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

Phase 4

• Conditions: Egyptian Patients, HCV Treatment, Kidney Function
• Interventions: Drug: Sofosbuvir Oral Product

• Registration Number: NCT04169464
• Lead Sponsor: MTI University

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-04-01
• Status Verified: 2019-11
• Primary Completion: 2019-11
• Study First Submitted: 2019-11-17
• Study First Submitted QC: 2019-11-17
• Last Update Submitted: 2019-11-17
• Study First Posted: 2019-11-19
• Last Update Posted: 2019-11-19
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
group I	Sofosbuvir Oral Product	A group of HCV infected patients treated with DAA therapy including Sofospovir

Primary Outcome Measures

Name	Time	Method
occurance of AKI during therapy	3 months	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.

Trial Locations

Locations (1)

Thabet Thabet hospital; 🇪🇬 Cairo, Egypt