Observational Cohort Study of Clinical Outcomes After Antiviral Therapy for Chronic Hepatitis C

Study Overview
=================
Brief Summary
-----------------
This study was a clinical observational cohort study of two-way, non-intervention long-term dynamic follow-up. Enrolled in the Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, with interferon combined with ribavirin (PR) antiviral therapy (PR treatment greater than or equal to 6 months) and/or direct acting antivirals (DAAs) In patients with chronic hepatitis C, the baseline, antiviral treatment and withdrawal follow-up data before the antiviral treatment were collected, and the patients were followed up for 3-6 months. Clinical data such as clinical biochemistry, HCV RNA and serological markers (anti-HCV), AFP and liver imaging (liver ultrasound) were collected during the study period. At least 144 weeks of observation on the virological response and clinical outcome of anti-viral treatment of chronic hepatitis C, the main evaluation index of liver cancer and decompensated liver cirrhosis after stopping the drug, and exploring the antiviral treatment of patients Long-term virological response and clinical outcomes, clarifying their influencing factors.

Detailed Description
-----------------
This study was a clinical observational cohort study of two-way, non-intervention long-term dynamic follow-up. Enrolled in the Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, with interferon combined with ribavirin (PR) antiviral therapy (PR treatment greater than or equal to 6 months) and/or direct acting antivirals (DAAs) In patients with chronic hepatitis C, the baseline, antiviral treatment and withdrawal follow-up data before the antiviral treatment were collected, and the patients were followed up for 3-6 months. Clinical data such as clinical biochemistry, HCV RNA and serological markers (anti-HCV), AFP and liver imaging (liver ultrasound) were collected during the study period. At least 144 weeks of observation on the virological response and clinical outcome of anti-viral treatment of chronic hepatitis C, the main evaluation index of liver cancer and decompensated liver cirrhosis after stopping the drug, and exploring the antiviral treatment of patients Long-term virological response and clinical outcomes, clarifying their influencing factors.

Official Title
-----------------
Observational Cohort Study of Clinical Outcomes After Antiviral Therapy in Chronic Hepatitis C Patients

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: Interferon
* Drug: ribavirin
* Drug: DAAs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic hepatitis C patients treated with interferon plus ribavirin (PR) antiviral therapy (PR treatment greater than or equal to 6 months) and/or direct antiviral drugs (DAAs) Exclusion Criteria: Co-infected with hepatitis B virus or human immunodeficiency virus Had an autoimmune disease, liver tumour, or severe cardiac disease.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Interferon combined with ribavirin group<br>Interferon combined with ribavirin (PR) antiviral therapy (PR treatment for 6 months or more) in patients with chronic hepatitis C, collect basic data before antiviral therapy, and during the PR antiretroviral treatment period, Follow-up was performed every 3-6 months in March, June, September, December, DAAs antiviral treatment during January, March, and withdrawal follow-up, and clinical biochemistry, HCV RNA, and serological markers were used during follow-up ( anti-HCV), AFP and liver imaging (liver ultrasound) examination. | Drug: Interferon<br>* Interferon combined with ribavirin antiviral therapy<br>Drug: ribavirin<br>* Interferon combined with ribavirin antiviral therapy<br>|
| DAAs treatment group<br>Patients with chronic hepatitis C treated with direct acting antivirals (DAAs), collect basic data before antiviral therapy, and during the period of PR antiviral treatment, January, March, June, September, December Follow-up was performed every 3-6 months during January, March, and withdrawal follow-up during DAAs antiviral therapy. Clinical biochemistry, HCV RNA and serological markers (anti-HCV), AFP, and liver imaging were performed at follow-up. Liver ultrasound) check. | Drug: DAAs<br>* DAAs antiviral treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of liver cancer | The incidence of liver cancer after anti-viral treatment of chronic hepatitis C | up to 144 weeks | 
| The incidence of decompensated cirrhosis | The incidence of decompensated cirrhosis after anti-viral treatment of chronic hepatitis C | up to 144 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of persistent virological response or relapse | Percentage of persistent virological response or relapse after antiviral therapy for chronic hepatitis C | up to 144 weeks | 
| Related factors of liver cancer | Related factors including viral indicators (HCV RNA content, anti-HCV), clinical biochemical indicators (ALT, AST, ALB, Tbil), blood routine and coagulation function indicators (PTA) and serum AFP and liver ultrasound results of liver cancer after anti-viral treatment of chronic hepatitis C | up to 144 weeks | 
| Related factors of decompensated cirrhosis | Related factors including viral indicators (HCV RNA content, anti-HCV), clinical biochemical indicators (ALT, AST, ALB, Tbil), blood routine and coagulation function indicators (PTA) and serum AFP and liver ultrasound results of decompensated cirrhosis after anti-viral treatment of chronic hepatitis C | up to 144 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic hepatitis C, Interferon, Ribavirin, Clinical outcome