CROI 2025 Abstract eBook

Abstract eBook

Poster Abstracts

Results: There were 2,858 suppressed CAB+RPV LA users (median age: 39 [IQR: 31, 51], 84% male, 42% Black, 30% Hispanic, 55% in the US South, median years since HIV diagnosis: 6 [IQR: 2, 13], 24% with history of an AIDS defining event, 30% with BMI ≥30 kg/m 2 , median CD4 count: 698 cells/µL [IQR: 519, 912], 78% on an INSTI prior to CAB+RPV LA). Among 2,626 (92%) PWH who completed initiation, median follow-up time was 11 months (IQR: 6, 18; Table) and 2,182 (83%) were on CAB+RPV LA at time of analysis; 83% received their second injection on-time, and all maintenance injections were on-time in 60% of the 2,401 PWH with maintenance injections. Most PWH maintained virologic suppression (95% <50 c/mL at last VL and 83% had no virologic blips [all VLs <50 c/mL]). Of those with 6, 12, and 24-month VLs, virologic suppression was observed in 954/1,015 (94%), 511/538 (95%), and 85/89 (96%), respectively. CVF was observed in 32 (1%) PWH, with 17 CVFs occurring within the first 6 months. Across BMI categories (<30 kg/m 2 vs. ≥30 kg/m 2 ), neither virologic suppression <50 c/mL (all VLs: 83% vs. 84%; last VL: 95% vs. 94%) nor CVF (1% vs 1%) differed. Conclusions: In this large cohort of suppressed CAB+RPV initiators with long-term follow-up, most individuals were able to remain on the regimen and adhere to the dosing schedule over the first 3 years of availability. Suppressed PWH on CAB+RPV LA had favorable virologic outcomes as most maintained VLs <50 c/mL and CVF was infrequent. Further, virologic suppression was maintained regardless of BMI category at initiation.

models allowed for different baseline levels and trends over time by demographic/clinical factors. Based on fitted models, estimates of marker levels and changes since ART initiation were compared across factor groups at 8&10 years post-ART initiation. Results: Of 4486 participants initiating ART, 2305 (51%) were in the Immediate and 943 (21%), 694 (16%), and 544 (12%) in the three Deferred groups, respectively. All 3 markers rose steeply in the first year post-ART, then plateaued around 5-6 years. Deferred groups starting ART with ≤500 CD4 cells/μL had lower levels of all 3 markers and remained below the Immediate group levels through 10 years. CD4 counts at 10 years were 997 cells/μL in the Immediate and 734 cells/μL in the Deferred <350 CD4 cells/μL subgroup. Key factors influencing long-term marker trends included treatment group, HIV transmission mode, randomization region, HIV-RNA, first ART class, BMI, and age. Multivariable analyses showed no significant differences in 8&10-year CD4 count between the Immediate and the Deferred >500 CD4 cells/μL group, though moderate differences were seen for CD4% and CD4/CD8 ratio (Figure). In the Deferred ≤350 CD4 cells/μL group, 40% of those on INSTI-based regimens achieved a CD4/CD8 ratio >1 at 8 years compared to 45% for NNRTI-based regimens. Conclusions: The extent and trajectory of immune recovery, judged with any of the 3 markers, is consistently greater in those with earlier ART initiation; those starting with CD4 ≤500 cells/μL do not catch up over 8&10 years on ART. While there are differences by sex, region and comorbidity, the improved long-term outcomes associated with earlier initiation are consistent across the markers measured.

Poster Abstracts

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Outcomes on Cabotegravir + Rilpivirine in Suppressed People With HIV (PWH) in TRIO Health US Cohort Andrew Frick 1 , Paul Sax 2 , Supriya Sarkar 3 , Janna Radtchenko 1 , Gayathri Sridhar 3 , Leigh Ragone 3 , Joseph J. Eron 4 , Steven Santiago 5 , Moti Ramgopal 6 , Karam Mounzer 7 , Charles Walworth 8 , Jean van Wyk 9 , Richard A. Elion 1 , Vani Vannappagari 3 1 Trio Health, Louisville, CO, USA, 2 Brigham and Women's Hospital, Boston, MA, USA, 3 ViiV Healthcare, Durham, NC, USA, 4 University of North Carolina at Chapel Hill, Chapel Hill, NC, USA, 5 Care Resource, Miami, FL, USA, 6 Midway Immunology and Research Center, Fort Pierce, FL, USA, 7 Philadelphia FIGHT, Philadelphia, PA, USA, 8 Monogram Biosciences, South San Francisco, CA, USA, 9 ViiV Healthcare, Brentford, UK Background: Cabotegravir+Rilpirivine (CAB+RPV) is the first complete long-acting injectable antiretroviral therapy (ART) for the treatment of HIV for ART-experienced PWH with undetectable viral load (VL <50 copies/mL [cpm]). This study examined the utilization and effectiveness of CAB+RPV in real-world settings in the US. Methods: ART-experienced adults with undetectable VL at initiation who received ≥1 CAB+RPV injection between Feb 2021-Mar 2024 were identified from electronic health records in the Trio Health Cohort. Discontinuation of CAB+RPV was defined as 2 consecutive missed injections or an ART regimen switch, while confirmed virologic failure (CVF) was defined as 2 consecutive VLs >200 cpm or 1 VL >200 cpm with discontinuation within 4 months (mo) of the first elevated VL; delayed injections were defined as occurring >7 days after target date (Q1M or Q2M). ART resistance based on HIV genotype results prior to baseline and at CVF was available for a subset of PWH and analyzed using the Stanford HIVdb algorithm. Results: Analyses included 1198 PWH who initiated CAB+RPV; median age was 43 years (IQR: 34-54), predominately male (77%), non-Black (52%), and treated in the US South (52%). Median follow-up time after the first injection was 12 mo (IQR 5-19). At the end of follow-up, 923 (77%) PWH remained on CAB+RPV; among 275 PWH who discontinued CAB+RPV, 24 (9%) re-initiated CAB+RPV, 4 (1.5%) experienced injection site reactions. Among all CAB+RPV initiators, 928 (77%) individuals had ≥1 follow-up VL; among these, 882 (95%) had last

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Long-Term CAB+RPV LA Effectiveness in Virologically Suppressed Individuals in the OPERA Cohort Brooke Levis 1 , Ricky K. Hsu 2 , Jennifer S. Fusco 1 , Michael Sension 3 , Laurence Brunet 1 , Quateka Cochran 4 , Gayathri Sridhar 5 , Vani Vannappagari 5 , Jean van Wyk 6 , Michael B. Wohlfeiler 7 , Gregory P. Fusco 1 1 Epividian, Inc, Durham, NC, USA, 2 AIDS Healthcare Foundation, New York, NY, USA, 3 CAN Community Health, Fort Lauderdale, FL, USA, 4 AIDS Healthcare Foundation, Fort Lauderdale, FL, USA, 5 ViiV Healthcare, Durham, NC, USA, 6 ViiV Healthcare, Brentford, UK, 7 AIDS Healthcare Foundation, Miami, FL, USA Background: Cabotegravir + rilpivirine long-acting (CAB+RPV LA) injectable was FDA approved for treatment experienced, suppressed (viral load [VL] <50 c/ mL) people with HIV (PWH) on a monthly (Q1M; 2021) or every 2 months (Q2M; 2022) schedule. We assessed CAB+RPV LA use in a real-world setting over its first 3 years of availability. Methods: Suppressed adults with HIV switching to CAB+RPV LA (21JAN2021 31DEC2023) were followed through 29FEB2024 in the OPERA Cohort. Among complete initiators (first 2 injections ≤67 days apart), on-time injections (23-37 days after last Q1M injection, 53-67 days after last Q2M injection) and discontinuation (no injection for ≥68 days [Q1M] or ≥128 days [Q2M]) were described. Confirmed virologic failure (CVF; 2 VLs ≥200 c/mL or 1 VL ≥200 c/mL + discontinuation) was assessed among those with ≥1 follow-up VL. Virologic outcomes were assessed overall and stratified by body mass index (BMI) at initiation (<30 vs. ≥30 kg/m 2 ).

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