Effect of Direct AntiViral Drugs of Chronic HCV on eGFR in Assuit Universiry Hospital

May 24, 2019 updated by: Moamen mohey AbdElhamid, Assiut University
  1. evaluation of glomerular filtration rate(eGFR)changes during HCV treatment with direct antiviral drugs according to 2018 guideline.
  2. TO estimate the frequency of renal impairment by direct antiviral drugs By detection of any changes in e GFR.
  3. Assessment The Renal safety during HCV treatment with direct antiviral drugs according to 2018 guideline.
  4. To clarify the importance of laboratory and other modalities in detection and estimation of frequency of renal impairment by direct antiviral drugs according to 2018 guideline.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Hepatitis C virus (HCV) has an estimated global prevalence of 2%-3% with 130-170 million people infected with HCV.(1) HCVcauses chronic inflammation of the liver leading to chronic hepatitis, which can advance to liver cirrhosis and hepatocellular carcinoma and significant extrahepatic complications.(2) Additionally, HCV has been shown to have a significant negative effect on apatient's overall quality of life, including decreased work hours and productivity and increased healthcare costs.(3) Cirrhosis and hepatocellular carcinoma related to HCV infection represent the most common indications for liver transplantation duo to poor treatment options.(4) Until recently, interferon-based treatments were thebackbone of HCV treatment options.(5) Unfortunately,therapy was only modestly effective and associatedwith significant side effects.(6) Therefore, research has focused on HCV eradication using oral antiviral therapy.

Recent clinical studies have demonstrated efficacy using the nucleotide analogue inhibitor sofosbuvir(Sovaldi; Gilead Sciences, Inc., Foster City, CA) as the backbone in treatment of non transplant and post transplant recurrent HCV.(7) Both the ION-1 and ION-2 trials demonstrated nearly 99% efficacy in the treatment ofnontransplant, noncirrhotic HCV patientsusing sofosbuvir in a fixed-dose combination with theNS5A inhibitor ledipasvir (Harvoni, Gilead Sciences,Inc.), both with and without ribavirin.(8,9) The side effect profile of ledipasvir/sofosbuvir (LDV/SOF) hasbeen relatively mild and the drug has been well tolerated in trials, especially compared with previous interferon-based regimens.

The ION trials report that LDV/SOF therapy was primarily complicated by headaches or fatigue inapproximately 10% of patients. Less frequently, patients experienced rashes, nausea, diarrhea, and insomnia.Serious side effects, such as nephrotoxicity, were not demonstrated by the ION-1 and ION-2 trials; however, these trials were conducted in a controlled clinical setting with rigorous exclusion criteria. Such trials are not always entirely reflective of the general patient population. Early data suggest possible risk of renal impairment during treatment with the use of direct antiviral drugs(10) this study is about renal safety and changes in eGFR in patients with chronic HCV undergoing direct acting antiviral therapy according to 2018 guideline.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

chronic hepatitis C virus patients will be on direct antiviral therapy attending to the outpatient clinics and inpatient of gastroenterology units of Internal medicine department .

Description

Inclusion Criteria:

  • chronic hepatitis C virus patients will be on direct antiviral therapy .

Exclusion Criteria:

  • patients with DM ,HTN ,CKD,Autoimmune Diseases Patients with kidney injury other than DAAs Patients with sever heart failure or malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with chronic HCV will be on direct antiviral drugs
is defined as the presence of detectable viral replication for at least six months diagnosed by quantitative HCV RNA polymerase chain reaction (PCR)
Drug: DAAs
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) 12 weeks Daily simeprevir (150 mg) plus sofosbuvir (400 mg) 12 weeks Daily daclatasvir (60 mg) plus sofosbuvir (400 mg) 12 weeks Daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) with dasabuvir (600 mg) 12weeks
Other Names:
  • ledipasvir/sofosbuvir/daclatasvir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glomerular filtration rate(eGFR) changes during HCV treatment
Time Frame: 3 month
the frequency of renal impairment by evaluation of glomerular filtration rate(eGFR) changes during HCV treatment with direct antiviral drugs before and after the treatment using different equation for eGFR such as (MDRD, CKD_EPI,Cockroft)
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of direct anti Viral drugs on kidney function
Time Frame: 3 month
the frequency of renal impairment by direct antiviral drugs by measurement of serum BUN and creatinine
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Enas Alkareemy, MD, Assuit University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2019

Primary Completion (ANTICIPATED)

June 1, 2020

Study Completion (ANTICIPATED)

July 1, 2020

Study Registration Dates

First Submitted

May 19, 2019

First Submitted That Met QC Criteria

May 24, 2019

First Posted (ACTUAL)

May 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 29, 2019

Last Update Submitted That Met QC Criteria

May 24, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAAs on eGFR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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