Several studies have showed that combining peg-interferon alpha (Peg-IFN alpha) with nucleotide analogues has complementary effects in chronic hepatitis B (CHB), but the optimal regimen and potential mechanisms remain unclear. This was a prospective, longitudinal and multicentre clinical trial (NCT03013556). HBeAg-positive CHB naive patients were randomly assigned to three groups: tenofovir disoproxil fumarate (TDF) monotherapy for 96 weeks, TDF alone for 48 weeks and sequentially Peg-IFN alpha added for 48 weeks, TDF de novo combination with Peg-IFN alpha for 48 weeks then TDF alone for 48 weeks. The primary endpoint was HBeAg seroconversion at week 96 and HBsAg loss as the secondary endpoint. Furthermore, the levels of 12 cytokines in serum were assessed at different time points. A total of 133 patients were included in the analysis. The rates of HBeAg seroconversion at 96 weeks were not significant different among the three groups (p = 0.157). Interestingly, patients in the Peg-IFN alpha add-on group showed markedly lower HBsAg level compared with the other two groups at week 96. In addition, only three patients in the Peg-IFN alpha add-on group achieved HBsAg loss. For the following 24 weeks from week 96, no HBsAg reappearance in the three patients and no new patients with HBsAg loss were observed in the three groups. Serum cytokine analysis showed that the baseline level of interferon-inducible protein-10 (IP-10) was strongly higher in HBeAg conversion patients and HBsAg loss patients. Compared with de novo combination and TDF alone, the addition of Peg-IFN alpha in TDF-treated group might be an effective strategy for HBsAg loss in HBeAg-positive CHB naive patients.
基金:
Grant of Shanghai Shen Kang Hospital Center [SHDC12016101]; International Cooperation Grant of Shanghai Scientific and Technology Committee [16410711900]; National Nature Science Grant [81672069]; National Key Grant [2017ZX10202202, 2018ZX10302204-001-003]; Electronic Data Capture System
第一作者机构:[1]Shanghai Jiao Tong Univ, Sch Med, Ruijin Hosp, Dept Infect Dis,Res Lab Clin Virol, 197 Ruijin Second Rd, Shanghai 200025, Peoples R China
共同第一作者:
通讯作者:
通讯机构:[1]Shanghai Jiao Tong Univ, Sch Med, Ruijin Hosp, Dept Infect Dis,Res Lab Clin Virol, 197 Ruijin Second Rd, Shanghai 200025, Peoples R China[8]Fudan Univ, Huashan Hosp, Dept Infect Dis, 12 Middle Wulumuqi Rd, Shanghai 200032, Peoples R China[9]Shanghai Jiao Tong Univ, Sch Med, Ruijin Hosp, Sino French Res Ctr Life Sci & Genom, Shanghai, Peoples R China[*1]Department of Infectious Diseases, Research Laboratory of Clinical Virology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, NO.197 Ruijin Second Road, Shanghai, 200025, China.[*2]Department of Infectious Diseases, Huashan Hospital, Fudan University, 12 Middle Wulumuqi Road, Jing'an, Shanghai, 200032, China
推荐引用方式(GB/T 7714):
Li Jing,Qu Lihong,Sun Xuehua,et al.Peg-interferon alpha add-on Tenofovir disoproxil fumarate achieved more HBsAg loss in HBeAg-positive chronic hepatitis B naive patients[J].JOURNAL OF VIRAL HEPATITIS.2021,28(10):1381-1391.doi:10.1111/jvh.13571.
APA:
Li, Jing,Qu, Lihong,Sun, Xuehua,Liu, Yanhong,Gong, Qiming...&Zhang, Xinxin.(2021).Peg-interferon alpha add-on Tenofovir disoproxil fumarate achieved more HBsAg loss in HBeAg-positive chronic hepatitis B naive patients.JOURNAL OF VIRAL HEPATITIS,28,(10)
MLA:
Li, Jing,et al."Peg-interferon alpha add-on Tenofovir disoproxil fumarate achieved more HBsAg loss in HBeAg-positive chronic hepatitis B naive patients".JOURNAL OF VIRAL HEPATITIS 28..10(2021):1381-1391