Clinical trial NCT03510637: "Real Life" Evaluation of Efficacy and Safety of Direct Antiviral Agents (DAAs) for the Treatment of Hepatitis C Virus in Egypt
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis C
Keywords: Hepatitis C, Genotype 4, DAAs, Real life evaluation
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Institut Pasteur
First posted: 2018-04-27
Enrollment: 7500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a Chronic Hepatitis C and with prior approval from the Ministry of Health to begin HCV therapy

Brief 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).

Detailed 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

Eligibility criteria: 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%)

Primary outcomes:
measure: Sustained Virological Response 12 weeks after the end of treatment (SVR12)
timeFrame: Post-treatment Week 12 (Week 24 or Week 36)
Secondary outcomes:
measure: Proportion of patients with adverse reactions/events leading to dosage reduction and/or treatment discontinuation
timeFrame: End of Treatment Week 12 or Week 24
measure: Adherence to treatment strategy
timeFrame: Post-treatment Week 12 (Week 24 or Week 36)
measure: Resistance-Associated Variants (RAVs)
timeFrame: Post-Treatment Week 12 (Week 24 or Week 36)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: El Fatemia El Kahera Centre
city: Cairo
country: Egypt
facility: National Hepatology and Tropical Medicine Institute
city: Cairo
country: Egypt
facility: New Cairo Hospital
Study officials:
affiliation: Ain Shams University
name: Yehia Mohamed El Sayed El Shazly, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Pasteur
name: Arnaud Fontanet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.