ABSTRACT
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
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 COVID- 19 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.