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

作者：Chloe Orkin, Amy Paterson, Alexa Elias, Melanie Smuk, Kyle Ring, Alain Volny‐Anne, Alexandra Calmy, Aniruddha Hazra, Anna María Geretti, Asa Radix, Boghuma K Titanji, Bruno Spire, Carlos del Rı́o, Caroline Foster, Carolyn Bolton‐Moore, Claudia P. Cortés, Cristina Mussini, Daniel R. Kuritzkes, Darrell H. S. Tan, Estebán Martínez, Ferdinand W N M Wit, Fiona V Cresswell, François Venter, Itzchak Levy, Jason Zucker, Jean‐Michel Molina, Jennifer Hoy, José Ramón Arribas, Josep M. Llibre, Judith S. Currier, Juergen Rockstroh, Jussi Sutinen, Kelly A. Gebo, Laura Waters, Magnus Gisslén, Mark O’Reilly, Marta Boffito, Melanie Thompson, Miłosz Parczewski, Mina John, Monica Gandhi, Nagalingeswaran Kumarasamy, Nicholas I. Paton, Nicola Mackie, Pedro Cahn, Rick Elion, Sebastian Noé, Sharon Walmsley, Simon Collins, Susan Cole‐Haley, Vanessa Apea, William R. Short, Yvonne Gilleece, Sara Paparini · 发表于：The Lancet HIV · 年份：2025 · DOI：10.1016/s2352-3018(25)00131-6 · 被引用次数：10 · 研究领域：HIV/AIDS drug development and treatment、HIV/AIDS Research and Interventions、HIV-related health complications and treatments

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...