ANRS 12332 HepNile : Evaluation of "Real Life" Efficacy and Safety of Antiviral Treatments Including New Direct Antiviral Agents Among Patients Treated for Chronic Hepatitis C (CHC) in Three National Treatment Centres in Cairo
试验速览
- 阶段
- 不适用
- 入组人数
- 7,500
- 试验地点
- 3
- 主要终点
- Sustained Virological Response 12 weeks after the end of treatment (SVR12)
研究概览
简要总结
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).
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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%)
结局指标
主要结局
Sustained Virological Response 12 weeks after the end of treatment (SVR12)
时间窗: 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.
次要结局
- Proportion of patients with adverse reactions/events leading to dosage reduction and/or treatment discontinuation(End of Treatment Week 12 or Week 24)
- Resistance-Associated Variants (RAVs)(Post-Treatment Week 12 (Week 24 or Week 36))
- Adherence to treatment strategy(Post-treatment Week 12 (Week 24 or Week 36))