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Acceptance and Factors Associated With Participation in functional cure–Related Trials Among People Living With HIV: A Cross-sectional Study in Southern China

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Infectious Microbes & Diseases 2024年第1期6卷 11-19页

作者： Zhaomin Deng Minjuan Shi Yue Yuan GuangjinCao Chunyan Wen Lijuan Chen Xueying Fan Linan Wu Jianhui Yuan Huachun Zou Linghua Li Caijun Sun School of Public Health(Shenzhen) Shenzhen Campus of Sun Yat-sen UniversityShenzhenChina Department of Diseases Control Panyu District Center for Disease Control and PreventionGuangzhouChina Infectious Disease Center Guangzhou Eighth People's HospitalGuangzhou Medical UniversityGuangzhouChina Nanshan District Center for Disease Control and Prevention ShenzhenChina Key Laboratory of Tropical Disease Control(Sun Yat-sen University) Ministry of EducationGuangzhouChina

HIV remains a global health challenge,and research efforts directed towards a functional cure require people living with HIV(PLHIV)in-volvement in clinical trials.Our study assessed willingness to participate in HIV functional cure–related clinical trials and associated factors among PLHIV in Guangzhou,China,using a questionnaire survey approach.We analyzed responses from 718 questionnaires,finding that 71.2%were willing to participate in Phase Ⅲtrials,while 51.7%were willing to participate in Phase I trials and 42.9%expressed acceptability for analytic treatment interruption.Multivariate logistic regression demonstrated that male PLHIV,those with awareness of functional cure,and PLHIV,who had been on antiretroviral therapy(ART)for less than 1 year,were more willing to partic-ipate in Phase Ⅲtrials.Those with a body mass index greater than 24,and those without resistance to ART drug were more willing to participate in Phase I trials.The major motivations for participation in Phase Ⅲtrials were access to cutting-edge treatments(62.6%)and supporting research(55.3%).Safety was the main concern contributing to hesitancy.Our study revealed a high willingness to participate in HIV functional cure–related trials among PLHIV in Guangzhou,China,and willingness varied across different trial phases and was influenced by multiple factors.This study provides valuable references for future clinical trial recruitment strategies and public health policy formulation.

关键词： people living with HIV functional cure clinical trials willingness

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functional cure of Chronic Hepatitis B with Antiviral Treatment in Children having High-level Viremia and Normal or Mildly Elevated Serum Aminotransferase

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Journal of Clinical and Translational Hepatology 2023年第5期11卷 1011-1022页

作者： Jing Li Peiyao Fan Zhiqiang Xu Yi Dong Fuchuan Wang Weiguo Hong Jinfang Zhao Yinjie Gao Jianguo Yan Lili Cao Chao Zhang Shishu Zhu Fu-Sheng Wang Min Zhang Peking University 302 Clinical Medical School BeijingChina Senior Department of Infectious Diseases The Fifth Medical Center of Chinese PLA General HospitalNational Clinical Research Center for Infectious DiseasesBeijingChina Senior Department of Liver Diseases The Fifth Medical Center of Chinese PLA General HospitalBeijingChina

Background and Aims:There is a lack of data supporting the notion that antiviral treatments can beneft children with chronic hepatitis B(CHB)having high viremia and normal or mildly elevated serum alanine aminotransferase(ALT)levels.We aimed t analyze the efficacy of antiviral treatments in children with CHB and explore the factors associated with functional cure.Methods:Forty-eight children with CHB having high viremia and normal or mildly elevated serum ALT levels were screened in this real-world study.Thirty-two children received either interferon-alpha(IFN-α)monother-apy,IFN-a therapy with a nucleoside analog(NA)add-on,or IFN-α and NA combination therapy.The 16 children in the control group did not receive antiviral treatment.All 48 chil-dren were available for follow-up assessments for the entire 36-month study period.We identified a functional cure with respect to hepatitis B virus(HBV)DNA loss,loss/seroconver-sion of circulating hepatitis B e antigen(HBeAg),and loss of hepatitis B surface antigen(HBsAg)with or without serocon-version.Cox regression analysis was employed to evaluate the factors that may have influenced the functional cure.Re-sults:After 36 months,the cumulative functional cure rate was 56.25%(18/32)in the treated group and 0%(0/16)in the control group(pcured children achieved a loss rate of 100%(18/18)within 16 months of beginning treatment,compared with 64.29%(9/14)of the uncured children(pcured children than among the uncured children(pcure was associated with younger ages(1-6 vs.7-14 years,p=0.013),CD8^(+)T lymphocyte counts(p=0.013),and B lymphocyte counts(p=0.003).No serious adverse events were observed.Conclusi

关键词： Child HBV Chronic hepatitis B Antiviral therapy functional cure

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Immunomodulatory and Antiviral Therapy Improved functional cure Rate in CHB Patients with High HBsAg Level Experienced NA

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Journal of Clinical and Translational Hepatology 2023年第5期11卷 1003-1010页

作者： Hongyu Jia Guodong Yu Jiong Yu Xiaoli Zhang Lisha Yang Bin Wang Jiming Zhang Lang Bai Xinxin Zhang Kai Wang Ping Zhao Dongliang Yang Yingren Zhao Yanyan Yu Yimin Zhang Jueqing Gu Chanyuan Ye Huan Cai Yingfeng Lu Dairong Xiang Liang Yu Jiangshan Lian Jianhua Hu Shanyan Zhang Ciliang Jin Yida Yang State Key Laboratory for Diagnosis and Treatment of Infectious Diseases National Clinical Research Center for Infectious DiseasesNational Medical Center for Infectious DiseasesCollaborative Innovation Center for Diagnosis and Treatment of Infectious DiseasesThe First Affiliated HospitalZhejiang University School of MedicineResearch Units of Infectious disease and MicroecologyChinese Academy of Medical SciencesHangzhouZhejiangChina Department of Infectious Diseases Branch of the First Affiliated Hospital of Zhejiang University School of MedicineNingboZhejiangChina Key Laboratory of Medical Molecular Virology(MOE/NHC/CAMS) Shanghai Institute of Infectious Disease and BiosecurityShanghaiChina Department of Infectious Diseases Huashan HospitalFudan UniversityShanghaiChina Center of Infectious Diseases West China Hospital of Sichuan UniversityChengduSichuanChina Department of Infectious Disease Research Laboratory of Clinical VirologyRuijin HospitalShanghai Jiao Tong UniversitySchool of MedicineShanghaiChina Department of Hepatology Qilu Hospital of Shandong UniversityJinanShandongChina International Center for Liver Disease Treatment 302 Hospital BeijingBeijingChina Department of Infectious Diseases Union HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhanHubeiChina Department of Infectious Diseases The First Affiliated Hospital of Xi’an Jiaotong UniversityXi’anShaanxiChina Department of Infectious Diseases Peking University First HospitalBeijingChina

Background and Aims:A functional cure,or hepatitis B virus(HBV)surface antigen(HBsAg)loss,is difficult to achieve in patients with hepatitis B virus e antigen(HBeAg)-positive chronic hepatitis B.The HBV vaccine and granulocyte-macrophage colony-stimulating factor(GM-CSF)have been reported to help reduce HBsAg levels and promote HBsAg loss.In this prospective randomized trial,we evaluated HBsAg loss in patients receiving pegylated interferon α2b(PEGIFN-α2b)and tenofovir disoproxil fumarate(TDF),with and without GM-CSF and HBV vaccination.Methods:A total of 287 patients with HBeAg positive chronic hepati-tis B and seroconversion after nucleot(s)ide analog treat-ment were assigned randomly to three treatment groups for 48 weeks,TDF alone(control),PEGIFN-α2b+TDF,and PEGIFN-α2b+TDF+GM-CSF+HBV vaccine.The prima-ry endpoints were the proportions of patients with HBsAg loss and seroconversion at 48 and 72 weeks.Resu/ts:The cumulative HBsAg loss rates in the control,PEGIFN-α2b+TDF,and PEGIFN-α2b+TDF+GM-CSF+HBV vaccine groups at week 48 were 0.0%,28.3%,and 41.1%,respec-tively.The cumulative HBsAg seroconversion rates in these groups at week 48 were 0.0%,21.7%,and 33.9%,respec-tively.Multivariate regression analysis showed that GM-CSF use plus HBV vaccination was significantly associated with HBsAg loss(p=0.017)and seroconversion(p=0.030).Con-clusions:In patients with HBeAg-positive chronic hepatitis B and seroconversion after nucleot(s)ide analog treatment,immunomodulatory/antiviral treatment regimens effective-ly improved HBsAg loss,and the regimen including GM-CSF and HBV vaccination was most effective.

关键词： Chronic hepatitis B HBsAg loss functional cure Immunomodulatory/antiviral therapy Pegylated interferon-α2b Tenofovir disoproxil fumarate Granulacyte-macrophage colony-stimulating factor Hepatitis B virus vaccine

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Classifying hepatitis B therapies with insights from covalently closed circular DNA dynamics

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Virologica Sinica 2024年第1期39卷 9-23页

作者： Jie-Li Hu Ai-Long Huang Key Laboratory of Molecular Biology on Infectious Diseases Ministry of EducationChongqing Medical UniversityChongqing400016China

The achievement of a functional cure for chronic hepatitis B(CHB)remains limited to a minority of patients treated with currently approved drugs.The primary objective in developing new anti-HBV drugs is to enhance the functional cure rates for CHB.A critical prerequisite for the functional cure of CHB is a substantial reduction,or even eradication of covalently closed circular DNA(cccDNA).Within this context,the changes in cccDNA levels during treatment become as a pivotal concern.We have previously analyzed the factors influencing cccDNA dynamics and introduced a preliminary classification of hepatitis B treatment strategies based on these dynamics.In this review,we employ a systems thinking perspective to elucidate the fundamental aspects of the HBV replication cycle and to rationalize the classification of treatment strategies according to their impact on the dynamic equilibrium of cccDNA.Building upon this foundation,we categorize current anti-HBV strategies into two distinct groups and advocate for their combined use to significantly reduce cccDNA levels within a well-defined timeframe.

关键词： Hepatitis B cccDNA functional cure Dynamics Treatment Strategy

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Reduction in Intrahepatic cccDNA and Integration of HBV in Chronic Hepatitis B Patients with a functional cure

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Journal of Clinical and Translational Hepatology 2023年第2期11卷 314-322页

作者： Weiqiang Gan Na Gao Lin Gu Zhishuo Mo Xiuqing Pang Ziying Lei Zhiliang Gao Department of Infectious Diseases The Third Affiliated Hospital of Sun Yat-sen UniversityGuangzhouGuangdongChina Guangdong Key Laboratory of Liver Disease Research The Third Affiliated Hospital of Sun Yat-sen UniversityGuangzhouGuangdongChina Key Laboratory of Tropical Disease Control(Sun Yat-sen University) Ministry of EducationGuangzhouGuangdongChina

Background and Aims:functional cure(FC)is characterized by the clearance of the hepatitis B surface antigen from the serum of patients with chronic hepatitis B(CHB).However,the level of intrahepatic covalently closed circular DNA(cccDNA)and hepatitis B virus(HBV)integration remains unclear.We conducted this study to determine them and reveal their value in the treatment of CHB.Methods:There were two sessions to elucidate the changes in intrahepatic cccDNA and HBV integration after antiviral therapy.In the first session,116 patients were enrolled and divided into FC,non-functional cure(NFC),and CHB groups,including 48 patients with functionally cured CHB,27 with CHB without functional cure after antiviral treatment,and 41 with treatment-naïve CHB.Patients were tested for both intrahepatic cccDNA and other viral markers.All patients in the FC group were followed up for at least 24 weeks to observe relapse.In the second session,another ten patients were included for in-depth whole-genome sequencing to analyze HBV integration.Results:Thirteen patients in the FC group were negative for intrahepatic cccDNA.Intrahepatic cccDNA was much higher in the CHB group compared with the FC group.Seven patients had HBsAg seroreversion,including two with virological relapse.Integration of HBV was detected in one(33.3%)functionally cured patients and in seven(100%)with CHB.28.0%of the HBV breakpoints were assigned in the 1,500 nt to 1,900 nt range of the HBV genome.Conclusions:After achieving an FC,the rate of intrahepatic cccDNA and HBV integration was significantly reduced in patients with CHB.For those patients who cleared intrahepatic cccDNA,the chances of developing virological relapse were even lower.

关键词： Chronic Hepatitis B Virological markers functional cure cccDNA Integration

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Expanding indications for chronic hepatitis B treatment: Is it really desirable to treat everyone?

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World Journal of Gastroenterology 2024年第17期30卷 2294-2297页

作者： Fabiola Di Dato Raffaele Iorio Department of Translational Medical Science Section of PediatricsUniversity of Naples Federico IINaples 80131Italy

Chronic viral hepatitis causes an increased risk of progressive liver disease and hepatocellular carcinoma.On the wave of the World Health Organization’s goal to reduce new cases and deaths from hepatitis B and C by 2030,there is an increasing call to expand the indications for treatment of chronic hepatitis B.Currently,the main goal of treatment is to achieve a functional cure due to the inability of current drugs to completely eradicate the virus.There are still many discrepancies between available guidelines in terms of eligibility for treatment as well as an uncertainty about the appropriate treatment duration.This editorial addresses key questions about the topic and whether indications for treatment should be expanded.

关键词： Hepatitis B virus Interferon Nucleos(t)ide analogues functional cure Children

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Toward a new era of hepatitis B virus therapeutics:The pursuit of a functional cure

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World Journal of Gastroenterology 2021年第21期27卷 2727-2757页

作者： Efthymios P Tsounis Evanthia Tourkochristou Athanasia Mouzaki Christos Triantos Division of Gastroenterology Department of Internal MedicineMedical SchoolUniversity of PatrasPatras 26504Greece Division of Hematology Department of Internal MedicineMedical SchoolUniversity of PatrasPatras 26504Greece

Hepatitis B virus(HBV)infection,although preventable by vaccination,remains a global health problem and a major cause of chronic liver disease.Although current treatment strategies suppress viral replication very efficiently,the optimal endpoint of hepatitis B surface antigen(HBsAg)clearance is rarely achieved.Moreover,the thorny problems of persistent chromatin-like covalently closed circular DNA and the presence of integrated HBV DNA in the host genome are ignored.Therefore,the scientific community has focused on developing innovative therapeutic approaches to achieve a functional cure of HBV,defined as undetectable HBV DNA and HBsAg loss over a limited treatment period.A deeper understanding of the HBV life cycle has led to the introduction of novel direct-acting antivirals that exert their function through multiple mechanisms,including inhibition of viral entry,transcriptional silencing,epigenetic manipulation,interference with capsid assembly,and disruption of HBsAg release.In parallel,another category of new drugs aims to restore dysregulated immune function in chronic hepatitis B accompanied by lethargic cellular and humoral responses.Stimulation of innate immunity by pattern-recognition receptor agonists leads to upregulation of antiviral cytokine expression and appears to contribute to HBV containment.Immune checkpoint inhibitors and adoptive transfer of genetically engineered T cells are breakthrough technologies currently being explored that may elicit potent HBV-specific T-cell responses.In addition,several clinical trials are attempting to clarify the role of therapeutic vaccination in this setting.Ultimately,it is increasingly recognized that elimination of HBV requires a treatment regimen based on a combination of multiple drugs.This review describes the rationale for progressive therapeutic interventions and discusses the latest findings in the field of HBV therapeutics.

关键词： Chronic hepatitis B functional cure Direct-acting antivirals Gene silencing Immunotherapy Therapeutic vaccination

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An Ideal Hallmark Closest to Complete cure of Chronic Hepatitis B Patients:High-sensitivity Quantitative HBsAg Loss

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Journal of Clinical and Translational Hepatology 2023年第1期11卷 197-206页

作者： Zi-Long Wang Jia-Rui Zheng Rui-Feng Yang Lin-Xiang Huang Hong-Song Chen Bo Feng Peking University People’s Hospital Peking University Hepatology InstituteBeijing Key Laboratory of Hepatitis C and Immunotherapy for Liver DiseasesBeijingChina

In the era of antiviral therapy,the main goal of treatment has shifted from the persistent inhibition of hepatitis B virus(HBV)replication to the pursuit of serological clearance of HBs surface antigen(HBsAg).Based on the life cycle of HBV,HBsAg originates from covalently closed circular DNA(cccDNA)and integrated HBV DNA,thus reflecting their transcriptional activity.Complete HBsAg loss may mean elimination or persistent inactivity of the HBV genome including cccDNA and integrated HBV DNA.HBsAg loss improves the recovery of abnormal immune function,which in turn,may further promote the clearance of residual viruses.Combined with functional cure and the great improvement of clinical outcomes,the continuous seroclearance of high-sensitivity quantitative HBsAg may represent the complete cure of chronic hepatitis B(CHB).For many other risk factors besides HBV itself,patients with HBsAg loss still need regular monitoring.In this review,we summarized the evolution of CHB treatment,the origin of serum HBsAg,the pattern of HBsAg seroclearance,and the effect of HBsAg loss on immune function and disease outcomes.In addition,we discuss the significance of high-sensitivity HBsAg detection and its possibility as a surrogate of complete cure.

关键词： Hepatitis B virus Chronic hepatitis B HBsAg Immunoassay functional cure Complete cure Biomarker

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Consolidation treatment needed for sustained HBsAg-negative response induced by interferon-alpha in HBeAg positive chronic hepatitis B patients

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Virologica Sinica 2022年第3期37卷 390-397页

作者： Minghui Li Fangfang Sun Xiaoyue Bi Yanjie Lin Liu Yang Yao Lu Lu Zhang Gang Wan Wei Yi Linqing Zhao Yao Xie Department of Hepatology Division 2 Beijing Ditan HospitalCapital Medical UniversityBeijing100015China Department of Hepatology Division 2 Peking University Ditan Teaching HospitalBeijing100015China Department of Biostatistics Beijing Ditan HospitalCapital Medical UniversityBeijing100015China Department of Gynecology and Obstetrics Beijing Ditan HospitalCapital Medical UniversityBeijing100015China Laboratory of Virology Beijing Key Laboratory of Etiology of Viral Diseases in ChildrenCapital Institute of PediatricsBeijing100020China

Hepatitis B surface antigen(HBsAg)clearance is considered as functional cure in patients with chronic hepatitis B(CHB).This study aimed to assess the durability of HBsAg clearance achieved by interferon-based therapies in patients with CHB who were originally positive for hepatitis B envelope antigen(HBeAg).In this prospective study,HBeAg-positive CHB patients with confirmed HBsAg loss under interferon-based therapies were enrolled within 12 weeks from end of treatment and followed up for 48 weeks.Virological markers,biochemical indicators,and liver imaging examinations were observed every 3–6 months.Sustained functional cure was analysed as primary outcome.Factor associated with sustained HBsAg loss or reversion was also investigated.The rate of HBsAg loss sustainability was 91.8%(212/231).Patients receiving consolidation treatment for 12–24weeks or≥24 weeks had higher rates of sustained HBsAg negativity than those receiving consolidation treatment forfunctional cure,and HBeAg-positivity at cessation of treatment(OR 12.271,95%CI 1.076–139.919,P=0.043)was a predictor of HBsAg reversion.Interferon-alpha induced functional cure was durable and a consolidation treatment of≥12–24 weeks was needed after HBsAg loss in HBeAg-positive CHB patients.

关键词： Chronic hepatitis B(CHB) functional cure HBeAg positive HBsAg loss Interferon(IFN)

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Advances in new antivirals for chronic hepatitis B

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Chinese Medical Journal 2022年第5期135卷 571-583页

作者： Yanhua Tang Hongyan Liang Ge Zeng Sheng Shen Jian Sun State Key Laboratory of Organ Failure Research Guangdong Provincial Key Laboratory of Viral Hepatitis ResearchDepartment of Infectious DiseasesNanfang HospitalSouthern Medical UniversityGuangzhouGuangdong 510515China

Chronic hepatitis B virus(HBV)infection remains a global health burden.Timely and effective antiviral therapy is beneficial for patients with HBV infection.With existing antiviral drugs,including nucleos(t)ide analogs and interferon-alfa,patients can achieve viral suppression with improved prognosis.However,the rate of hepatitis B surface antigen loss is low.To achieve a functional cure and even complete cure in chronic hepatitis B patients,new antivirals need to be developed.In this review,we summarized the advantages and disadvantages of existing antiviral drugs and focused on new antivirals including direct-acting antiviral drugs and immunotherapeutic approaches.

关键词： Hepatitis B virus New antivirals functional cure Complete cure

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