Quality of Life in Patients With HCV Related Liver Cirrhosis Before and After Direct Acting Antiviral Drugs
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Quality of Life in patients with HCV related liver cirrhosis before and after Direct Acting Antiviral Drugs
研究概览
简要总结
To evaluate the effects of DAAs on HRQL in patients with liver cirrhosis secondary to chronic HCV infection
详细描述
Hepatitis C has been associated with substantial resource utilization as a result of its effect on the liver as well as other organ systems (the extrahepatic manifestations of HCV). It has been widely reported to have a profound negative impact on patient's health-related quality of life (HRQL).
The reduction of HRQL is probably also due to physical and psychiatric symptoms as a direct consequence of this chronic infection and its sequelae (such as cirrhosis). The chronic inflammation is believed to signal the brain and to give rise to neurovegetative symptoms (e.g. malaise and fatigue) and to amongst others depression and concentration difficulties. Possibly, also the brain itself is infected by HCV . The Egyptian government introduced Sofosbuvir as the first DAAs into Egypt through the government funded National Treatment Program. These agents are highly efficacious with significantly fewer side effects .
To date, there is only one study reported about how Egyptian HCV patients receiving the new DAAs perceive their HRQL. This study is first one to be done in Upper Egypt to assess health-related quality of life of HCV patients receiving direct acting antivirals (DAAs) therapy prior and at the end of therapy
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 11 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hepatitis C related liver cirrhosis (diagnosed clinically laboratory and by imaging).
- •Age 18 years or older
- •Eligible for starting DAAs therapy according to Egyptian National Guidelines will be enrolled.
- •Follow up of those patients during and after DAAs therapy (clinically ,laboratory,imaging and with a questionnaire ) to determine HRQL.
排除标准
- •Any patient with liver cirrhosis secondary to causes other than chronic HCV infection e. g. auto immune liver disease, PBC
- •Coinfection with other viruses as HBV, HIV.
- •Had significant psychiatric illnesses (diagnosed by psychiatrist)
结局指标
主要结局
Quality of Life in patients with HCV related liver cirrhosis before and after Direct Acting Antiviral Drugs
时间窗: one year
evaluate the effects of DAAs on HRQL in patients with liver cirrhosis secondary to chronic HCV infection
次要结局
未报告次要终点
研究者
Hossam eldeen Esmael Zayan
RESIDENT DOCTOR
Assiut University