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

Chronic Hepatitis C Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03510637
Study type Observational
Source French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Contact Arnaud Fontanet, MD, PhD
Phone +33 (0) 140613763
Email arnaud.fontanet@pasteur.fr
Status Recruiting
Phase
Start date January 22, 2018
Completion date August 2020
View Details
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