Phase III BRIGHTE study of GSK 3684934 shows positive results in HIV.- ViiV Healthcare.

ViiV Healthcare announced 48-week results from the phase III BRIGHTE study of investigational GSK 3684934 (fostemsavir) in heavily treatment-experienced (HTE) patients with HIV-1 infection. Fostemsavir, in combination with optimised background treatment (OBT), maintained virologic suppression from Week 24 to Week 48 in this difficult-to-treat population.

Results show 54% of patients in the randomised cohort (n = 146/272) achieved virologic suppression (<40 copies ml at 48 weeks of treatment with fostemsavir plus optimised background therapy. additionally patients in the randomised cohort showed immunologic improvement through week 48 as demonstrated by an increase in cd4 t-cell counts mean change from baseline of 139 cells l. these data at 48 weeks build on the primary endpoint data day 8 announced last year. most patients who received fostemsavir experienced at least one adverse event ae by week 48. the most commonly reported drug-related aes were diarrhoea nausea and headache. thirty-five percent of participants had one or more serious adverse events sae most commonly related to infections and these occurred in the most immunocompromised patients. three percent 3 of saes related to the study medication and seven percent 7 of participants discontinued due to an ae.>

In addition to the primary efficacy results, a pre-specified subgroup analysis was also conducted and showed numerically higher rates of virologic response in patients >50 years, females, or in patients who self-reported their race as �black� or �African-American� compared to their respective counterparts through Week 48. Not unique to the BRIGHTE study was the fact that subgroups with high baseline HIV-1 RNA (at least 100,000 c/mL) and low baseline CD4+ cell counts (less than 20 cells/mm3) had lower rates of virologic response through Week 48. There were comparable increases in CD4+ T-cell counts across subgroups of: age, gender, race, and geographic region. Notably, subjects with the lowest baseline CD4 counts (less than 20 cells/microL), had comparable improvement in mean change in baseline CD4 count to those with the highest baseline CD4 values (more than 200 cells/microL); +145 and +150 cells/microL, respectively.