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

NCT03499639 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2020-01-10

No results posted yet for this study

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.

Conditions

  • End-stage Renal Disease
  • HCV Coinfection

Interventions

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.

Sponsors & Collaborators

  • Sohag University

    collaborator OTHER

  • South Valley University

    collaborator OTHER

  • Assiut University

    lead OTHER

Principal Investigators

  • Mohamed A Mekky, MD · Assiut University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2018-08-01
Completion
2018-09-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03499639 on ClinicalTrials.gov