China DAA Initial treatment gene 3 type B compensatory cirrhosis chronic c hepatitis
Conditions
Interventions
The treatment group 1:sofosbuvir 400 mg + velpatasvir 100mg + ribavirin 1000 mg/1200 mg
The treatment group 2:sofosbuvir 400 mg + velpatasvir 100 mg + voxilaprevir 100 mg
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent; 2. Male or female, aged >= 18 years; 3. Body mass index (BMI) between 18.0-35.0 kg/m2 and bodyweight 40 kg; 4. Chronic HCV infection (>= 6 months) documented by prior medical history or liver biopsy; 5. Anti-HCV positive at screening; 6. HCV RNA 104 IU/mL at screening by the Central Laboratory; 7. HCV genotype 3b assessed at screening by the Central Laboratory; 8. DAA treatment nave defined as having never been exposed to approved or experimental HCV-specific direct-acting antiviral agents; Pegylated interferon/interferon based prior treatment is allowed; 9. Cirrhosis Determination: cirrhosis is defined as any one of the following: (1) Liver biopsy showing cirrhosis (e.g., Metavir score = 4 or Ishak score >= 5) in 24 months before screening, or; (2) Fibroscan with a result of >12.5 kPa in 6 months before screening; 10. The lab test at screening should meet all the criterion below: (1) ALT = 60,000/mL; (5) Neutrophile >= 1,500/mL; (6) HbA1c = 60 mL /min as calculated by the Cockcroft-Gault equation; (8) Hemoglobin >= 11 g/dL for female subjects; >= 12 g/dL for male subjects; (9) Albumin >= 3 g/dL; (10) INR <= 1.7 x ULN; (11) AFP < 100ng/mLif 20 ng/mL <= AFP <= 100 ng/mL, HCC should be exclude by liver ultrasound; 11. Females of childbearing potential must have a negative serum pregnancy test at screening; 12. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception; 13. Male subjects must agree to avoid donating sperm in 6 months after the last dose of drug; 14. Subject must be of generally good health, with the exception of chronic HCV infection, as determined by the investigator; 15. Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
Exclusion criteria
Exclusion criteria: 1. Decompensated cirrhosis, including but not limited to: prior or current ascites, variceal hemorrhage and/or hepatic encephalopathy; prior or current Child-Pugh B or C; 2. HBsAg posititve at screening; 3. Anti-HIV positive at screening; 4. Alcohol abuse; 5. Contraindication of ribavirin, including but not limited to hemoglobinapathy; 6. Pregnant or nursing female or male with pregnant female partner; 7. Use of any prohibited concomitant medications as described in Section before screening; 8. Known hypersensitivity to SOF, VEL, RBV or formulation excipients; 9. Subjects who has any of the following history: (1) Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilsons disease, alfa-1 antitrypsin deficiency, cholangitis); (2) Solid organ transplantation; (3) Significant pulmonary disease, significant cardiac disease or porphyria; (4) Pancreatitis; (5) Autoimmune diseases (e.g., systemic lupus erythematosus, sarcoidosis, psoriasis); (6) Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years. (7) Malignancy within the 5 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are not eligible; (8) Significant drug allergy (such as anaphylaxis or hepatotoxicity); 10. Assessed as ineligible by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained viral response achieved at 12 weeks (SVR12) (defined as HCV RNA below the lower quantitation limit); | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of solfosbuvir/vipatavir in combination with ribavirin or solfosbuvir/vipatavir/vosireivir; To evaluate the proportion of subjects who achieved sustained viral response (SVR12 and SVR24) at 12 and 24 weeks after completion of treatment;Evaluate the proportion of subjects who achieved "HCV RNA below the quantification lower limit" during treatment;To evaluate the proportion of subjects who achieved "HCV RNA undetected" during and after treatment;Evaluate the proportion of subjects who experienced virological failure (including breakthrough and rebound) during treatment and relapse after treatment; | — |
Countries
China
Contacts
Public ContactHuiying Rao
Peking University People's Hospital
Outcome results
None listed