CROI 2025 Abstract eBook

Abstract eBook

Poster Abstracts

and two have long-standing viremia despite CAB/RPV+LEN without resistance to RPV or CAB. Of 645 CAB/RPV injections administered (500 q4wk; 145 q8wk), 99% were on-time (within 7-day window). CAB/RPV were covered by medical benefits (n=54), ADAP (n=22) and pharmacy benefits (n=5). Five discontinued LA ART in follow-up. Conclusions: This is the largest reported single cohort of PWH to initiate LA ART with viremia and 93% achieved VS despite significant barriers to care and burden of disease, underscoring the potential of LA ART to help achieve Ending HIV Epidemic goals. Long-Acting Injectable Versus Oral HIV Antiretroviral Therapy for People Experiencing Homelessness Kathleen O'Connor 1 , Sarah Strieff 1 , Alexandra Strough 1 , Stephen Matzat 1 , Barry Zevin 1 , Joanna Eveland 1 , Nicky Mehtani 2 1 San Francisco Department of Public Health, San Francisco, CA, USA, 2 University of California San Francisco, San Francisco, CA, USA Background: People experiencing homelessness (PEH) face higher rates of HIV-related morbidity due to structural barriers that impede adherence to HIV antiretroviral therapy (ART) adherence, challenges compounded by co-occurring substance use disorders and severe mental illness. Long-acting injectable ART (LA-ART) formulations offer a promising solution to these adherence challenges, yet their use in PEH remains understudied. We conducted a retrospective analysis to compare HIV virologic suppression between patients receiving LA-ART and those on oral ART at a status-neutral, low-barrier public health clinic designated to serve PEH in San Francisco. Methods: Data were abstracted from the electronic medical records of patients receiving HIV care between January to December 2023. Descriptive statistics were used to assess differences in HIV virologic suppression, care engagement, demographics, and co-morbidities between those prescribed LA-ART and oral ART. Patients who attended only one visit or received HIV care elsewhere were excluded. Results: Among 94 unique patients, 87 were on oral ART and 20 received LA-ART during the 2023 calendar year. While 62% of oral ART patients achieved HIV virologic suppression (<30 copies/mL) at least once and 48% remained suppressed at the latest follow-up, 100% of LA-ART patients achieved and maintained virologic suppression, including 16 who initiated injections with detectable viremia. LA-ART regimens included intramuscular cabotegravir/ rilpivirine (CAB/RPV) alone (n = 14), CAB/RPV with subcutaneous lenacapavir (LEN) (n = 5), and CAB with LEN (n = 1). LA-ART patients had more clinic visits per person-year than those on oral ART (mean 27.6 vs. 11.2 visits), were more likely to identify as transgender or non-binary (30% vs. 16%), and had higher rates of psychotic disorders (40% vs. 27%) and other mental health conditions (60% vs. 48%) (p < 0.001). The groups were otherwise comparable in terms of age (mean 43.5, SD 11.6), race/ethnicity (71% non-White), sex (64% cisgender male), and the prevalence of stimulant (71%) and opioid use disorders (30%). Conclusions: At a status-neutral community-based clinic, LA-ART was associated with significantly higher rates of virologic suppression and clinic visits compared to oral ART among PEH engaged in low-barrier HIV care. These findings underscore the potential of LA-ART to improve HIV outcomes in this population and advocate for increased public health investment in LA-ART implementation. A5359: Decreasing Oral Induction Duration in Support of LAI ART Use With Hardly-Reached Populations Aadia Rana 1 , Lu Zheng 2 , Sara Sieczkarski 3 , Jordan E. Lake 4 , Carl Fichtenbaum 5 , Pablo Belaunzarán-Zamudio 6 , Jonathan Li 7 , Paul Wannamaker 8 , Jose Castillo Mancilla 8 , Kati Vandermeulen 9 , Chanelle Wimbish 10 , Karen T. Tashima 11 , Raphael J. Landovitz 12 , for the ACTG A5359 Study Team 1 University of Alabama at Birmingham, Birmingham, AL, USA, 2 Harvard TH Chan School of Public Health, Boston, MA, USA, 3 Frontier Science & Technology Research Foundation, Inc, Amherst, NY, USA, 4 University of Texas Health Science Center at Houston, Houston, TX, USA, 5 University of Cincinnati Medical Center, Cincinnati, OH, USA, 6 National Institute of Allergy and Infectious Diseases, Baltimore, MD, USA, 7 Brigham and Women's Hospital, Boston, MA, USA, 8 ViiV Healthcare, Brentford, UK, 9 Johnson & Johnson, New Brunswick, NJ, 10 DLH Corporation, Atlanta, GA, USA, 11 Brown University, Providence, RI, USA, 12 University of California Los Angeles, Los Angeles, CA, USA Background: Large randomized clinical trials of investigational agents in people with HIV (PWH) routinely exclude participants with adherence challenges. ACTG 5359, a phase III, prospective, randomized, open-label trial comparing long acting cabotegravir + rilpivirine (LAI) vs. oral standard of care (SOC) ART in PWH with a history of suboptimal adherence (persistent HIV-1 RNA

>200 c/mL or loss to follow-up), successfully enrolled 437 participants in the US when an independent Data and Safety Monitoring Board recommended to stop randomization and offer LAI to all eligible participants at an interim review. Here we present transition status from induction phase to randomization with successive refinement of randomization eligibility. Methods: Enrolled participants received conditional cash incentives for viral suppression along with a menu of adherence support strategies on SOC for up to 24 weeks prior to randomization (Step 1). Participants who achieved HIV-1 RNA ≤200 c/mL in Step 1 were eligible for randomization to monthly LAI vs. continuation of SOC ART for 52 weeks (Step 2). After study initiation (March 2019), the HIV-1 RNA threshold for Step 2 was increased from <50 c/mL to <200c/mL, and the minimum duration of Step 1 was progressively shortened from 20 weeks to 12 weeks (Dec 2021) and then to 4 weeks (Jan 2023). Results: As of 3 Jan 2024, 878 participants screened and 437 eligible were enrolled. The most common screen failure reasons include HIV-1 RNA ≤200 c/ mL (106, 25%), ineligible genotype/exclusionary mutations (93, 22%), and failure to return to clinic (48, 11%). Among those enrolled: median age 40 years, 70% male, 64% Black/African American, 17% Hispanic, 5% transgender, median CD4+ cells 270/mm3, and median HIV-1 RNA 3.55 log10 c/mL. Twenty percent had less than a high school education, 44% reported income of <$10k/ year, and 10% were unstably housed/homeless. One-quarter screened positive for moderate/severe depression, 27% for moderate/severe anxiety, 32% for hazardous drinking, and 45% for drug use related problems. Of the 411 eligible for transition at the interim analysis, 61%, 77%, and 89% transitioned successfully to Step 2 with progressively shorter duration of viral suppression in Step 1(Table). Conclusions: A5359 successfully enrolled a population not generally included in studies of investigational ART strategies and demonstrated that in-stream shortening of the required duration of virologic suppression significantly increased enrollment for the randomized strategy comparison.

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Poster Abstracts

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Simplified Access and Retention Model for Vulnerable People With HIV: SIMPLIFIED Study Results Pablo Ryan 1 , Guillermo Cuevas 1 , Pedro Alfonso Torres 1 , Laura Laguna Garcia 1 , Beatriz Brazal 2 , Marta De Miguel 2 , Mariano Matarranz 1 , Samuel Manzano 1 , Juan Torres-Macho 1 , Laura Martin-Gonzalez 3 , Samuel Estevez 1 , Victor De La Fuente 1 , Lucia Serrano 2 , Jorge Valencia 1 1 Hospital Universitario Infanta Leonor, Madrid, Spain, 2 Fundación SEIMC-GeSIDA, Madrid, Spain, 3 Hospital General Universitario Gregorio Marañón, Madrid, Spain Background: HIV virological suppression in vulnerable populations is influenced by various social determinants of health that affect access to healthcare. This study evaluates the feasibility and efficacy of a “test, treat, and retain” strategy implemented via street teams and a mobile unit using BIC/FTC/ TAF. Methods: A clinical trial conducted in Madrid/Spain in 2023-2024 that included vulnerable individuals >18 years with HIV, both ART-naive and pre-treated participants who had discontinued ART. Recruitment occurred in non-hospital settings, primarily on the streets by NGO street teams and a mobile unit. Participants-initiated ART at the same day and were followed for 48 weeks. During this period, they received social support to encourage attendance at follow-up visits and collect ART at the pharmacy. Results: 101 participants were included, median age of 34 years, 86.1% male, and predominantly Hispanic (73.3%). Sixty-three percent had unstable home, with 25% being homeless. 44% had problematic drug use in the last year. Thirty percent had never taken ART, and 70% had discontinued it (average of 6.9 months), with 9% showing previous virological failure). The prevalence of

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