Real Life Evaluation of Efficacy and Safety of Direct Antiviral Agents (DAAs) for the Treatment of Hepatitis C Virus in Egypt

Study Overview
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Brief Summary
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The primary purpose of the ANRS 12332 HepNile study cohort is to assess in Real-Life condition the efficacy and the safety profile of new Direct Acting Antivirals (DAAs) introduced in the Egyptian National Treatment Programme for the treatment of Chronic Hepatitis C (CHC).

Detailed Description
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Clinical trials are performed under optimal conditions where patients are highly selected with no co-morbidity, clinical supervision is provided by the best specialists in the field, and strict protocols are used to enhance patients' compliance. Thus, results may not be generalizable to real-world clinical practice. Observational studies are now gaining attention, showing with previous treatments (combined pegylated interferon and ribavirin) a wide range of results in terms of treatment effectiveness (SVR from 21% to 63% overall), whereas related pivotal clinical trials had estimated SVRs between 54% and 63% overall. Egypt is the first low/middle-income country where a national treatment program has been established on a large scale, allowing an evaluation that might be useful to itself and other similar countries. A real life evaluation will be particularly relevant now that new anti-viral drugs, direct-acting antivirals, are being introduced in Egypt. ANRS 12332 HepNile cohort study will allow in real life condition the study of: Efficacy (cure rate) and safety of new HCV regimens introduced in Egypt Emergence of resistance variants for patients with virological breakthrough Factors associated with treatment failure Drug-Drug interactions Adherence to the treatment regimens

Official Title
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ANRS 12332 HepNile : Evaluation of Real Life Efficacy and Safety of Antiviral Treatments Including New Direct Antiviral Agents Among Patients Treated for Chronic Hepatitis C (CHC) in Three National Treatment Centres in Cairo

Conditions
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Chronic Hepatitis C

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HCV RNA positivity 18 years =< Age =< 70 years Patients >= 65 years should undergo cardiological assessment prior to therapy by ECG echocardiography and cardiological consultation Effective contraception (Women of childbearing potential should use an effective contraception; Male patients and their female partners must also practice effective contraception) both during treatment and for the 3-months post-therapy); no breast-feeding Signed informed consent and willingness to participate in the study Exclusion Criteria: Child C cirrhotic patients Platelet count > 50000/mm3 Hepatocellular Carcinoma (HCC), except 6 months after intervention aiming at cure with no evidence of activity by dynamic imaging (CT or MRI) Extra-hepatic malignancy except after two years of disease-free interval (in case of lymphomas and chronic lymphatic leukemia, treatment can be initiated immediately after remission) Pregnancy or inability to use effective contraception inadequately controlled diabetes mellitus (HbA1C>9%)

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Virological Response 12 weeks after the end of treatment (SVR12) | Efficacy of treatment given by the proportion of patients with an HCV RNA undetectable 12 weeks after the completion of treatment. | Post-treatment Week 12 (Week 24 or Week 36) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with adverse reactions/events leading to dosage reduction and/or treatment discontinuation | Safety and tolerance profiles given by the proportion of patients with adverse reactions/events leading to dosage reduction and/or treatment discontinuation. | End of Treatment Week 12 or Week 24 | 
| Adherence to treatment strategy | Adherence given by the proportion of patients who have completed the treatment scheduled (defined by a patient who received 80% of drugs doses for 80% of the expected duration of therapy) | Post-treatment Week 12 (Week 24 or Week 36) | 
| Resistance-Associated Variants (RAVs) | Assess the occurence of viral resistance patterns in HCV genotype 4 patients | Post-Treatment Week 12 (Week 24 or Week 36) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, Genotype 4, DAAs, Real life evaluation