Effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide in people with HIV in Asia: 24-Month findings from the observational BICSTaR study

BICtegravir Single Tablet Regimen is a multiregional, observational cohort study assessing the effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-naïve (TN) and treatment-experienced (TE) people with HIV. We present 24-month data for the BICtegravir Single Tablet Regimen Asia cohort. Between December 2020 and March 2024, prospective and retrospective data were collected from TN and TE people with HIV receiving B/F/TAF in routine clinical care in the Republic of Korea, Singapore, and Taiwan. Endpoints at month 24 included effectiveness (HIV-1 RNA <50 copies/mL; missing = excluded and discontinuation = failure analyses), immunological endpoints (CD4 cell count and CD4/CD8 ratio), persistence, safety, and patient-reported outcomes (prospective cohort). Overall, 334 participants (252 prospective, 82 retrospective; 66 TN, 268 TE) were included in the analysis population. Most were male (97% TN, 93% TE) with ≥1 comorbidity (56% TN, 67% TE). At month 24, HIV-1 RNA was <50 copies/mL in 91% (50/55) of TN and 97% (225/331) of TE participants (missing = excluded analysis). Median (quartile [Q]1, Q3) CD4 count increased by +260 (155, 386; P < .001) cells/μL in TN and +40 (−65, 150; P = .008) cells/μL in TE participants. Median (Q1, Q3) CD4/CD8 ratio increased by +0.38 (0.21, 0.48; P < .001) in TN and +0.08 (0.00, 0.19; P < .001) in TE participants. Patient-reported outcomes indicated an improvement in mental health and a decrease in the number of bothersome symptoms in TN participants. Persistence at month 24 was high, with 98% (60/61) of TN and 97% (251/260) of TE participants remaining on B/F/TAF. Drug-related adverse events occurred in 9% (6/66) of TN and 8% (22/268) of TE participants, leading to B/F/TAF discontinuation in <1% (3/334) of participants, all of whom were TE. B/F/TAF demonstrated high levels of effectiveness, persistence, and tolerability over 24 months in people with HIV in Asia.