The Efficacy and Safety of 12-week SOF/VEL Regimen Combined With Prophylactic Use of TAF for Treatment-naïve Genotype 1-6 HCV/HBV Co-infection Adult Patients With or Without Compensated Cirrhosis in China
BDTAF
1 other identifier
interventional
120
1 country
1
Brief Summary
Subjects can be classified into two groups, Group 1 include non-cirrhotic patients, Group 2 include cirrhotic patients. All the patients will be received prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. In total, Group 1 patients will be discontinued TAF once daily therapy at the end of week 28 if no HBV reactivation occurs during treatment , Group 2 patients will be received TAF once daily for 64 weeks. In this study, after week 64, Group 2 patients will continue NUC treatment but pay by themselves. For those who is GT3 cirrhosis patients, RBV added simultaneously with SOF/VEL for 12 weeks. For patients weighing \< 75 kg, the dose is 500 mg twice; for patients weighing ≥ 75 kg, the dose is 600 mg twice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2021
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedFirst Posted
Study publicly available on registry
August 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedAugust 9, 2021
August 1, 2021
2.3 years
July 13, 2021
August 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To evaluate the efficacy of treatment with SOF/VEL for 12 weeks in subjects with GT1-6 HCV/HBV co-infection as measured by the proportion of subjects with SVR.
hepatitis C virus is a chronic viral hepatitis caused by hepatitis C virus infection in the human body, it belongs to the liver virus, after the invasion of the human body, mainly into the human liver, can lead to chronic hepatitis
The first group of patients was evaluated from 16 weeks to 28 weeks（for 12 weeks）
To evaluate the efficacy of treatment with SOF/VEL for 12 weeks in subjects with GT1-6 HCV/HBV co-infection as measured by the proportion of subjects with SVR.
hepatitis C virus is a chronic viral hepatitis caused by hepatitis C virus infection in the human body, it belongs to the liver virus, after the invasion of the human body, mainly into the human liver, can lead to chronic hepatitis
The second group of patients was evaluated from 16 weeks to 28 weeks（for 12 weeks）
Secondary Outcomes (5)
To evaluate the proportion of subjects with HBV reactivation during the treatment and after cessation of treatment
From the commencement of SOF/VEL treatment(week 4) to week 64.
To evaluate the proportion of subjects with virologic failure (virological breakthrough/ viral relapse)of HCV
The first group of patients was evaluated at week 16 to week 28
To evaluate the proportion of subjects with virologic failure (virological breakthrough/ viral relapse)of HCV
The second group of patients was evaluated at week 16 to week 64
To evaluate the proportion of subjects with virologic failure (virological breakthrough/ viral relapse)of HBV
The first group of patients was evaluated at week 4 to week 28
To evaluate the proportion of subjects with virologic failure (virological breakthrough/ viral relapse)of HBV
The second group of patients was evaluated at week 4 to week 64
Study Arms (2)
non-cirrhotic patients
EXPERIMENTALpatients will be discontinued TAF once daily therapy at the end of week 28 if no HBV reactivation occurs during treatment
cirrhotic patients
OTHERpatients will be received TAF once daily for 64 weeks. In this study, after week 64, and patients will continue NUC treatment but pay by themselves.
Interventions
All the patients will use prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. Group 1 patients will be discontinued TAF once daily therapy at the end of week 28 if no HBV reactivation occurs during treatment .
All the patients will use prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. Group 2 patients will be received TAF once daily for 64 weeks. In this study, after week 64.
Eligibility Criteria
You may qualify if:
- Willing and able to provide written informed consent
- Male or female, age≥18 years
- Bodyweight≥40 kg
- HCV RNA positive (15 IU/mL )at Screening
- HCV genotype 1, 2, 3, 4, 5, 6, or indeterminate as assessed at Screening by the Central Laboratory
- Chronic HBV/HCV coinfection (≥ 6 months) documented by prior medical history or liver biopsy. For non-cirrhotic patients, and for HBeAg positive patients, HBV DNA\<20000IU/ml. For HBeAg negative patients, HBV DNA\<2000IU/ml.
- For cirrhosis patients, HBV DNA was dectable or undectable. Cirrhosis Determination (approximately 20% of subjects may have cirrhosis)
- Cirrhosis by B Ultrasound/CT/ MRI.
- Cirrhosis is defined as Fibroscan® with a result of ≥ 17.5 kPa
- Absence of cirrhosis is defined as Fibroscan with a result of \<10.6 kPa within ≤ 6 months of Day 1
- Classification as treatment naïve for CHC patients Treatment naïve is defined as having never been exposed to approved or experimental HCV-specific direct-acting antiviral agents or prior treatment of HCV with interferon or ribavirin
- Individuals must not be taking or requiring treatment with HBV antiviral therapy at screening. For participants that are HBV treatment experienced, the most recent treatment must have been completed at least 6 months prior to Day 1.
- Patients with HBsAg positive as least 6 month without decompensated cirrhosis.
- Liver imaging within 6 months of Day 1 is required in cirrhotic patients only to exclude hepatocellular carcinoma (HCC)
- Females of childbearing potential (as defined in Appendix 4) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 prior to enrollment
- +4 more criteria
You may not qualify if:
- Any direct antiviral drugs (DAAs) used before screening, including non-structural proteins NS3/4A inhibitor, NS5A inhibitor or NS5B polymerase inhibitor.
- Patients who received hepatitis B antiviral therapy within 6 months.
- Diagnosis of primary liver cancer or support for the following evidence: alpha-fetoprotein (AFP) \>100 ng/ml or cirrhosis imaging studies of the liver revealed suspicious nodules in the liver
- A history of malignant tumors within 5 years prior to screening, except for specific cancers that have been cured by surgical resection (eg.Basal cell skin cancer, etc.), or patients suspected of having malignant tumors
- Current or previous evidence of liver decompensation, including but not limited to: Child-Pugh score Grade B or C, ascites, or hepatic encephalopathy, variceal bleeding or diuretics for the treatment of ascites.
- A current or previous history of a major medical condition or any other major medical disorder that may interfere with the individual's treatment, assessment or compliance program.
- Clinically significant disease (except HBV, HCV) or any other major disease that may interfere with subject treatment, assessment, or protocol compliance; subjects that are currently undergoing assessment of a potentially clinically significant disease (except HBV，HCV) are also excluded.
- Gastrointestinal disease, or the condition after surgery may interfere with the absorption of the study drug.
- Difficulty in collecting blood and/or poor venous access for blood collection.
- Solid organ transplantation.
- Severe lung disease, severe heart disease or porphyria.
- Psychiatric hospitalization, attempted suicide and/or a period of disability due to mental illness in the past 5 years. Subjects with psychiatric illness (without previously mentioned conditions) who are well-controlled or who have not needed medication for the past 12 months before Day 1 may Will be included in the study.
- Serious drug allergies (such as allergic reactions or hepatotoxicity).
- Pregnant or lactating women.
- HIV or HDV infection.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
July 13, 2021
First Posted
August 9, 2021
Study Start
August 1, 2021
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
August 9, 2021
Record last verified: 2021-08