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

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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 longterm 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.). Conclusions: 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 QutcomesFigure:: Median MDRD eGFR over time for people with results at all timepoints

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