CROI 2025 Abstract eBook

Abstract eBook

Poster Abstracts

Conclusions: While each academic HIV clinic has been prescribing LA-CAB/ RPV to underserved populations, including people with VNS and people who inject drugs, the rollout across clinics is uneven. Future scale-up efforts need to address access issues at the state/health system level to ensure that the diverse PWH populations that each clinic serves can benefit from LA-CAB/RPV.

1361 Longitudinal Renal Safety of a Population-Level TDF-Based HIV PrEP Program in British Columbia Raquel M. Espinoza 1 , K. Junine Toy 1 , Rosie B. Murphy 1 , Shannon Bytelaar 1 , Jason Trigg 1 , Erin Ding 1 , Erin Ready 2 , Paul Sereda 1 , David Moore 1 , Rolando Barrios 1 , Julio S. G. Montaner 1 1 British Columbia Centre for Excellence in HIV/AIDS, Vancouver, Canada, 2 St Paul's Hospital, Vancouver, Canada Background: Since 1-Jan-2018, publicly-funded oral HIV Pre-Exposure Prophylaxis (PrEP) with generic emtricitabine-tenofovir disoproxil fumarate (FTC-TDF) has been available to key HIV populations in British Columbia (BC). We examined the renal safety of over 10,000 clients on FTC-TDF in BC’s population level PrEP program. Methods: Using data from BC’s PrEP program, we included clients with ≥1 FTC-TDF PrEP prescription dispensed between 1-Jan-2018 and 31-Dec-2023 and with ≥ 1 follow up eGFR at least 7 days after first PrEP dispense (study follow-up to 30-Jun-2024). Clients with follow-up eGFR <60mL/min at least twice, 30 days apart, and clients with ≥1 severely increased urine albumin/creatinine ratio value (uACR >30mg/mmol) subsequent to first PrEP dispense, were determined. Results: A total of 10,267 clients were included [median age 32 (Q1-Q3, 27-40) years; 97% cis-men, 1.5% trans-women (TGW); 0.7% cis-women; 0.4% trans men; 0.4% nonbinary]. 98% were men who have sex with men [MSM] or TGW with median HIRI-MSM score 18 (Q1-Q3, 15-22), and 12% reported PrEP use prior to program enrolment. Median baseline eGFR was 104 (Q1-Q3, 90-116) mL/min, with 33 (0.3%) clients with baseline eGFR <60mL/min at program enrolment, including 4 clients with eGFR <50mL/min. Median follow-up time was 22 (Q1-Q3, 9-47) months, and the median eGFR testing rate was 3.4 (Q1-Q3, 2.1-4.5) tests per person year. There was a median of 5 (Q1-Q3, 2-10) PrEP dispenses per client with an estimated median 81% (Q1-Q3, 49-97) proportion of days covered by PrEP medication during client follow-up. Overall, 151 (1.5%) of clients had incident eGFR <60mL/min at least twice consecutively, at median 24 (range 4-68) months (See Figure). For these clients, 97% were cis-men, median age was 56 (range 27-81) years, and baseline eGFR was median 68 (range 42-121) mL/min. Of the 2470 (24%) clients with ≥1 uACR result available, 31 (1.2%) had a value >30mg/mmol reported. Conclusions: Over 6 years of BC’s population-level HIV PrEP program, we found that incident decreased renal function was infrequent amongst clients, with most cases occurring >6 months after PrEP initiation. Due to the overall safety of FTC-TDF, the quarterly frequency of renal monitoring may be re-evaluated in young PrEP users with normal baseline renal function. For individuals experiencing renal adverse effects, novel PrEP agents may offer an alternative.

1360 Clinical Consequences of Delaying Implementation of LA-ART for PWH With Persistent Viremia in the US Ruitian Hu 1 , Michelle Jones 1 , Pamela Pen-Erh Pei 1 , Wanyi Chen 1 , Paul Sax 2 , Ankur Pandya 3 , Krishna Reddy 1 , Emily Hyle 1 , Kenneth A. Freedberg 1 1 Massachusetts General Hospital, Boston, MA, USA, 2 Brigham and Women's Hospital, Boston, MA, USA, 3 Harvard TH Chan School of Public Health, Boston, MA, USA Background: Long-acting (LA-) injectable cabotegravir-rilpivirine (CAB/RPV) can achieve viral suppression (VS) in PWH with poor adherence to daily ART and persistent viremia. While current DHHS guidelines recommend this indication for CAB/RPV on a case-by-case basis, the FDA is requiring a randomized trial for approval. Our objective was to project the clinical impact of delaying CAB/ RPV implementation in the US for PWH with persistent viremia while awaiting further trial data. Methods: Using the CEPAC microsimulation model, we considered 2 treatment strategies in a prevalent cohort of PWH with persistent viremia and no prior NNRTI or INSTI resistance: 1) standard daily INSTI-based oral ART, and 2) bi-monthly CAB/RPV injections. Both are coupled with social service supports to improve engagement in care. We evaluated different scenarios of CAB/ RPV uptake: 1) current practice with 99% on oral ART, 1% on CAB/RPV; 2) 100% uptake of CAB/RPV after 0 to 5y of delay; 3) 2 trial types: a single-arm 1y demonstration project with 5%/y uptake thereafter, and a 3y RCT, with 20%/y uptake thereafter; and 4) immediate 3%/y uptake of CAB/RPV for 5y. We modeled a prevalent cohort of 50,000 PWH with persistent viremia in the US and added 1,500 new people yearly. Model outcomes were person-years (PY) with VS, PY viremic, and deaths, all reported at 5y. Model inputs from published studies included: mean age 46y, mean initial CD4 count 150/µL, 6m VS of 23% for oral ART and 65% for CAB/RPV. We varied key parameters in sensitivity analysis. Results: Current practice leads to 67,730 PY with VS (of 322,500 total PY) and 29,800 deaths (of 57,500 PWH) at 5y (Table). 100% uptake of CAB/RPV with no delay increases PY with VS by 49,800 and averts 6,800 deaths (23% of deaths). Each year of delay to 100% uptake leads to ~9,960 fewer PY with VS and ~1,350 more deaths. Compared to current practice, a single-arm demonstration project yields 2,490 more PY with VS and 330 fewer deaths, while an RCT produces 2,460 more PY with VS and 200 fewer deaths. With immediate uptake of CAB/RPV, similar gains (~2,400 PY with VS) would be achieved at only 3%/y uptake. In sensitivity analysis, disengagement from care is the most influential parameter affecting survival. Conclusions: LA-CAB/RPV for PWH with persistent viremia in the US would increase VS and life expectancy. Each year of delayed uptake would substantially increase years of viremia and mortality. Rapid implementation of CAB/RPV should be undertaken, even while awaiting RCT results.

Poster Abstracts

CROI 2025 455