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Effect Of DAAs For Treatment Of HCV On Normal Kidney

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ClinicalTrials.gov Identifier: NCT03296930
Recruitment Status : Unknown
Verified September 2017 by Hazem shoman, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : September 29, 2017
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
Hazem shoman, Assiut University

Study Description
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Brief Summary:
The aim of the study is to determine the effect of different direct acting antiviral drugs used for treatment of chronic HCV infected patients on normal kidney.

Condition or disease Intervention/treatment Phase
Antiviral Drug Adverse Reaction Drug: Sofosbuvir 400 MG Oral Tablet, Drug: Ombitasvir/paritaprevir/ritonavir Phase 4

Detailed Description:

Hepatitis C virus (HCV) infection is a major health problem. The World Health Organization (WHO) estimated that at least 150-170 million people, approximately 3% of the world's population, are chronically infected. These patients are known to be at risk of developing liver complications, i.e., cirrhosis and liver cancer, with an estimated liver-related mortality of 350,000 people/year. However, the risks of morbidity and mortality are underestimated because they do not take into account the extra-hepatic consequences of HCV infection. Numerous extra-hepatic manifestations (HCV-EHMs) have been reported. In some large cohort studies, up to 74% of patients experienced HCV-EHMs of different severity, from perceived to disabling conditions.

Treatment of HCV infection has a long history. It began with interferon (IFN) mono-therapy, with less than 20% sustained virological response (SVR). Milestones include the addition of ribavirin (RBV) to the treatment protocol and providing pegylated-IFN (PegIFN) as an alternative treatment.

Treatment with PegIFN/RBV was the standard of care for about 10 years. The success rate of treatment with this regimen is very dependent on patient characteristics, including age, body mass index, ethnicity, and genetic factors.

Viral factors, especially HCV genotype, also affect the response to HCV treatment, and there are always additional factors that should be taken into account in each treatment approach, including treatment success rate, duration, cost, and side effects.

In light of these concerns, attempts have continued to introduce better therapeutic regimens.

Treatment of chronic HCV infection has been revolutionized in recent years. The FDA has approved different IFN-free direct acting antiviral regimens (DAAs) including: Sofosbuvir (SOF) in combination with Ledipasvir (LDV), combination of Ombitasvir/Paritaprevir/ Dasabuvir (a three direct acting antiviral, or 3D), combination therapy with Grazoprevir/Elbasvir (GZR/EBR), Simeprevir (SMV) and Daclatasvir (DCV) also in combination with SOF.

More than 95% of patients have a sustained viral response (SVR) using DAA. The recent Cohort studies have demonstrated that the new regimens of DAAs may be associated with renal side effects, especially when using SOF combinations. So, to aid in the correct use of DAAs in treatment of HCV patients, their potential renal toxicity must be known.

The close monitoring of renal function is required. Although, new DAAs were well tolerated, recent real-life studies have demonstrated some nephrotoxic effect in Frail populations treated with SOF based regimens.

The use of direct acting antiviral agents (DAAs) in HCV patients might be expected to result in improved outcomes in hepatic functions even in end stage liver disease. But, the effect of DAAs on the kidney still needing a specific study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect Of Interferon-Free Direct Acting Antiviral Agents For Treatment Of Hepatitis C Virus Patients On The Normal Kidney
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: first drug group
Sofosbuvir 400 MG Oral Tablet
 Drug: Sofosbuvir 400 MG Oral Tablet,
Interferon free direct acting antiviral drugs used for treatment of HCV.
Other Names:
  • daclatasvir
  • ribavirin
Active Comparator: second drug group
Ombitasvir/paritaprevir/ritonavir
 Drug: Ombitasvir/paritaprevir/ritonavir
Interferon free direct acting antiviral drugs used for treatment of HCV.
Other Name: ribavirin


Outcome Measures
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Primary Outcome Measures :
  1. Effect of the direct acting antiviral agents used for HCV treatment on the function of the normal kidney by measurement of serum creatinine. [ Time Frame: one year ]
    assessment of the renal toxicity of direct acting antivirals used for HCV treatment by measurement of the serum creatinine to detect any deviation beyond the normal values.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Both male and female patients with age above 18 years presented with chronic HCV infection (diagnosed by HCV RNA positive) with normal kidney functions, i.e.:

    • Normal S.creatinine
    • Normal urine analysis (without proteinuria, haematuria or abnormal casts).
    • Normal renal sonography.
  • and candidate for direct acting antiviral drugs.

Exclusion Criteria:

  • Any chronic HCV patient with known renal disease.

  • Patients with abnormal kidney functions, i.e.:

    • Abnormal S.creatinine.
    • Abnormal urine analysis (with proteinuria, haematuria or abnormal casts).
    • Abnormal renal US
  • Any other known renal disease (lupus nephritis, diabetic nephropathy).
  • Severe co-morbidity as severe heart failure or malignancy.
  • Other liver disease (autoimmune hepatitis, HBV, Wilson, ……).
  • Decompansated liver disease (ascites, hepatic encephalopathy, …).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296930


Contacts
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Contact: Hazem Y Shouman, M.B.B.Ch +201111114746 dr.hazem.shoman1@gmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: Zainelabdeen A Sayed, MD Assistant Professor of Internal Medicine
Study Chair: Mohammed M Abdallah, MD Professor of Internal Medicine
More Information
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Publications:

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Responsible Party: Hazem shoman, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03296930    
Other Study ID Numbers: DAAs on Normal Kidney
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hazem shoman, Assiut University:
Direct Acting Antiviral Agents (DAAs)
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Ritonavir
Ribavirin
Sofosbuvir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antimetabolites