 months for treatment and follow up. A total number of fifty (50) chronic renal disease patients with HCV infection to be treated with the DAAs will be selected to be adjusted for age, sex, comorbid conditions, serum albumin, phosphorus and creatinine clearance and divided in two groups. Group 1: 25 CKD Patients with eGFR more than 30ml/min with HCV infection and will receive Sofosbuvir and Daclatasvir regimen for 12 weeks. Group 2: 25 CKD Patients with eGFR less than 30ml/min with HCV infection and will receive Paritaprevir, Ombitasvir, Ritonavir and Ribavirin for 12 weeks. Blood samples will be collected at enrollment and periodically to evaluate the serum levels of: 1. Liver Function Tests: • ALT, AST, Serum Albumin \& Serum Bilirubin. 2. Kidney Function Tests: • Serum Creatinine \& Urea 3. Serum Electrolytes: • Serum Calcium, Serum Potassium \& Serum Phosphorus. 4. HCV RNA quantitative PCR. 5. AFP for Cirrhotic Patients. 6. INR. 7. Parathormone (PTH) for HD Patients. 8. Blood Sugar for Diabetic Patients 9. CBC. Health-related quality of life measures will be assessed using KDQOL 36 survey. Study design: * This clinical study is non randomized, interventional, prospective and open label study groups. * HCV status will be determined based on an established diagnosis of HCV infection or positive HCV serology at study enrollment. * Group 1: 25 CKD Patients with eGFR˃30ml/min with HCV infection and will receive Sofosbuvir 400mg/day and Daclatasvir 60mg/day for 12 weeks. * Group 2: 25 CKD Patients with eGFR≤30ml/min with HCV infection and will receive Paritaprevir 150mg, Ombitasvir 25mg, Ritonavir 100mg (2 Tablets Qurevo®/day) and Ribavirin 200mg for 12 weeks. * Qurevo® will be given for Group B (on the day of dialysis, it will be given after dialysis session for the HD patients). * Ribavirin will be given for Group B (on the day of dialysis, it will be given 4 hrs. before dialysis session for the HD patients). * Health-related quality of life measures will be assessed using specific survey.