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

Chronic Hepatitis C Clinical Trial

— HepNile  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT03510637
• Other study ID #: ANRS 12332
• Status: Recruiting
• Start date: January 22, 2018
• Est. completion date: August 2020

Study information

• Verified date: July 2019
• 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
• Is FDA regulated: No
• Study type: Observational

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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7500
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• HCV RNA positivity

• 18 years =< Age =< 70 years

• Patients >= 65 years should undergo cardiological assessment prior to therapy by ECG echocardiography and cardiological consultation

• Effective contraception (Women of childbearing potential should use an effective contraception; Male patients and their female partners must also practice effective contraception) both during treatment and for the 3-months post-therapy); no breast-feeding

• Signed informed consent and willingness to participate in the study

Exclusion Criteria:

• Child C cirrhotic patients

• Platelet count > 50000/mm3

• Hepatocellular Carcinoma (HCC), except 6 months after intervention aiming at cure with no evidence of activity by dynamic imaging (CT or MRI)

• Extra-hepatic malignancy except after two years of disease-free interval (in case of lymphomas and chronic lymphatic leukemia, treatment can be initiated immediately after remission)

• Pregnancy or inability to use effective contraception

• inadequately controlled diabetes mellitus (HbA1C>9%)

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Egypt	El Fatemia El Kahera Centre	Cairo
Egypt	National Hepatology and Tropical Medicine Institute	Cairo
Egypt	New Cairo Hospital	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	Institut Pasteur

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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. Review. — View Citation

Obach D, Yazdanpanah Y, Esmat G, Avihingsanon A, Dewedar S, Durier N, Attia A, Anwar WA, Cousien A, Tangkijvanich P, Eholié 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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
Secondary	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)
Secondary	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)

External Links

•   Plan of action for the Prevention , Care & Treatment of Viral Hepatitis, Egypt, 2014-2018