Efficacy and Safety of Qurevo Plus Ribavirin Based Therapy for Hepatitis C With or Without Cirrhosis in Haemodialysis Patients

Study Overview
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Brief Summary
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To evaluate efficacy and safety of Ombitasvir, paritaprevir, and ritonavir plus ribavirin based therapy for chronic hepatitis C with or without compensated cirrhosis in haemodialysis patients.

Detailed Description
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The aim of this study is; To evaluate the efficacy and safety of ombitasvir, paritaprevir, and ritonavir based therapy for chronic hepatitis C with or without compensated cirrhosis in HCV treatment naïve patients receiving long-term haemodialysis through assessment of: The proportion of patients with a sustained virological response (HCV RNA <25 IU/mL) 12 weeks after the last dose of study drug (SVR12). To determine withdrawal rate related to side effects and /or adverse effects for patients receiving at least 1 dose of the study medication.

Official Title
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Evaluation of Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir Plus Ribavirin Based Therapy for Chronic Hepatitis C With or Without Compensated Cirrhosis in Haemodialysis Patients

Conditions
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Chronic Hepatitis c

Intervention / Treatment
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* Drug: Ombitasvir, Paritaprevir and Ritonavir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Under regular HD for at least 6 months Clinically stable condition as outpatients. Treatment naïve patients with serum positive for HCV GT4 with HCV RNA > 1000 IU/ml by PCR. White blood cell count > 2500/mm^3. Platelet count > 7500/mm^3. Patients categorised as having compensated cirrhosis had a diagnosis of cirrhosis based on a previous screening liver FibroTest score of 0·72 or lower (eg, Metavir Fibrosis Score >3 [including 3/4 or 3-4] ). Exclusion Criteria: Confirmed pregnancy. HCV-HIV co infection. HBV-HCV co infection. Uncontrolled hyper or hypothyroidism. For patients without cirrhosis, Patients will be excluded if alanine or aspartate aminotransferase more than five times the upper limit of normal, for patients with cirrhosis they will be excluded if alanine or aspartate aminotransferase are higher than seven times the upper limit of normal Patients on peritoneal dialysis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, cohort, open label trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interventional Qurevo group<br>A total of 40 HCV treatment naïve patients with or without compensated cirrhosis on regular hemodialysis will be enrolled in the study. These patients will receive intervention of '25 mg ombitasvir, 150 mg paritaprevir, and 100 mg ritonavir' (2 capsules Qurevo®) plus ribavirin 200 mg daily for 12 weeks. Qurevo will be given once daily (on the day of dialysis, it will be given after dialysis session). Ribavirin will be given once daily (on the day of dialysis, it will be given 4 hrs before dialysis session ). | Drug: Ombitasvir, Paritaprevir and Ritonavir<br>* A total of 40 HCV treatment naïve patients with or without compensated cirrhosis on regular hemodialysis will be enrolled in the study. These patients will receive an intervention of '25 mg ombitasvir, 150 mg paritaprevir, and 100 mg ritonavir' (2 capsules Qurevo®) plus ribavirin 200 mg daily for 12 weeks. Qurevo will be given once daily (on the day of dialysis, it will be given after dialysis session). Ribavirin will be given once daily (on the day of dialysis, it will be given 4 hrs before dialysis session ).<br>* Other names: qurevo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Virological Response | The proportion of patients with a sustained virological response (HCV RNA <25 IU/mL) 12 weeks after the last dose of study drug (SVR12). | After 12 weeks after the last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment related withdrawal rate | To determine withdrawal rate related to side effects and /or adverse effects for patients receiving at least 1 dose of the study medication. | during treatment period, average duration 3 months |