葛兰素史克的反义寡核苷酸药物贝普若韦生于2026年8月24日获得日本厚生劳动省批准，成为全球首个获批的慢性乙肝功能性治愈疗法 1。该药物通过抑制乙肝病毒DNA复制和HBsAg水平，刺激免疫系统产生持久应答，使患者有望在停止治疗后实现病毒学控制 1。根据定义，功能性治愈是指停止治疗后，血清乙肝表面抗原（HBsAg）在至少24周内无法检测到 1。
贝普若韦生适用于既往接受至少6个月核苷（酸）类似物治疗且HBsAg≤3000 IU/mL的成人慢性乙肝患者 1。临床试验表明，6个月疗程后，总体人群在72周时的功能性治愈率达19%，而HBsAg≤1000 IU/mL的亚组治愈率则升至26% 1。这一突破具有重要的全球公共卫生意义——根据2024年数据，全球约有慢性乙肝病毒感染者2.4亿，乙肝相关死亡约110万 1。该药物的上市标志着乙肝治疗从长期病毒抑制迈向功能性治愈的新阶段 1。
GlaxoSmithKline's antisense oligonucleotide drug bepirovirsen received approval from Japan's Ministry of Health, Labour and Welfare on August 24, 2026, marking the first globally approved therapy for functional cure of chronic hepatitis B 1. The medication works by suppressing hepatitis B virus DNA replication and hepatitis B surface antigen (HBsAg) levels while stimulating a sustained immune response, enabling some patients to achieve undetectable HBsAg after stopping treatment 1.
The drug is indicated for adults with chronic hepatitis B who have received at least six months of prior nucleos(t)ide analog treatment with HBsAg levels of 3,000 IU/mL or lower 1. After a six-month treatment course, the overall population demonstrated a 72-week functional cure rate of 19%, which increased to 26% among patients with HBsAg levels of 1,000 IU/mL or below 1. Functional cure is defined as the inability to detect serum HBsAg for at least 24 weeks after treatment cessation 1.
This development addresses a significant global health challenge. Approximately 240 million people worldwide were living with chronic hepatitis B virus infection in 2024, with an estimated 1.1 million hepatitis B-related deaths occurring annually 1. The approval represents a shift in hepatitis B treatment from long-term viral suppression toward the possibility of sustained remission without continuous medication.
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