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Ombitasvir/ Paritaprevir / Ritonavir Plus Ribavirin in Management HCV and End-stage Kidney Disease

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ClinicalTrials.gov Identifier: NCT03499639
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : January 10, 2020
Sponsor:
Collaborators:
Sohag University
South Valley University
Information provided by (Responsible Party):
Mohamed Abdelsabour Mekky, Assiut University

Brief Summary:
Management of patients with hepatitis C virus (HCV) related liver disease with concomitant co-morbidity was challenging, especially in the period before the era of new direct-acting antiviral (DAA) agents. With the introduction of DAAs protocols, the therapeutic options were expanded to endorse many patients that were previously assigned as difficult-to-treat population. Different situations were encountered with co-infection with HCV such as chronic kidney disease (CKD) with its spectrum from mild forms to the end-stage kidney disease (ESKD), patients on hemodialysis (HD), and in post-renal transplant settings. Till now, pooled data about the safety and efficacy of different DAAs regimens in different renal situations are still under evaluation, especially in Egypt, where HCV genotype 4 the most dominating genotype. In Egypt, there were two adopted protocols for patients with HCV and CKD; the sofosbuvir-based combinations and the ombitasvir, paritaprevir, and ritonavir plus ribavirin-based combination. Sofosbuvir was proved to be contraindicated in patients with end-stage renal diseases as its elimination based mainly on renal route that may affect its bioavailability. On the other hand, ombitasvir, paritaprevir, and ritonavir plus ribavirin regimen was proved to be a well-tolerated protocol in non-cirrhotic patients with CKD.

Condition or disease Intervention/treatment Phase
End-stage Renal Disease HCV Coinfection Drug: Ombitasvir / Paritaprevir / Ritonavir /Ribavirin Oral Tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Ombitasvir/ Paritaprevir / Ritonavir Plus Ribavirin in Management HCV Genotype 4 and End-stage Kidney Disease With or Without Hemodialysis (An Open Label- Multicenter Prospective Study)
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
patients with HCV and ESKD
Ombitasvir / Paritaprevir / Ritonavir/Ribavirin Oral Tablet
Drug: Ombitasvir / Paritaprevir / Ritonavir /Ribavirin Oral Tablet
  • Patients with eGFR between 59-30ml/min: a co-formula of ombitasvir (OBV; 25mg)/ paritaprevir (PTV; 150mg)/ ritonavir (r; 100mg) (OBV/PTV/r) once-daily plus ribavirin (RIB) was given for 12 weeks. Dose adjustment of RIB was made as follow: If eGFR was 30-59 ml/min, an alternating dosing of 200 mg and 400 mg daily; if eGFR 15-30 ml/min, dosing was 200 mg once daily.
  • Patients on hemodialysis: a co-formula of OBV/PTV/r (25/150/100mg) once-daily plus RIB 200 mg 3 times/week, only in the days that they have their hemodialysis settings, 4 hours before the hemodialysis setting for 12 weeks.




Primary Outcome Measures :
  1. The primary endpoint was the achievement of SVR at week 12 (SVR12) post-treatment. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The potential adverse events were evaluated in each visit for the development of adverse events or any significant interactions. [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients were 18 years old or more,
  • naive to HCV treatment,
  • HCV genotype 4,
  • compensated liver disease.

Exclusion Criteria:

  • Patients with combined HCV/HBV co-infection
  • hepatocellular carcinoma (HCC)
  • decompensated liver cirrhosis (Child-Pugh score above 6)
  • non-genotype 4

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): NCT03499639


Locations
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Egypt
Assiut University Hopsital
Assiut, Egypt, 71515
Sponsors and Collaborators
Assiut University
Sohag University
South Valley University
Investigators
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Principal Investigator: Mohamed A Mekky, MD Assiut University
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Responsible Party: Mohamed Abdelsabour Mekky, Ass. Professor, Assiut University
ClinicalTrials.gov Identifier: NCT03499639    
Other Study ID Numbers: IRB 17100240
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: share through publishing a scientific paper

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coinfection
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Infections
Ritonavir
Ribavirin
HIV Protease Inhibitors
Viral 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