This is a prospective, interventional, case-control study at King Faisal Specialist Hospital \& Research Centre in post-renal transplant patients who are receiving Grazoprevir/Elbasvir combination. Data will be compared with matched historical controls, which will be selected according to the following matching criteria: age, time from transplant to initiation of therapy. Only patients who completed at least 48 weeks of pegylated Interferon + Ribavirin therapy in the control group and 12 weeks of therapy on the case group will be enrolled. Any patient who received at least one dose of Grazoprevir/Elbasvir combination will be included in the safety analysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Medication for treatment of patient
Percentage of participants achieving sustained virologic response at 12 weeks after the end of all treatment (SVR12)
SVR12 was defined as HCV RNA below the lower limit of quantification (\<LLOQ) at 12 weeks after the end of all study therapy. The primary efficacy hypothesis for this study is that the percentage of participants with Hepatitis C Virus (HCV) Genotype 4 post renal transplant achieving SVR12 with Grazoprevir/Elbasvir combination
Time frame: 12 weeks after end of all therapy
Percentage of participants with change in circulating HCV RNA during treatment and after treatment discontinuation as compared to baseline.
Hepatitis C viral load refers to the amount of hepatitis C virus in a person's blood. The results of this test (known as a viral RNA test or HCV RNA test) are usually expressed as International Units/mL (IU/mL) or RNA copies/mL. The percentage of participants with change in circulating HCV RNA during treatment and after treatment discontinuation as compared to baseline will be reported.
Time frame: 12 weeks during therapy
Percentage of participants with a decrease, no change, or increase between baseline and post treatment week 12 in kidney function as measured by Estimated Glomerular Filtration Rate and Albumin Creatinine Ratio (ACR)
Any worsening of a preexisting condition related to kidney function that was associated with the use of Elbasvir/Grazoprevir. The Percentage of participants with a decrease, no change, or increase between baseline and post treatment week 12 in kidney function as measured by Estimated Glomerular Filtration Rate and Albumin Creatinine Ratio (ACR) will be reported.
Time frame: 12 weeks during therapy
Percentage of participants experiencing acute kidney transplant rejection compared to historical control.
Any worsening of a preexisting condition related to kidney transplant rejection that was associated with the use of Elbasvir/Grazoprevir. The percentage of participants experiencing acute kidney transplant rejection compared to historical control will be reported.
Time frame: 12 weeks during therapy
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