Observational Cohort Study of Clinical Outcomes After Antiviral Therapy in Chronic Hepatitis C Patients
Overview
- Phase
- Not Applicable
- Intervention
- Interferon
- Conditions
- Chronic Hepatitis C
- Sponsor
- Beijing Ditan Hospital
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- The incidence of liver cancer
- Last Updated
- 6 years ago
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.
Investigators
Yao Xie
Director of liver disease
Beijing Ditan Hospital
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.
Arms & Interventions
Interferon combined with ribavirin group
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.
Intervention: Interferon
Interferon combined with ribavirin group
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.
Intervention: ribavirin
DAAs treatment group
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.
Intervention: DAAs
Outcomes
Primary Outcomes
The incidence of liver cancer
Time Frame: up to 144 weeks
The incidence of liver cancer after anti-viral treatment of chronic hepatitis C
The incidence of decompensated cirrhosis
Time Frame: up to 144 weeks
The incidence of decompensated cirrhosis after anti-viral treatment of chronic hepatitis C
Secondary Outcomes
- Related factors of decompensated cirrhosis(up to 144 weeks)
- Percentage of persistent virological response or relapse(up to 144 weeks)
- Related factors of liver cancer(up to 144 weeks)