Fostemsavir (1) – Rukobia®

• Clinical trials
  • The BRIGHTE study is an ongoing, multicentre Phase III study involving two cohorts over a period of at least 96 weeks, investigating the efficacy and safety of fostemsavir.
  • The study included adults with multi-drug-resistant HIV-1 infection (defined as an HIV-1 RNA viral load ≥ 400 copies/ml and confirmed resistance, intolerance and/or contraindications to antiretroviral agents in ≥ 3 drug classes), who at the start of the study were either assigned to the randomised cohort if one or two fully active ingredients from a maximum of two drug classes were still available to them, or to the non-randomised cohort, if no fully active agents were available.

Adults with multi-drug-resistant HIV-1 infection for whom no other suppressive antiretroviral treatment regimen is available

• For adults with multi-resistant HIV-1 infection for whom no other suppressive antiretroviral treatment regimen is available, the additional benefit is not proven.
• For adults with multidrug-resistant HIV-1 infection for whom no other suppressive antiretroviral treatment regimen is available, there are no direct comparative data for fostemsavir against a patient-specific antiretroviral therapy as an appropriate comparator therapy.
• The BRIGHTE study submitted by the pharmaceutical manufacturer, as well as the supplementary matching-adjusted indirect comparisons (MAIC) submitted, are not suitable for assessing the additional benefit of fostemsavir, as explained below.
• The BRIGHTE study is not suitable for the present benefit assessment, as the 8-day comparative study phase is clearly too short for assessing the additional benefit in the present therapeutic indication, and the continuation of a failing therapy does not correspond to the specified appropriate comparator therapy.
• Furthermore, the studies presented on the comparator side of the MAIC analyses do not correspond to the appropriate comparator therapy, meaning that no conclusions regarding additional benefit can be drawn from the indirect comparisons presented.
• Furthermore, due to the inadequate review of the MAIC analyses, it remains unclear whether the data included in the indirect comparisons are complete and whether the studies included are comparable with one another.
• Conclusion
  • Overall, the submitted BRIGHTE study, as well as the MAIC analyses presented supplementarily by the pharmaceutical manufacturer, are considered unsuitable for assessing the additional benefit of fostemsavir compared with the appropriate comparator therapy.
  • Consequently, there are no data relevant to the benefit assessment of fostemsavir, meaning that an additional benefit is not proven.

Courtesy translation only, please refer to the German original.