A Prospective, Non-Interventional Cohort Study of Approved Sofosbuvir-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Proportion of participants experiencing adverse drug reactions (ADRs), serious adverse events (SAEs), and adverse events (AEs) during the treatment period and posttreatment follow-up period
研究概览
简要总结
This study will collect and evaluate information on the safety and efficacy of Sovaldi-based regimens in routine clinical practice in Mexico. The primary objective of this study is to assess the rates of serious adverse events/reactions (SAEs/SADRs) and adverse events/reactions (AEs/ADRs) in adult participants with chronic hepatitis C virus (HCV) infection treated with Sovaldi in routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV-infected patients living in Mexico
- •Treatment with a Sovaldi-based regimen, per the approved prescribing information, as determined by the patient's treating physician
排除标准
- •Concurrent participation in an HCV clinical trial (except trials not testing investigational medicinal products)
- •Patients presenting a risk of not being able to be followed (eg, patients planning to move or leave the country prior to their SVR12 visit)
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Sovaldi-based regimens
Adult patients with chronic HCV infection living in Mexico who take Sovaldi as part of routine clinical care at a participating clinical site.
干预措施: Sovaldi (Drug)
结局指标
主要结局
Proportion of participants experiencing adverse drug reactions (ADRs), serious adverse events (SAEs), and adverse events (AEs) during the treatment period and posttreatment follow-up period
时间窗: Up to Posttreatment Week 4
次要结局
- Frequency of concurrent use of Sovaldi with amiodarone and another direct acting antiviral (DAA) or with potent intestinal P-gp inducers in routine clinical practice(Up to 24 weeks)
- Proportion of patients with sustained virologic response (SVR) at 12 weeks post treatment (SVR12), defined as HCV RNA < lower limit of quantification between 10 and 24 weeks post-treatment(Up to Posttreatment Week 24)