Studies have shown that chronic hepatitis B patients with low levels of HBsAg after nucleos(t)ide analog therapy have a higher chance of functional cure with sequential or combined pegylated interferon therapy, with about 30-50% of patients achieving HBsAg clearance and discontinuing therapy. There are some clinical practices on the long-term benefits of discontinuing antiviral therapy, but there is a lack of evidence-based clinical studies, especially on the relapse rate, duration of relapse, and factors influencing relapse after achieving functional cure. Furthermore, there is no guideline or expert consensus on the follow-up management strategy for patients who haven't achieved functional cure but whose HBsAg levels have been substantially reduced by treatment and are at low levels. Therefore, this study is planned to enroll participants who have completed the TB1901IFN to evaluate the long-term benefit of Peginterferon in combination with tenofovir disoproxil fumarate(TDF) and relapse in patients who have achieved functional cure, for participant with low-level HBsAg at the end of treatment, peginterferon combined with tenofovir alafenamide fumarate (TAF)therapy will be administered to explore the efficacy and safety of starting treatment after a period of drug discontinuation. Participants will be divided into 3 cohorts based on functional achievement and/or HBsAg levels after completion of TB1901IFN
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
Peginterferon α-2b Injection, subcutaneous injection, once a week. Tenofovir Alafenamide Fumarate, Oral administration, once a day.
Peking University First Hospital
Beijing, China
Beijing Youan Hospital, Capital Medical University
Beijing, China
The fifth medical center of PLA General Hospital
Beijing, China
The Second Xiangya Hospital of Central South University
Changsha, China
Xiangya Hospital Central South University
Changsha, China
The incidence of Hepatocellular Carcinoma(HCC).
Time frame: 5 years after the completion of the TB1901IFN study.
The incidence all-cause mortality.
Time frame: 5 years after the completion of the TB1901IFN study.
Relapse within 5 years of discontinuation in participants who achieved functional cure.
Relapse was defined as the occurrence of two consecutive time, interval greater than one month, HBsAg≥0.05 IU/ml at any time during the follow-up period
Time frame: 5 years after the completion of the TB1901IFN study.
Rate of functional cure of re-initiation of combination therapy after discontinued for more than 24 weeks in participants who had a favorable outcome on prior therapy and obtained low levels of S antigen.
Time frame: After completing the 72-week combined re-treatment.
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Public Health Clinical Center of Chengdu
Chengdu, China
Sichuan Provincial People's Hospital
Chengdu, China
Mengchao Hepatobiliary Hosipital of Fujian Medical University
Fuzhou, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Guangzhou Eighth People's Hospital
Guangzhou, China
...and 20 more locations