Evaluation of the National Treatment Program of Hepatitis C in Egypt

Study Overview
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Brief Summary
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The aim of the study is to analyse data coming from two treatment centres of the National Treatment Program Centres of hepatitis C in Egypt

Detailed Description
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Analyse data coming from two centres of the National Treatment Program of hepatitis C in Egypt: 1500 patients who started treatment between April 1st 2013 and March 31st 2014 and will be seen for their week 60 visit between July 1st 2014 and June 30th 2015 (Cohort A). 1000 patients recruited between July 1st 2014 and estimated March 31st 2015, of which 200 are expected to be early defaulters and will be contacted by the study team (Cohort B).

Official Title
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Evaluation of the National Treatment Program of Hepatitis C in Egypt, Using Data Coming From Two Treatment Centres.

Conditions
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Chronic Hepatitis C

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age < 18 years and > 60 years Positive HCV antibodies using a third generation test Detectable HCV RNA by PCR Liver biopsy showing chronic hepatitis with either a METAVIR score F1 with elevated liver enzymes or scores F2/F3 Naïve to treatment with PEG-IFN and RBV HBs antigen negative Prothrombin time ≥60 %, normal bilirubin, alpha-foeto protein < 3*normal range of the laboratory, anti-nuclear antibodies<1/160 Effective contraception during the treatment period; no breast-feeding Signed informed consent and willingness to participate in the study Exclusion Criteria: Serious co-morbid conditions such as severe hypertension, heart failure, significant coronary heart disease, poorly controlled diabetes (HbA1C>8%) , chronic obstructive pulmonary disease Major uncontrolled depressive illness Solid transplant organ (renal, heart, or lung) Untreated thyroid disease History of previous anti-HCV therapy Body mass index (BMI) greater than 30 kg/m² Known human immunodeficiency virus (HIV) coinfection: although HIV testing will not be proposed or done, patients with known HIV coinfection will not be included in the trial hypersensitivity to one of the two drugs (PEG-IFN, RBV) pregnancy or unwilling to comply with adequate contraception breast-feeding neutropenia (<1500/mm3) anaemia (<11g/dL for women ; <12g/dL for men) thrombocytopenia (<100.000/mm3) elevated creatinin (>1.5mg/dL) concomitant liver disease other than hepatitis C (immuno-active chronic hepatitis B, autoimmune hepatitis, alcoholic liver disease, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson disease) liver biopsy showing severe steatosis (>66%) and steatohepatitis; decompensated cirrhosis (Child Pugh>A); hepatocellular carcinoma, METAVIR score F4. TSH>5 mU/L

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients under Dual therapy<br>- 1500 patients who started treatment between April 1st 2013 and March 31st 2014 and will be seen for their week 60 visit between July 1st 2014 and June 30th 2015 (Cohort A). | |
| Early Defaulters<br>- 1000 patients recruited between July 1st 2014 and estimated March 31st 2015, of which 200 are expected to be early defaulters and will be contacted by the study team (Cohort B). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate real life Sustained Virological Response rate | Put in place mechanisms to ensure systematic reporting of HCV RNA testing at week 60 in the two project centres to obtain reliable estimates of response rates at this crucial time point. | 60 weeks after initiation of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the efficacy of Reiferon®, a biosimilar produced by a local company, Minapharm©, to that of other pegylated interferon of known efficacy (Pegasys®, Pegintron®) | Response rates at week 12, week 24 and week 60 will be compared across the three treatment regimens available in Egypt. Reiferon's efficacy will be assessed by comparison of: Complete early virological response (cEVR): defined by undetectable HCV RNA at 12 weeks post initiation of dual therapy by PEG IFN + RBV Early virological response (EVR): defined by at least a 2 log-reduction of HCV RNA or undetectable HCV-RNA at 12 weeks of combination therapy. Sustained virological response (SVR): defined by HCV RNA below the detection limit based on quantitative PCR 12 weeks after stopping treatment (week 60) Normalization of ALT: Proportion of patients who have ALT below the upper limit of normal (ULN) during the treatment and 12 weeks after the end of treatment. Adverse events: Evaluation of Incidence of AE and SAE related to dual therapy. | 12 weeks, 24 weeks and 60 weeks after initiation of treatment | 
| Understand the determinants of not returning for follow-up among defaulting patients | Describe the timing of premature termination of treatment, and understand factors associated with it, throughout the 60 weeks of follow-up. Patients compliance in terms of regularity of injections intake will be described | 60 weeks after the initiation of dual-therapy | 
| Optimize selection criteria for patients to be enrolled in the National Treatment Program | Explore various inclusion criteria combining fibrosis stage and serological markers of treatment response to optimize the selection of patients for the National Treatment Program | 60 weeks after the initiation of dual therapy | 
| Estimate real life Response rate at the end of treatment | Put in place mechanisms to ensure systematic reporting of HCV RNA testing at week 48 in the two project centres to obtain reliable estimates of response rates at the end of treatment. | 48 weeks after initiation of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Viral Hepatitis C, Genotype 4, SVR, Egyptian National Program