Fostemsavir

(Rukobia®)

Rukobia®

Drug updated on 10/28/2024

Dosage FormTablet (oral; 600 mg)
Drug ClassHuman immunodeficiency virus type 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.

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Summary
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  • 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) HIV (human immunodeficiency virus)-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 LEN + OBR (OR = 6.57; 95% CI (confidence interval) 1.34-32.28) and 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 optimized background therapy (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 heavily treatment-experienced (HTE) individuals with multidrug-resistant (MDR) HIV-1. These individuals demonstrated significant virologic and immunologic responses with fostemsavir combined with optimized background therapy (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.