2024 Clinical Practice Guideline Update by the Infectious Diseases Society of America on the Management of COVID-19: Anti-SARS-CoV-2 Neutralizing Antibody Pemivibart for Pre-exposure Prophylaxis
Adarsh Bhimraj, Yngve Falck-Ytter, Arthur Y Kim, Jonathan Z Li, Lindsey R Baden, Steven Johnson, Robert W Shafer, Shmuel Shoham, Pablo Tebas, Roger Bedimo, Vincent Chi-Chung Cheng, Kara W Chew, Kathleen Chiotos, Eric S Daar, Amy L Dzierba, David V Glidden, Erica J Hardy, Greg S Martin, Christine Macbrayne, Nandita Nadig, Mari M Nakamura, Amy Hirsch Shumaker, Phyllis Tien, Jennifer Loveless, Rebecca L Morgan, Rajesh T Gandhi
Clinical Infectious Diseases, doi:10.1093/cid/ciae435
This article provides a focused update to the clinical practice guideline on the treatment and management of patients with coronavirus disease 2019, developed by the Infectious Diseases Society of America. The guideline panel presents a recommendation on the use of the anti-severe acute respiratory syndrome coronavirus 2 neutralizing antibody pemivibart as pre-exposure prophylaxis. The recommendation is based on evidence derived from a systematic review and adheres to a standardized methodology for rating the certainty of evidence and strength of recommendation according to the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach. Information on pemivibart is included in the U.S. Food and Drug Administration
and Gilead Sciences; K.W.C. for Pardes Biosciences (concluded); E.D. for Gilead Sciences; D.V.G. for Gilead Sciences and Merck; A.K. for Shionogi; S.S. for Pfizer; P.T. for Merck and Shionogi. Importantly, these companies have developed COVID-19 treatment (but not prophylaxis) agents. No disclosures reported for all other authors including the chair and vice chair. Additional information. More detailed information on the analysis and development of recommendations is available in the Supplementary Material.
References
Bhimraj, Morgan, Shumaker, Infectious Diseases Society of America guidelines on the treatment and management of patients with COVID-19 (September 2022), Clin Infect Dis
Evans, Dube, Lu, Impact of COVID-19 on immunocompromised populations during the Omicron era: insights from the observational populationbased INFORM study, Lancet Reg Health Eur
Follmann, Brien, Fintzi, Examining protective effects of SARS-CoV-2 neutralizing antibodies after vaccination or monoclonal antibody administration, Nat Commun
Guyatt, Oxman, Vist, GRADE: an emerging consensus on rating quality of evidence and strength of recommendations, BMJ
Invivyd, A study to evaluate the efficacy and safety of VYD222 for prevention of COVID-19 (CANOPY)
Ison, Weinstein, Dobryanska, Prevention of COVID-19 following a single intramuscular administration of adintrevimab: results from a phase 2/3 randomized, double-blind, placebo-controlled trial (EVADE), Open Forum Infect Dis
Levin, Ustianowski, Wit, Intramuscular AZD7442 (tixagevimabcilgavimab) for prevention of COVID-19, N Eng J Med
Loo, Tamney, Arends, The SARS-CoV-2 monoclonal antibody combination, AZD7442, is protective in nonhuman primates and has an extended half-life in humans, Sci Transl Med
Rappazzo, Tse, Kaku, Broad and potent activity against SARS-like viruses by an engineered human monoclonal antibody, Science
Solera, Árbol, Mittal, Longitudinal outcomes of COVID-19 in solid organ transplant recipients from 2020 to 2023, Am J Transplant
Stadler, Burgess, Schlub, Monoclonal antibody levels and protection from COVID-19, Nat Commun
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"abstract": "<jats:title>Abstract</jats:title>\n <jats:p>This article provides a focused update to the clinical practice guideline on the treatment and management of patients with coronavirus disease 2019, developed by the Infectious Diseases Society of America. The guideline panel presents a recommendation on the use of the anti–severe acute respiratory syndrome coronavirus 2 neutralizing antibody pemivibart as pre-exposure prophylaxis. The recommendation is based on evidence derived from a systematic review and adheres to a standardized methodology for rating the certainty of evidence and strength of recommendation according to the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach. Information on pemivibart is included in the U.S. Food and Drug Administration Emergency Use Authorization for this agent.</jats:p>",
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