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

Last updated: July 26, 2019
Sponsor: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatitis

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT03510637
ANRS 12332
  • Ages 18-70
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • HCV RNA positivity

  • 18 years =< Age =< 70 years

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

  • Effective contraception (Women of childbearing potential should use an effectivecontraception; Male patients and their female partners must also practice effectivecontraception) both during treatment and for the 3-months post-therapy); nobreast-feeding

  • Signed informed consent and willingness to participate in the study

Exclusion

Exclusion Criteria:

  • Child C cirrhotic patients

  • Platelet count > 50000/mm3

  • Hepatocellular Carcinoma (HCC), except 6 months after intervention aiming at cure withno evidence of activity by dynamic imaging (CT or MRI)

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

  • Pregnancy or inability to use effective contraception

  • inadequately controlled diabetes mellitus (HbA1C>9%)

Study Design

Total Participants: 7500
Study Start date:
January 22, 2018
Estimated Completion Date:
August 31, 2020

Study 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

Connect with a study center

  • El Fatemia El Kahera Centre

    Cairo,
    Egypt

    Active - Recruiting

  • National Hepatology and Tropical Medicine Institute

    Cairo,
    Egypt

    Active - Recruiting

  • New Cairo Hospital

    Cairo,
    Egypt

    Active - Recruiting

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