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Background: Real‐world evidence is an essential component of evidence‐based medicine. The aim of the BICSTaR (BICtegravir Single Tablet Regimen) study is to assess effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in antiretroviral treatment‐naïve (TN) and treatment‐experienced (TE) people with HIV. Methods: BICSTaR is a prospective, observational cohort study. Participants (≥18 years) are being followed for 24 months. A pooled analysis is presented at 12 months, with the primary endpoint of effectiveness (HIV‐1 RNA <50 copies/mL) and secondary endpoints of safety and tolerability (as per protocol). An exploration of patient‐reported outcome measures using standardized questionnaires is included. Results: Between June 2018 and May 2021, 1552 people with HIV were enrolled across 12 countries. The analysed population comprised 1509 individuals (279 TN, 1230 TE); most were white (76%), male (84%) and had one or more comorbid conditions (68%). Median age was 47 years. After 12 months of B/F/TAF treatment, HIV‐1 RNA was <50 copies/mL in 94% (221/236) of TN participants and 97% (977/1008) of TE participants. Median CD4 cell count increased by 214 cells/μL (p < 0.001) in TN participants and 13 cells/μL (p = 0.014) in TE participants; median CD4/CD8 ratios increased by 0.30 and 0.03, respectively (both p < 0.001). Persistence was high at 12 months (TN, 97%; TE, 95%). No resistance to B/F/TAF emerged. Study drug‐related adverse events occurred in 13% of participants through 12 months, leading to B/F/TAF discontinuation in 6%. Conclusions: The findings of this study provide robust real‐world evidence to support the broad use of B/F/TAF in both TN and TE people with HIV. [ABSTRACT FROM AUTHOR]

Introduction: BICSTaR (GS-EU-380-4472/GS-CA-380-4574/GS-IL-380- 5335) is an ongoing, multinational, observational cohort study evaluating real-world effectiveness and safety of B/F/TAF in ART naïve (TN) and ARTexperienced (TE) PLWH. Materials and Methods: This 12M pooled analysis included PLWH starting B/F/TAF in clinical practice from June 2018 to September 2020 (latterly during the COVID-19 pandemic) in Europe/Israel/Canada. Outcomes included virological effectiveness (HIV‐1 RNA <50 copies/ml [missing=excluded]), persistence, drug‐related adverse events (DRAEs), and laboratory parameters. Results: One-thousand one hundred thirty-five PLWH were included (Table 1). The TE group had older median age than TN. Of TE participants, 65%/20%/16% switched from INSTI/NNRTI/PI-based regimens (36% TDF/46% TAF/13% ABC); 12% had prior virologic failure. Baseline resistance was documented in 124/535 participants (NRTI/NNRTI/PI/ INSTI=6%/6%/3%/0.2%). Prevalence of comorbidities (47%/72% TN/TE) and concomitant medication usage was high. At 12M, 97% (149/154) of TN and 96% (771/800) of TE participants had HIV-1 RNA <50 copies/ml, and persistence on B/F/TAF was high [91% (1032/1135)]. In a multivariable analysis, TE participants with neuropsychiatric disorder ongoing at baseline had lower odds for viral suppression (odds ratio=0.45, 95% CI: 0.21-0.96). There was no emergence of resistance to the components of B/F/TAF. DRAEs occurred in 13% (148/1135) of participants; gastrointestinal and neuropsychiatric DRAEs were the most common (3% each). Discontinuations due to DRAEs were low (TN 4%; TE 6%). Serious DRAEs were rare (0.2%; 2 TE participants with depression). Lipidchanges are shown (Figure 1). Conclusion: B/F/TAF was associated with high levels of effectiveness and persistence after 12M in this large real-world cohort of TN and TE PLWH with a high comorbidity burden. Effectiveness was demonstrated across key subgroups (females, older participants, late presenters). Importantly, there were no new or unexpected safety findings. Collectively, these real-world data continue to support the use of B/F/TAF in clinical practice. [ABSTRACT FROM AUTHOR]

Introduction: BICSTaR is an ongoing, multinational, observational cohort study evaluating B/F/TAF in ART therapy-naïve (TN) and ART-experienced (TE) PLWH. The BICSTaR population has a high baseline prevalence of comorbidities (particularly neuropsychiatric). PROs were prospectively collected. Materials and Methods: One hundred eighty TN/955 TE participants were considered for the 12M analysis (cut-off Feb 2021, including people enrolled from Jun 2018 to Sept 2020, i.e. partially during the COVID19 pandemic). PRO measures: Adherence [visual analogue scale (VAS)]; physical/mental health [short form 36 (SF-36) questionnaire: Aggregated physical/mental component summary (PCS/MCS) scores; HIV-symptom index (HIV-SI; symptoms dichotomised into bothersome/not bothersome); HIV treatment satisfaction questionnaire (HIVTSQ; TE only); physician visits. VAS/SF-36/HIV-SI: Analysis population restricted to participants with questionnaires completed at both baseline/12M. SF-36/HIV-SI/HIVTSQ were described for participants with/without prior/ongoing neuropsychiatric comorbidities (TE only as TN subgroup was small). Results: Adherence to treatment was high at baseline (TE) and was maintained at 12M after switch to B/F/TAF [Table 1 (T1)]. Statistically significant improvements in PCS/MCS scores were observed in TN participants at 12M (p<0.05); scores remained stable in TE participants (Figure 1). The medyan (Q1, Q3) number of bothersome symptoms in TN participants declined from 6 (2, 9) at baseline to 2 (0, 6) at 12M (p<0.001; T1); TE, no change in absolute count. Statistically significant reductions in the frequency of several bothersome symptoms were reported in TN participants (p<0.05) (TE: No statistically significant changes). Treatment satisfaction was high at baseline (TE), with improvements observed at 12M following switch to B/F/TAF (p<0.001) (T1). Physician visits are shown (T1). In TE participants with baseline prior/ongoing neuropsychiatric comorbidities [275/955 (29%)], similar PRO trends were seen. Conclusion: In this real-world cohort of PLWH with a high prevalence of comorbidities (and in the setting of a global pandemic), patient-reported adherence, physical/mental health, bothersome symptoms, and treatment satisfaction were maintained/showed improvements during 12M of B/F/ TAF treatment. [ABSTRACT FROM AUTHOR]

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]