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

A

ANRS, Emerging Infectious Diseases

Status

Unknown

Conditions

Chronic Hepatitis C

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03510637
ANRS 12332

Details and patient eligibility

About

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).

Full 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

Enrollment

7,500 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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%)

Trial contacts and locations

3

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Central trial contact

Arnaud Fontanet, MD, PhD; Amélie Dublineau, PhD

Data sourced from clinicaltrials.gov

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