Consensus recommendations for the use of novel antiretrovirals in persons with HIV who are heavily treatment-experienced and/or have multidrug-resistant HIV-1: Endorsed by the American Academy of HIV Medicine, American College of Clinical Pharmacy

David B Cluck¹, Daniel B Chastain², Milena Murray^{3

4}, Spencer H Durham⁵, Elias B Chahine⁶, Caroline Derrick⁷, Julie B Dumond⁸, E Kelly Hester⁵, Sarah B Jeter⁹, Melissa D Johnson¹⁰, Christin Kilcrease¹¹, Wesley D Kufel^{12

13

14}, Jeffrey Kwong¹⁵, Amber F Ladak¹⁶, Nimish Patel¹⁷, Sarah E Pérez¹⁸, Jonell B Poe^{16

19

20}, Charlotte Bolch²¹, Ian Thomas²², Elizabeth Asiago-Reddy^{13

23}, William R Short²⁴

Affiliations

¹ Department of Pharmacy Practice, East Tennessee State University Bill Gatton College of Pharmacy, Johnson City, Tennessee, USA.
² University of Georgia College of Pharmacy, Albany, Georgia, USA.
³ Midwestern University College of Pharmacy, Downers Grove, Illinois, USA.
⁴ Northwestern Medicine, Evanston, Illinois, USA.
⁵ Department of Pharmacy Practice, Auburn University Harrison College of Pharmacy, Auburn, Alabama, USA.
⁶ Department of Pharmacy Practice, Palm Beach Atlantic University Gregory School of Pharmacy, West Palm Beach, Florida, USA.
⁷ Prisma Health Midlands, Columbia, South Carolina, USA.
⁸ Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
⁹ University of Kentucky HealthCare, Lexington, Kentucky, USA.
¹⁰ Duke University School of Medicine, Durham, North Carolina, USA.
¹¹ HIV Prevention/Treatment and Primary Care, The Johns Hopkins Hospital, John G. Bartlett Specialty Practice, Baltimore, Maryland, USA.
¹² Binghamton University School of Pharmacy and Pharmaceutical Sciences, Binghamton, New York, USA.
¹³ Division of Infectious Diseases, State University of New York Upstate Medical University, Syracuse, New York, USA.
¹⁴ State University of New York Upstate University Hospital, Syracuse, New York, USA.
¹⁵ Division of Advanced Practice, School of Nursing, Rutgers, The State University of New Jersey, Newark, New Jersey, USA.
¹⁶ Ryan White Program, Division of Infectious Disease, Augusta University, Augusta, Georgia, USA.
¹⁷ Division of Clinical Pharmacy, Skaggs School of Pharmacy & Pharmaceutical Sciences, University of California, San Diego, La Jolla, California, USA.
¹⁸ HIV and Primary Care, Ruth M. Rothstein CORE Center, Chicago, Illinois, USA.
¹⁹ School of Allied Health, Augusta University, Augusta, Georgia, USA.
²⁰ Department of Psychiatry, HIV/LBTGQ Behavioral Track, Augusta University, Augusta, Georgia, USA.
²¹ Office of Research and Sponsored Programs, Midwestern University, Glendale, Arizona, USA.
²² University of Georgia, Athens, Georgia, USA.
²³ Inclusive Health Services, State University of New York Upstate Medical University, Syracuse, New York, USA.
²⁴ Division of Infectious Diseases, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.

PMID: 38853601
DOI: 10.1002/phar.2914

Review

Consensus recommendations for the use of novel antiretrovirals in persons with HIV who are heavily treatment-experienced and/or have multidrug-resistant HIV-1: Endorsed by the American Academy of HIV Medicine, American College of Clinical Pharmacy

David B Cluck et al. Pharmacotherapy. 2024 May.

. 2024 May;44(5):360-382.

doi: 10.1002/phar.2914.

Authors

Affiliations

¹ Department of Pharmacy Practice, East Tennessee State University Bill Gatton College of Pharmacy, Johnson City, Tennessee, USA.
² University of Georgia College of Pharmacy, Albany, Georgia, USA.
³ Midwestern University College of Pharmacy, Downers Grove, Illinois, USA.
⁴ Northwestern Medicine, Evanston, Illinois, USA.
⁵ Department of Pharmacy Practice, Auburn University Harrison College of Pharmacy, Auburn, Alabama, USA.
⁶ Department of Pharmacy Practice, Palm Beach Atlantic University Gregory School of Pharmacy, West Palm Beach, Florida, USA.
⁷ Prisma Health Midlands, Columbia, South Carolina, USA.
⁸ Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
⁹ University of Kentucky HealthCare, Lexington, Kentucky, USA.
¹⁰ Duke University School of Medicine, Durham, North Carolina, USA.
¹¹ HIV Prevention/Treatment and Primary Care, The Johns Hopkins Hospital, John G. Bartlett Specialty Practice, Baltimore, Maryland, USA.
¹² Binghamton University School of Pharmacy and Pharmaceutical Sciences, Binghamton, New York, USA.
¹³ Division of Infectious Diseases, State University of New York Upstate Medical University, Syracuse, New York, USA.
¹⁴ State University of New York Upstate University Hospital, Syracuse, New York, USA.
¹⁵ Division of Advanced Practice, School of Nursing, Rutgers, The State University of New Jersey, Newark, New Jersey, USA.
¹⁶ Ryan White Program, Division of Infectious Disease, Augusta University, Augusta, Georgia, USA.
¹⁷ Division of Clinical Pharmacy, Skaggs School of Pharmacy & Pharmaceutical Sciences, University of California, San Diego, La Jolla, California, USA.
¹⁸ HIV and Primary Care, Ruth M. Rothstein CORE Center, Chicago, Illinois, USA.
¹⁹ School of Allied Health, Augusta University, Augusta, Georgia, USA.
²⁰ Department of Psychiatry, HIV/LBTGQ Behavioral Track, Augusta University, Augusta, Georgia, USA.
²¹ Office of Research and Sponsored Programs, Midwestern University, Glendale, Arizona, USA.
²² University of Georgia, Athens, Georgia, USA.
²³ Inclusive Health Services, State University of New York Upstate Medical University, Syracuse, New York, USA.
²⁴ Division of Infectious Diseases, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.

PMID: 38853601
DOI: 10.1002/phar.2914

Abstract

Treatment options are currently limited for persons with HIV-1 (PWH) who are heavily treatment-experienced and/or have multidrug-resistant HIV-1. Three agents have been approved by the U.S. Food and Drug Administration (FDA) since 2018, representing a significant advancement for this population: ibalizumab, fostemsavir, and lenacapavir. However, there is a paucity of recommendations endorsed by national and international guidelines describing the optimal use (e.g., selection and monitoring after initiation) of these novel antiretrovirals in this population. To address this gap, a modified Delphi technique was used to develop these consensus recommendations that establish a framework for initiating and managing ibalizumab, fostemsavir, or lenacapavir in PWH who are heavily treatment-experienced and/or have multidrug-resistant HIV-1. In addition, future areas of research are also identified and discussed.

Keywords: HIV; antiretrovirals; anti‐HIV agents; attachment inhibitor; capsid inhibitor; drug resistance; post‐attachment inhibitor.

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References

REFERENCES

1. U.S. Department of Health and Human Services. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Accessed July 1, 2023. https://clinicalinfo.hiv.gov/en/guidelines/adult‐and‐adolescent‐arv
1. Gandhi RT, Bedimo R, Hoy JF, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2022 recommendations of the international antiviral society‐USA panel. JAMA. 2023;1(329):63‐84. doi:10.1001/jama.2022.22246
1. McClung RP, Oster AM, Ocfemia MCB, et al. Transmitted drug resistance among human immunodeficiency virus (HIV)‐1 diagnoses in the United States, 2014–2018. Clin Infect Dis. 2021;6(74):1055‐1062. doi:10.1093/cid/ciab583
1. Grover D, Copas A, Green H, et al. What is the risk of mortality following diagnosis of multidrug‐resistant HIV‐1? J Antimicrob Chemother. 2008;3(61):705‐713. doi:10.1093/jac/dkm522
1. Lalezari JP, Henry K, O'Hearn M, et al. Enfuvirtide, an HIV‐1 fusion inhibitor, for drug‐resistant HIV infection in North and South America. N Engl J Med. 2003;22(348):2175‐2185. doi:10.1056/NEJMoa035026

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Consensus recommendations for the use of novel antiretrovirals in persons with HIV who are heavily treatment-experienced and/or have multidrug-resistant HIV-1: Endorsed by the American Academy of HIV Medicine, American College of Clinical Pharmacy

Affiliations

Consensus recommendations for the use of novel antiretrovirals in persons with HIV who are heavily treatment-experienced and/or have multidrug-resistant HIV-1: Endorsed by the American Academy of HIV Medicine, American College of Clinical Pharmacy

Authors

Affiliations

Abstract

References

REFERENCES

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous