HCV Infection ( Genotype 4) in CKD Patients
Conditions
Keywords
CKD/HCV
Brief summary
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.
Detailed description
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.
Interventions
DRUGSOF+DCV
25 CKD Patients with eGFR˃30ml/min with HCV infection and will receive one oral tablet of Sofosbuvir 400mg/day and one oral tablet of Daclatasvir 60mg/day for 12 weeks.
25 CKD Patients with eGFR≤30ml/min with HCV infection and will receive 2 oral tablets Qurevo®/day (Paritaprevir 150mg, Ombitasvir 25mg, Ritonavir 100mg ) and one oral capsule of Ribavirin 200mg for 12 weeks.
Sponsors
Tanta University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study ia also prospective
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Both male and female. 2. Adults more than 18 years. 3. Patients with CKD different stages stable on treatment with or without HD. 4. HD Patients should be stable for at least 6 months under regular hemodialysis. 5. Clinically stable condition as outpatients. 6. Patients with HCV infections (serum positive for HCV GT4 with HCV RNA\>1000 IU/ml by PCR). 7. White blood cells count more than 2500/mm3. 8. Platelet count more than 7500/mm3.
Exclusion criteria
1. Confirmed pregnancy. 2. HCV-HIV co infection. 3. HBV-HCV co infection. 4. Unstable CKD patients. 5. Patients who are recently stabilized on HD (less than 6 months). 6. Patients on peritoneal dialysis. 7. For patients without cirrhosis, Patients will be excluded if ALT or AST more than five times the upper limit of normal. 8. For patients with cirrhosis, Patients will be excluded if ALT or AST are higher than seven times the upper limit of normal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment efficacy | 12 weeks | HCV eradication expressed as sustained virological response (SVR12) following 12 weeks after the last dose HvV RNA drop to undetectable levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment safety | 12 weeks | Safety of the treatment by recording the side effects appear on the patients after treatment. |
Countries
Egypt
Contacts
CONTACTAhmed El Gammalh, Bsc in pharmaceutical sciences
Outcome results
None listed