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).
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
Study Type
OBSERVATIONAL
Enrollment
7,500
El Fatemia El Kahera Centre
Cairo, Egypt
RECRUITINGNational Hepatology and Tropical Medicine Institute
Cairo, Egypt
RECRUITINGNew Cairo Hospital
Cairo, Egypt
RECRUITINGSustained 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.
Time frame: Post-treatment Week 12 (Week 24 or Week 36)
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.
Time frame: 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)
Time frame: 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
Time frame: Post-Treatment Week 12 (Week 24 or Week 36)
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