Observational Cohort Study of Clinical Outcomes After Antiviral Therapy for Chronic Hepatitis C
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Interferon
Interferon combined with ribavirin antiviral therapy
Drug: ribavirin
Interferon combined with ribavirin antiviral therapy
|
| 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. |
Drug: DAAs
DAAs antiviral treatment
|
Outcome Measures
Primary Outcome Measures
- The incidence of liver cancer [up to 144 weeks]
The incidence of liver cancer after anti-viral treatment of chronic hepatitis C
- The incidence of decompensated cirrhosis [up to 144 weeks]
The incidence of decompensated cirrhosis after anti-viral treatment of chronic hepatitis C
Secondary Outcome Measures
- Percentage of persistent virological response or relapse [up to 144 weeks]
Percentage of persistent virological response or relapse after antiviral therapy for chronic hepatitis C
- Related factors of liver cancer [up to 144 weeks]
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
- Related factors of decompensated cirrhosis [up to 144 weeks]
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
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | liver disease center, Beijing Ditan Hospital | Beijing | Beijing | China | 100015 |
Sponsors and Collaborators
- Beijing Ditan Hospital
Investigators
- Study Director: Yao Xie, phD/MD, Beijing Ditan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DTXY021