Evaluation of Treatment of Chronic HCV Patients in Chronic Kidney Disease Versus End Stage Renal Disease Patients

Phase 1

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Ombitasvir-Paritaprevir-Ritonavir Tab 12.5-75-50 milligram

• Registration Number: NCT03341988
• Lead Sponsor: Assiut University

Brief Summary

1. To asses curability of( Ombitasvir ,Paritaprevir,Ritonavir) in chronic HCV infected patients in those with CKD versus ESRD in Assiut Hospital University .

2. Also assess duration of sustained viral response,treatment, relapse or failure of therapy in CKD versus ESRD in Assiut Hospital.

Detailed Description

Hepatitis C virus (HCV) is a leading cause of liver disease worldwide, as 130-170 million individuals are chronically infected and 350,000 patients die every year from HCV infection. The HCV prevalence varies widely among countries being highest in several African and Eastern Mediterranean countries. So public health authorities should recognise the importance of HCV and make resources available for the implementation of effective primary prevention, screening and management policies .

The hepatitis C virus (HCV) genotype is an important predictor of disease progression and treatment response. Genotype 1b has a worldwide distribution and is often found to be the most common genotype. HCV-genotype 4 causes approximately 20% of the 180 million cases of chronic hepatitis C in the world, is predominant in the Middle East and Northern Africa, and has recently spread to Southern Europe. Genotype 4 accounts for more than 90% of the reported cases from Egypt, a country with a massive HCV-related disease burden.

The prevalence of anti-hepatitis C virus Ab (anti-HCV) positivity among dialysis patients varies across countries, ranging from 3 to 75%; unfortunately, Egypt is considered one of the countries with the highest prevalence despite the existence of guidelines for a comprehensive infection control program.

In Egypt In the 15-59-year age groups, the prevalence of HCV antibody was found to be 10.0% and that of HCV RNA to be 7.0%. Approximately, 3.7 million persons have chronic HCV infection in the age group 15-59 in 2015.

In the treatment of chronic HCV in renal impairment For patients with mild to moderate renal impairment (CrCl 30 mL/min-80 mL/min), no dosage adjustment is required when using fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) .

Abbvie's 2D regimen (paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir(25mg)) was recently approved with specific indication for genotype 4 treatment naïve and experienced patients without cirrhosis achieved an sustained viral response rate of 100% following 12 weeks of 2D regimen with RBV, 2D can be used without RBV but may have slightly lower SVR (91% vs 100%). Currently, there is no FDA indication for 2D regimen use in patients with cirrhosis.

. Ombitasvir (25 mg once daily), Paritaprevir (150 mg once daily), Ritonavir (100 mg once daily)Ribavirin (RBV): weight-based and divided bid (1000 mg/day if \< 75kg or 1200 mg/day if ≥ 75kg) .

Study Timeline

• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-11-09
• Study First Posted: 2017-11-14
• Study Start: 2017-11-22
• Primary Completion: 2018-01-01
• Status Verified: 2018-05
• Study Completion: 2018-05-01
• Last Update Submitted: 2018-05-18
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. The patients aged from18- 60 years.
2. Chronic HCV infection with Plasma HCV RNA greater than 15,000 IU/mL
3. Treatment naïve.
4. compensated liver cirrhosis.
5. Absence of coinfection with HBV or HIV.

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Exclusion Criteria

1. Patients with hepatitis B virus or HIV.
2. prior antiviral therapy.
3. Haemoglobin level less than 10mg/dl.
4. Decompensated liver disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ombitasvir (25 mg ), Paritaprevir (150 mg ) once daily	Ombitasvir-Paritaprevir-Ritonavir Tab 12.5-75-50 milligram	Ombitasvir (25 mg once daily), Paritaprevir (150 mg once daily), Ritonavir (100 mg once daily)Ribavirin (RBV): weight-based and divided bid (1000 mg/day if \< 75kg or 1200 mg/day if ≥ 75kg) given to 50 chronic HCV infected patients with renal impairment for 12 week

Primary Outcome Measures

Name	Time	Method
Evaluation of the sustained viral response of Ombitasvir/Paritaprevir/Ritonavir regimen in the treatment of Chronic HCV patients in CKD versus ESRD patients in Assiut University Hospital	6 months	pathologic complete remission for HCV after tretment

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt