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

Author:

Cluck David B.1ORCID,Chastain Daniel B.2ORCID,Murray Milena34ORCID,Durham Spencer H.5ORCID,Chahine Elias B.6ORCID,Derrick Caroline7ORCID,Dumond Julie B.8ORCID,Hester E. Kelly5ORCID,Jeter Sarah B.9,Johnson Melissa D.10ORCID,Kilcrease Christin11,Kufel Wesley D.121314ORCID,Kwong Jeffrey15,Ladak Amber F.16,Patel Nimish17ORCID,Pérez Sarah E.18,Poe Jonell B.161920,Bolch Charlotte21ORCID,Thomas Ian22,Asiago‐Reddy Elizabeth1323,Short William R.24

Affiliation:

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

Abstract

AbstractTreatment 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.

Publisher

Wiley

Reference102 articles.

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

2. Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults

3. Transmitted Drug Resistance Among Human Immunodeficiency Virus (HIV)-1 Diagnoses in the United States, 2014–2018

4. What is the risk of mortality following diagnosis of multidrug-resistant HIV-1?

5. Enfuvirtide, an HIV-1 Fusion Inhibitor, for Drug-Resistant HIV Infection in North and South America

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