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

NCT03499639 | Completed Phase 4

• 1 other identifier: IRB 17100240
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Renal Disease; HCV Coinfection

Outcome Measures

Primary Outcomes (1)

• The primary endpoint was the achievement of SVR at week 12 (SVR12) post-treatment.

  6 months

Secondary Outcomes (1)

• The potential adverse events were evaluated in each visit for the development of adverse events or any significant interactions.

  6 months

Study Arms (1)

patients with HCV and ESKD

OTHER

Ombitasvir / Paritaprevir / Ritonavir/Ribavirin Oral Tablet

Drug: Ombitasvir / Paritaprevir / Ritonavir /Ribavirin Oral Tablet

Interventions

Ombitasvir / Paritaprevir / Ritonavir /Ribavirin Oral Tablet DRUG

* 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.

patients with HCV and ESKD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead
• Sohag University: collaborator
• South Valley University: collaborator

Study Sites (1)

Assiut University Hopsital

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

ombitasvir; paritaprevir; Ritonavir; Ribavirin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Mohamed A Mekky, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Professor

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 17, 2018
• Study Start: May 1, 2018
• Primary Completion: August 1, 2018
• Study Completion: September 30, 2018
• Last Updated: January 10, 2020

Record last verified: 2020-01

Locations

EG (1)