Drug updated on 12/11/2024
| Dosage Form | Injection (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
- Indicated, in combination with other antiretroviral(s), 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
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Lenacapavir (LEN) + optimized background regimen (OBR) exhibited statistically significantly higher odds of achieving virologic suppression at weeks 24 to 28, with an odds ratio of 6.57 compared to fostemsavir (FTR) + OBR, 8.93 compared to ibalizumab (IBA) + OBR, and 12.74 compared to OBR alone, indicating superior efficacy over these regimens.
- FTR + optimized background therapy (OBT) demonstrated significant improvements in CD4(+) cell counts compared to OBT alone, with an increase of 135.78 cells/mm³ (95% confidence interval (CI): 91.93-179.63, P < 0.001) at week 96, while showing similar changes in CD4 cell counts when compared to IBA + OBT (mean difference = 7.05 cells/mm³; 95% CI, -60.88 to 74.98; P = 0.834).
- Virologic suppression (human immunodeficiency virus (HIV)-1 RNA < 50 copies/mL) rates at week 144 were similar across dolutegravir + lamivudine (DTG + 3TC), bictegravir/emtricitabine/tenofovir (BIC/FTC/TAF), and DTG/abacavir (ABC)/3TC regimens, with no significant differences in virologic failure (HIV-1 RNA ≥ 50 copies/mL) between the groups, and no specific subgroup analysis provided.
- The study indicates that there were discontinuations due to adverse events for the LEN + OBR regimen, but specific comparative data for IBA + OBR were not provided.
- Safety outcomes and all-cause discontinuations varied across studies; however, specific safety outcomes for fostemsavir + OBT compared to IBA + OBT were not detailed.
- There is no population or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Trogarzo (ibalizumab-uiyk) Prescribing Information. | 2023 | Theratechnologies Inc., Jersey City, NJ |
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 |