Drug updated on 4/17/2024
| Dosage Form | Tablet (oral: 600 mg) |
| Drug Class | HIV-1 gp120-directed attachment inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
Summary
- Fostemsavir (Rukobia) is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
- A total of 1 Randomized Controlled Trial document was reviewed which provided information about the efficacy and safety profile of fostemsavir (Rukobia).
- The BRIGHTE study enrolled heavily treatment-experienced adults who were failing antiretroviral therapy into two cohorts: one received oral fostemsavir plus optimised background therapy; the other received a placebo along with their failing regimen for 8 days followed by fostemsavir plus optimised background therapy.
- In terms of effectiveness, virological suppression rates increased from 53% at week 24 to 60% at week 96 in the cohort that initially received Rukobia as part of their regimen while response rates remained constant at around 37% through weeks 24 and up till week 96 in those without any remaining antiretroviral options.
- Regarding safety concerns, few adverse events led to discontinuation (7%) across both cohorts but mortality rate was higher among participants without any remaining antiretroviral options compared to those who had some left - 17% vs. 4%, respectively.
- Overall, it can be inferred that Fostemsavir-based regimens are generally well tolerated and show an increasing trend over time regarding virological response rates making them a viable option for this vulnerable population group struggling with advanced HIV-1 disease and limited treatment choices.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Rukobia (fostemsavir) Prescribing Information. | 2022 | ViiV Healthcare, Research Triangle Park, NC |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced individuals: week 96 results of the phase 3 BRIGHTE study. | Data not availableSubjects F: null% M: null% | 2020 | The Lancet |
Sex Distribution:
Year:
2020
Source:The Lancet