CROI 2024 Abstract eBook

Abstract eBook

Poster Abstracts

and virologic failure (VF: > 200 HIV RNA copies/mL) were collected. Data was pooled to determine the proportion of participants with HIV RNA >50 copies/mL in those with BMI >30 kg/m 2 compared to those who with BMI <30 kg/m 2 . Results: We analyzed 369 participants across 5 medical centers and 148 (40.1 %) had a BMI > 30 kg/m 2 . Individuals received a median 202 days of therapy (range 22-664). Sixteen (4.3 %) were on q4w, 250 (67.8%) were on q8w, and 103 (27.9 %) were on a combination q4-q8w. For those with BMI > 30 the median BMI was 35.1 (range 30.0-67.4) kg/m 2 . Eighteen individuals (4.8%) had HIV RNA > 50 copies/mL with BMI>30 kg/m 2 compared to 20 (5.4%) with a BMI < 30 kg/ m 2 . Additionally, we found that 3 individuals (0.08%) experienced VF at the last timepoint with BMI>30 kg/m 2 compared to 4 (1.04%) with a BMI < 30 kg/m 2 . Conclusion: Based on our analysis, the incidence of HIV RNA > 50 copies/mL and VF were similar between groups regardless of BMI category. HIV-1 RNA Blips and Low-Level Viral Replication: SOLAR (CAB+RPV LA vs BIC/FTC/TAF) Christine Latham 1 , Rimgaile Urbaityte 2 , Kenneth Sutton 1 , William Spreen 1 , Ronald D'Amico 1 1 ViiV Healthcare, Durham, NC, 2 GlaxoSmithKline, Brentford, United Kingdom Background: Cabotegravir plus rilpivirine long-acting (CAB+RPV LA) administered every 2 months (Q2M) is the first and only complete LA regimen recommended for virologically suppressed people living with HIV-1. Here, we report HIV-1 RNA viral blips and target virus not detected (TND), as well as the impact of HIV-1 RNA blips on viral load measurements at Month 12 and confirmed virologic failure (CVF), in participants switching to CAB+RPV LA vs. continuing daily oral bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/ TAF) through Month 12 in the SOLAR study. Methods: SOLAR (NCT04542070) is a Phase 3b, randomized (2:1), open-label, multicenter, noninferiority study assessing switching virologically suppressed adults to CAB+RPV LA Q2M vs. continuing BIC/FTC/TAF. The analysis was based on the modified intention-to-treat exposed (mITT-E) population (exclusion of one trial site for non-compliance to protocol entry criteria). HIV-1 RNA viral blips were defined as a single HIV-1 RNA value between 50 and <200 c/mL with adjacent values <50 c/mL. CVF was defined as two consecutive HIV-1 RNA ≥200 c/mL values. Plasma samples were analyzed for HIV-1 RNA viral load using the Abbott RealTime HIV-1 assay, and TND outcomes were provided for HIV-1 RNA <40 c/mL. Results: Of 670 participants (mITT-E), 447 (67%) switched to LA and 223 (33%) continued BIC/FTC/TAF. The proportion of participants with HIV-1 viral blips through Month 12 was 4% (n=19/447) in the CAB+RPV LA arm and 4% (n=9/223) in the BIC/FTC/TAF arm. Of participants with viral blips, 5% (n=1/19) and 11% (n=1/9) in the CAB+RPV LA and BIC/FTC/TAF arms, respectively, had HIV-1 RNA ≥50 c/mL at Month 12; no participants with HIV-1 RNA viral blips developed CVF. The proportions of participants with viral blips were consistently ≤1% of participants with available data across both treatment arms at any time point. TND outcomes at individual study visits were similar between study arms (CAB+RPV LA, 85–88%; BIC/FTC/TAF, 80–86%), and the proportions of participants with HIV-1 RNA <40 c/mL (CAB+RPV LA, 90–97%; BIC/FTC/TAF, 90–97%) were comparable between treatment arms through Month 12. Conclusion: The proportions of study participants with HIV-1 RNA viral blips, TND, and HIV-1 RNA <40 c/mL were similar between CAB+RPV LA and BIC/FTC/ TAF through Month 12. HIV-1 viral blips with CAB+RPV LA did not appear to be associated with CVF, consistent with prior CAB+RPV LA Phase 3 clinical study data.

defined as 2 consecutive VLs > 200 copies/mL or 1 VL > 200 copies/mL with discontinuation within 4 months of last recorded injection. ARV resistance from HIV genotype results was available for a subset of individuals and was analyzed through Stanford HIVdb algorithm among those with identified CVF. Results: The analysis included 278 ART-experienced individuals with undetectable VL who initiated CAB+RPV; initiators were a median of 44 years (IQR: 35-54) of age, predominately male (80%), non-Black (64%), and from the US South (73%). Median follow-up time after first injection was 10 months (IQR 5-13) with median of 5 injections (IQR: 3-7). There were 246 (88%) CAB+RPV initiators who remained on the regimen at end of follow-up; among those who discontinued CAB+RPV, none experienced injection site reaction. Among all initiators, 221 (80%) individuals had ≥1 recorded follow-up VL. Those with no follow-up VLs had median 1 injection (IQR: 1-2). Among individuals with VL data, 213 (96%) had all follow-up VL <200 copies/mL throughout follow-up, with 196 (89%) undetectable at last recorded VL. Only 2 (0.9%) individuals experienced CVF, both of whom discontinued CAB+RPV after one unsuppressed VL. Resistance data prior to initiation was available for 1 individual, who had extensive resistance to NNRTI and NRTI. Genotype results were not recorded for this individual at the time of CVF, and suppression had not been documented on subsequent therapy (DRV/c/FTC/TAF: 3 months). Conclusion: Among ART-experienced adults with undetectable VL initiating CAB+RPV, the vast majority continued the regimen and maintained virologic suppression throughout the follow-up period. Additionally, confirmed virologic failure was rare, suggesting high effectiveness of CAB+RPV in real world settings.

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Poster Abstracts

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Real-World Virologic Outcomes of Cabotegravir/Rilpivirine in Patients With Elevated Body Mass Index Christina Maguire 1 , Eric Farmer 2 , Emily Huesgen 2 , Kaitlyn Rueve 2 , Marisa Brizzi 3 , Amanda Binkley 1 , Bernice Kear 4 , Pallavi Chary 1 , Helen Koenig 1 , Peter Sung 1 , Emily Hiserodt 5 , Karam Mounzer 5 , Danielle Rocha 5 , Adrian Altieri 1 , William R. Short 1 1 University of Pennsylvania, Philadelphia, PA, USA, 2 Indiana University, Bloomington, IN, USA, 3 University of Cincinnati, Cincinnati, OH, USA, 4 Drexel College of Medicine, Philadelphia, PA, USA, 5 Philadelphia FIGHT, Philadelphia, PA, USA Background: Injectable cabotegravir (CAB) and rilpivirine (RPV) is the first complete long-acting antiretroviral (ARV) regimen approved in persons with HIV with sustained virologic suppression (HIV RNA <50 copies/mL) on current ARV therapy. In a multivariable analysis, body mass index (BMI) > 30 kg/ m 2 alone was not predictive of confirmed virologic failure; however, data are limited due to small sample sizes. The primary objective of this study is to determine the incidence proportion of participants with a plasma HIV-1 RNA > 50 copies/mL at last observed endpoint in those with and without body mass index > 30 kg/m 2 . Secondary objectives evaluated include incidence proportion of virologic failure (VF: > 200 HIV-1 RNA copies/mL) in those with and without body mass index > 30 kg/m 2 and assessing the primary outcome stratified by BMI categories (> 40 kg/m 2 , > 45 kg/m 2 , and > 50 kg/m 2 ). Methods: We conducted a retrospective, multi-center cohort study from January 22, 2021 to February 15, 2023 for participants receiving either every 4 or 8 weeks dosing of CAB/RPV (Q4w or Q8w). We included participants who were >18 years of age, received at least one injection of CAB/RPV, had HIV RNA < 50 copies/mL at baseline, and had at least one follow up HIV RNA. We excluded those with no weight available within 90 days of first CAB/RPV injection. Baseline characteristics such as prior regimens, resistance history, smoking history, and history of gluteal implants were collected. HIV RNA > 50 copies/mL

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