机构:[1]Sun Yat Sen Univ, Affiliated Hosp 1, Guangzhou, Peoples R China中山大学附属第一医院[2]Sichuan Univ, West China Hosp, Chengdu, Peoples R China四川大学华西医院[3]Guangzhou Eighth Peoples Hosp, Guangzhou, Peoples R China[4]Publ Hlth Clin Ctr Chengdu, Chengdu, Peoples R China[5]Chongqing Med Univ, Affiliated Hosp 2, Chongqing, Peoples R China[6]First Peoples Hosp Yunnan Prov, Kunming, Yunnan, Peoples R China云南省第一人民医院[7]Sir Run Run Shaw Hosp, Hangzhou, Peoples R China[8]Brii Biosci, Shanghai, Peoples R China[9]Brii Biosci, Beijing, Peoples R China
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摘要:
Background and aims: BRII-179, a novel therapeutic vaccine
comprised of PreS1, PreS2 and S hepatitis B virus (HBV) surface
antigens that can induce functional HBV specific B-cell and T-cell
immune responses is currently under evaluation in a randomized,
double-blind, placebo-controlled phase 2a study in China. In the
previous interim analyses, BRII-179 as an add-on therapy in patients
with chronic hepatitis B (CHB) receiving Peginterferon alfa (PEG) and
nucleos (t)ide reverse transcriptase inhibitors (NRTI) therapy
improved HBsAg loss at end-of-treatment (EOT) (Primary end
point, 26.3% vs. 19.3% in full analysis set [FAS]) and the numerical
difference maintained through 24-week post EOT. Besides, HBsAb
≥10 IU/L was strongly associated with sustained HBsAg loss at 12
weeks and 24 weeks post EOT.