Same-Day BIC/FTC/TAF Initiation for HIV: Real-Life Effectiveness in Achieving Viral Suppression
Introduction
Current ART guidelines recommend initiating therapy with the coformulated regimen bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Rapid or same-day ART initiation improves outcomes and reduces transmission risk however evidence on the real-world effectiveness of rapid initiation of BIC/FTC/TAF is limited.
Aim
To evaluate efficacy of same-day BIC/FTC/TAF initiation in a real-life in achieving viral suppression.
Patient Profile
- 107 ART-naïve PLWH initiating BIC/FTC/TAF within 24 hours of first visit (May 2019–Dec 2022).
- The mean age of participants was 38.5 years
- The mean CD4 cell count was 343.8 cells/μL, with 26.2% of participants having CD4 counts below 200 cells/μL
- The mean HIV-1 RNA viral load was 4.9 log10 copies/mL, & 43.9% of participants had viral loads greater than 100,000 copies/mL, while 18.7% had levels exceeding 500,000 copies/mL.
Methods
- Retrospective single-arm
- A total of 107 people living with HIV (PLWH) initiating BIC/FTC/TAF within 24 hours of first visit were included in the study.
- Primary outcome: Virological suppression (HIV-1 RNA <50 copies/mL) at 12 months.
Results
- At month 12, the intention-to-treat (ITT) analysis showed that 78.5% of participants achieved virological suppression vs on-treatment (OT) analysis demonstrated a higher efficacy rate of 91.3% among those who remained on therapy and had viral load measurements available
Figure 1: Virologic response (HIV-1 RNA, copies/mL) in intention-to-treat (ITT) and on-treatment (OT) analyses at 6 months and 12 months
- Retention in care was excellent, with 94.4% of participants still engaged in care at month 12.
- There were no discontinuations or switches from BIC/FTC/TAF to other antiretroviral regimens during the study period
- The mean CD4 cell count increased by 211.8 cells/μL at month 6 and by 352.6 cells/μL at month 12 compared to baseline
- The CD4/CD8 ratio also improved from 0.4 at baseline to 0.7 at month 12, indicating immune restoration
Table 1: Changes in Laboratory Parameters from Baseline to Month 6 and Month 12
|
Parameter |
Baseline (Mean) |
Month 6 (Mean) |
Month 12 (Mean) |
p-value |
|
CD4 cell count (cells/μL) |
343.8 |
555.7 |
645.5 |
<0.001 |
|
CD4/CD8 ratio |
0.4 |
0.6 |
0.7 |
<0.001 |
|
Hemoglobin (g/L) |
141.6 |
147.7 |
148.2 |
<0.001 |
|
Glucose (mmol/L) |
5.5 |
5.3 |
5.2 |
0.018 |
|
Creatinine (μmol/L) |
76.8 |
90.1 |
92.1 |
0.036 |
|
eGFR (mL/min/1.73 m²) |
109.6 |
100.8 |
101.2 |
<0.001 |
|
AST (U/L) |
38.6 |
27.5 |
26.1 |
0.008 |
|
ALT (U/L) |
43.4 |
28.0 |
25.9 |
0.006 |
|
Gamma-GT (U/L) |
42.8 |
26.4 |
25.3 |
0.004 |
|
Total Cholesterol (mmol/L) |
4.5 |
5.1 |
5.1 |
<0.001 |
|
HDL Cholesterol (mmol/L) |
1.0 |
1.2 |
1.2 |
<0.001 |
|
LDL Cholesterol (mmol/L) |
3.0 |
3.3 |
3.3 |
<0.001 |
|
Triglycerides (mmol/L) |
1.5 |
1.5 |
1.5 |
0.881 |
|
Weight (kg) |
75.6 |
80.4 |
80.9 |
<0.001 |
|
BMI (kg/m²) |
23.6 |
25.0 |
25.1 |
<0.001 |
|
Systolic BP (mmHg) |
120.7 |
122.8 |
121.1 |
0.524 |
- Changes in Weight and BMI Lipid Levels
- Weight and BMI increased notably: the mean weight rose by 5.2 kg & BMI increased by 1.5 kg/m² from baseline to month 12
- The proportion of overweight participants increased from 28.1% at baseline to 34.9% at month 12, and obesity prevalence rose from 2.1% to 14.0%
- Lipid profile changes included an increase in total cholesterol, LDL cholesterol & HDL cholesterol between baseline & month 6, with no significant changes between months 6 & 12
- The proportion of participants with LDL cholesterol ≥3.0 mmol/L rose from 44.9% at baseline to 53.3% at month 12
- No participant met the WHO criteria for virological failure (HIV-1 RNA >1000 copies/mL) & all individuals with detectable viral loads had levels below 200 copies/mL, minimizing the risk of onward HIV transmission.
Conclusion
- Same-day initiation of BIC/FTC/TAF is effective & feasible in real-life settings.
- High efficacy, retention & treatment persistence observed.
- Supports guideline recommendations for rapid ART initiation.
Reference
Infect Dis Ther. 2025;14:867–880
