CROI 2025 Abstract eBook

Abstract eBook

Poster Abstracts

OLI groups (43.2% vs 38.5%, p=.633) or VF (1.2% vs 3.2%, p=.624). CAB and RPV Ctrough levels, regardless of OLI use, remained well above the 4xPAIC90 threshold from clinical trials (see Figure). In multivariable models, lower CAB Ctrough was significantly associated with higher BMI (p=.017), and showed trends towards lower levels in males (p=.067) and smokers (p=.055), with no influence of OLI use. Lower RPV levels were significantly associated with smoking (p=.011) and younger age (p=.047). Secondary analyses of participants with baseline VL<20 cp/mL (N=147) showed similar trends. Conclusions: In conclusion, the use of an oral lead-in did not result in significant differences in pharmacokinetics or virological outcomes for PWH transitioning to CAB+RPV LA over 9 months.

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Outcomes of LAI ART for People With Detectable HIV Viremia in the NYC Public Healthcare System Anthony Gerber 1 , Eunice Casey 2 , Ofole Mgbako 3 , Emma Kaplan-Lewis 4 1 Bellevue Hospital, New York, NY, USA, 2 NYC Health and Hospitals, New York, NY, USA, 3 New York University Langone Medical Center, New York, NY, USA, 4 Elmhurst Hospital Center, Queens, NY, USA Background: Long-acting injectable cabotegravir/rilpivirine (LAI CAB/RPV) has changed the landscape of antiretroviral therapy (ART) by creating an alternative to daily oral ART. While FDA approval is currently limited to individuals with viral load suppression (VLS), there is growing evidence that CAB/RPV may also benefit virally unsuppressed patients who face adherence challenges taking oral ART. Our study evaluated LAI use in the country’s largest municipal health system and compared patient characteristics and viral load outcomes of people starting LAIs with unsuppressed viral loads to those starting LAIs with baseline VLS. Methods: From 1/2021-6/2024, electronic medical record data was extracted for all NYC Health+Hospitals patients with HIV who had at least 1 HIV primary care visit in the preceding 12-months and who received at least 1 dose of LAI CAB/RPV. Baseline viral loads were obtained prior to the initial order for LAI CAB/RPV, and descriptive statistics were used to compare individuals whose baseline viral load prior to LAI initiation was not suppressed (>/=200 cp/mL) to those whose baseline viral load was <200 cp/mL. Results: 325 patients received at least 1 dose of LAI CAB/RPV during the study period. 14 individuals had unsuppressed viral loads and 311 were virally suppressed at the time LAI CAB/RPV was initially ordered. Those starting LAI CAB/RPV when viremic were more likely to be female (64% vs. 36%), have baseline CD4 <200 cp/mL (71% vs. 5%) and to screen positive for a social determinants of health (SDOH) need (36% vs. 15%). The most common SDOH needs identified those patients were financial insecurity (21%), housing insecurity (21%) and un/under-employment (14%). VLS at the end of the study period using the most recent available viral load was expectedly lower in the baseline viremic group (79% vs. 98%) (Table 1). Conclusions: CAB/RPV initiation in patients with baseline viremia led to high rates of VLS in a population with low baseline CD4 and high rates of unmet social needs. This supports the growing body of evidence that LAIs are a vital option for patients with adherence challenges on oral ART. One limitation of our study is that the period of observation for follow up VLS varied for each patient, (e.g. our assessment included most recent viral load). Addressing barriers to LAI access, including expanding current FDA labeling to include certain patients with baseline viremia, is crucial to achieve VLS and improved health outcomes in this population.

Poster Abstracts

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Low-Level Viremia & Risk Factors for Failure on Long-Acting Cabotegravir/Rilpivirine (LA CAB/RPV) Natalie Nielsen 1 , Bradley Taranto 2 , Mohammad Mahdee Sobhanie 1 , Ashley Lipps 1 , Joy Lehman 1 , Susan Koletar 1 , Carlos Malvestutto 1 , Yesha Patel 1 1 The Ohio State University, Columbus, OH, USA, 2 Mount Carmel Health System, Columbus, OH, USA Background: LA CAB/RPV has transformed the HIV treatment paradigm as an alternative to daily oral antiretroviral therapy (ART). Potential challenges with CAB/RPV include therapeutic failures characterized by virologic failure and/or the development of resistance-associated mutations (RAMs). Methods: This was a single-center, retrospective cohort study of adults with HIV on LA CAB/RPV at the Ohio State University Wexner Medical Center (OSUWMC) from 3/1/22 to 12/31/23. We describe clinical outcomes among LA CAB/RPV recipients and investigated associations with HIV-specific factors. Results: 115 participants were referred for initiation of LA CAB/RPV and 91 received at least one dose (79.1%). Reasons for not starting treatment varied and included insurance issues, participant decision, unable to follow up, labs not completed, and prior RPV resistance. 69/115 (60%) had a genotype (next-generation sequencing assay or proviral assay) available for review prior to CAB/RPV initiation. 1/91 had a detectable viral load between 40 and 200 copies/mL at treatment start with all other participants undetectable prior to CAB/RPV start. 8/91 (8.8%) had detectable HIV-1 viral load (VL) (range 42-445 copies/mL) after initiating CAB/RPV. 4/8 (50%) experienced low-level viremia (LLV) (≥2 VL >40 copies/mL but <200 copies/mL) and 4/8 (50%) had at least one blip (isolated VL >40 copies/mL but <200 copies/mL). The duration of LLV ranged from 1 to 5 months. 6/8 (75%) of those that experienced LLV or blips subsequently experienced them again at another point within the study period. 1/4 (25%) with LLV was temporarily transitioned from 8 to 4-week dosing with subsequent viral suppression. Notably, all participants with LLV or blips received on time LA CAB/RPV, had a genotype available prior to treatment initiation without CAB or RPV RAMs, and none subsequently developed therapeutic failure. Apart from body mass index ≥30kg/m 2 , our study population lacked other risk factors for virologic failure with LA CAB/RPV (Table 1). Conclusions: Clinicians should have awareness of and develop monitoring processes for the early detection of LA CAB/RPV therapeutic failures. This study is the first to report that low-level viremia was not associated with virologic failure in clinical practice. Further research is needed to identify those at risk of virologic failure and to develop optimal prevention strategies.

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