Twelve-month effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide in people with HIV from the Canadian cohort of the observational BICSTaR study.
Medicine (Baltimore)
; 103(16): e37785, 2024 Apr 19.
Article
in En
| MEDLINE
| ID: mdl-38640301
ABSTRACT
The BICSTaR (BICtegravir Single Tablet Regimen) study is investigating the effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus (HIV) treated in routine clinical practice. BICSTaR is an ongoing, prospective, observational cohort study across 14 countries. Treatment-naïve (TN) and treatment-experienced (TE) people with HIV (≥18 years of age) are being followed for 24 months. We present an analysis of the primary endpoint (HIV-1 RNAâ
<â
50 copies/mL; missing-equals-excluded [Mâ
=â
E]) at month 12 in the BICSTaR Canada cohort, including secondary (CD4 count, CD4/CD8 ratio, safety/tolerability) and exploratory (persistence, treatment satisfaction) endpoints. In total, 201 participants were enrolled in the BICSTaR Canada cohort. The analysis population included 170 participants (TN, nâ
=â
10; TE, nâ
=â
160), with data collected between November 2018 and September 2020. Of the participants, 88% were male, 72% were White, and 90% hadâ
≥â
1 comorbid condition(s). Median (quartile [Q]1-Q3) age was 50 (39-58) years and baseline CD4 count was 391.5 (109.0-581.0) cells/µL in TN participants and 586.0 (400.0-747.0) cells/µL in TE participants. After 12 months of B/F/TAF treatment, HIV-1 RNA wasâ
<â
50 copies/mL in 100% (9/9) of TN-active participants and 97% (140/145) of TE-active participants (Mâ
=â
E analysis). Median (Q1-Q3) CD4 cell count increased byâ
+195 (125-307) cells/µL in TN participants and byâ
+â
30 (-50 to 123) cells/µL in TE participants. Persistence on B/F/TAF was high through month 12 with 10% (1/10) of TN and 7 % (11/160) of TE participants discontinuing B/F/TAF within 12 months of initiation of treatment. No resistance to B/F/TAF emerged. Study drug-related adverse events occurred in 7% (12/169) of participants, leading to B/F/TAF discontinuation in 4 of 169 participants. Improvements in treatment satisfaction were observed in TE participants. B/F/TAF demonstrated high levels of effectiveness, persistence, and treatment satisfaction, and was well tolerated through month 12 in people with HIV treated in routine clinical practice in Canada.
Full text:
1
Database:
MEDLINE
Main subject:
Piperazines
/
Pyridones
/
HIV Infections
/
HIV-1
/
Anti-HIV Agents
/
Alanine
/
Tenofovir
/
Amides
Limits:
Child, preschool
/
Female
/
Humans
/
Male
/
Middle aged
Country/Region as subject:
America do norte
Language:
En
Year:
2024
Type:
Article