Introduction 

Tenofovir alafenamide/emtricitabine/bictegravir (TAF/FTC/BIC) is a once‑daily, single‑tablet regimen .It  has demonstrated strong antiviral efficacy, a robust resistance barrier, minimal drug‑interaction potential, and a favourable safety profile in randomized control trials.

Aim 

To assess the effectiveness & safety of TAF/FTC/BIC in patients newly diagnosed with HIV (PWH) in a non-experimental setting. 

Patient Profile

Patients with newly diagnosed PWH treated with TAF/FTC/BIC.

Methods

• Single-center, retrospective observational study.
• 236 patients were enrolled.

Table 1 : Study Population Characteristics

• Patients were followed from treatment initiation until regimen interruption, death whichever occurred first.
• Comprehensive clinical data was collected through medical record review, including demographics, HIV‑related parameters, CD4 cell count, HIV‑RNA levels, treatment duration, adverse events, and reasons for discontinuation 
• Patients were categorized by CD4 cell count strata (<350 vs ≥350 cells/mm³, and <200 vs ≥200 cells/mm³) and by HIV‑RNA zenith (<500,000 vs ≥500,000 copies/mL) to assess differences in outcomes across disease severity levels.
• The median follow-up period was 13 months (interquartile range 4–27 months)

Study Outcomes

• The primary outcome was the occurrence of protocol-defined virological failure.
  1. Virological failure was defined as two consecutive HIV‑RNA measurements >50 copies/mL after 48 weeks of therapy 
• The secondary outcome was the assessment of reasons for treatment discontinuation and the durability of the regimen evaluated using Kaplan–Meier survival analysis

Results 

Virological Failure

1. Only 1 case (0.4%) among 221 individuals with adequate follow-up.
2. Incidence rate: 3.1 per 1000 person-years.

Treatment Discontinuation

1. 22% interrupted therapy for reasons other than virological failure. 
   • Simplification: 14.4%
   • Toxicity: 2.5%
   • Clinical trial enrollment: 1.7%
   • Death: 0.8%
   • Pregnancy: 0.4%

Durability 

• The estimated durability of the TAF/FTC/BIC regimen was 84.8% at 12 months and 75.5% at 24 months.
•  There was no significant difference in treatment durability by
  1. Age( p= 0.357), indicating similar outcomes across younger and older individuals.
  2. Biological sex (p=0.285)
  3. CD4 cell count at treatment initiation did not influence durability; this was true for both the <350 vs ≥350 cells/mm³ comparison (p = 0.973) and the<200 vs ≥200 cells/mm³ comparison (p = 0.517).
  4. AIDS presentation at baseline (p=0.166)

Figure 1: Durability of the TAF/FTC/BIC regimen at 12 months  & 24 months 

Conclusion

• Among individuals newly diagnosed with HIV, treatment with TAF/FTC/BIC showed strong durability, with approximately 75% of patients remaining on the regimen after two years.
• Treatment discontinuations were rare and were mainly due to medication‑related toxicities, while virological failure occurred infrequently—even in patients who presented late or had AIDS‑defining conditions at baseline.

Reference

IJID Regions. 2025;15;100622