NCT03510637

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 7,500 (estimated)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Chronic Hepatitis C

Timeline

• Start date: 2018-01-22
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2018-04-27
• Last updated: 2019-07-29

Locations

3 sites across 1 country: Egypt