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临床试验/NCT03894696
NCT03894696Unknown不适用

Frequency of Anxiety and Depression in Chronic Hepatitis C Patients Recieving Direct-Acting Antiviral Agents.

Assiut University0 个研究点目标入组 200 人开始时间: 2019年8月1日最近更新:
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相关药物

试验速览

阶段
不适用
入组人数
200
主要终点
frequency of anxiety and depression in chronic HCV patients recieving DAAs.

研究概览

简要总结

The primary objective of this study is to prospectively analyse psychiatric outcomes, specifically depression and anxiety in patients with hepatitis C virus infection who are initiated on DAA therapy (sofosbuvir based regimen).

详细描述

Hepatitis C is a major cause of chronic liver disease worldwide with an estimated 71 million people infected in 2015 and approximately 1.75 million new infections each year .

Egypt had high burden of liver disease from viral hepatitis , and near to 15% of the adult population had HCV seropositivity and more than 4 million persons had also viraemia .

The discovery of direct-acting antiviral agents (DAAs) has dramatically changed HCV treatment by increasing the cure rate and decreasing the duration of therapy .The current generation of DAAs (e.g., daclatasvir [DCV], sofosbuvir [SOF], simeprevir [SIM] and ledipasvir [LDV]) is used without IFN .

The approval of direct - acting antiviral (DAA) agents revolutionized HCV treatment and allowed for non-IFN-a-based regimens. Psychiatric and psychosocial contraindications to treatment are reduced due to shorter duration of therapy and improved side effect profiles . Also, the favorable side effect profiles of DAA agents (less fatigue and blood dyscrasias) lead to high adherence rates of 96.2%, compared to 84.3% and 77.6% in IFN-free RBV-containing regimens and IFN- and RBV containing regimen respectively .

Sofosbuvir and daclatasvir are new direct acting antivirals (DAAs) which are tolerable and safe. Daclatasvir is a first-in-class HCV NS5A replication complex inhibitor with pangenotypic activity and can be used once-daily. Sofosbuvir is an orally administered HCV nucleotide polymerase NS5B inhibitor. It is given once daily with a good safety profile . The sofosbuvir and daclatasvir combination is associated with a high rate of SVR in difficult-to-treat patients infected with genotype 1 or 4. Addition of ribavirin increases the SVR rate in cirrhotic and treatment-experienced patients .

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years and older Chronic Hepatitis C infection Naive patients who will start a 12-week DAA therapy Acceptance to share in study

排除标准

  • Recieving antipsychotic . Previous failure of DAA agents. Significant life-threatening diseases HCV related liver cirrhosis. Non HCV related liver disease

结局指标

主要结局

frequency of anxiety and depression in chronic HCV patients recieving DAAs.

时间窗: 6 months .

to detect occurance of psychatric disorders specifically anxiety and depression in chronic HCV patients treated with DAAs ( sofosbuvir based regimens).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dina Khaled Mostafa Mohamed

resident at gastroenterology and tropical medicine -Assiut university

Assiut University

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