Kidney Week

Abstract: TH-PO1072

Real-World Effectiveness and Tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Treatment-Experienced (TE) People with HIV with a History of CKD

Session Information

• CKD Progression and Complications: Diagnosis, Prognosis, Risk Factors
  November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: CKD (Non-Dialysis)

• 2302 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

• Rieke, Ansgar, Gemeinschaftsklinikum Mittelrhein, Kemperhof Koblenz, Koblenz, Germany

Ansgar Rieke,

• De Wet, Joss, Spectrum Health, Vancouver, British Columbia, Canada

Joss De Wet,

• Esposito, Vincenzo, Infectious Diseases and Gender Medicine Unit, Cotugno Hospital, AO dei Colli, Naples, Italy

Vincenzo Esposito,

• Silva-Klug, Ana, HIV and STD Unit (Infectious Disease Service), Hospital Universitari de Bellvitge-Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain

Ana Silva-Klug,

• Levy, Itzchak, Infectious Disease Unit, Sheba Medical Center, Tel Hashomer, Israel

Itzchak Levy,

• Lambert, John S., Mater Misericordiae University Hospital, Dublin, Ireland

John S. Lambert,

• Boffito, Marta, HIV Department, Chelsea and Westminster Hospital Foundation Trust, London, United Kingdom

Marta Boffito,

• van Welzen, Berend, Department of Infectious Diseases, University Medical Centre Utrecht, Utrecht, Netherlands

Berend van Welzen,

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

Rachel Rogers,

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

Nathan Unger,

• Cassidy, Tali, Gilead Sciences, Stockley Park, United Kingdom

Tali Cassidy,

• Harrison, Rebecca, Gilead Sciences, Stockley Park, United Kingdom

Rebecca Harrison,

• Katlama, Christine, Infectious Diseases Department, Sorbonne University, Hôpital Pitié-Salpêtrière, Paris, France

Christine Katlama,

Background

TAF-containing regimens, eg B/F/TAF, are approved in the US in people with an estimated CrCl ≥30 mL/min and have demonstrated comparable long-term renal safety vs non–tenofovir-based regimens. No proximal renal tubulopathies have been reported in 26 TAF trials or in a trial rechallenging those with history of tubulopathy on tenofovir disoproxil fumarate.

Methods

We investigated the renal safety profile and efficacy of B/F/TAF in the BICSTaR study, in which 963 TE participants with HIV switched from current antiretroviral therapy (ART) to B/F/TAF.

Results

Of 843 participants with baseline (BL) eGFR data available, 90 had CKD (MDRD eGFR <60 mL/min/1.73 m²), 83% were male and 85% were non-Black. More participants with vs without BL CKD were >50 yrs old (79% vs 43%; P<0.001), had ≥1 cardiovascular condition (54% vs 20%; P<0.001), diabetes mellitus (12% vs 6%; P=0.029) and hypertension (44% vs 16%; P<0.001). Those with vs without BL CKD had longer prior exposure to ART and time from diagnosis to B/F/TAF initiation (Table).

Drug-related (DR) AEs were reported in 16% of people with BL CKD vs 15% in those without. A single DR renal AE (RAE) was reported in 1 person with BL CKD (proteinuria, drug continued); there were no DR RAE discontinuations or serious DR RAEs. Median eGFR was stable through 24 months for people with BL CKD (Fig.).

Conclusion

B/F/TAF was effective and safe with respect to renal outcomes in this real-world study in TE people with HIV and CKD switching to B/F/TAF, supporting use of TAF-based regimens in people with eGFR <60 mL/min/1.73 m².