Ibalizumab-uiyk

(Trogarzo®)

Trogarzo®

Drug updated on 5/22/2024

Dosage FormInjectable (intravenous; 200 mg/1.33 mL [150 mg/mL])
Drug ClassCD4-directed post-attachment HIV-1 inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • In combination with other antiretroviral(s), Trogarzo is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.

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Summary
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  • Ibalizumab-uiyk (Trogarzo) is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen.
  • Two studies were reviewed to gather information about Trogarzo's safety and effectiveness compared to other antiretroviral drugs.
  • When comparing Lenacapavir + OBR versus Trogarzo + OBR, Lenacapavir demonstrated significantly greater odds of achieving virologic suppression at weeks 24 to 28; however, both treatments provided a comparable immunological response in terms of CD4 cell count recovery.
  • An indirect comparison between Fostemsavir + OBT and Trogarzo + OBT did not demonstrate a significant difference in the odds of achieving virologic suppression or an increase in CD4+ cell count through week 24.
  • Detailed safety data specific to Trogarzo was not provided within these studies, but there is an emphasis on evaluating individual tolerance and safety profiles when considering this drug for individuals with multi-drug resistant HIV infections.
  • The two studies focused specifically on heavily treatment-experienced (HTE) individuals with multi-drug resistant (MDR) HIV - no further subgroup analyses based on age, sex, racial, or ethnic backgrounds were mentioned which might reveal differential responses or considerations for using ibalizumab-uiyk (Trogarzo).

Product Monograph / Prescribing Information

Document TitleYearSource
Trogarzo (ibalizumab-uiyk) Prescribing Information.2021Theratechnologies Inc., Montréal, Québec, Canada

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
Guidelines for the use of antiretroviral agents in adults and adolescents with HIV.2023National Institutes of Health