Drug updated on 3/28/2024
| Dosage Form | Injectable (intravenous: 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.
Summary
- Ibalizumab-uiyk (Trogarzo) is a humanized IgG4 monoclonal antibody that blocks the entry of human immunodeficiency virus type 1 (HIV-1) by noncompetitive binding to CD4.
- The drug was tested in a single-group, open-label, phase 3 study on adults with multidrug-resistant HIV-1 infection for whom multiple antiretroviral therapies had failed.
- All patients enrolled in the trial had a viral load of more than 1000 copies of HIV-1 RNA per milliliter and received an initial loading dose of ibalizumab followed by regular doses combined with an individually optimized background regimen including at least one fully active agent.
- Of the total participants, 83% experienced a decrease in viral load from baseline after receiving Trogarzo treatment; this result was statistically significant compared to control period results where only one patient showed similar reduction prematurely due to receipt of optimized background regimen.
- At week 25 post-treatment initiation, patients who received ibalizumab plus an optimized background regimen demonstrated mean decrease from baseline; approximately half achieved less than or equal to 200 copies per milliliter viral load count indicating substantial effectiveness against MDR HIV-1 infection.
- Adverse events were reported among some participants during the study period - diarrhea being most common affecting about fifth population while four deaths occurred due underlying illnesses and one serious adverse event related directly to Trogarzo therapy identified as immune reconstitution inflammatory syndrome suggesting cautionary use among heavily treated individuals with advanced disease state and limited options left for effective management strategies against their condition.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Trogarzo (ibalizumab-uiyk) Prescribing Information. | 2022 | Theratechnologies Inc., Montréal, Québec, Canada |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Phase 3 study of ibalizumab for multidrug-resistant HIV-1. | 40Subjects F: 15% M: 85% | 2018 | N Engl J Med |
Sex Distribution:
F:15%
M:85%
40Subjects
Year:
2018
Source:N Engl J Med
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. | 2023 | NIH |