Fostemsavir

(Rukobia®)

Rukobia®

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Drug updated on 5/17/2024

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.

Summary
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  • Fostemsavir (Rukobia) is 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.
  • Two studies compared Rukobia's efficacy and safety against other treatments such as lenacapavir (LEN) + optimized background regimen (OBR), ibalizumab (IBA) + OBR, and OBR alone.
  • The first study revealed that LEN + OBR demonstrated statistically significantly greater odds of virologic suppression at weeks 24 to 28 across all comparators including Rukobia. However, the increase in CD4 cell count from baseline was similar across treatments involving LEN + OBR, Rukobia + OBR indicating comparable immunologic recovery capabilities.
  • In terms of safety profile, according to the first study review, specific details on discontinuation due to adverse events for Rukobia were not provided but it suggests that these outcomes were part of comparative analysis.
  • The second study highlighted results from the BRIGHTE trial where Rukobia showed sustained virologic and immunologic responses over 96 weeks. When indirectly compared using matching-adjusted analyses: Rukobia achieved numerically higher but nonsignificant odds of virologic suppression and a similar increase in CD4+ cell counts compared to Ibalizumab through week 24.
  • Safety comparisons varied across studies as per the second study review indicating some variation between different treatments including Rukobia however, no specific data on adverse events or discontinuations due to adverse events for this drug were provided.

Product Monograph / Prescribing Information

Document TitleYearSource
Rukobia (fostemsavir) Prescribing Information.2022ViiV Healthcare, Research Triangle Park, NC

Systematic Reviews / Meta-Analyses