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Introduction: The ongoing observational BICSTaR study aims to demonstrate effectiveness, safety and tolerability of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in routine clinical practice in at least 1400 antiretroviral treatment (ART)-naive (TN) and ARTexperienced (TE) people living with HIV (PLHIV). Materials and Methods: This 12-month (12M) analysis of PLHIV receiving B/F/TAF in Europe and Canada assessed HIV 1-RNA (missing data=excluded analysis), drug-related (DR) adverse events (AEs), persistence and weight/body mass index (BMI) change. Results: At the time of data cut-off (March 2020), 513 participants (n=84 TN/n=429 TE) completed a 12M visit. Most were male (91%) and white (89%); the median age was 38 (TN) and 49 (TE) years. Prevalence of comorbidities at baseline was 76%; the most common were neuropsychiatric (28%), hyperlipidemia (18%) and hypertension (18%). 71%/18%/13% of TE participants switched from INSTI/NNRTI/PI-based regimens, respectively (26% TDF); 8% had a history of prior virologic failure. Baseline primary resistance prevalence by historical genotype was 9% [n=43/513; 5% had resistance mutations associated with NNRTIs, 3% PIs, 3% NRTIs (n=8 M184V/I, n=1 K65R) and 0.2% with INSTIs (n=1 G140S)]. At 12M, 100% of TN (n=74/74) and 96% (n=357/373) TE participants had viral load (VL) <50 copies/ml. Comparable and high effectiveness was observed in both male and female participants, including older individuals (Table 1). No major resistance substitutions to the components of B/F/TAF emerged. DRAEs occurred in 14% (n=12/84) of TN and 15% (n=64/429) of TE participants, with the most common being gastrointestinal (5%) and neuropsychiatric (4%); discontinuations due to DRAE were low (TN 3.6% and 7.2% TE) and 90% of study participants remained on B/F/TAF (n=462/513). Serious DRAEs were rare [0.4%; all in TE participants (n=2 depression)]. At 12M, median (Q1, Q3) weight change was +2.5 kg (0.5, 6.3) for TN (n=48) and +0.9 kg (-1.0, 3.0) for TE (n=269), with small changes in BMI of +0.8 kg/m² (0.1, 1.9) for TN and +0.3 kg/m² (-0.3, 1.0) for TE. Weight increase >10% was observed in 19% (n=9/48) and 5% (n=15/269) of TN and TE participants, respectively. Conclusion: The use of B/F/TAF in this real-world clinical cohort was associated with a high level of effectiveness and safety through 12M, inclusive of male, female and older PLHIV. [ABSTRACT FROM AUTHOR]