In the Phase 3 BRIGHTE trial, 60% of heavily treatment-experienced adults receiving Rukobia with an optimised background therapy reported positive results
Scanning electron micrograph of HIV-1. (Credit: C. Goldsmith/Wikipedia.)
ViiV Healthcare, a GSK company specialised in HIV therapies, has received the US Food and Drug Administration (FDA) approval for Rukobia (fostemsavir), 600mg extended-release tablets, for the treatment for HIV in adults with limited treatment options.
Rukobia is a novel attachment inhibitor indicated for use in combination with other antiretroviral (ARV) therapies to treat HIV-1 infection in heavily treatment-experienced (HTE) adults who are failing current ARV regimen due to resistance, intolerance or safety considerations.
ViiV Healthcare CEO Deborah Waterhouse said: “There is a small group of heavily treatment-experienced adults living with HIV who are not able to maintain viral suppression with currently available medication and, without effective new options, are at great risk of progressing to AIDS.
“The approval of Rukobia is a culmination of incredibly complex research, development, and manufacturing efforts to ensure we leave no person living with HIV behind.”
FDA approval for Rukobia is based on data from the Phase 3 BRIGHTE study
The US regulatory approval was based on data from the Phase 3 BRIGHTE study, which evaluated the safety and efficacy of Rukobia in combination with optimised background therapy (OBT) in HTE adults living with multidrug-resistant HIV.
According to the company, HTE adults with limited options due to resistance, tolerability or safety considerations are at risk of the disease progressing to AIDS and require additional therapies.
The study demonstrated that 60% of subjects in the randomised cohort, who received Rukobia in addition to an investigator-selected OBT experienced undetectable HIV viral load and meaningful improvements to CD4+ T-cell count.
The most common adverse reactions observed in randomised and nonrandomised participants include nausea, fatigue and diarrhoea.
Serious drug reactions were reported in 3% of people, due to severe immune reconstitution inflammatory syndrome, and the most common adverse events that resulted in discontinuation were related to infections
Quest Clinical Research chief executive officer and director Jacob Lalezari said: “As a novel HIV attachment inhibitor, fostemsavir targets the first step of the viral lifecycle offering a new mechanism of action to treat people living with HIV.
“In the BRIGHTE study, fostemsavir in combination with other ARVs effectively achieved and maintained long-term viral suppression and demonstrated clinically meaningful rise in CD4+ T-cell count even among heavily immunocompromised patients.
“These are exciting advances for the HTE population and an advancement the HIV community has long been waiting for. As an activist as well as researcher, I am very grateful to ViiV Healthcare for their commitment to heavily-treatment experienced people living with HIV.”