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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon | Drug | Interferon combined with ribavirin antiviral therapy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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). All patients with chronic hepatitis C were eligible for the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis C (2015).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yao Xie, doctor | Contact | 8613501093293 | xieyao00120184@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Yao Xie, phD/MD | Beijing Ditan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| liver disease center, Beijing Ditan Hospital | Recruiting | Beijing | Beijing Municipality | 100015 | China |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D007372 | Interferons |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| ribavirin | Drug | Interferon combined with ribavirin antiviral therapy |
|
| DAAs | Drug | DAAs antiviral treatment |
|
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 |
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |