CROI 2025 Abstract eBook

Abstract eBook

Poster Abstracts

859

Renal Outcomes in People With HIV-1 and Renal Impairment Treated With B/F/TAF in Randomized Trials Frank Post 1 , David Wohl 2 , Geoffroy Liegeon 3 , Indira Brar 4 , Debbie Hagins 5 , Yazdan Yazdanpanah 6 , Anchalee Avihingsanon 7 , Hui Liu 8 , Keith Aizen 8 , Jason T. Hindman 8 , Samir K. Gupta 9 1 King's College Hospital NHS Foundation Trust, London, UK, 2 University of North Carolina at Chapel Hill, Chapel Hill, NC, USA, 3 Université Paris Cité, Paris, France, 4 Henry Ford Hospital, Detroit, MI, USA, 5 Chatham Care Center, Savannah, GA, USA, 6 Hôpital Bichat-Claude-Bernard, Paris, France, 7 HIV-NAT, Thai Red Cross AIDS and Infectious Disease Research Centre, Bangkok, Thailand, 8 Gilead Sciences, Inc, Foster City, CA, USA, 9 Indiana University, Indianapolis, IN, USA Background: Chronic kidney disease is common in people with HIV (PWH), with prevalence likely to rise as this population ages. Compared with tenofovir disoproxil fumarate–based antiretroviral regimens, tenofovir alafenamide (TAF)–based regimens have shown a superior renal safety profile, improving treatment options for PWH with renal impairment. Using pooled trial data, we assessed renal outcomes in PWH with mild to moderate renal impairment receiving bictegravir/emtricitabine/TAF (B/F/TAF). Methods: Participant data from nine Phase 3/3b trials (NCT02607930, NCT02607956, NCT03547908, NCT02603120, NCT02603107, NCT02652624, NCT03110380, NCT03405935, NCT03631732) were pooled. Treatment-naïve or virologically suppressed adult PWH with Cockcroft-Gault estimated glomerular filtration rate (eGFR) ≥30–<90 mL/min at treatment initiation who received B/F/TAF for up to 5 years were included. We evaluated absolute eGFR and eGFR change from baseline, renal treatment-emergent adverse events (TEAEs), and treatment discontinuations due to renal TEAEs. Results: Of 1069 participants, 975 had eGFR ≥60–<90 mL/min (Stage 2 eGFR), 86 had eGFR ≥45–<60 mL/min (Stage 3a eGFR), and 8 had eGFR ≥30–<45 mL/ min (Stage 3b eGFR). Overall, 31% of included participants were female, 51% were White, and 8% were treatment naïve. Median (Q1, Q3) age was 53 (44, 60) years. Median (Q1, Q3) B/F/TAF exposure duration was 83.4 (52.4, 101.9) weeks, with 46 participants exposed for ≥240 weeks. Absolute eGFR remained stable from baseline to Week 96 for those with Stage 2 eGFR and Stage 3a eGFR ( Figure, panel A ). Median (Q1, Q3) eGFR (mL/min) change from baseline at Week 96 was 0.6 (-5.4, 6.6) overall; Stage 2, 0.1 (-5.8, 6.6); Stage 3a, 2.0 (-3.6, 5.7) ( panel B ). Absolute eGFR for Stage 2 participants was largely stable, with minimal change in eGFR from baseline to Week 240. Data for Stage 3b participants, and past Week 96 for those with Stage 3a eGFR, were limited by low participant numbers. Renal TEAEs occurred in 28 (2.6%) participants (most frequent: acute kidney injury [AKI] [n=10], decreased creatinine renal clearance [n=6], and proteinuria [n=5]). One participant with Stage 2 eGFR discontinued B/F/TAF treatment following AKI; the discontinuation was judged as unrelated to the study drug. Conclusions: Among PWH with mild to moderate renal impairment, stable kidney function was observed in participants receiving B/F/TAF for up to 5 years. The overall rate of renal TEAEs was low, with only one discontinuation due to renal TEAEs.

860

Racial Inequity in Initiation of Semaglutide Therapy Among People With HIV in Care Across the US Stephanie A. Ruderman 1 , Andrew W. Hahn 1 , Lara Haidar 2 , Sherif Eltonsy 2 , Lydia N. Drumright 1 , Jimmy Ma 1 , Conall O'Cleirigh 3 , Sonia Napravnik 4 , Katerina Christopoulos 5 , Edward Cachay 6 , George Yendewa 7 , Amanda Willig 8 , Geetanjali Chander 1 , Heidi M. Crane 1 , Rob Fredericksen 1 , for the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) 1 University of Washington, Seattle, WA, USA, 2 University of Manitoba, Winnipeg, Canada, 3 Harvard Medical School, Boston, MA, USA, 4 University of North Carolina at Chapel Hill, Chapel Hill, NC, USA, 5 University of California San Francisco, San Francisco, CA, USA, 6 University of California San Diego, La Jolla, CA, USA, 7 Case Western Reserve University, Cleveland, OH, USA, 8 University of Alabama at Birmingham, Birmingham, AL, USA Background: Antiretroviral therapy has resulted in a reduction in HIV associated wasting among people with HIV (PWH) and a concomitant rise in overweight and obesity. Semaglutide has been difficult to obtain for some populations, we therefore evaluated use of semaglutide among PWH with medical indications assessing for potential disparities based on race/ethnicity. Methods: Our study is set in the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) cohort at 9 sites. We identified PWH in CNICS eligible for semaglutide therapy, with either a body mass index (BMI) ≥30 or hemoglobin A1c (HbA1c) ≥6.5. The outcome was having been prescribed semaglutide between 2019-2023. We evaluated differences in semaglutide receipt by race/ethnicity using relative risk regression with robust standard errors to estimate the association between demographic/clinical characteristics and receipt of semaglutide including age, sex, site, maximum BMI and race/ ethnicity defined as a four-level variable: non-Hispanic White, non-Hispanic Black, Hispanic, and Other. We repeated models stratifying by indication for semaglutide therapy (BMI or HbA1c). Results: Among 11,617 people who met at least one criterion for semaglutide, 774 (6.7%) received it with higher rates in the later part of the time period. Of those who received semaglutide, 92% had a BMI ≥30, 62% had an A1c ≥6.5, and 54% met both criteria. A lower proportion of eligible Black PWH received semaglutide compared to White PWH (279 [36%] vs. 315 [41%]), despite making up a larger proportion of PWH qualifying for therapy (48% Black and 35% White). In adjusted models, Black PWH were 20% less likely to receive semaglutide therapy compared with White PWH with similar indications (Prevalence Ratio [PR]: 0.80, 95% Confidence Interval [CI]: 0.67,0.95). Hispanic PWH showed a non-significant trend towards lower initiation overall and for BMI ≥30 (Table). The lower rate of semaglutide use for Black PWH (PR: 0.66, 95%CI: 0.53-0.83), as well as for Hispanic PWH (PR: 0.70, 95%CI: 0.53,0.93), was even more pronounced among those with poorly controlled A1c (≥8.0) (Table). Conclusions: We describe inequitable semaglutide use among PWH, with lower initiation rates in eligible Black PWH despite more frequent indication. Given our evidence that baseline diabetic severity at diagnosis is similar across race/ethnicity in PWH, this underscores the urgent need to improve equitable care for marginalized PWH and address potential implicit bias among providers.

Poster Abstracts

CROI 2025 263