Section 1 of 6
Terms and abbreviations
1 evidence topic · 0 sources
| Abbreviation | Term |
|---|---|
| 2′-MOE, MOE | 2′-O-(2-methoxyethyl) (ribose modification of the oligonucleotide wings) |
| 3TC | Lamivudine |
| AASLD | American Association for the Study of Liver Diseases |
| AB-729 | Arbutus Biopharma development code for imdusiran |
| ACM | All-cause mortality |
| ACS | American Community Survey |
| ADA, ADAs | Anti-drug antibodies |
| AE, AEs | Adverse event |
| AESI, AESIs | Adverse events of special interest |
| AFP | Alpha-fetoprotein |
| AHB-137 | Investigational unconjugated antisense oligonucleotide for chronic hepatitis B |
| AHFS | American Hospital Formulary Service |
| aHR | Adjusted hazard ratio |
| AI | Artificial intelligence |
| AIDS | Acquired immunodeficiency syndrome |
| ALT | Alanine aminotransferase |
| ANC | Absolute neutrophil count |
| ANCA | Antineutrophil cytoplasmic antibody |
| anti-HBc | Antibody to hepatitis B core antigen |
| anti-HBe, anti-HBeAg | Antibody to hepatitis B e antigen |
| anti-HBs, Anti-HBs, HBsAb | Antibody to hepatitis B surface antigen |
| anti-HBV | Active against hepatitis B virus |
| aOR | Adjusted odds ratio |
| A/PI | Asian or Pacific Islander |
| APRI | Aspartate aminotransferase to platelet ratio index |
| ART | Antiretroviral therapy |
| AS01B-4 | GSK adjuvant system used with the HBc-HBs proteins of GSK3528869A |
| ASO, ASOs | Antisense oligonucleotide |
| ASO12, ASO24 | Study arms receiving bepirovirsen for 12 or 24 weeks without subsequent targeted immunotherapy |
| ASO12-TI, ASO24-TI | Study arms receiving bepirovirsen for 12 or 24 weeks followed by chronic hepatitis B targeted immunotherapy |
| AST | Aspartate aminotransferase |
| ATC | Anatomical Therapeutic Chemical classification |
| AUC | Area under the concentration-time curve |
| AUC0-24, AUC0-24h, AUC(0-24) | Area under the concentration-time curve from time 0 to 24 hours |
| AUC0-inf, AUC0-∞, AUC(0-inf), AUC(0-∞), AUC(0-infinity) | Area under the concentration-time curve from time of administration extrapolated to infinity |
| AUC(0-t) | Area under the concentration-time curve from time 0 to the last quantifiable concentration |
| AUC0-tau, AUCtau | Area under the concentration-time curve over the dosing interval |
| AWP | Average wholesale price |
| BCRP | Breast cancer resistance protein |
| BMI | Body mass index |
| BRII-179 | Brii Biosciences investigational therapeutic hepatitis B vaccine |
| BSA | Body surface area |
| BTD | Breakthrough Therapy Designation |
| C3, C4 | Complement factors C3 and C4 |
| cACLD | Compensated advanced chronic liver disease |
| Calif. | California |
| CAS | Chemical Abstracts Service (registry number) |
| CBC | Complete blood count |
| cccDNA | Covalently closed circular DNA |
| CCL2, CCL4, CCL19 | C-C motif chemokine ligands 2, 4, and 19 |
| CDA-AMC | Canada's Drug Agency (L'Agence des médicaments du Canada) |
| CDC | Centers for Disease Control and Prevention |
| CFB | Change from baseline |
| ChAd155-hIi-HBV | Chimpanzee adenovirus type 155-vectored hepatitis B vaccine encoding HBV antigens with the human invariant chain (hIi) |
| CHB, CH-B | Chronic hepatitis B |
| CHB-TI | Chronic hepatitis B targeted immunotherapy (GSK3528869A) |
| cHBV, cHCV, cHDV | Chronic hepatitis B, C, and D virus infection |
| CHIP | Children's Health Insurance Program |
| CI, CIs | Confidence interval; credible interval |
| CKD-EPI | Chronic Kidney Disease Epidemiology Collaboration (equation) |
| CL | Clearance |
| CLD | Chronic liver disease |
| CLDQ | Chronic Liver Disease Questionnaire |
| CL/F | Apparent clearance |
| Cmax | Maximum plasma concentration |
| Cmin | Minimum plasma concentration |
| CMIT | CMS Measures Inventory Tool |
| CN | China |
| COVID-19 | Coronavirus disease 2019 |
| CP-A, CP-B | Child-Pugh class A, Child-Pugh class B |
| CpG | Cytosine-phosphate-guanine (dinucleotide motif) |
| CPGs | Clinical practice guidelines |
| C-QTc, C-QTcF | Concentration-QTc (concentration-QTcF) analysis |
| CR, CRs | Complete response (complete responder) |
| CRP | C-reactive protein |
| CS1, CS3 | Ionis clinical study numbers of ISIS 505358 (CS1, first-in-human phase 1 study; CS3, phase 2a study) |
| CSF1, CSF3 | Colony stimulating factor 1 (macrophage) and colony stimulating factor 3 (granulocyte) |
| CSPH | Clinically significant portal hypertension |
| Ctrough | Trough plasma concentration |
| CTTQ | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
| CV | Coefficient of variation |
| CXC, CXCL10 | C-X-C motif chemokine ligand; C-X-C motif chemokine ligand 10 |
| CYP | Cytochrome P450 |
| CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4, CYP3A4/5 | Cytochrome P450 isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A4, and 3A4/5 |
| D1, D337 | Day 1, Day 337 |
| DAIDS | Division of AIDS (National Institute of Allergy and Infectious Diseases) grading table |
| DAP/TOM | Daplusiran/tomligisiran |
| DC | Decompensated cirrhosis; District of Columbia (Washington, DC) |
| DDI | Drug-drug interaction |
| DNA | Deoxyribonucleic acid |
| DPC | Diagnosis Procedure Combination (Japanese inpatient payment system) |
| EA | Each (package unit) |
| EASL | European Association for the Study of the Liver |
| EC50 | 50% effective concentration |
| ECG | Electrocardiogram |
| EEA | European Economic Area |
| eGFR | Estimated glomerular filtration rate |
| EHBC-AD | Evaluation of Hepatitis B and C (Medicaid quality measure, administrative data) |
| ELISA | Enzyme-linked immunosorbent assay |
| EMA | European Medicines Agency |
| EOF | End of follow-up |
| EoS, EOS | End of study |
| EoT, EOT | End of treatment |
| EQ-5D, EQ-5D-3L, EuroQoL-5D-3L | EuroQol 5-dimension health status instrument (3-level version) |
| ETV | Entecavir |
| EU | European Union |
| EU CT | European Union clinical trial (number) |
| EudraCT | European Union Drug Regulating Authorities Clinical Trials Database |
| F0-F3, F4 | METAVIR fibrosis stages 0 to 3 (noncirrhotic) and 4 (cirrhosis) |
| F5/6 | Ishak fibrosis stages 5 and 6 |
| FACIT | Functional Assessment of Chronic Illness Therapy |
| FAS | Full analysis set |
| FB | Foreign-born |
| FC | Functional cure |
| FDA | Food and Drug Administration |
| FIB-4 | Fibrosis-4 index |
| FL | Florida |
| FTC | Emtricitabine |
| FUW48 | Follow-up week 48 |
| GalNAc | N-acetylgalactosamine |
| GFR | Glomerular filtration rate |
| GMR, GMRs | Geometric mean ratio |
| Gr | Grade |
| GSK | GSK plc (formerly GlaxoSmithKline) |
| GSK3228836 | GSK development code for bepirovirsen |
| GSK3389404 | GSK development code for a GalNAc-conjugated antisense oligonucleotide targeting HBV RNA |
| GSK3528869A | GSK development code for chronic hepatitis B targeted immunotherapy (CHB-TI) |
| GSK5637608, JNJ-3989 | Development codes for daplusiran/tomligisiran |
| H1 | First half of the year; ribonuclease H1 (RNase H1); category H1 of Japan's cost-effectiveness evaluation |
| H2 | Second half of the year |
| HBc-HBs | Hepatitis B core and surface antigen proteins (component of GSK3528869A) |
| HBeAg | Hepatitis B e antigen |
| HBQOL | Hepatitis B Quality of Life instrument |
| HBs | Hepatitis B surface (antigen) |
| HBsAg | Hepatitis B surface antigen |
| HBV | Hepatitis B virus |
| HBV DNA, HBV-DNA | Hepatitis B virus deoxyribonucleic acid |
| HBVr | Hepatitis B virus reactivation |
| HBx | Hepatitis B X protein |
| HCC | Hepatocellular carcinoma |
| HCP | Health care professional |
| HCV | Hepatitis C virus |
| HDI | Highest density interval |
| HDV | Hepatitis D (delta) virus |
| HEDIS | Healthcare Effectiveness Data and Information Set |
| HepB | Hepatitis B (laboratory test) |
| HepG2 | Human hepatoblastoma cell line (HepG2.2.15, an HBV-producing subline) |
| HI | Hepatic impairment |
| HIV, HIV-1 | Human immunodeficiency virus (type 1) |
| HP, HPs | Healthy participant |
| HR | Hazard ratio |
| HRQL, HRQOL, HRQoL | Health-related quality of life |
| hTLR8 | Human toll-like receptor 8 |
| I2 | I-squared statistic of between-study heterogeneity |
| IC50,u | Unbound 50% inhibitory concentration |
| ICD9 | International Classification of Diseases, Ninth Revision |
| ICER | Institute for Clinical and Economic Review |
| ICH | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use |
| ICH E14 | ICH guideline E14 on clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential |
| ICH S7B | ICH guideline S7B on nonclinical evaluation of delayed ventricular repolarization |
| ID, IDs | Identifier |
| IDMC | Independent data monitoring committee |
| IDR | Imdusiran |
| IDSA | Infectious Diseases Society of America |
| IFN, IFN-α, IFN-β, IFN-γ | Interferon; interferon alfa, beta, and gamma |
| IgG, IgM | Immunoglobulin G, immunoglobulin M |
| IID-13, IID-15 | Healthy People 2030 infectious disease objectives 13 and 15 |
| IL-12B, IL-12p40 | Interleukin 12 subunit beta (gene); interleukin-12 p40 subunit |
| IND | Investigational New Drug application |
| INR | International normalized ratio |
| IONIS-HBVRx, IONIS-HBVRX | Ionis former name for bepirovirsen |
| IONS | Ionis Pharmaceuticals stock ticker symbol (Nasdaq) |
| IP | Investigational product |
| IQR | Interquartile range |
| IR | Incidence rate |
| ISIS 505358 | Ionis development code for bepirovirsen |
| ISRs | Injection site reactions |
| ITT | Intent to treat |
| IU | International units |
| JAN | Japanese Accepted Name |
| JNJ-6379 | Janssen development code for bersacapavir, a capsid assembly modulator |
| JP | Japan |
| JSN-CKDI | Japanese Society of Nephrology Chronic Kidney Disease Initiative (equation) |
| KEGG | Kyoto Encyclopedia of Genes and Genomes |
| kPa | Kilopascal |
| LD | Lactation day; loading dose |
| LFT | Liver function test |
| LLOD | Lower limit of detection |
| LLOQ | Lower limit of quantification |
| LOCF | Last observation carried forward |
| LOD | Limit of detection |
| LoE | Level of evidence |
| LOQ | Limit of quantification |
| LS | Least squares |
| LSE | London Stock Exchange |
| LSM | Liver stiffness measurement |
| LT | Liver transplantation |
| LTFU | Long-term follow-up |
| M1, M2, M3 | Multiple-dose cohorts of the first-in-human study (150, 300, and 450 mg) |
| MAA | Marketing authorisation application |
| MAD | Multiple ascending dose |
| MATE1, MATE2-K | Multidrug and toxin extrusion proteins 1 and 2-K |
| mcg | Microgram |
| MedDRA | Medical Dictionary for Regulatory Activities |
| METAVIR | Meta-analysis of Histological Data in Viral Hepatitis (fibrosis scoring system) |
| MHLW | Ministry of Health, Labour and Welfare (Japan) |
| MIPS | Merit-based Incentive Payment System |
| mIU | Milli-international units |
| MoA | Mechanism of action |
| MODRN | Medicaid Outcomes Distributed Research Network |
| MRHD | Maximum recommended human dose |
| MRI | Magnetic resonance imaging |
| mRNA, mRNAs | Messenger ribonucleic acid |
| MRP2 | Multidrug resistance-associated protein 2 |
| MVA-HBV | Modified vaccinia virus Ankara-vectored hepatitis B vaccine |
| NA, NAs | Nucleos(t)ide analogue; not available (table values) |
| NaCl | Sodium chloride |
| NC | Noncirrhotic; North Carolina |
| NCA | Noncompartmental analysis |
| NCHS | National Center for Health Statistics |
| NCQA | National Committee for Quality Assurance |
| NCT | National Clinical Trial (ClinicalTrials.gov identifier) |
| NDA | New Drug Application |
| NDC | National Drug Code |
| NE | Not estimable |
| NH | Non-Hispanic |
| NHANES | National Health and Nutrition Examination Survey |
| NICE | National Institute for Health and Care Excellence |
| NMPA | National Medical Products Administration (China) |
| NOC | Notice of Compliance (Health Canada) |
| NQ | Non-quantifiable |
| NrtI, NrtIs | Nucleos(t)ide analog reverse transcriptase inhibitor |
| NUC | Nucleos(t)ide analogue |
| NYSE | New York Stock Exchange |
| OAT1, OAT3 | Organic anion transporters 1 and 3 |
| OATP1B1, OATP1B3 | Organic anion transporting polypeptides 1B1 and 1B3 |
| OCT1, OCT2 | Organic cation transporters 1 and 2 |
| OR | Odds ratio |
| OUD | Opioid use disorder |
| P450 | Cytochrome P450 |
| PAGE-B | Platelets, age, and gender hepatocellular carcinoma risk score for hepatitis B |
| PBMC | Peripheral blood mononuclear cell |
| PBPK | Physiologically based pharmacokinetic (model) |
| PD | Pharmacodynamic |
| PDC | Proportion of days covered |
| PDUFA | Prescription Drug User Fee Act |
| PEG-IFNα, PEG-IFNα-2a, Peg-IFN, peg-IFN, PegIFN, PegIFN-α2a, pegIFNa, PegINF, PEG-interferon | Pegylated interferon alfa (pegylated interferon alfa-2a) |
| PFS | Prefilled syringe |
| P-gp | P-glycoprotein |
| pgRNA | Pregenomic ribonucleic acid |
| PI | Principal investigator |
| PICO | Population, intervention, comparison, outcome |
| PK, PKs | Pharmacokinetics |
| PLT | Platelet count |
| POC | Proof of concept |
| PPPY | Per patient per year |
| PR, PRs | Partial response (partial responder) |
| preS1, preS2 | Pre-surface 1 and pre-surface 2 regions of the HBV envelope gene |
| PRO, PROs | Patient-reported outcome |
| PRR | Pattern recognition receptor |
| PSPO | Parent study primary outcome |
| PYs | Person-years |
| Q1, Q3, Q4 | First, third, and fourth quarter of the year |
| QALY, QALYs | Quality-adjusted life year |
| qHBsAg | Quantitative hepatitis B surface antigen |
| QHP | Qualified Health Plan |
| qPCR | Quantitative polymerase chain reaction |
| QRS | Quality Rating System |
| QT | QT interval |
| QTc | QT interval corrected for heart rate |
| QTcF | QT interval corrected using the Fridericia method |
| RBD-1016 | Investigational small interfering RNA for chronic hepatitis B |
| RCTs | Randomized controlled trials |
| RE | Random effects (meta-analysis model) |
| REVEAL-HBV | Risk Evaluation of Viral Load Elevation and Associated Liver Disease/Cancer-Hepatitis B Virus (cohort study) |
| RG-6346 | Roche development code for xalnesiran |
| RNA, RNAs | Ribonucleic acid |
| RNAi | RNA interference |
| RNase H1 | Ribonuclease H1 |
| RR | Relative risk |
| RT-qPCR | Reverse transcription quantitative polymerase chain reaction |
| RxDx | Companion diagnostic |
| SAE, SAEs | Serious adverse event |
| SBP | Sino Biopharmaceutical Limited |
| s.c., SC | Subcutaneous |
| SD | Standard deviation |
| SDD | Safety syringe device (as written in the registry record) |
| SHTAC | Southampton Health Technology Assessment Centre |
| siRNA, siRNAs | Small interfering ribonucleic acid |
| SNPs | Single nucleotide polymorphisms |
| SOT | Start of peginterferon therapy |
| SSD | Safety syringe device |
| STA | Single technology appraisal |
| SVR | Sustained virologic response |
| t1/2 | Elimination half-life |
| TAF | Tenofovir alafenamide |
| TDF | Tenofovir disoproxil fumarate |
| TE | Transient elastography |
| TEAE, TEAEs | Treatment-emergent adverse event |
| TFV | Tenofovir |
| T-IA | Treated immune-active (chronic hepatitis B) |
| TLR, TLR8 | Toll-like receptor; toll-like receptor 8 |
| tmax, Tmax | Time to maximum plasma concentration |
| TN | Trade name |
| TNF, TNF-α | Tumor necrosis factor; tumor necrosis factor alpha |
| TX | Texas |
| uACR | Urine albumin-to-creatinine ratio |
| UCOD | Underlying cause of death |
| UGT | Uridine diphosphate glucuronosyltransferase |
| UI | Uncertainty interval |
| U-IT | Untreated immune-tolerant (chronic hepatitis B) |
| UK | United Kingdom |
| ULN | Upper limit of normal |
| US, U.S., USA | United States |
| USAN | United States Adopted Name |
| USD | United States dollars |
| USP | United States Pharmacopeia |
| USPSTF | United States Preventive Services Task Force |
| UT | University of Texas |
| VCTE | Vibration-controlled transient elastography |
| VIR-2218 | Vir Biotechnology development code for elebsiran |
| VR | Virological relapse |
| VRON-0200 | Investigational therapeutic hepatitis B vaccine |
| Vss/F | Apparent volume of distribution at steady state |
| Vz/F | Apparent terminal phase volume of distribution |
| W24 | Week 24 |
| WAC | Wholesale acquisition cost |
| WDEs | Wide disruptive events (such as the coronavirus disease 2019 pandemic) |
| WHO | World Health Organization |