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| Name | Class |
|---|---|
| Institut Pasteur | INDUSTRY |
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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 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:
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| Measure | Description | Time Frame |
|---|---|---|
| Sustained Virological Response 12 weeks after the end of treatment (SVR12) | Efficacy of treatment given by the proportion of patients with an HCV RNA undetectable 12 weeks after the completion of treatment. | Post-treatment Week 12 (Week 24 or Week 36) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with adverse reactions/events leading to dosage reduction and/or treatment discontinuation | Safety and tolerance profiles given by the proportion of patients with adverse reactions/events leading to dosage reduction and/or treatment discontinuation. | End of Treatment Week 12 or Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a Chronic Hepatitis C and with prior approval from the Ministry of Health to begin HCV therapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arnaud Fontanet, MD, PhD | Contact | +33 (0) 140613763 | arnaud.fontanet@pasteur.fr | |
| Amélie Dublineau, PhD | Contact | +33(0)140613887 | amelie.dublineau@pasteur.fr |
| Name | Affiliation | Role |
|---|---|---|
| Yehia Mohamed El Sayed El Shazly, MD | Ain Shams University | Principal Investigator |
| Arnaud Fontanet, MD, PhD | Institut Pasteur | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| El Fatemia El Kahera Centre | Recruiting | Cairo | Egypt | |||
| National Hepatology and Tropical Medicine Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23286845 | Background | Esmat G, El Kassas M, Hassany M, Gamil ME, El Raziky M. How to optimize HCV therapy in genotype 4 patients. Liver Int. 2013 Feb;33 Suppl 1:41-5. doi: 10.1111/liv.12059. | |
| 25937436 | Background | Doss W, Shiha G, Hassany M, Soliman R, Fouad R, Khairy M, Samir W, Hammad R, Kersey K, Jiang D, Doehle B, Knox SJ, Massetto B, McHutchison JG, Esmat G. Sofosbuvir plus ribavirin for treating Egyptian patients with hepatitis C genotype 4. J Hepatol. 2015 Sep;63(3):581-5. doi: 10.1016/j.jhep.2015.04.023. Epub 2015 May 1. |
| Label | URL |
|---|---|
| Plan of action for the Prevention , Care \& Treatment of Viral Hepatitis, Egypt, 2014-2018 | View source |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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Blood sample (15 mL):
Samples (serum, plasma, DNA) stored in a dedicated biobank
| Adherence to treatment strategy |
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) |
| Post-treatment Week 12 (Week 24 or Week 36) |
| Resistance-Associated Variants (RAVs) | Assess the occurence of viral resistance patterns in HCV genotype 4 patients | Post-Treatment Week 12 (Week 24 or Week 36) |
| Recruiting |
| Cairo |
| Egypt |
| New Cairo Hospital | Recruiting | Cairo | Egypt |
| 25581111 | Background | Obach D, Yazdanpanah Y, Esmat G, Avihingsanon A, Dewedar S, Durier N, Attia A, Anwar WA, Cousien A, Tangkijvanich P, Eholie SP, Doss W, Mostafa A, Fontanet A, Mohamed MK, Deuffic-Burban S. How to optimize hepatitis C virus treatment impact on life years saved in resource-constrained countries. Hepatology. 2015 Jul;62(1):31-9. doi: 10.1002/hep.27691. Epub 2015 Feb 27. |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |