The trial demonstrated that 54% of patients in the randomised cohort achieved virologic suppression after 48 weeks of treatment with fostemsavir in combination with optimised background therapy. These results build on the primary endpoint data unveiled last year. Patients in the randomised cohort experienced immunologic improvement, as measured by an increase in CD4+ T-cell counts. The majority of patients treated with fostemsavir had at least one adverse event (AE) by week 48. The most common drug-related AEs included diarrhoea, nausea and headache. It was also found that 35% of patients had one or more serious adverse events (SAE), most commonly related to infections, while 3% of SAEs related to fostemsavir. Treatment was stopped in 7% of patients due to an AE.
ViiV Healthcare chief scientific and medical officer John Pottage Jr said: “People living with HIV who participated in this study were failing on their current antiretroviral regimens and had few treatment options left available to them. “We were encouraged to see that treatment with fostemsavir resulted in meaningful reductions in viral load.” “We were encouraged to see that treatment with fostemsavir resulted in both meaningful reductions in viral load and improvements in the health of their immune systems. “At ViiV Healthcare, we remain dedicated to developing innovative medicines for all people living with HIV and expect to seek regulatory approval for fostemsavir in 2019.”
A total of 371 patients were included in the BRIGHTE trial in randomised and non-randomised cohorts. Patients were randomised in 3:1 ratio to receive blinded fostemsavir or blinded placebo to their current regimen for eight days of functional monotherapy. A total of 99 patients without any remaining fully active approved antiretroviral therapies (ARVs) were included in the non-randomised cohort to receive open-label fostemsavir, along with optimised background therapy on day one. The trial’s primary objective was mean change in log10 HIV-1 RNA between day one and day eight for the randomised cohort. Its key secondary objectives comprised durability of response at weeks 24, 48 and 96, safety changes from baseline, and appearance of viral resistance.