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

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%)