{
  "abstract": "Introduction The functional cure of chronic hepatitis B (CHB) is an ideal goal of therapy, as it is associated with improved long-term outcomes. Patients with low levels of HBsAg have higher rates of functional cure by pegylated interferon α (PEG-IFNα) therapy, and similar results have been observed in patients treated with PD-1 antibody. However, the combination therapy of PD-1 antibody and PEG-IFNα for promoting functional cure has not been studied. This study protocol aims to evaluate the efficacy and safety of a novel combined strategy, PD-1 antibody combined with PEG-IFNα therapy, in nucleos(t)ide analogues (NAs)-treated CHB patients.Methods and analysis This is a prospective, multicentre, open-label, randomised controlled study. Virologically suppressed CHB patients by NAs therapy will be recruited and randomised into PEG-IFNα group, PD-1 antibody group or PD-1 antibody combined PEG-IFNα group. PD-1 antibody will be injected intravenously once per 3 weeks for 24 weeks, and PEG-IFNα will be injected subcutaneously once a week for 48 weeks. The primary outcomes are the rate of HBsAg loss at 24 weeks. For safety analysis, adverse events in different groups will be compared.Ethics and dissemination This study has been approved by the Ethics Committee of the Fifth Medical Center of the Chinese PLA General Hospital (KY-2023-12-86-3). All results of the study will be submitted to a peer-reviewed journal.Trial registration number NCT06357806.",
  "authors": [
    {
      "affiliations": [
        "The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, China",
        "Senior Department of lnfectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China"
      ],
      "name": "Hongmin Wang"
    },
    {
      "affiliations": [
        "Shandong Public Health Clinical Center, Jinan, China"
      ],
      "name": "Xiaoying Li"
    },
    {
      "affiliations": [
        "First Department of Liver Disease, Beijing You’an Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Junfeng Lu"
    },
    {
      "affiliations": [
        "Senior Department of lnfectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China"
      ],
      "name": "Xin Zhang"
    },
    {
      "affiliations": [
        "Department of Hepatology and Infectious Diseases, Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China"
      ],
      "name": "Shuangsuo Dang"
    },
    {
      "affiliations": [
        "Department of Hepatology and Infectious Diseases, Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China"
      ],
      "name": "Yaping Li"
    },
    {
      "affiliations": [
        "Department of Infectious Diseases, First Teaching Hospital, SOM, Xi’an JiaoTong University, Xi’an, China"
      ],
      "name": "Yingli He"
    },
    {
      "affiliations": [
        "Deparment of Hepatology, The Third People’s Hospital of Taiyuan, Taiyuan, China"
      ],
      "name": "Ying Guo"
    },
    {
      "affiliations": [
        "Shandong Public Health Clinical Center, Jinan, China"
      ],
      "name": "Jiaojiao Wang"
    },
    {
      "affiliations": [
        "Hotan District Infectious Disease Specialist Hospital, Hetian, China"
      ],
      "name": "Wubuliaishan Maimaitijiang"
    },
    {
      "affiliations": [
        "First Department of Liver Disease, Beijing You’an Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Sujun Zheng"
    },
    {
      "affiliations": [
        "First Department of Liver Disease, Beijing You’an Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Shan Ren"
    },
    {
      "affiliations": [
        "The Fourth People’s Hospital of Qinghai Province, Xining, China"
      ],
      "name": "Haifang Cao"
    },
    {
      "affiliations": [
        "Hepatobiliary Center, Gansu Wuwei Tumour Hospital, Wuwei, China"
      ],
      "name": "Wenhua Zhang"
    },
    {
      "affiliations": [
        "Senior Department of lnfectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China"
      ],
      "name": "Xiaoning Zhang"
    },
    {
      "affiliations": [
        "Senior Department of lnfectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China"
      ],
      "name": "Hecheng Ma"
    },
    {
      "affiliations": [
        "The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, China",
        "Senior Department of lnfectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China"
      ],
      "name": "Fu-Sheng Wang"
    },
    {
      "affiliations": [
        "Senior Department of lnfectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China"
      ],
      "name": "Junliang Fu"
    }
  ],
  "title": "Safety and efficacy of PD-1 antibody combined with pegylated interferon α for functional cure in nucleos(t)ide analogues-suppressed chronic hepatitis B patients: protocol for a multicentre randomised controlled trial",
  "uid": "3bc18ace-c93b-5afb-8720-8e2e9abbeb5f"
}