"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 : July 29, 2019
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|