Quality of Life in Patients With HCV Related Liver Cirrhosis Before and After Direct Acting Antiviral Drugs

• Conditions: HCV Related Liver Cirrhosis Direct Acting Antiviral Drugs

• Registration Number: NCT03897608
• Lead Sponsor: Assiut University

Brief Summary

To evaluate the effects of DAAs on HRQL in patients with liver cirrhosis secondary to chronic HCV infection

Detailed Description

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

Study Timeline

• Study First Submitted: 2019-03-29
• Study First Submitted QC: 2019-03-29
• Study First Posted: 2019-04-01
• Status Verified: 2020-02
• Study Start: 2020-02-01
• Last Update Submitted: 2020-02-09
• Last Update Posted: 2020-02-11
• Primary Completion: 2020-07-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of Life in patients with HCV related liver cirrhosis before and after Direct Acting Antiviral Drugs	one year	evaluate the effects of DAAs on HRQL in patients with liver cirrhosis secondary to chronic HCV infection