Li Ming-Hui, Zhang Lu, Qu Xiao-Jing, Lu Yao, Shen Ge, Wu Shu-Ling, Chang Min, Liu Ru-Yu, Hu Lei-Ping, Li Zhen-Zhen, Hua Wen-Hao, Song Shu-Jing, Xie Yao
Liver Diseases Center, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China.
Clinical Test Center, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China.
Chin Med J (Engl). 2017 Mar 5;130(5):559-565. doi: 10.4103/0366-6999.200554.
Hepatitis B surface antigen (HBsAg) loss/seroconversion is considered to be the ideal endpoint of antiviral therapy and the ultimate treatment goal in chronic hepatitis B (CHB). This study aimed to assess the patterns of HBsAg kinetics in CHB patients who achieved HBsAg loss during the treatment of pegylated interferon (PEG-IFN) α-2a.
A total of 150 patients were enrolled, composing of 83 hepatitis B envelope antigen (HBeAg)-positive and 67 HBeAg-negative patients. Patients were treated with PEG-IFN α-2a180 μg/week until HBsAg loss/seroconversion was achieved, which occurred within 96 weeks. Serum hepatitis B virus deoxyribonucleic acid and serological indicators (HBsAg, anti-HBs, HBeAg, and anti-HBe) were determined before and every 3 months during PEG-IFN α-2a treatment. Biochemical markers and peripheral blood neutrophil and platelet counts were tested every 1-3 months.
Baseline HBsAg levels were 2.5 ± 1.3 log IU/ml, and decreased rapidly at 12 and 24 weeks by 48.3% and 88.3%, respectively. The mean time to HBsAg loss was 54.2 ± 30.4 weeks, though most patients needed extended treatment and 30.0% of HBsAg loss occurred during 72-96 weeks. Baseline HBsAg levels were significantly higher in HBeAg-positive patients (2.9 ± 1.1 log IU/ml) compared with HBeAg-negative patients (2.0 ± 1.3 log IU/ml; t = 4.733, P < 0.001), but the HBsAg kinetics were similar. Patients who achieved HBsAg loss within 48 weeks had significantly lower baseline HBsAg levels and had more rapid decline of HBsAg at 12 weeks compared to patients who needed extended treatment to achieve HBsAg loss.
Patients with lower baseline HBsAg levels and more rapid decline during early treatment with PEG-IFN are more likely to achieve HBsAg loss during 96 weeks of treatment, and extended therapy longer than 48 weeks may be required to achieve HBsAg loss.
乙肝表面抗原（HBsAg）消失/血清学转换被认为是抗病毒治疗的理想终点以及慢性乙型肝炎（CHB）的最终治疗目标。本研究旨在评估聚乙二醇干扰素（PEG-IFN）α-2a治疗期间实现HBsAg消失的CHB患者的HBsAg动力学模式。
共纳入150例患者，其中83例乙肝e抗原（HBeAg）阳性患者和67例HBeAg阴性患者。患者接受每周180μg的PEG-IFNα-2a治疗，直至实现HBsAg消失/血清学转换，该情况在96周内出现。在PEG-IFNα-2a治疗前及治疗期间每3个月测定血清乙肝病毒脱氧核糖核酸及血清学指标（HBsAg、抗-HBs、HBeAg和抗-HBe）。每1 - 3个月检测生化指标及外周血中性粒细胞和血小板计数。
基线HBsAg水平为2.5±1.3 log IU/ml，在第12周和第24周时迅速下降，分别下降了48.3%和88.3%。HBsAg消失的平均时间为54.2±30.4周，不过大多数患者需要延长治疗，30.0%的HBsAg消失发生在72 - 96周。与HBeAg阴性患者（2.0±1.3 log IU/ml；t = 4.733，P < 0.001）相比，HBeAg阳性患者的基线HBsAg水平显著更高（2.9±1.1 log IU/ml），但HBsAg动力学相似。与需要延长治疗以实现HBsAg消失的患者相比，在48周内实现HBsAg消失的患者基线HBsAg水平显著更低，且在第12周时HBsAg下降更快。
基线HBsAg水平较低且在PEG-IFN早期治疗期间下降更快的患者在96周治疗期间更有可能实现HBsAg消失，可能需要超过48周的延长治疗才能实现HBsAg消失。
