Chronic Hepatitis C
Conditions
Keywords
Hepatitis C, Genotype 4, DAAs, Real life evaluation
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
Interventions
None listed
Sponsors
Institut Pasteur
ANRS, Emerging Infectious Diseases
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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%)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
| 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 |
Countries
Egypt
Contacts
Primary ContactArnaud Fontanet, MD, PhD
Backup ContactAmélie Dublineau, PhD
Outcome results
None listed