A look at the BRIGHTE study data which evidenced the recently FDA-approved add-on agent.
Last week, the US Food and Drug Administration (FDA) approved fostemsavir (Rukobia) for the add-on treatment of adults with HIV who cannot be successfully treated with other therapies due to resistance, intolerance, or safety considerations.
The novel ViiV Healthcare drug was backed by findings from the nearly 400-patient BRIGHTE study, which showed twice-daily fostemsavir plus failing antiretroviral therapy (ART) resulted in significant HIV RNA decrease and suppression among patients who have long sought true control of their HIV.
By 96 weeks of care, 3 in every 5 patients achieved RNA suppression—no small feat for a population of patients who had exhausted treatment options.
What do the study’s findings mean for the market of HIV care, and what does a new oral, daily tablet for the population mean for patient optimism?
In an interview with Contagion® during the International AIDS Society (IAS) AIDS 2020 Virtual Sessions, Cathy Creticos, MD, Director of Infectious Disease at Howard Brown Health, discussed the usability of fostemsavir in a highly-treated HIV patient group.
“Probably, the most remarkable thing about it is that it’s a whole new class of drugs,” Creticos explained. “It’s the first in class of this new viral attachment inhibitor.”
Creticos also shared perspective on why a simple, efficacious, twice-daily oral agent is hugely beneficial addition to an HIV regimen for a patient population that is already burdened by a wide array of daily therapies and disappointment.
“Many patients hear so much in the press about single-tablet regimens, how easy it is to treat HIV, how it’s no longer a death sentence—all wonderful things, and all true,” she said. “But for this population, they feel to some extent they don’t fit into that—they’re beginning to lose hope.”