Twelve‐month effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide in people with HIV: Real‐world insights from BICSTaR cohorts

Abstract

BackgroundReal‐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.MethodsBICSTaR 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.ResultsBetween 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%.ConclusionsThe 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.

Twelve-month effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide in people with HIV from the Canadian cohort of the observational BICSTaR study

“…The use of a common protocol across all BICSTaR cohorts allows for direct comparison of these Canadian cohort data with the findings of larger, more diverse global populations in the BICSTaR program. Our findings are consistent with a pooled 12-month analysis of BICSTaR data from more than 1500 participants across 12 countries (including Canada), [33] in which reported virologic suppression rates were 94% in TN participants and 97% in TE participants. Further analyses in the pooled cohort showed high B/F/TAF effectiveness in different groups of people with HIV, including in participants aged ≥ 50 years and in those with comorbidities at baseline.…”

“…Further analyses in the pooled cohort showed high B/F/TAF effectiveness in different groups of people with HIV, including in participants aged ≥ 50 years and in those with comorbidities at baseline. [33] Data from both our Canadian cohort and the larger pooled cohort indicate immunologic restoration, favorable safety and tolerability, and high levels of persistence (low proportion of B/F/TAF discontinuation [<10%], including discontinuation due to DRAEs [<7%]) across both TN and TE participants at month 12 follow-up in both studies.…”

“…Detailed methods for the BICSTaR program are described elsewhere. [33] In this analysis, we included individuals aged ≥ 18 years with HIV-1 in Canada and initiating B/F/TAF in routine clinical practice at 1 of 6 medical centers: Clinique de Médicine Urbaine du Quartier Latin, Montreal; Maple Leaf Research, Toronto; Regina General Hospital, Regina; St Clair Medical Associates, Toronto; Spectrum Health, Vancouver; and The Ottawa Hospital, Ottawa.…”

“…Detailed endpoint and assessment information for the BICSTaR program are described elsewhere. [33] Follow-up visits occurred according to the standard practice of each site and the judgment of the treating physician. No additional diagnostic or laboratory monitoring procedures were required.…”

“…Pooled, prospective, 12-month data from 12 countries in BICSTaR have been published elsewhere. [33] Here, we report 12-month effectiveness, safety, and tolerability data for 170 people with HIV in the BICSTaR Canada cohort.…”