Drug updated on 5/22/2024
| Dosage Form | Injectable (intravenous; 200 mg/1.33 mL [150 mg/mL]) |
| Drug Class | CD4-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.
Latest News
Summary
- 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 Title | Year | Source |
|---|---|---|
| Trogarzo (ibalizumab-uiyk) Prescribing Information. | 2021 | Theratechnologies Inc., Montréal, Québec, Canada |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Indirect treatment comparisons of lenacapavir plus optimized background regimen versus other treatments for multidrug-resistant human immunodeficiency virus. | 2023 | Value Health |
| Comparative efficacy and safety of fostemsavir in heavily treatment-experienced people with HIV-1. | 2022 | Clinical Therapeutics |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. | 2023 | National Institutes of Health |