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

Bhimraj et al., Clinical Infectious Diseases, doi:10.1093/cid/ciae435

Oct 2024

Update to IDSA clinical practice guidelines on the treatment and management of COVID-19, providing a conditional recommendation for pre-exposure prophylaxis with pemivibart, an anti-SARS-CoV-2 neutralizing antibody, in moderately or severely immunocompromised individuals aged 12 years or older at risk for progression to severe COVID-19, when predominant regional variants are susceptible to the agent. The recommendation is based on low certainty of evidence derived from immunobridging studies. Serious adverse events included a 0.6% risk of anaphylaxis with pemivibart.

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Bhimraj et al., 29 Oct 2024, USA, peer-reviewed, 26 authors. Contact: practiceguidelines@idsociety.org.

This Paper Pemivibart All

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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