Treatment-na?ve genotype 1-6 HCV/HBV co-infection adult patients with or without compensated cirrhosis in China
Conditions
Interventions
Group 1:12-week SOF/VEL regimen combined with prophylactic use of TAF
Group 2:12-week SOF/VEL regimen combined with prophylactic use of TAF
Sponsors
The First Hospital of Peking University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria in order to be eligible for this study. 1. Patients willing and able to provide written informed consent; 2. Male or female patients, aged >= 18 years; 3. Patients with weight >= 40kg; 4. HCV RNA positive (> 15 IU / ml) patients were screened; 5. Patients with chronic HBV / HCV infection (>= 6 months) confirmed by previous medical history or liver biopsy should meet one of the following conditions: (1) Non cirrhosis: if HBeAg is positive, HBV DNA should be 14.6kpa. (if the results of FibroScan or fibrotouch are inconsistent with those of abdominal ultrasound, CT and MRI, the results of ultrasound, CT and MRI shall prevail.) 6. CHC subjects who are newly treated are defined as those who have never been exposed to approved or experimental HCV specific direct antiviral drugs, or who have previously used interferon or ribavirin to treat HCV; 7. At the time of screening, individuals should not be or need to receive antiviral treatment for HBV. For participants with a history of HBV treatment, the most recent treatment must be completed at least 6 months prior to the visit on day 1; 8. Patients with HBsAg positive for at least 6 months; 9. Only cirrhotic subjects need to carry out liver imaging examination within 6 months from the first day to exclude patients with HCC; 10. The serum pregnancy test of fertile women must be negative during the screening, and the urine pregnancy test of the day before entering the group must be negative; 11. Male / female subjects with fertility and heterosexual partners must agree to take contraceptive measures; 12. The subjects must be able to follow the dosage instructions of the study drug and be able to complete the study; 13. Drug compliance was 80% - 120%. Compliance of medication = total amount of actual medication / dosage to be taken x 100%. Compliance is classified as 120%, 80% - 120% is good.
Exclusion criteria
Exclusion criteria: Subjects who met any of the following exclusion criteria were excluded from the study. 1. Patients who used any direct antiviral drugs before screening, including NS3 / 4A inhibitors, NS5A inhibitors or NS5B polymerase inhibitors; 2. Patients who received antiviral treatment of hepatitis B within 6 months; 3. Patients diagnosed as primary liver cancer or supported by the following evidence: AFP 100ng / ml or liver imaging showed suspicious nodules in the liver; 4. To screen the patients who have the history of malignant tumor in the previous 5 years, except for the specific cancer (such as basal cell skin cancer) cured by surgical resection, or the patients suspected of having malignant tumor; 5. Patients with evidence of current or past decompensation of liver function, including but not limited to: child Pugh grade B or C, ascites or encephalopathy, variceal bleeding or the use of diuretics to treat ascites; 6. Patients with present or past history of major diseases may interfere with personal treatment, evaluation or compliance. Major diseases are 25 major diseases specified by CIRC; (1) Clinically significant diseases (except HBV, HCV) or any other major diseases that may interfere with the treatment, evaluation or program compliance of subjects; subjects currently undergoing the evaluation of potentially clinically significant diseases (except HBV, HCV) are also excluded; (2) Gastrointestinal diseases or postoperative conditions may interfere with the absorption of the study drug; (3) Difficulty in blood collection and / or poor venous access during blood collection; (4) Solid organ transplantation, bone marrow transplantation; (5) Severe lung disease, heart disease or porphyria; (6) Psychiatric hospitalization, attempted suicide and / or temporary disability due to mental illness in the past 5 years. Psychotic subjects who were well controlled or did not need medication within the 12 months before day 1 (there was no condition mentioned above) could be included in the study; (7) Severe drug allergy (such as allergic reaction or hepatotoxicity). 7. Pregnant or lactating women; 8. Patients infected with HIV or HDV; 9. Patients with clinically significant abnormality indicated by ECG screening; 10. The following laboratory test parameters were abnormal during screening: (1) ALT > 10 x upper normal (ULN) (2) AST > 10 ULN (3) Direct bilirubin > 1.5 ULN (4) Platelet 8.5% (6) EGFR 1.5 x ULN, unless the subject is known to have hemophilia or INR is affected by anticoagulant therapy; 11. Patients with chronic liver diseases (such as hemochromatosis, hepatolenticular degeneration, a - 1 antitrypsin deficiency, cholangitis) other than HCV related liver diseases; 12. Subjects who were not considered suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HCV RNA; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBV DNA; | — |
Countries
China
Contacts
Public ContactXiaoyuan Xu
The First Hospital of Peking University
Outcome results
None listed