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Sequential combination therapy with interferon, interleukin-2 and therapeutic vaccine in entecavir-suppressed chronic hepatitis B patients: the Endeavor study
Authors
Authors and affiliations
Di WuPeng WangMeifang HanYongping ChenXinyue ChenQi XiaWeiming YanXiaoyang WanChuanlong ZhuQing XieJiaji JiangLai WeiDeming TanXiaoguang DouYanyan Yu
Di Wu
1
Peng Wang
1
Meifang Han
1
Yongping Chen
2
Xinyue Chen
3
Qi Xia
4
Weiming Yan
1
Xiaoyang Wan
1
Chuanlong Zhu
5
Qing Xie
6
Jiaji Jiang
7
Lai Wei
8
Deming Tan
9
Xiaoguang Dou
10
Yanyan Yu
11
Jinlin Hou
12
Xiaoping Luo
13
Qin Ning
1Email authorView author's OrcID profile
1.Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanChina
2.Department of Infectious DiseaseThe First Affiliated Hospital of Wenzhou Medical UniversityWenzhouChina
3.International Medical Department, Beijing You’an HospitalCapital Medical UniversityBeijingChina
4.State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, School of MedicineZhejiang UniversityHangzhouChina
5.Department of Infectious Disease, Anhui Provincial HospitalAnhui Medical UniversityHefeiChina
6.Department of Infectious Diseases, Shanghai Ruijin HospitalJiaotong University School of MedicineShanghaiChina
7.Liver Research CenterFirst Affiliated Hospital of Fujian Medical UniversityFuzhouChina
8.Department of HepatologyPeking University People’s HospitalBeijingChina
9.Department of Infectious Diseases, Xiangya HospitalCentral South UniversityChangshaChina
10.Department of Infectious DiseaseShengjing Hospital of China Medical UniversityShenyangChina
11.Department of Infectious DiseasesPeking University First HospitalBeijingChina
12.Department of Infectious Diseases, Nanfang HospitalSouthern Medical UniversityGuangzhouChina
13.Department of Pediatrics, Tongji Hospital, Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanChina
Original Article
First Online: 06 June 2019
135 Downloads
Abstract
Background
Switching from nucleos(t)ide analogues to interferon (IFN) improves hepatitis B surface antigen (HBsAg) loss. We aimed to evaluate whether combining immunomodulators such as interleukin-2 (IL-2) and therapeutic vaccine with IFN enhances HBsAg loss in entecavir (ETV)-suppressed patients.
Methods
Ninety-four patients exhibiting virological suppression and hepatitis B e antigen (HBeAg) loss following ETV treatment were randomized 1:1:1 to receive ETV (group I) or IFN (group II) for 48 weeks, or IFN and vaccine for 48 weeks plus IL-2 for 12 weeks (group III). The primary endpoint was HBsAg loss at week 48. Peripheral natural killer (NK) cells and regulatory T cells (Treg) were measured as immune checkpoint indicators.
Results
Mean HBsAg decline at week 48 was significantly greater in group III (0.85 log 10 IU/mL) and group II (0.74 log 10 IU/mL), than in group I (0.13 log 10 IU/mL). At week 48, 9.38%, 3.03%, and 3.70% of subjects in group III, II, and I, respectively, achieved HBsAg loss. Among patients with baseline HBsAg titers ranging from 100 to 1500 IU/mL, HBsAg loss rate was 27.3, 7.1, and 0% in group III, II, and I, respectively. Responders in group III showed a significantly higher increase in CD56bright CD16−NK cells from week 24 to 36, and a significant decline in Treg from week 12 to 24 than non-responders.
Conclusion
For ETV-suppressed patients, particularly those with low baseline HBsAg levels, combination therapy with IFN and other immunomodulators may enhance HBsAg loss, while successful response correlates with partial restoration of NK cells and Tregs.
Keywords
Hepatitis B surface antigen loss Interferon Entecavir Combination therapy |
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发表于 2019-9-18 17:27
