Evaluation of Treatment of Chronic HCV Patients in Chronic Kidney Disease Versus End Stage Renal Disease Patients
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

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) .
    

Intervention name(s): Ombitasvir-Paritaprevir-Ritonavir Tab 12.5-75-50 milligram
Intervention type(s): Drug
Intervention description(s): To asses curability of( Ombitasvir ,Paritaprevir,Ritonavir) in ch HCV infected patients in those with CKD vs ESRD 2- Also assess duration of sustained viral response,treatment, relapse or failure of therapy in CKD vs ESRD
Intervention MeSH terms: Ritonavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment