Scientific Poster Session III - Encore

Encore Presentations
  Monday, October 14, 2024
  01:00 PM–02:30 PM

Abstract

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

Ansgar Rieke¹, Joss de Wet², Vincenzo Esposito³, Ana Silva-Klug⁴, Itzchak Levy^5,6, John S Lambert^7,8, Marta Boffito^9,10, Berend van Welzen¹¹, Rachel Rogers¹², Nathan Unger¹², Tali Cassidy¹³, Rebecca Harrison¹³, Christine Katlama¹⁴

Institutions:

1. Gemeinschaftsklinikum Mittelrhein, Kemperhof Koblenz, Koblenz, Germany
2. Spectrum Health, Vancouver, BC, Canada
3. Infectious Diseases and Gender Medicine Unit, Cotugno Hospital, AO dei Colli, Naples, Italy
4. HIV and STD Unit (Infectious Disease Service), Hospital Universitari de Bellvitge-Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain
5. Infectious Disease Unit, Sheba Medical Center, Tel Hashomer, Israel
6. Sackler Medical School, Tel Aviv University, Tel Aviv, Israel
7. Mater Misericordiae University Hospital, Dublin, Ireland
8. School of Medicine, University College Dublin, Dublin, Ireland
9. HIV Department, Chelsea and Westminster Hospital Foundation Trust, London, UK
10. Department of Infectious Diseases, Imperial College London, London, UK
11. Department of Infectious Diseases, University Medical Centre Utrecht, Utrecht, the Netherlands
12. Gilead Sciences, Inc., Foster City, CA, US
13. Gilead Sciences, Stockley Park, UK
14. Infectious Diseases Department, Sorbonne University, Hôpital Pitié-Salpêtrière, Paris, France

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.

Table: Baseline Characteristics and 24-Month Effectiveness and Safety Outcomes
	eGFR <60 mL/min/1.73m2(N=90)	eGFR =60 mL/min/1.73m2(N=753)	P-value*
Baseline Characteristics
HIV-1 RNA, n (%)†: <50 c/mL / =50 c/mL	80 (93) / 6 (7)	676 (92) / 60 (8)	0.704
No. of previous antiretroviral therapy regimens, median (IQR)	3.0 (2.0, 5.5)	2.0 (1.0, 4.0)	0.027
MDRD eGFR (numeric formula), median (IQR), mL/min/1.73 m2	55.2 (51.2, 57.3)	85.5 (74.4, 99.6)	<0.001
Time from HIV diagnosis to B/F/TAF, median (IQR), years	14.5 (7.2, 21.8)	10.0 (4.0, 17.0)	<0.001
24-Month Effectiveness and Safety Outcomes
HIV-1 RNA viral load at 24 months, n (%)†: <50 c/mL / =50 c/mL	67 (100) / 0 (0)	556 (95) / 30 (5)	0.058
Change in MDRD eGFR at 24 months from baseline, median (IQR), mL/min/1.73 m2	1.3 (-3.6, 6.7)	-6.0 (-15.0, 1.6)	<0.001
Drug-related AE within 24 months, n (%)	14 (16)	111 (15)	0.978
Drug-related renal AE within 24 months, n (%)	1 (13)‡	0 (0)	0.062
*Chi squared test for categorical data / Kruskal–Wallis tests for numeric data; †Missing = Excluded analysis; ‡Proteinuria (did not result in dosage change/study withdrawal). AE, adverse event; B/F/TAF, bictegravir/emtricitabine/tenofovir alafenamide; c, copies

Presenting AuthorNathan Unger PharmD
Gilead Sciences

Authors

Marta Boffito MD, PhD, FRCP
HIV Department, Chelsea and Westminster Hospital Foundation Trust, London, UK; Department of Infectious Diseases, Imperial Colle

Tali Cassidy PhD, MPH
Gilead Sciences, Stockley Park, UK

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

Rebecca Harrison MS
Gilead Sciences, Stockley Park, UK

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

Ana Silva Klug MD
HIV and STD Unit (Infectious Disease Service), Hospital Universitari de Bellvitge-Bellvitge Biomedical Research Institute (IDIBE

John S Lambert MD
Mater Misericordiae University Hospital, Dublin, Ireland; School of Medicine, University College Dublin, Dublin, Ireland

Itzchak Levy MD
Infectious Disease Unit, Sheba Medical Center, Tel Hashomer, Israel; Sackler Medical School, Tel Aviv University, Tel Aviv, Isra

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

Rachel Rogers PharmD
Gilead Sciences, Inc., Foster City, CA, US

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

Joss de Wet MD
Spectrum Health, Vancouver, BC, Canada