Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV

March 23, 2023

Lenacapavir, a first-in-class HIV capsid inhibitor, was approved by the U.S. Food and Drug Administration in December 2022 to be used in combination with other antiretroviral (ARV) drugs for the treatment of heavily treatment-experienced adults with multidrug-resistant HIV-1 infection. In this update to the guidelines, the following sections are revised to incorporate information regarding the use of lenacapavir:

• Drug-Resistance Testing
• Virologic Failure
• Hepatitis C Virus/HIV Coinfection
• Adverse Effects of Antiretroviral Agents
• Cost Considerations and Antiretroviral Therapy
• Drug–Drug Interactions
  • Overview
  • Table 24g—a new table with guidance on drug–drug interactions between lenacapavir and other drugs (including ARV agents)
• Appendix B, Table 11. Characteristics of the Capsid Inhibitor—a new table on the characteristics of lenacapavir

The Financial Disclosure has been updated to include the Panel on Antiretroviral Guidelines for Adults and Adolescents members’ financial disclosure for companies related to HIV treatment or diagnostics for the period of March 1, 2022 to February 28, 2023.