The Renal Safety in Patients With Chronic HCV Undergoing Sofosbuvir Containing Antiviral Therapy

Study Overview
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Brief Summary
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The aim of this study is to investigate the occurrence of AKI during antiviral therapy, when compared with baseline values in Egyptian patients. In addition, the study aims to evaluate the change in insulin resistance value after treating patients from HCV.

Detailed Description
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There are limited published data, currently, suggesting the risk of AKI during oral direct acting antiviral treatment. Most case reports and retrospective studies reported the presence of an intrinsic cause of renal injury, with most of the available biopsies showing acute tubular necrosis (ATN) and acute interstitial nephritis (AIN). Most of these patients had returned to baseline renal function on cessation of sofosbuvir combination therapy. Recently it was found that a notable percentage of patients experienced a transient increase in creatinine during therapy, which could occasionally lead to a more than 50% decrease in patients' eGFR. Previous studies had also shown that the co-use of nonsteroidal anti-inflammatory drugs (NSAIDs) and recurrent ascites were at increased risk for AKI during sofosbuvir-based antiviral therapy (Brawn et al., 2018). The primary endpoint of this study is to investigate the occurrence of AKI in Egyptian patients during antiviral therapy and to highlight its reasons and time of incidence in addition to the mechanism of this injury.

Official Title
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The Renal Safety and Rates of Acute Kidney Injury (AKI) in Patients With Chronic HCV Undergoing Sofosbuvir Containing Direct Acting Antiviral Therapy

Conditions
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Egyptian Patients, HCV Treatment, Kidney Function

Intervention / Treatment
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* Drug: Sofosbuvir Oral Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥ 18 years Chronic infection with HCV GT 4 No prior HCV treatment experience Exclusion Criteria: Co-infection with HBV or HIV, clinical evidence of ischemic heart disease, the presence of diabetic ketoacidosis, Patients admitted to the intensive care unit (ICU), or expected to undergo surgery during the study period, and Child Pough score C.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: group I<br>A group of HCV infected patients treated with DAA therapy including Sofospovir | Drug: Sofosbuvir Oral Product<br>* to investigate the drug effect on renal function and insulin resistance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurance of AKI during therapy | investigate the occurrence of AKI during antiviral therapy, defined as an increase of 0.3 mg/dL or 50% at least in serum creatinine level when compared with baseline values or more than a 25% reduction in (eGFR) when compared with baseline eGFR in Egyptian patients. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV, DAAs, Egyptian patients, creatinine, insulin resistence, GFR