US biotech major Gilead Sciences (Nasdaq: GILD) has announced findings from multiple studies in Asian population that evaluated the safety and efficacy of switching to once-daily, single tablet regimen, Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets, B/F/TAF) from baseline regimens. The data were presented at the 2020 Asia Pacific AIDS & Co-Infections Conference (APACC).
A post-hoc pooled analysis from three studies demonstrated efficacy of switching to B/F/TAF from integrase strand transfer inhibitor (INSTI) based antiretroviral therapy, or a boosted protease inhibitor (PI) with two nucleotide reverse transcriptase inhibitors (NRTIs) baseline regimens, among virologically-suppressed Asian adults living with HIV. In the analysis, 100% of the 63 Asian adults who switched to B/F/TAF maintained virologic suppression (defined as HIV-1 RNA <50 copies/mL) with no emergent resistance, versus 95.9% (70/73) in those that stay on baseline regimen (SBR) group, through a maximum of 48 weeks. B/F/TAF was well tolerated with no adverse events leading to discontinuation among Asian participants in the studies.
Similarly, an open-label, randomized, Phase III study of women with HIV who were virologically suppressed (HIV-1 RNA < 50 copies/mL) on a baseline regimen (elvitegravir (E)/cobicistat (C)/F/TAF, E/C/F/tenofovir disoproxil fumarate (TDF), or atazanavir + ritonavir + F/TDF), found that virologic suppression was maintained in 100% of the subgroup of Asian women participants (n=48) vs 98% in the SBR group (53/54). B/F/TAF was well tolerated with no adverse events leading to discontinuation.
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