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出境医 / 临床实验 / Effect of Direct AntiViral Drugs of Chronic HCV on eGFR in Assuit Universiry Hospital

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

Study Description
Brief Summary:
  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.

Condition or disease Intervention/treatment
Antiviral Drug Drug: DAAs

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 Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Direct AntiViral Drugs of Chronic HCV on eGFR in Assuit Universiry Hospital
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020
Arms 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 Name: ledipasvir/sofosbuvir/daclatasvir
Outcome Measures
Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 .
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Moamen Mohey 01091094556 momen_mohey880@yahoo.com
Contact: Samir Kmal samirkamal@aun.edu.eg

Sponsors and Collaborators
Assiut University
Investigators
Layout table for investigator information
Study Director: Enas Alkareemy, MD Assuit university hospital
Tracking Information
First Submitted Date May 19, 2019
First Posted Date May 29, 2019
Last Update Posted Date May 29, 2019
Estimated Study Start Date June 1, 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 24, 2019) 		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)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 24, 2019) 		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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Direct AntiViral Drugs of Chronic HCV on eGFR in Assuit Universiry Hospital
Official Title Effect of Direct AntiViral Drugs of Chronic HCV on eGFR in Assuit Universiry Hospital
Brief Summary
  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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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 .
Condition Antiviral Drug
Intervention 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 Name: ledipasvir/sofosbuvir/daclatasvir
Study Groups/Cohorts 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)
Intervention: Drug: DAAs
Publications *
  • Brown PR, Sadiq O, Weick A, Lenhart A, Elbatta M, Fernandez C, Kutait A, Pompa R, Jafri SM. Acute Kidney Injury in Patients Undergoing Chronic Hepatitis C Virus Treatment With Ledipasvir/Sofosbuvir. Hepatol Commun. 2018 Sep 24;2(10):1172-1178. doi: 10.1002/hep4.1243. eCollection 2018 Oct.
  • Soeiro CASP, Gonçalves CAM, Marques MSC, Méndez MJV, Tavares APRA, Horta AMLMFCA, Sarmento-Castro RMDR. Glomerular filtration rate change during chronic hepatitis C treatment with Sofosbuvir/Ledipasvir in HCV/HIV Coinfected patients treated with Tenofovir and a boosted protease inhibitor: an observational prospective study. BMC Infect Dis. 2018 Aug 3;18(1):364. doi: 10.1186/s12879-018-3278-3.
  • Shah H, Bilodeau M, Burak KW, Cooper C, Klein M, Ramji A, Smyth D, Feld JJ; Canadian Association for the Study of the Liver. The management of chronic hepatitis C: 2018 guideline update from the Canadian Association for the Study of the Liver. CMAJ. 2018 Jun 4;190(22):E677-E687. doi: 10.1503/cmaj.170453.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 24, 2019) 		80
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03965286
Other Study ID Numbers DAAs on eGFR
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Moamen mohey AbdElhamid, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators
Study Director: Enas Alkareemy, MD Assuit university hospital
PRS Account Assiut University
Verification Date May 2019

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