New Perspectives on Development of Curative Strategies for Chronic Hepatitis B
Tài liệu tham khảo
World Health Organization, 2021
Jeng, 2021, Should treatment indications for chronic hepatitis B be expanded?, Clin Gastroenterol Hepatol, 19, 2006, 10.1016/j.cgh.2020.04.091
Hirode, 2022, Off-therapy response after nucleos(t)ide analogue withdrawal in patients with chronic hepatitis B: an international, multicenter, multiethnic cohort (RETRACT-B study), Gastroenterology, 162, 757, 10.1053/j.gastro.2021.11.002
Sonneveld, 2022, Probability of HBsAg loss after nucleo(s)tide analogue withdrawal depends on HBV genotype and viral antigen levels, J Hepatol, 76, 1042, 10.1016/j.jhep.2022.01.007
Testoni, 2015, Liver capsule: Validated and potential novel targets to treat hepatitis B virus, Hepatology, 62, 1619, 10.1002/hep.28144
Fanning, 2019, Therapeutic strategies for hepatitis B virus infection: towards a cure, Nat Rev Drug Discov, 18, 827, 10.1038/s41573-019-0037-0
Martinez, 2021, Covalently closed circular DNA: the ultimate therapeutic target for curing HBV infections, J Hepatol, 75, 706, 10.1016/j.jhep.2021.05.013
Werle-Lapostolle, 2004, Persistence of cccDNA during the natural history of chronic hepatitis B and decline during adefovir dipivoxil therapy, Gastroenterology, 126, 1750, 10.1053/j.gastro.2004.03.018
Boyd, 2016, Decay of ccc-DNA marks persistence of intrahepatic viral DNA synthesis under tenofovir in HIV-HBV co-infected patients, J Hepatol, 65, 683, 10.1016/j.jhep.2016.05.014
Wong, 2013, Reduction of hepatitis B surface antigen and covalently closed circular DNA by nucleos(t)ide analogues of different potency, Clin Gastroenterol Hepatol, 11, 1004, 10.1016/j.cgh.2013.01.026
Hsu, 2022, Inhibition of viral replication reduces transcriptionally active distinct hepatitis B virus integrations with implications on host gene dysregulation, Gastroenterology, 162, 1160, 10.1053/j.gastro.2021.12.286
Chow, 2023, Effect of antiviral treatment on hepatitis B virus integration and hepatocyte clonal expansion, Clin Infect Dis, 76, e801, 10.1093/cid/ciac383
Wooddell, 2017, RNAi-based treatment of chronically infected patients and chimpanzees reveals that integrated hepatitis B virus DNA is a source of HBsAg, Sci Transl Med, 9, 10.1126/scitranslmed.aan0241
Freitas, 2018, Relative abundance of integrant-derived viral RNAs in infected tissues harvested from chronic hepatitis B virus carriers, J Virol, 92, 10.1128/JVI.02221-17
Zhao, 2016, Genomic and oncogenic preference of HBV integration in hepatocellular carcinoma, Nat Commun, 7
Meier, 2021, Ubiquitous expression of HBsAg from integrated HBV DNA in patients with low viral load, J Hepatol, 75, 840, 10.1016/j.jhep.2021.04.051
Martinez, 2022, Gene editing technologies to target HBV cccDNA, Viruses, 14, 2654, 10.3390/v14122654
Maini, 2019, Restoring, releasing or replacing adaptive immunity in chronic hepatitis B, Nat Rev Gastroenterol Hepatol, 16, 662, 10.1038/s41575-019-0196-9
Ganchua, 2022, Reduction of hepatitis B surface antigen mediated by RNA interference therapeutic AB-729 in chronic hepatitis B patients is associated with T cell activation and a decline in exhausted CD8 T cells, J Hepatol, 77, S851, 10.1016/S0168-8278(22)01999-7
Lok, 2017, Hepatitis B cure: from discovery to regulatory approval, J Hepatol, 67, 847, 10.1016/j.jhep.2017.05.008
Cornberg, 2020, Guidance for design and endpoints of clinical trials in chronic hepatitis B - report from the 2019 EASL-AASLD HBV Treatment Endpoints Conference, J Hepatol, 72, 539, 10.1016/j.jhep.2019.11.003
Yip, 2019, HBsAg seroclearance further reduces hepatocellular carcinoma risk after complete viral suppression with nucleos(t)ide analogues, J Hepatol, 70, 361, 10.1016/j.jhep.2018.10.014
Hwang, 2014, Management of patients with hepatitis B who require immunosuppressive therapy, Nat Rev Gastroenterol Hepatol, 11, 209, 10.1038/nrgastro.2013.216
Revill, 2019, A global scientific strategy to cure hepatitis B, Lancet Gastroenterol Hepatol, 4, 545, 10.1016/S2468-1253(19)30119-0
Dusheiko, 2023, New approaches to chronic hepatitis B, N Engl J Med, 388, 55, 10.1056/NEJMra2211764
Lim, 2023, The scientific basis of combination therapy for chronic hepatitis B functional cure, Nat Rev Gastroenterol Hepatol, 20, 238, 10.1038/s41575-022-00724-5
Wong, 2022, How to achieve functional cure of HBV: Stopping NUCs, adding interferon or new drug development?, J Hepatol, 76, 1249, 10.1016/j.jhep.2021.11.024
Urban, 2014, Strategies to inhibit entry of HBV and HDV into hepatocytes, Gastroenterology, 147, 48, 10.1053/j.gastro.2014.04.030
Wedemeyer, 2023, Safety and efficacy of bulevirtide in combination with tenofovir disoproxil fumarate in patients with hepatitis B virus and hepatitis D virus coinfection (MYR202): a multicentre, randomised, parallel-group, open-label, phase 2 trial, Lancet Infect Dis, 23, 117, 10.1016/S1473-3099(22)00318-8
Hehle, 2020, Potent human broadly neutralizing antibodies to hepatitis B virus from natural controllers, J Exp Med, 217, 10.1084/jem.20200840
Bournazos, 2020, Fc-optimized antibodies elicit CD8 immunity to viral respiratory infection, Nature, 588, 485, 10.1038/s41586-020-2838-z
Mak, 2021, Novel antivirals in clinical development for chronic hepatitis B infection, Viruses, 13, 1169, 10.3390/v13061169
Agarwal, 2022, Efficacy and safety of finite 48-week treatment with the siRNA JNJ-3989 and the capsid assembly modulator (CAM-N) JNJ-6379 in HBeAg negative virologically suppressed (VS) chronic hepatitis B (CHB) patients: results from REEF-2 study, J Hepatol, 77, S8, 10.1016/S0168-8278(22)00437-8
Gane, 2022, Safety, tolerability, and antiviral activity of the siRNA VIR-2218 in combination with the investigational neutralizing monoclonal antibody VIR-3434 for the treatment of chronic hepatitis B virus infection: preliminary results from the phase 2 MARCH trial, Hepatology, 76, S18
Yuen, 2022, Combination treatments including the small-interfering RNA JNJ-3989 induce rapid and sometimes prolonged viral responses in patients with CHB, J Hepatol, 77, 1287, 10.1016/j.jhep.2022.07.010
Yuen, 2022, Preliminary 48-week safety and efficacy data of VIR-2218 alone and in combination with pegylated interferon alfa in participants with chronic HBV infection, Hepatology, 76, S19
Gane, 2022, Efficacy and safety of siRNA JNJ-73763989, capsid assembly modulator JNJ-56136379, nucleos(t)ide analog (NA), and pegylated interferon alpha-2a (PEGIFNα2a) for treatment of chronic hepatitis B (CHB): week 24 results from the phase 2 PENGUIN study, Hepatology, 76, LB5035
George, 2022, Evaluation of the Vebicorvir, NRTI and AB-729 combination in virologically suppressed patients with HBeAg negative chronic hepatitis B virus infection: interim analysis from an open label phase 2 study, Hepatology, 76, LB5064
Yuen, 2020, RNA interference therapy with ARC-520 results in prolonged hepatitis B surface antigen response in patients with chronic hepatitis B infection, Hepatology, 72, 19, 10.1002/hep.31008
Yuen, 2022, Long-term serological, virological and histological responses to RNA inhibition by ARC-520 in Chinese chronic hepatitis B patients on entecavir treatment, Gut, 71, 789, 10.1136/gutjnl-2020-323445
Yuen, 2022, Hepatitis B viral control maintained during extended follow up of HBeAg- chronic hepatitis B (CHB) subjects who discontinued nucleos(t)ide analogue (NA) therapy after completion of AB-729 treatment, and in HBeAg+ subjects still on NA therapy, Hepatology, 76, LB5047
Gehring, 2022, Immunological biomarker discovery in cure regimens for chronic hepatitis B virus infection, J Hepatol, 77, 525, 10.1016/j.jhep.2022.02.020
Yuen, 2022, Efficacy and safety of bepirovirsen in chronic hepatitis B infection, N Engl J Med, 387, 1957, 10.1056/NEJMoa2210027
Yuen, 2022, Phase IIa, randomised, double-blind study of GSK3389404 in patients with chronic hepatitis B on stable nucleos(t)ide therapy, J Hepatol, 77, 967, 10.1016/j.jhep.2022.05.031
Yuen, 2021, Safety, tolerability and antiviral activity of the antisense oligonucleotide bepirovirsen in patients with chronic hepatitis B: a phase 2 randomized controlled trial, Nat Med, 27, 1725, 10.1038/s41591-021-01513-4
You, 2022, Bepirovirsen, antisense oligonucleotide (ASO) against hepatitis B virus (HBV), harbors intrinsic immunostimulatory activity via Toll-like receptor 8 (TLR8) preclinically, correlating with clinical efficacy from the Phase 2a study, J Hepatol, 77, S873, 10.1016/S0168-8278(22)02041-4
Zoulim, 2022, Nomenclature of HBV core protein-targeting antivirals, Nat Rev Gastroenterol Hepatol, 19, 748, 10.1038/s41575-022-00700-z
Zoulim, 2020, JNJ-56136379, an HBV capsid assembly modulator, is well-tolerated and has antiviral activity in a phase 1 study of patients with chronic infection, Gastroenterology, 159, 521, 10.1053/j.gastro.2020.04.036
Yuen, 2021, Safety, pharmacokinetics, and antiviral activity of RO7049389, a core protein allosteric modulator, in patients with chronic hepatitis B virus infection: a multicentre, randomised, placebo-controlled, phase 1 trial, Lancet Gastroenterol Hepatol, 6, 723, 10.1016/S2468-1253(21)00176-X
Yuen, 2020, Safety, pharmacokinetics, and antiviral effects of ABI-H0731, a hepatitis B virus core inhibitor: a randomised, placebo-controlled phase 1 trial, Lancet Gastroenterol Hepatol, 5, 152, 10.1016/S2468-1253(19)30346-2
Zhang, 2021, Antiviral activity and pharmacokinetics of the hepatitis B virus (HBV) capsid assembly modulator GLS4 in patients with chronic HBV infection, Clin Infect Dis, 73, 175, 10.1093/cid/ciaa961
Feld, 2022, EDP-514 in healthy subjects and nucleos(t)ide reverse transcriptase inhibitor-suppressed patients with chronic hepatitis B, Antivir Ther, 27, 10.1177/13596535221127848
Yuen, 2022, Safety and efficacy of vebicorvir in virologically suppressed patients with chronic hepatitis B virus infection, J Hepatol, 77, 642, 10.1016/j.jhep.2022.04.005
Sulkowski, 2022, Safety and efficacy of vebicorvir administered with entecavir in treatment-naive patients with chronic hepatitis B virus infection, J Hepatol, 77, 1265, 10.1016/j.jhep.2022.05.027
Gane, 2021, Viral response and safety following discontinuation of treatment with the core inhibitor vebicorvir and a nucleos (t)ide reverse transcriptase inhibitor in patients with HBeAg positive or negative chronic hepatitis B virus infection, J Hepatol, 75, S736
Yuen, 2022, Safety, pharmacokinetics, and antiviral activity of the capsid inhibitor AB-506 from Phase 1 studies in healthy subjects and those with hepatitis B, Hepatol Commun, 6, 3457, 10.1002/hep4.2095
Yuen, 2022, Effects of the siRNA JNJ-3989 and/or the capsid assembly modulator (CAM-N) JNJ-6379 on viral markers of chronic hepatitis B (CHB): results from the REEF-1 study, J Hepatol, 77, S864, 10.1016/S0168-8278(22)02024-4
Boulon, 2020, Characterization of the antiviral effects of REP 2139 on the HBV lifecycle in vitro, Antiviral Res, 183, 10.1016/j.antiviral.2020.104853
Bazinet, 2020, Safety and efficacy of 48 weeks REP 2139 or REP 2165, tenofovir disoproxil, and pegylated interferon alfa-2a in patients with chronic HBV infection naive to nucleos(t)ide therapy, Gastroenterology, 158, 2180, 10.1053/j.gastro.2020.02.058
Lanford, 2013, GS-9620, an oral agonist of Toll-like receptor-7, induces prolonged suppression of hepatitis B virus in chronically infected chimpanzees, Gastroenterology, 144, 1508, 10.1053/j.gastro.2013.02.003
Janssen, 2018, Safety, efficacy and pharmacodynamics of vesatolimod (GS-9620) in virally suppressed patients with chronic hepatitis B, J Hepatol, 68, 431, 10.1016/j.jhep.2017.10.027
Amin, 2021, Therapeutic potential of TLR8 agonist GS-9688 (Selgantolimod) in chronic hepatitis B: remodeling of antiviral and regulatory mediators, Hepatology, 74, 55, 10.1002/hep.31695
Gane, 2021, Safety, pharmacokinetics, and pharmacodynamics of the oral TLR8 agonist selgantolimod in chronic hepatitis B, Hepatology, 74, 1737, 10.1002/hep.31795
Yuen, 2023, A phase 2, open-label, randomized, multiple-dose study evaluating Inarigivir in treatment-naive patients with chronic hepatitis B, Liver Int, 43, 77, 10.1111/liv.15465
Agarwal, 2020, Liver toxicity in the phase 2 Catalyst 206 trial of inarigivir 400 mg daily added to a nucleoside in HBV EAg negative patients, J Hepatol, 73, S125
Gane, 2019, Anti-PD-1 blockade with nivolumab with and without therapeutic vaccination for virally suppressed chronic hepatitis B: A pilot study, J Hepatol, 71, 900, 10.1016/j.jhep.2019.06.028
Evans, 2022, Phase 1b/2a study of heterologous ChAdOx1-HBV/MVA-HBV therapeutic vaccination (VTP-300) combined with low-dose nivolumab (LDN) in virally-suppressed patients with CHB on nucleos (t)ide analogues, J Hepatol, 77, S868, 10.1016/S0168-8278(22)02030-X
Bunse, 2022, PD-L1 silencing in liver using siRNAs enhances efficacy of therapeutic vaccination for chronic hepatitis B, Biomolecules, 12, 470, 10.3390/biom12030470
Wang, 2022, ALT flares were linked to HBsAg reduction, seroclearance and seroconversion: interim results from a phase IIb study in chronic hepatitis B patients with 24-week treatment of subcutaneous PD-L1 Ab ASC22 (Envafolimab) plus nucleos (t)ide analogs, J Hepatol, 77, S70, 10.1016/S0168-8278(22)00538-4
Gehring, 2019, Targeting innate and adaptive immune responses to cure chronic HBV infection, Gastroenterology, 156, 325, 10.1053/j.gastro.2018.10.032
Lang-Meli, 2021, Immunotherapy and therapeutic vaccines for chronic HBV infection, Curr Opin Virol, 51, 149, 10.1016/j.coviro.2021.10.002
Michler, 2020, Knockdown of virus antigen expression increases therapeutic vaccine efficacy in high-titer hepatitis B virus carrier mice, Gastroenterology, 158, 1762, 10.1053/j.gastro.2020.01.032
Agarwal, 2022, Dose-dependent durability of hepatitis B surface antigen reductions following administration of a single dose of VIR-3434, a novel neutralizing vaccinal monoclonal antibody, J Hepatol, 77, S831, 10.1016/S0168-8278(22)01959-6
Lampertico, 2022, Bulevirtide with or without pegIFNalpha for patients with compensated chronic hepatitis delta: from clinical trials to real-world studies, J Hepatol, 77, 1422, 10.1016/j.jhep.2022.06.010
Agarwal, 2022, A case of HBV-induced liver failure in the REEF-2 phase II trial: Implications for finite treatment strategies in HBV 'cure', J Hepatol, 77, 245, 10.1016/j.jhep.2022.03.006
Agarwal, 2022, Efficacy and safety of combination treatment with siRNA JNJ-73763989 and capsid assembly modulator JNJ-56136379 (Bersacapavir) in HBeAg negative virologically suppressed chronic hepatitis B (CHB) patients: follow-up week 48 end of study results from REEF-2, Hepatology, 76, LB5012
Kramvis, 2022, A roadmap for serum biomarkers for hepatitis B virus: current status and future outlook, Nat Rev Gastroenterol Hepatol, 19, 727, 10.1038/s41575-022-00649-z
Tseng, 2013, Serum hepatitis B surface antigen levels help predict disease progression in patients with low hepatitis B virus loads, Hepatology, 57, 441, 10.1002/hep.26041
Testoni, 2019, Serum hepatitis B core-related antigen (HBcrAg) correlates with covalently closed circular DNA transcriptional activity in chronic hepatitis B patients, J Hepatol, 70, 615, 10.1016/j.jhep.2018.11.030
Boettler, 2022, Assessing immunological and virological responses in the liver: Implications for the cure of chronic hepatitis B virus infection, JHEP Rep, 4