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

• Conditions: Chronic Hepatitis C

• Registration Number: NCT03510637
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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

Study Timeline

• Study Start: 2018-01-22
• Study First Submitted: 2018-04-13
• Study First Submitted QC: 2018-04-26
• Study First Posted: 2018-04-27
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-26
• Last Update Posted: 2019-07-29
• Primary Completion: 2020-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 7500

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%)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sustained Virological Response 12 weeks after the end of treatment (SVR12)	Post-treatment Week 12 (Week 24 or Week 36)	Efficacy of treatment given by the proportion of patients with an HCV RNA undetectable 12 weeks after the completion of treatment.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with adverse reactions/events leading to dosage reduction and/or treatment discontinuation	End of Treatment Week 12 or Week 24	Safety and tolerance profiles given by the proportion of patients with adverse reactions/events leading to dosage reduction and/or treatment discontinuation.
Resistance-Associated Variants (RAVs)	Post-Treatment Week 12 (Week 24 or Week 36)	Assess the occurence of viral resistance patterns in HCV genotype 4 patients
Adherence to treatment strategy	Post-treatment Week 12 (Week 24 or Week 36)	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)

Trial Locations

Locations (3)

El Fatemia El Kahera Centre; 🇪🇬 Cairo, Egypt

National Hepatology and Tropical Medicine Institute; 🇪🇬 Cairo, Egypt

New Cairo Hospital; 🇪🇬 Cairo, Egypt