Hepatitis B surface antigen (HBsAg) clearance represents a clinical cure, although the clearance rate is extremely low. The aim of this study was to evaluate the feasibility and safety profiles of pegylated‐interferon α‐2a (PEG‐IFNα‐2a) as a therapeutic option for inactive HBsAg carriers. There were 144 inactive HBsAg carriers enrolled and divided into a therapeutic group (102 subjects) and a control group (42 subjects). PEG‐IFNα‐2a and PEG‐IFNα‐2a combined with adefovir dipivoxil were used for treatment group subjects with hepatitis B virus DNA <20 IU/mL and 20 IU/mL ≤ hepatitis B virus DNA < 2,000 IU/mL, respectively. Total therapy duration was no more than 96 weeks. HBsAg clearance and seroconversion rates at therapeutic weeks 48 and 96 were used to evaluate the therapeutic efficacy. Per protocol analysis showed that the HBsAg clearance rate and seroconversion rate in the treatment group were 29.8% and 20.2% at week 48 and increased to 44.7% and 38.3% at week 96, respectively. However, the HBsAg clearance rate in the control group was 2.4% at weeks 48 and 96, and no subject achieved seroconversion. The quantitative HBsAg levels and changes during the early period of treatment (at week 12 and week 24) as well as the alanine aminotransferase elevation at week 12 were strong predictors of HBsAg clearance. The adverse events were similar to those with treatment for chronic hepatitis B patients. Conclusion: High rates of HBsAg clearance and seroconversion could be achieved by PEG‐IFNα‐2a‐based treatments and the treatments were relatively safe for inactive HBsAg carriers. (Hepatology 2017;66:1058‐1066).

中文翻译：

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聚乙二醇化干扰素α治疗乙型肝炎表面抗原非活性携带者的强效乙型肝炎表面抗原反应

乙型肝炎表面抗原 (HBsAg) 清除代表临床治愈，尽管清除率极低。本研究的目的是评估聚乙二醇化干扰素 α-2a（PEG-IFNα-2a）作为非活动性 HBsAg 携带者治疗选择的可行性和安全性。招募了 144 名非活动性 HBsAg 携带者，并分为治疗组（102 名受试者）和对照组（42 名受试者）。PEG-IFNα-2a和PEG-IFNα-2a联合阿德福韦酯分别用于乙肝病毒DNA<20IU/mL和20IU/mL≤乙肝病毒DNA<2000IU/mL的治疗组受试者。总治疗时间不超过 96 周。使用治疗第 48 周和第 96 周的 HBsAg 清除率和血清转换率来评估治疗效果。根据方案分析显示，治疗组的 HBsAg 清除率和血清转换率在第 48 周分别为 29.8% 和 20.2%，在第 96 周分别增加到 44.7% 和 38.3%。然而，在第 48 周和第 96 周，对照组的 HBsAg 清除率为 2.4%，并且没有受试者实现血清转换。治疗早期（第 12 周和第 24 周）的定量 HBsAg 水平和变化以及第 12 周的丙氨酸转氨酶升高是 HBsAg 清除的强预测因子。不良事件与慢性乙型肝炎患者的治疗相似。结论：基于 PEG-IFNα-2a 的治疗可以实现高 HBsAg 清除率和血清转换率，并且这些治疗对非活动性 HBsAg 携带者相对安全。（肝病学 2017；66：1058-1066）。