Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; 600 mg) |
| Drug Class | Human immunodeficiency virus type 1 (HIV-1) gp120-directed attachment inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of HIV-1 infection in combination with other antiretrovirals in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
Latest News
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- In heavily treatment-experienced (HTE) individuals with multidrug-resistant (MDR) human immunodeficiency virus (HIV)-1, fostemsavir combined with optimized background therapy (OBT) demonstrated sustained virologic suppression over 96 weeks in the BRIGHTE trial. Fostemsavir had lower odds of achieving virologic suppression compared to lenacapavir (LEN) + optimized background regimen (OBR) (OR = 6.57; 95% confidence interval (CI) 1.34-32.28) and ibalizumab (IBA) + OBR (OR = 8.93; 95% CI 2.07-38.46).
- Fostemsavir combined with N = 40 (OBT) significantly increased + (CD4) cell counts, with an increase of 135.78 cells/mm³ (95% CI 91.93-179.63, P < 0.001) compared to OBT alone at week 96, as seen in the BENCHMRK-1/-2 trial.
- The BRIGHTE trial did not provide specific adverse event rates or safety outcomes for fostemsavir combined with OBT, but comparisons of safety data between fostemsavir and other regimens were indirectly analyzed, adjusting for demographic and baseline characteristics.
- The population targeted in the studies consisted of HTE individuals with MDR HIV-1. These individuals demonstrated significant virologic and immunologic responses with fostemsavir combined with OBT, highlighting its importance in patients with limited treatment options due to resistance. Adjustments were made in the analyses to balance populations across trials based on demographic and baseline characteristics.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Rukobia (fostemsavir) Prescribing Information. | 2024 | ViiV Healthcare, NC |
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 |