Chronic hepatitis C
Conditions
Interventions
CHC patients receiving SOF/VEL or LDV/SOF treatment:None
Sponsors
The 2nd Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male and female patients with chronic hepatitis C who were at least 18 years old at the time of treatment; 2. According to the local prescription information approved by the National Medical Products Administration's Drug Evaluation Center (CNDA) and/or the local standard clinical practices, patients receiving treatment with sofosbuvir/velpatasvir (SOF/VEL) or ledipasvir/sofosbuvir (LDV/SOF) for a treatment course of 12 weeks or 24 weeks can be combined with ribavirin. 3. It also includes complete HCV RNA data and other follow-up data for both "4 weeks after the end of treatment" and "12 weeks after the end of treatment".
Exclusion criteria
Exclusion criteria: 1. Include autoimmune liver diseases, alcoholic liver diseases, drug-induced liver diseases and other liver disorders; 2. Patients with a previous history of hepatocellular carcinoma or diagnosed with hepatocellular carcinoma within 6 months after their first admission; 3. Suffer from other significant diseases that affect the patient's survival, including hematological diseases, immune disorders or other major malignancies; 4. Have a history of splenectomy surgery, transjugular intrahepatic portosystemic shunt surgery or liver transplantation during follow-up; 5. Complicated with human immunodeficiency virus (HIV) infection or hepatitis B virus (HBV) infection; 6. Insufficient data, including baseline data, follow-up data or outcome data, which cannot meet the data analysis requirements of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive Predictive Value (PPV) of Sustained Virological Response at Week 4 (SVR4) for Sustained Virological Response at Week 12 (SVR12);Negative Predictive Value (NPV) of Sustained Virological Response at Week 4 (SVR4) for Sustained Virological Response at Week 12 (SVR12); | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Patients Achieving Sustained Virological Response at Week 4 (SVR4);Proportion of Patients Achieving Sustained Virological Response at Week 12 (SVR12);Alanine Aminotransferase (ALT) Normalization Rate (Proportion of Patients with Baseline ALT > Upper Limit of Normal [ULN] Who Achieve ALT Upper Limit of Normal [ULN] Who Achieve AST <= ULN at Follow-up);Predictive Factors Analysis: Potential Variables in Multivariate Logistic Regression Model (Age, Sex, HCV Genotype, Baseline HCV RNA Level, Liver Cirrhosis Status, Child-Pugh Score, Treatment Regimen, Comorbidities, etc.);Incremental Cost-Effectiveness Ratio (ICER) in Pharmacoeconomic Evaluation; | — |
Countries
China
Contacts
Public ContactHu Peng
The 2nd Affiliated Hospital of Chongqing Medical University
Outcome results
None listed