Establishing shared definitions of virological failure and discontinuation for long-acting injectable cabotegravir and rilpivirine therapy (the CONSENSUS-LAI Study): an international survey and Delphi process

Chloe Orkin¹, Amy Paterson², Alexa Elias³, Melanie Smuk³, Kyle Ring³, Alain Volny-Anne³, Alexandra Calmy⁴, Aniruddha Hazra⁵, Anna Maria Geretti⁶, Asa Radix⁷, Boghuma K Titanji⁸, Bruno Spire⁹, Carlos Del Rio¹⁰, Caroline Foster¹¹, Carolyn Bolton Moore¹², Claudia P Cortes¹³, Cristina Mussini¹⁴, Daniel R Kuritzkes¹⁵, Darrell H S Tan¹⁶, Esteban Martinez¹⁷, Ferdinand W N M Wit¹⁸, Fiona Cresswell¹⁹, W D Francois Venter²⁰, Itzchak Levy²¹, Jason Zucker²², Jean-Michel Molina²³, Jennifer Hoy²⁴, Jose Arribas²⁵, Josep M Llibre²⁶, Judith Currier²⁷, Juergen Rockstroh²⁸, Jussi Sutinen²⁹, Kelly Gebo³⁰, Laura Waters³¹, Magnus Gisslen³², Mark O'Reilly³³, Marta Boffito³⁴, Melanie Thompson³⁵, Milosz Parczewski³⁶, Mina John³⁷, Monica Gandhi³⁸, Nagalingeswaran Kumarasamy³⁹, Nicholas Paton⁴⁰, Nicola Mackie⁴¹, Pedro Cahn⁴², Rick Elion⁴³, Sebastian Noe⁴⁴, Sharon Walmsley⁴⁵, Simon Collins⁴⁶, Susan Cole-Haley⁴⁷, Vanessa Apea³, William R Short⁴⁸, Yvonne Gilleece⁴⁹, Sara Paparini³

Affiliations

¹ SHARE Collaborative, Centre for Immunobiology, Blizard Institute, Queen Mary University of London, London, UK. Electronic address: c.m.orkin@qmul.ac.uk.
² SHARE Collaborative, Centre for Immunobiology, Blizard Institute, Queen Mary University of London, London, UK; Pandemic Sciences Institute, University of Oxford, Oxford, UK.
³ SHARE Collaborative, Centre for Immunobiology, Blizard Institute, Queen Mary University of London, London, UK.
⁴ HIV/AIDS Unit, Center for Clinical Research, Geneva University Hospitals, Geneva, Switzerland.
⁵ Section of Infectious Diseases & Global Health, University of Chicago, Chicago, IL, USA.
⁶ University of Rome Tor Vergata, Division of System Medicine, Infectious Diseases Unit, Rome, Italy.
⁷ Department of Medicine, Callen-Lorde Community Health Center, New York, NY, USA.
⁸ Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Médecins du Cameroun (Medcamer), Yaoundé, Cameroon.
⁹ Inserm, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, ISSPAM, Aix Marseille University, Marseille, France.
¹⁰ Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA.
¹¹ Department of Adolescent Infectious Diseases, Imperial College Healthcare NHS Trust, London, UK.
¹² Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
¹³ University of Chile School of Medicine, Santiago, Chile.
¹⁴ Division of Infectious Diseases, University of Modena and Reggio Emilia, Emilia-Romagna, Italy.
¹⁵ Division of Infectious Diseases, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
¹⁶ Division of Infectious Diseases, St Michael's Hospital, Toronto, ON, Canada.
¹⁷ Hospital Clínic, IDIBAPS, Universitat de Barcelona, Barcelona, Spain; CIBER de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain.
¹⁸ Stichting HIV Monitoring & Department of Internal Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.
¹⁹ Global Health and Infection, Brighton and Sussex Medical School, Brighton, UK; The Medical Research Council/Uganda Virus Research Institute and London School of Hygiene & Tropical Medicine, Uganda Research Unit, Entebbe, Uganda.
²⁰ Wits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Public Health Medicine, School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa.
²¹ Sheba Medical Center and Tel Aviv University Medical School, Israel.
²² Division of Infectious Diseases, Columbia University Irving Medical Center, New York, NY, USA.
²³ Department of Infectious Diseases, Saint-Louis and Lariboisière Hospitals, University of Paris Cité, Paris, France.
²⁴ Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, VIC, Australia.
²⁵ Hospital La Paz, CIBERINFEC, Madrid, Spain.
²⁶ Infectious Diseases Division, University Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain; Fight Infections Foundation, Badalona, Barcelona, Spain.
²⁷ Division of Infectious Diseases, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
²⁸ University Hospital Bonn, Bonn, Germany.
²⁹ Division of Infectious Diseases, Inflammation Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
³⁰ Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
³¹ Central & North West London NHS Trust and University College London, London, UK.
³² Department of Infectious Diseases, Sahlgrenska Academy at University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden; Public Health Agency of Sweden, Solna, Sweden.
³³ East Sydney Doctors, Darlinghurst, NSW, Australia; Taylor Square Private Clinic, Surry Hills, NSW, Australia.
³⁴ Chelsea and Westminster Hospital Foundation Trust and Imperial College London, London, UK.
³⁵ Thacker and Thompson, MD, Atlanta, GA, USA.
³⁶ Department of Infectious, Tropical Diseases and Immune Deficiency, Pomeranian Medical University, Szczecin, Poland.
³⁷ Department of Clinical Immunology, Royal Perth Hospital, Perth, WA, Australia.
³⁸ Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine, University of California, San Francisco, CA, USA.
³⁹ VHS Infectious Diseases Medical Centre, CART Clinical Research Site, Chennai, India.
⁴⁰ Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
⁴¹ Imperial College Healthcare NHS Trust, London, UK.
⁴² Fundacion Huesped, Buenos Aires, Argentina.
⁴³ George Washington University School of Medicine, Washington Health Institute, Washington, DC, USA.
⁴⁴ Medizinisches Versorgungszentrum, München am Goetheplatz, Munich, Germany.
⁴⁵ University Health Network, Department of Medicine, University of Toronto, Toronto, ON, Canada.
⁴⁶ HIV i-Base, London, UK.
⁴⁷ The Global Network of People Living with HIV, Amsterdam, Netherlands.
⁴⁸ Division of Infectious Diseases, Department of Medicine, Perelman School of Medicine at The University of Pennsylvania, Philadelphia, PA, USA.
⁴⁹ Brighton & Sussex Medical School and University Hospitals Sussex NHS Foundation Trust, Brighton and Hove, UK.

PMID: 40774264
DOI: 10.1016/S2352-3018(25)00131-6

Free article

Establishing shared definitions of virological failure and discontinuation for long-acting injectable cabotegravir and rilpivirine therapy (the CONSENSUS-LAI Study): an international survey and Delphi process

Chloe Orkin et al. Lancet HIV. 2025 Sep.

Free article

. 2025 Sep;12(9):e649-e659.

doi: 10.1016/S2352-3018(25)00131-6. Epub 2025 Aug 4.

Authors

Affiliations

¹ SHARE Collaborative, Centre for Immunobiology, Blizard Institute, Queen Mary University of London, London, UK. Electronic address: c.m.orkin@qmul.ac.uk.
² SHARE Collaborative, Centre for Immunobiology, Blizard Institute, Queen Mary University of London, London, UK; Pandemic Sciences Institute, University of Oxford, Oxford, UK.
³ SHARE Collaborative, Centre for Immunobiology, Blizard Institute, Queen Mary University of London, London, UK.
⁴ HIV/AIDS Unit, Center for Clinical Research, Geneva University Hospitals, Geneva, Switzerland.
⁵ Section of Infectious Diseases & Global Health, University of Chicago, Chicago, IL, USA.
⁶ University of Rome Tor Vergata, Division of System Medicine, Infectious Diseases Unit, Rome, Italy.
⁷ Department of Medicine, Callen-Lorde Community Health Center, New York, NY, USA.
⁸ Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Médecins du Cameroun (Medcamer), Yaoundé, Cameroon.
⁹ Inserm, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, ISSPAM, Aix Marseille University, Marseille, France.
¹⁰ Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA.
¹¹ Department of Adolescent Infectious Diseases, Imperial College Healthcare NHS Trust, London, UK.
¹² Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
¹³ University of Chile School of Medicine, Santiago, Chile.
¹⁴ Division of Infectious Diseases, University of Modena and Reggio Emilia, Emilia-Romagna, Italy.
¹⁵ Division of Infectious Diseases, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
¹⁶ Division of Infectious Diseases, St Michael's Hospital, Toronto, ON, Canada.
¹⁷ Hospital Clínic, IDIBAPS, Universitat de Barcelona, Barcelona, Spain; CIBER de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain.
¹⁸ Stichting HIV Monitoring & Department of Internal Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.
¹⁹ Global Health and Infection, Brighton and Sussex Medical School, Brighton, UK; The Medical Research Council/Uganda Virus Research Institute and London School of Hygiene & Tropical Medicine, Uganda Research Unit, Entebbe, Uganda.
²⁰ Wits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Public Health Medicine, School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa.
²¹ Sheba Medical Center and Tel Aviv University Medical School, Israel.
²² Division of Infectious Diseases, Columbia University Irving Medical Center, New York, NY, USA.
²³ Department of Infectious Diseases, Saint-Louis and Lariboisière Hospitals, University of Paris Cité, Paris, France.
²⁴ Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, VIC, Australia.
²⁵ Hospital La Paz, CIBERINFEC, Madrid, Spain.
²⁶ Infectious Diseases Division, University Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain; Fight Infections Foundation, Badalona, Barcelona, Spain.
²⁷ Division of Infectious Diseases, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
²⁸ University Hospital Bonn, Bonn, Germany.
²⁹ Division of Infectious Diseases, Inflammation Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
³⁰ Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
³¹ Central & North West London NHS Trust and University College London, London, UK.
³² Department of Infectious Diseases, Sahlgrenska Academy at University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden; Public Health Agency of Sweden, Solna, Sweden.
³³ East Sydney Doctors, Darlinghurst, NSW, Australia; Taylor Square Private Clinic, Surry Hills, NSW, Australia.
³⁴ Chelsea and Westminster Hospital Foundation Trust and Imperial College London, London, UK.
³⁵ Thacker and Thompson, MD, Atlanta, GA, USA.
³⁶ Department of Infectious, Tropical Diseases and Immune Deficiency, Pomeranian Medical University, Szczecin, Poland.
³⁷ Department of Clinical Immunology, Royal Perth Hospital, Perth, WA, Australia.
³⁸ Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine, University of California, San Francisco, CA, USA.
³⁹ VHS Infectious Diseases Medical Centre, CART Clinical Research Site, Chennai, India.
⁴⁰ Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
⁴¹ Imperial College Healthcare NHS Trust, London, UK.
⁴² Fundacion Huesped, Buenos Aires, Argentina.
⁴³ George Washington University School of Medicine, Washington Health Institute, Washington, DC, USA.
⁴⁴ Medizinisches Versorgungszentrum, München am Goetheplatz, Munich, Germany.
⁴⁵ University Health Network, Department of Medicine, University of Toronto, Toronto, ON, Canada.
⁴⁶ HIV i-Base, London, UK.
⁴⁷ The Global Network of People Living with HIV, Amsterdam, Netherlands.
⁴⁸ Division of Infectious Diseases, Department of Medicine, Perelman School of Medicine at The University of Pennsylvania, Philadelphia, PA, USA.
⁴⁹ Brighton & Sussex Medical School and University Hospitals Sussex NHS Foundation Trust, Brighton and Hove, UK.

PMID: 40774264
DOI: 10.1016/S2352-3018(25)00131-6

Abstract

Background: Definitions of virological failure and treatment discontinuation for long-acting injectable (LAI) cabotegravir and rilpivirine antiretroviral therapy are inconsistent in clinical practice and observational studies, which complicates interpretation and implementation of findings. The CONSENSUS-LAI study aimed to establish consistent definitions of virological failure and treatment discontinuation to enhance evidence transferability and support optimal clinical outcomes.

Methods: The study had two phases. Phase 1 was an international online survey exploring existing definitions of virological and treatment discontinuation, conducted between April 25 and July 1, 2024. Eligible participants were health-care professionals working in infectious disease or sexual health services who had provided care to at least ten people living with HIV in the past 6 months, had prescribed LAI cabotegravir and rilpivirine in clinical trials or clinical practice, and were able to give informed consent. Participants were recruited via social media and mailing lists of medical specialist societies. Phase 2 was a Delphi process, in which a panel of experts, selected to ensure representation from all six WHO regions, scored leading definitions from phase 1 on a 9-point Likert scale. The proposed definitions were scored according to four validity criteria: clarity, usability in the expert's setting, appropriateness across clinical purposes, and applicability across relevant population groups. Revisions were suggested in iterative rounds until consensus was reached. Consensus was predefined as at least 75% of experts agreeing or strongly agreeing (scores 7-9) with the validity criteria.

Findings: 386 LAI cabotegravir and rilpivirine prescribers across 28 countries completed the survey, revealing 15 definitions for virological failure on LAI cabotegravir and rilpivirine and nine for treatment discontinuation. 52 experts participated in the Delphi process. Consensus agreement on both definitions was reached after two rounds for all validity criteria. For virological failure, the consensus definition was as follows: (a) viral load 200 copies or more per mL or more on two occasions 2-4 weeks apart, or (b) a single viral load of more than 1000 copies per mL, and/or (c) emergent resistance, in the context of timely injections and prior suppression of less than 200 copies per mL, OR (d) unable to suppress viral load to less than 200 copies per mL on continuous therapy. For treatment discontinuation the consensus definition was as follows: people on LAI cabotegravir and rilpivirine who have missed two consecutive injections and have not taken oral bridging in the interim, irrespective of reason for discontinuation.

Interpretation: The consensus definitions provide a foundation for aligning practice and evaluating patient outcomes. Further validation of the viral load threshold for virological failure and the optimal viral load retesting window is required.

Funding: ViiV Healthcare.

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Conflict of interest statement

Declaration of interests CO has received honoraria for advisory boards, lectureships, and travel sponsorships from Janssen, Gilead Sciences, ViiV Healthcare, MSD, and Bavarian Nordic; and has received research grants from Janssen, Gilead Sciences, ViiV Healthcare, MSD, and AstraZeneca. KR has received speaker and consultations fees from ViiV Healthcare; conference sponsorship from Janssen and Gilead; and is an investigator on drug trials sponsored by Gilead Sciences and MSD. AV-A receives consultation fees from AbbVie. AC has received grants from MS, ViiV Healthcare, and Gilead Sciences for unrelated research. AMG has received personal fees from Abbott, Gilead, GSK, MSD, Roche, and ViiV Healthcare; and research funding (paid to institution) form Gilead, Roche, and ViiV Healthcare. AH has received honoraria for consulting from Gilead Sciences and ViiV Healthcare; and grants for research studies from Gilead Sciences. CF has received honoraria for consulting from Gilead Sciences and ViiV Healthcare; and grants to the institution from Gilead Sciences and ViiV Healthcare. CPC has received honoraria for consulting from MSD, GSK, and ViiV Healthcare. CBM has participated in advisory boards, received study grants, and/or speaker honoraria from Abbvie, Gilead, ViiV Healthcare, Janssen, Angelini, BMS, and MSD. DRK receives grant support and/or consulting honoraria from AbbVie, Gilead Sciences, GlaxoSmithKline, Janssen, Merck, Roche, and ViiV Healthcare. DHST is supported by a Canada Research Chair in HIV Prevention and STIs. EM has received research grants from MSD and ViiV Healthcare; consultancy compensation from Janssen, MSD, and ViiV Healthcare; and payments for educational activities from Gilead Sciences, Janssen, MSD and ViiV Healthcare. FWNMW has received consultancy fees from ViiV Healthcare (paid to his institution); and fees for advisory boards from Gilead Sciences and ViiV Healthcare. FC has received grant funding to the institution from ViiV Healthcare, Johnson & Johnson, and Wellcome Trust. WDFV receives funding from the Bill & Melinda Gates Foundation, SA Medical Research Council, National Institutes for Health, Unitaid, Foundation for Innovative New Diagnostics, Merck, and the Children's Investment Fund Foundation; has previously received funding from US Agency for International Development; and receives drug donations from ViiV Healthcare, Merck, J&J, and Gilead Sciences for investigator-led clinical studies. The unit does investigator-led studies with Merck, J&J, and ViiV Heathcare providing financial support; and is doing commercial drug studies for Merck and Novo. The unit performs evaluations of diagnostic devices for multiple biotech companies. WDFV receives honoraria for educational talks and advisory board membership for Gilead, ViiV, Mylan/Viatris, Merck, Adcock-Ingram, Aspen, Abbott, Roche, Johnson & Johnson, Sanofi, Boehringer Ingelheim, Thermo-Fischer, and Virology Education. IL has been a consultant or advisor for Gilead Sciences, GSK, and MSD; provided expert testimony for GSK; received grants from Gilead Sciences; and payment for lectures from Gilead, GSK, MSD, and Pfizer. J-MM has received honoraria for advisory board participation from Gilead Sciences, Merck, and ViiV Healthcare; and received grant funding from Gilead Sciences. JH's institution has received reimbursement for her time on advisory boards for Gilead Sciences and ViiV Healthcare. JML received honoraria for lectures, presentations, or speaker's bureaus from Janssen-Cilag, Gilead Sciences, Thera Technologies, MSD, and ViiV Healthcare, outside of the present work; and received support from Gilead Sciences, Janssen Cilag, and ViiV Healthcare for attending meetings; received consulting fees from ViiV Healthcare, Gilead Sciences, MSD, and Janssen-Cilag; and declares payment for expert testimony from Gilead Sciences. JC has served as a Scientific Advisor for Merck and Company. JR has received honoraria for consulting or speaking at educational events from Abbvie, Boehringer, Gilead Sciences, Janssen, MSD, and ViiV Healthcare; received payment for participation on a data safety monitoring board or advisory board for Abivax; and is a European AIDS Clinical Society Board Member. JS has received honoraria, lecture fees, and conference support from Gilead, Merck, GSK, and ViiV Healthcare; and declares research grants from Gilead and Merck. KG has received royalties from UpToDate; was an uncompensated advisor to Pfizer; and has consulted for Shionogi, Spark HealthCare, Premier HealthCare, Harrison Consulting, and MedEd Learning. LW has received speaker or advisory fees from ViiV Healthcare, MSD, and Janssen; and she is an investigator in trials sponsored by Gilead. MG received research grants from Gilead Sciences and honoraria as speaker; and was a Data Safety Monitoring Board committee member and Scientific Advisor for Amgen, AstraZeneca, Biogen, Bristol-Myers Squibb, Gilead Sciences, GSK, ViiV Healthcare, Janssen-Cilag, MSD, Novocure, Novo Nordic, Pfizer, and Sanofi. MO'R has received honoraria for consulting or speaking at educational events from Gilead and ViiV Healthcare; received travel sponsorships from ViiV Healthcare; and is an investigator in Gilead Sciences-sponsored clinical trials. MB has received personal fees from Gilead Sciences, GSK, MSD, Roche, ViiV Healthcare, Pfizer, and Atea Pharmaceuticals; and received research funding (paid to institution) from Gilead, ViiV Healthcare, MSD, Moderna, and Sanofi. MT serves as the Chair of the Independent Data Monitoring Committee for Excision Biotherapeutics. MP has received personal fees from Gilead, GSK, ViiV Healthcare, MSD, Jannsen, and Roche. MJ has received research funding for consulting and educational activities from ViiV Healthcare, GSK, and Gilead Sciences. NK received grants or contracts from Hetero Labs, Viatris, Emcure, Johnson & Johnson, US National Institutes of Health, Indian Council of Medical Research, and WHO. NP has reports grants (paid to institution), donation of drugs (to institution), and speaker fees from Janssen. NM has participated in Advisory Boards for ViiV Healthcare and Gilead Sciences. PC has received consulting fees from Gilead, Merck, and ViiV Healthcare; and has participated in Data Safety Monitoring and Advisory Boards for Gilead Sciences, Janssen, Merck, Moderna, and ViiV Healthcare. RE has received grants or research support from Gilead Sciences, ViiV Healthcare, and Proteus; has served as an advisor for Gilead Sciences and ViiV Healthcare; and received honoraria from Janssen. SN has received honoraria as an advisor or speaker from Gilead Sciences, MSD, and ViiV Healthcare. SW has received honoraria as an advisor or speaker from Gilead Sciences, MSD, and ViiV Healthcare; and has received grant support (paid to her institution) from Gilead, MSD, and ViiV Healthcare. SC-H has received honoraria for consulting or speaking at educational events from Gilead Sciences and Viiv Healthcare. VA has received speaker or advisory fees from ViiV Healthcare, Gilead Sciences, and MSD. WRS has received honoraria for consulting for Gilead Sciences, Janssen, and ViiV Healthcare; and grants for research from ViiV healthcare and Gilead Sciences (paid to his institution). YG has received honoraria for consulting or speaking at educational events from Gilead Sciences and ViiV Healthcare. SP has received research grants from ViiV Healthcare and Gilead Sciences. BKT has recieved unrelated grants from Emory Center for AIDS Research and the Foundation for Atlanta Veterans Education and Research. CdR reported receiving consulting fees from Roche Diagnostics outside the submitted work. All other authors declare no competing interests.

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Establishing shared definitions of virological failure and discontinuation for long-acting injectable cabotegravir and rilpivirine therapy (the CONSENSUS-LAI Study): an international survey and Delphi process

Affiliations

Establishing shared definitions of virological failure and discontinuation for long-acting injectable cabotegravir and rilpivirine therapy (the CONSENSUS-LAI Study): an international survey and Delphi process

Authors

Affiliations

Abstract

Conflict of interest statement

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