"Real Life" Evaluation of Efficacy and Safety of Direct Antiviral Agents (DAAs) for the Treatment of Hepatitis C Virus in Egypt (HepNile)
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|ClinicalTrials.gov Identifier: NCT03510637|
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : April 27, 2018
|Condition or disease|
|Chronic Hepatitis 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
|Study Type :||Observational|
|Estimated Enrollment :||7500 participants|
|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|
|Actual Study Start Date :||January 22, 2018|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
- Sustained Virological Response 12 weeks after the end of treatment (SVR12) [ Time Frame: Post-treatment Week 12 (Week 24 or Week 36) ]Efficacy of treatment given by the proportion of patients with an HCV RNA undetectable 12 weeks after the completion of treatment.
- 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 ]Safety and tolerance profiles given by the proportion of patients with adverse reactions/events leading to dosage reduction and/or treatment discontinuation.
- Adherence to treatment strategy [ Time Frame: Post-treatment Week 12 (Week 24 or Week 36) ]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)
- Resistance-Associated Variants (RAVs) [ Time Frame: Post-Treatment Week 12 (Week 24 or Week 36) ]Assess the occurence of viral resistance patterns in HCV genotype 4 patients
Biospecimen Retention: Samples With DNA
Blood sample (15 mL):
- at inclusion,
- at the End of Treatment (EOT)
- 12 weeks after the end of treatment (only for patients who do not achieve a SVR).
Samples (serum, plasma, DNA) stored in a dedicated biobank
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03510637
|Contact: Arnaud Fontanet, MD, PhD||+33 (0) firstname.lastname@example.org|
|Contact: Amélie Dublineau, PhD||+33(0)email@example.com|
|El Fatemia El Kahera Centre||Recruiting|
|National Hepatology and Tropical Medicine Institute||Recruiting|
|New Cairo Hospital||Recruiting|
|Principal Investigator:||Yehia Mohamed El Sayed El Shazly, MD||Ain Shams University|
|Principal Investigator:||Arnaud Fontanet, MD, PhD||Institut Pasteur|