Drug updated on 9/4/2024
| 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.
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Summary
- Trogarzo (ibalizumab-uiyk) is indicated for use in combination with other antiretrovirals 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.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- LEN + OBR: Showed significantly higher odds of achieving virologic suppression (VS) at weeks 24 to 28 compared to FTR + OBR (6.57; 95% CI 1.34-32.28), IBA + OBR (8.93; 95% CI 2.07-38.46), and OBR alone (12.74; 95% CI 1.70-95.37).
- Fostemsavir (FTR) + OBT: Demonstrated significantly higher odds of VS compared to OBT alone in the BENCHMRK-1/-2 studies (OR = 3.26; 95% CI 2.08-5.11; P < 0.001), with non-significant results when compared to IBA + OBT (OR = 1.44; 95% CI 0.74-2.80; P = 0.284) and OBT alone in the VIKING-3 study (OR = 1.34; 95% CI 0.78-2.30; P = 0.297).
- Change in CD4 Cell Count: LEN + OBR, FTR + OBR, and IBA + OBR showed similar changes from baseline, while FTR + OBT demonstrated a significantly higher increase in CD4+ cell count compared to OBT alone in BENCHMRK-1/-2 studies (135.78 cells/mm³; 95% CI 91.93-179.63; P < 0.001).
- There is no specific safety information available in the reviewed studies.
- There is no population types or subgroups information available in the reviewed studies.
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 |