"Real Life" Evaluation of Efficacy and Safety of Direct Antiviral Agents (DAAs) for the Treatment of Hepatitis C Virus in Egypt
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Hepatitis C
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
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 c...
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
Tracking Information
- NCT #
- NCT03510637
- Collaborators
- Institut Pasteur
- Investigators
- Principal Investigator: Yehia Mohamed El Sayed El Shazly, MD Ain Shams University Principal Investigator: Arnaud Fontanet, MD, PhD Institut Pasteur