Kidney Week

Abstract: SA-PO0538

Kidney Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in People with HIV Across Baseline eGFR Subgroups: Five-Year Real-World Data from the BICSTaR Study

Session Information

• CKD: Clinical - Therapies, CKM Health, Special Populations, and More
  October 24, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: CKD (Non-Dialysis)

• 2202 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

• Wong, Alexander, Division of Infectious Diseases, University of Saskatchewan, Regina, Saskatchewan, Canada

Alexander Wong, MD

• Stephan, Christoph, University Hospital Frankfurt, Frankfurt am Main, Germany

Christoph Stephan

• Lee, Marcel, MVZ Isarpraxis, Munich, Germany

Marcel Lee

• Hedgcock, Malcolm, Spectrum Health, Vancouver, British Columbia, Canada

Malcolm Hedgcock, MD

• Beer, Daniel, PZB Aachen, Praxis/Labor Dr. med. Heribert Knechten, Aachen, Germany

Daniel Beer, MD

• Duvivier, Claudine, Institut Pasteur, Paris, France

Claudine Duvivier

• Robineau, Oliver, University of Lille, Centre Hospitalier de Tourcoing, Tourcoing, France

Oliver Robineau

• Desclaux, Arnaud, Service des Maladies Infectieuses et Tropicales, CHU de Bordeaux (Hôpital Pellegrin), Bordeux, France

Arnaud Desclaux, MD

• Rogers, Rachel, Gilead Sciences, Inc., Foster City, California, United States

Rachel Rogers, PharmD

• Unger, Nathan, Gilead Sciences, Inc., Foster City, California, United States

Nathan Unger

• Hu, Mo, IQVIA, Chicago, Illinois, United States

Mo Hu

• Harrison, Rebecca, IQVIA, London, United Kingdom

Rebecca Harrison

• Smith, Somer L., Gilead Sciences, Inc., Foster City, California, United States

Somer L. Smith, PharmD

• Trottier, Benoit, Département de Recherche, Clinique de Médecine Urbaine du Quartier Latin, Montreal, Quebec, Canada

Benoit Trottier, MD

Background

BICSTaR is a multicountry prospective cohort evaluating real-world effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-naïve (TN) and treatment-experienced (TE) adults with HIV. We report 5-year outcomes focusing on renal safety, virologic effectiveness, and tolerability, across baseline eGFR subgroups.

Methods

Participants completed 5 years of follow up. Outcomes were evaluated overall and by baseline eGFR (<60 vs ≥60 mL/min/1.73m²), age (<50, 50-64, ≥65 years), and comorbidities (cardiovascular disease, hypertension, diabetes, renal or urinary disease, chronic hepatitis B/C). Outcomes were virologic suppression, overall adverse events (AEs), and changes in eGFR (CKD-EPI).

Results

Among TN (n=127) and TE (n=610) participants at baseline, 26.0% TN and 48.3% TE were >50 years of age, and 18.9% TN and 33.6% TE had ≥1 comorbidity. Median eGFR change from baseline to 5 years was small overall and consistent across subgroups (Table 1 and Figure 1). Renal AEs were infrequent with no new or unexpected renal safety signals, including among participants with lower baseline eGFRs. B/F/TAF was generally well tolerated, with low rates of drug-related discontinuation. Virologic suppression was high (>95%) through 5 years in TN and TE participants (Figure 1).

Conclusion

This 5-year real-world analysis supports durable effectiveness and favorable long-term renal safety of B/F/TAF across clinically relevant populations.

Funding

• Commercial Support – Gilead Sciences, Inc.