Section 1 of 6
Terms and abbreviations
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| Abbreviation | Term |
|---|---|
| 14C | Carbon-14 (radiolabel) |
| 1H, H1 | First half of the year |
| 2H2025 | Second half of 2025 |
| AAC | Autorisation d'accès compassionnel (compassionate access authorization) |
| ABI-1179, GS-1179 | Investigational helicase-primase inhibitor from Assembly Biosciences, licensed to Gilead |
| ABI-4334, ABI-6250 | Assembly Biosciences investigational product candidates |
| ABI-5366, GS-5366 | Investigational helicase-primase inhibitor from Assembly Biosciences, licensed to Gilead |
| ACV | Acyclovir |
| ACV-R, ACV-r, ACVr | Acyclovir-resistant |
| ACV-R/R | Acyclovir-resistant or acyclovir-refractory |
| ACV-S | Acyclovir-susceptible |
| ACV/FOS | Acyclovir/foscarnet |
| ADR | Antiviral drug resistance |
| AdV | Adenovirus |
| AE, AEs | Adverse event |
| AESIs | Adverse events of special interest |
| aHCT | Allogeneic hematopoietic cell transplantation |
| AHFS | American Hospital Formulary Service |
| AI, AII, AIII | Guideline rating: strength of recommendation A with quality of evidence I, II, or III |
| AIC090015, AIC090105 | AiCuris codes for the two major inactive metabolites of pritelivir |
| AIC316, AIC-316 | AiCuris development code for pritelivir |
| AIC468 | AiCuris development code for a pipeline candidate |
| AIDS | Acquired immunodeficiency syndrome |
| AK | Actinic keratosis |
| AKI | Acute kidney injury |
| ALL-B | Acute lymphoid leukemia type B |
| allo-HCT, Allo-HCT | Allogeneic hematopoietic cell transplantation |
| allo-HSCT | Allogeneic hematopoietic stem cell transplantation |
| ALT | Alanine aminotransferase |
| AML | Acute myeloid leukemia |
| AMNV, AMV | Amenamevir |
| AMS | Accelerator mass spectrometry |
| ANC, ANCs | Absolute neutrophil count |
| ANSM | Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) |
| AP-HP | Assistance Publique - Hôpitaux de Paris (Paris public hospital system) |
| API | Active pharmaceutical ingredient |
| ARDS | Acute respiratory distress syndrome |
| ART | Antiretroviral therapy |
| ARV | Antiretroviral |
| ASS | Acetylsalicylic acid |
| AST | Aspartate aminotransferase |
| ATC | Anatomical Therapeutic Chemical classification |
| ATN | Acute tubular necrosis |
| ATP | Adenosine triphosphate |
| ATPase | Adenosine triphosphatase |
| ATS | Amino thiazole sulfonamide (pritelivir metabolite) |
| AUC | Area under the concentration-time curve |
| AUC0-24, AUC0-24h | Area under the concentration-time curve from time 0 to 24 hours |
| AUC0-inf, AUC0-∞, AUCinf | Area under the concentration-time curve from time of administration to infinity |
| AUC0-inf,m/p, AUC0-last,m/p | Metabolite-to-parent ratio of AUC0-inf, metabolite-to-parent ratio of AUC0-last |
| AUC0-inf,u, AUC0-last,u | Unbound AUC0-inf, unbound AUC0-last |
| AUC0-last | Area under the concentration-time curve from time of administration to the time of the last quantifiable concentration |
| AUCex | Extrapolated portion of AUC0-inf |
| AUCtau | Area under the concentration-time curve over the dosing interval |
| AUCτ,ss | Area under the concentration-time curve over the dosing interval at steady state |
| AZ | Algemeen Ziekenhuis (general hospital) |
| b.i.d., BID, bid | Twice daily |
| BAL | Bronchoalveolar lavage |
| BAY 57-1293, BAY-1293 | Bayer development code for pritelivir |
| BCRP | Breast cancer resistance protein |
| BCS | Biopharmaceutics Classification System |
| BEBO | Stichting Beoordeling Ethiek Biomedisch Onderzoek (Foundation for the Assessment of Ethics in Biomedical Research, a Dutch independent ethics committee) |
| BfArM | Bundesinstitut für Arzneimittel und Medizinprodukte (German Federal Institute for Drugs and Medical Devices) |
| BHT | Butylated hydroxytoluene |
| BI, BII, BIII | Guideline rating: strength of recommendation B with quality of evidence I, II, or III |
| BILS 22 BS | Boehringer Ingelheim development code for a helicase-primase inhibitor |
| BIM | Budget impact model |
| BMI | Body mass index |
| BP | Blood to plasma (ratio) |
| BSA | Body surface area |
| BUN | Blood urea nitrogen |
| C0h | Predose plasma concentration |
| C24h | Plasma concentration 24 hours after dosing |
| CA, CAs | Carbonic anhydrase |
| CD4, CD8 | Cluster of differentiation 4, cluster of differentiation 8 |
| CDC | Centers for Disease Control and Prevention |
| CDV | Cidofovir |
| CEO | Chief executive officer |
| cGVHD | Chronic graft-versus-host disease |
| CHSV | Chronic herpes simplex virus |
| CHU | Centre hospitalier universitaire (university hospital center) |
| CI, CIs | Confidence interval; continuous infusion |
| CIBMTR | Center for International Blood and Marrow Transplant Research |
| CID | Cidofovir |
| CIII | Guideline rating: strength of recommendation C with quality of evidence III |
| CKD | Chronic kidney disease |
| CKD-EPI | Chronic Kidney Disease Epidemiology Collaboration |
| CL | Clearance |
| CL/F | Apparent clearance |
| Clast | Last quantifiable concentration |
| CLIA | Clinical Laboratory Improvement Amendments |
| CLss/F | Apparent clearance at steady state |
| CLu/F | Apparent clearance of unbound drug |
| Cmax | Maximum plasma concentration |
| Cmax,ss | Maximum plasma concentration at steady state |
| Cmax,u | Unbound maximum plasma concentration |
| CMH | Cochran-Mantel-Haenszel |
| Cmin | Minimum plasma concentration |
| CMML | Chronic myelomonocytic leukemia |
| cMRI | Cranial magnetic resonance imaging |
| CMS | Centers for Medicare & Medicaid Services |
| CMV | Cytomegalovirus |
| CNS | Central nervous system |
| COVID-19 | Coronavirus disease 2019 |
| CPE | Cytopathic effect |
| CrCl | Creatinine clearance |
| CROI | Conference on Retroviruses and Opportunistic Infections |
| CRP | C-reactive protein |
| cryo-EM | Cryo-electron microscopy |
| CSF | Cerebrospinal fluid |
| CT, Ct | Cycle threshold |
| CUP | Compassionate Use Program |
| CV | Coefficient of variation |
| CVZV | Chronic varicella zoster virus |
| CY | Calendar year |
| CYP | Cytochrome P450 |
| CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4, CYP3A4/5 | Cytochrome P450 isoenzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4, and 3A4/5 |
| DAIDS | Division of AIDS (National Institute of Allergy and Infectious Diseases) |
| DDI, DDIs | Drug-drug interaction |
| DIII | Guideline rating: strength of recommendation D with quality of evidence III |
| DNA | Deoxyribonucleic acid |
| DOE | Duration of lesion episode |
| DP | DNA polymerase |
| dpm | Disintegrations per minute |
| DRM, DRMs | Drug resistance mutation |
| DST | Drug susceptibility testing |
| e.v. | Extravascular |
| EAP | Early Access Program; expanded access program |
| EBV | Epstein-Barr virus |
| EC | European Community |
| EC50 | 50% effective concentration |
| EC90 | 90% effective concentration |
| ECG, ECGs | Electrocardiogram |
| ECIL-2 | Second European Conference on Infections in Leukaemia |
| ECP | Extracorporeal photopheresis |
| ED50 | 50% effective dose |
| EEA | European Economic Area |
| eGFR | Estimated glomerular filtration rate |
| EGW | External genital and perianal warts |
| EHR | Electronic health record |
| EMA | European Medicines Agency |
| EOT, EoT, EoTr | End of trial |
| ESCMID | European Society of Clinical Microbiology and Infectious Diseases |
| ESO | Esomeprazole |
| ESRD | End-stage renal disease |
| EU | European Union |
| EUCT | European Union Clinical Trials (trial number) |
| EudraCT, Eudra-CT | European Union Drug Regulating Authorities Clinical Trials Database |
| FAM | Famciclovir |
| FAMHP | Federal Agency for Medicines and Health Products (Belgium) |
| FAS | Full analysis set |
| FCV | Famciclovir |
| FDA | Food and Drug Administration |
| FLAMSA-RIC | Fludarabine, amsacrine, and cytarabine with reduced-intensity conditioning |
| FOS, Fos | Foscarnet |
| FOS-I | Foscarnet intolerance |
| FSH | Follicle stimulating hormone |
| GC | Guanine-cytosine |
| GCP | Good Clinical Practice |
| GCSF | Granulocyte colony stimulating factor |
| GI | Gastrointestinal |
| GMR | Geometric mean ratio |
| GP | General practitioner |
| GVHD, GvHD | Graft-versus-host disease |
| Gy | Gray (unit of absorbed radiation dose) |
| H/P, HP | Helicase-primase |
| H2 | Histamine-2 (receptor) |
| HBc | Hepatitis B core antigen |
| HBc-Ab | Hepatitis B core antibody |
| HBsAg | Hepatitis B surface antigen |
| HCL | Hospices Civils de Lyon (Lyon university hospitals) |
| HCMV | Human cytomegalovirus |
| HCP | Health care professional |
| HCT, HCTs | Hematopoietic cell transplantation |
| HCTr | Hematopoietic cell transplantation recipients |
| HCV | Hepatitis C virus |
| HCV-Ab, HCVAb | Hepatitis C virus antibody |
| HD | High dose |
| HDIT101 | Investigational anti-HSV monoclonal antibody from Heidelberg ImmunoTherapeutics |
| HECON | Health economics |
| hERG | Human ether-à-go-go-related gene |
| HHS | Hypertrophic herpes simplex |
| HHV-6 | Human herpesvirus 6 |
| HHV1 | Human herpesvirus 1 |
| HIV | Human immunodeficiency virus |
| HIV-1, HIV-I | Human immunodeficiency virus type 1 |
| HIV-Ab | Human immunodeficiency virus antibody |
| HL | Herpes labialis |
| HLA | Human leucocyte antigen |
| HPC | Helicase-primase complex; hematopoietic progenitor cell |
| HPI, HPIs | Helicase-primase inhibitor |
| HPLC | High-performance liquid chromatography |
| HPLC-AMS | High-performance liquid chromatography with accelerator mass spectrometry |
| HPLC-MS, HPLC-MS/MS | High-performance liquid chromatography with mass spectrometry, with tandem mass spectrometry |
| HPMC | Hydroxypropyl methylcellulose |
| HPMPC | (S)-1-(3-hydroxy-2-phosphonylmethoxypropyl)cytosine (cidofovir) |
| HR, HRs | Hazard ratio; heart rate |
| HSCT, HSCTs | Haematopoietic stem cell transplantation |
| HSE | Herpes simplex encephalitis |
| HSV, HSVs | Herpes simplex virus |
| HSV-1, HSV1 | Herpes simplex virus type 1 |
| HSV-1/2, HSV1/2 | Herpes simplex virus types 1 and 2 |
| HSV-2, HSV2 | Herpes simplex virus type 2 |
| HSVDR | University of Washington laboratory test code for UL23 Sanger sequencing |
| HSVDRR | University of Washington laboratory test code for rapid polymerase chain reaction with reflex UL23 sequencing |
| HUG | Hôpitaux Universitaires de Genève (Geneva University Hospitals) |
| IAT | Investigator-assigned therapy |
| IC | Immunocompromised |
| IC50 | 50% inhibitory concentration |
| ICD-10 | International Classification of Diseases, Tenth Revision |
| 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 |
| ICT | Investigator's choice therapy |
| ICU | Intensive care unit |
| ID-50 | 50% inhibitory dose |
| IDSA | Infectious Diseases Society of America |
| IDWeek | Joint annual meeting of the Infectious Diseases Society of America and partner societies |
| IEC | Independent ethics committee |
| IgG, IgM | Immunoglobulin G, immunoglobulin M |
| IM-250 | Development code for adibelivir |
| IMP, IMPs | Investigational medicinal product |
| IND | Investigational New Drug application |
| INR | International normalized ratio |
| INT | Intermittent infusion |
| IPR | Independent photographic review |
| IQR | Interquartile range |
| IRCCS | Istituto di Ricovero e Cura a Carattere Scientifico (Italian scientific institute for research, hospitalization, and health care) |
| IRIS | Immune reconstitution inflammatory syndrome |
| ITT | Intent to treat |
| IU | Indiana University |
| IV, iv, i.v. | Intravenous |
| JAMA | Journal of the American Medical Association |
| JMML | Juvenile myelomonocytic leukemia |
| kb | Kilobase |
| kBq | Kilobecquerel |
| KDIGO | Kidney Disease: Improving Global Outcomes |
| KEGG | Kyoto Encyclopedia of Genes and Genomes |
| Ki | Inhibition constant |
| KM | Kaplan-Meier |
| KOLs | Key opinion leaders |
| LDTs | Laboratory-developed tests |
| LipP1 | Trial of pritelivir 5% ointment for recurrent herpes labialis (AIC316-02-II-01) |
| LLN | Lower limit of normal |
| LLOQ, LLOQs | Lower limit of quantification |
| LS | Least squares |
| LSmeans | Least squares means |
| LSU | Louisiana State University |
| m/p | Metabolite-to-parent (ratio) |
| MA | Marketing authorisation |
| MATE, MATE2-K | Multidrug and toxin extrusion protein, multidrug and toxin extrusion protein 2-K |
| MBq | Megabecquerel |
| MDMA | 3,4-methylenedioxymethamphetamine |
| MDS | Myelodysplastic syndrome |
| MedDRA | Medical Dictionary for Regulatory Activities |
| METC | Medisch Ethische Toetsingscommissie (Dutch medical ethics review committee) |
| mFAS | Modified full analysis set |
| MHRA | Medicines and Healthcare products Regulatory Agency |
| MIC | Minimum inhibitory concentration |
| MIRC | Midway Immunology and Research Center |
| MO | Missouri |
| MRI | Magnetic resonance imaging |
| MRT | Mean residence time |
| MSLs | Medical science liaisons |
| N.A. | Not applicable |
| NC | Not calculated |
| NCCN | National Comprehensive Cancer Network |
| NCI | National Cancer Institute |
| NCT | National Clinical Trial (ClinicalTrials.gov identifier) |
| NDA | New Drug Application |
| NDC | National Drug Code |
| NE | Not estimable |
| NGS | Next-generation sequencing |
| NHL | Non-Hodgkin lymphoma |
| Nhs | National Health Service |
| NIH | National Institutes of Health |
| NRS | Numeric rating scale |
| nt | Nucleotides |
| NTAP | New Technology Add-on Payment |
| NTD | N-terminal domain |
| NUC | Nucleoside analogue |
| OAT, OAT1, OAT3 | Organic anion transporter, organic anion transporters 1 and 3 |
| OATP, OATP1B1, OATP1B3, OATP2B1 | Organic anion transporting polypeptide, organic anion transporting polypeptides 1B1, 1B3, and 2B1 |
| OCT, OCT1, OCT2 | Organic cation transporter, organic cation transporters 1 and 2 |
| OH-bupropion | 4-hydroxy-bupropion |
| OH-flurbiprofen | 4-hydroxy-flurbiprofen |
| OP | Oropharynx |
| OTC | Over the counter |
| P-gp | P-glycoprotein |
| PCR | Polymerase chain reaction |
| PCV | Penciclovir |
| PD | Pharmacodynamics |
| PDUFA | Prescription Drug User Fee Act |
| PEG | Polyethylene glycol; percutaneous endoscopic gastrostomy |
| PFA | Phosphonoformic acid (foscarnet) |
| PI | Principal investigator |
| PIP | Paediatric investigation plan |
| PIT | Patient-initiated therapy |
| PK | Pharmacokinetics |
| PK-PD, PK/PD | Pharmacokinetic-pharmacodynamic |
| PKS | Pharmacokinetic set |
| PLHIV, PLWH | People living with HIV |
| PMDA | Pharmaceuticals and Medical Devices Agency (Japan) |
| PO, p.o. | By mouth |
| POL, Pol | DNA polymerase (gene) |
| PoTV | Post-treatment visit |
| PP1, PP2 | Per-protocol analysis sets 1 and 2 |
| PPA | Pyridinyl phenyl acetic acid (pritelivir metabolite) |
| PPI, PPIs | Proton pump inhibitor |
| PPS | Per-protocol set |
| PR | PR interval (electrocardiogram) |
| PRA | Plaque reduction assay |
| PreNDA | Pre-New Drug Application (meeting) |
| PRIOH-1 | Phase 3 trial of pritelivir in immunocompromised participants with refractory mucocutaneous HSV infection (NCT03073967) |
| PROC | Procedure (SAS software) |
| PRV | Pritelivir |
| PT, Pt, PTs | Preferred term |
| PTD | Posttransplant day |
| PTE | Proportion of treatment effect explained |
| PTT | Partial thromboplastin time |
| PTV | Pritelivir |
| pUL5, pUL30, pUL52 | Protein products of the UL5, UL30, and UL52 genes |
| PWH | People with HIV |
| Q1 | First quarter; first quartile |
| q12h, Q12h | Every 12 hours |
| Q2 | Second quarter |
| Q24h | Every 24 hours |
| Q3 | Third quartile |
| Q4 | Fourth quarter |
| q8h, Q8h | Every 8 hours |
| QALYs | Quality-adjusted life years |
| QD, qd | Once daily |
| qPCR | Quantitative polymerase chain reaction |
| QRS | QRS complex (electrocardiogram) |
| QT | QT interval |
| QT/QTc | QT interval and QT interval corrected for heart rate |
| QTc | QT interval corrected for heart rate |
| QTcF | QT interval corrected using the Fridericia method |
| QTcI | QT interval with individualized correction |
| QWK | Once weekly |
| R/I | Resistant or intolerant |
| R/R, r/r | Refractory and/or resistant |
| RAM | Resistance-associated mutation |
| RBC | Risk Benefit Committee |
| RED | Rapid equilibrium dialysis |
| RHL, rHL | Recurrent herpes labialis |
| RHS | Recurrent herpes simplex |
| RNA | Ribonucleic acid |
| RR | Relative risk |
| RT-PCR | Reverse transcription polymerase chain reaction |
| Rx | Prescription (drug therapy) |
| s/p | Status post |
| SAE, SAEs | Serious adverse event |
| SAMD9 | Sterile alpha motif domain-containing protein 9 (gene) |
| SAP | Statistical analysis plan |
| SARS-CoV-2 | Severe acute respiratory syndrome coronavirus 2 |
| SAS | Safety analysis set; Statistical Analysis System (software) |
| sBCC | Superficial basal cell carcinoma |
| SCT | Stem cell transplant |
| SD | Standard deviation |
| SmpC | Summary of product characteristics |
| SOC, SoC | Standard of care; system organ class |
| SOLSTICE | Trial of maribavir versus investigator-assigned therapy (NCT02931539) |
| SOT | Solid organ transplant |
| SS | Safety set |
| ssDNA | Single-stranded deoxyribonucleic acid |
| ST-T | ST segment and T wave (electrocardiogram) |
| t.i.d., TID, tid | Three times daily |
| T1, T2 | Treatment 1 (reference), treatment 2 (test) |
| t1/2z | Apparent terminal elimination half-life |
| TAT | Turnaround time |
| TAVI | Transplant-Associated Virus Infections (Forum) |
| TEAE, TEAEs | Treatment-emergent adverse event |
| TFT | Trifluorothymidine |
| TG | Trigeminal ganglia |
| TK | Thymidine kinase |
| TKA | Thymidine kinase altered |
| TKD | Thymidine kinase deficient |
| TKN | Thymidine kinase negative |
| TKP | Thymidine kinase partial |
| tlag, Tlag | Time between dosing and the first measurable concentration |
| tmax, Tmax | Time to maximum observed concentration |
| TNO | Nederlandse Organisatie voor Toegepast Natuurwetenschappelijk Onderzoek (Netherlands Organisation for Applied Scientific Research) |
| TQT | Thorough QT |
| TRA | Total radioactivity |
| TTP/HUS | Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome |
| UB-621 | Investigational anti-HSV monoclonal antibody |
| UCL | University College London |
| UF | University of Florida |
| UK | United Kingdom |
| UKHSA | UK Health Security Agency |
| UL23 | HSV gene encoding thymidine kinase |
| UL30 | HSV gene encoding DNA polymerase |
| UL5 | HSV gene encoding the helicase subunit of the helicase-primase complex |
| UL52 | HSV gene encoding the primase subunit of the helicase-primase complex |
| UL70 | Human cytomegalovirus homolog of HSV UL52 |
| UL8 | HSV gene encoding the noncatalytic subunit of the helicase-primase complex |
| ULN | Upper limit of normal |
| UPLC-MS/MS | Ultraperformance liquid chromatography with tandem mass spectrometry |
| US, U.S., USA | United States |
| USAN/INN | United States Adopted Name/International Nonproprietary Name |
| USD | U.S. dollars |
| USP | United States Pharmacopeia |
| VACV | Valacyclovir |
| Vd | Volume of distribution |
| Vd/F | Apparent volume of distribution |
| VL | Viral load |
| Vss/F | Apparent volume of distribution at steady state |
| VZV | Varicella-zoster virus |
| w/w | Weight per weight |
| WAC | Wholesale acquisition cost |
| WHO | World Health Organization |
| WT | Wild-type |
| WW | Worldwide |
| XRPD | X-ray powder diffraction |
| YE2026 | Year-end 2026 |
| β-HCG | Beta-human chorionic gonadotropin |
| ΔQTc, ΔQTcF | Change from baseline in QTc, change from baseline in QTcF |
| λz | Apparent terminal elimination rate constant |
| μCi | Microcurie |