CROI 2025 Abstract eBook

Abstract eBook

Poster Abstracts

Methods: Patterns of LEN uptake (prescriptions [Rx] and injections received) and characteristics of all ART-experienced adults with HIV-1 who were prescribed LEN from 22DEC2022-31DEC2023 in the OPERA cohort were described. Antiretrovirals (ARV) in the background regimen (BR) at LEN initiation were compared to ARVs in the prior regimen and classified as a continuation (all ARVs maintained), simplification (fewer ARV agents and/or fewer ARV classes and/or fewer pills/days), or change without simplification. Subsequent BR changes during LEN use were assessed through 31DEC2023 in those with ≥1 month of follow-up. Results: Of 104 individuals with a LEN Rx, 37 (36%) had no injection, with a median of 21 weeks (IQR: 9, 27) between Rx and study end (31DEC2023) or death. Among the 67 (64%) with ≥1 LEN injection visit (1 visit: 63%; 2 visits: 37%), the median time from Rx to 1st injection was 21 days (IQR: 8, 44), and the median time from 1st injection to study end or death was 24 weeks (IQR: 12, 35). The median age of LEN users was 55 years (IQR: 44, 62), 25% were women, 78% were Black, 15% were Hispanic, and 91% had ≥1 comorbidity. At LEN start, 68% had well controlled HIV viral loads (VL <50: 52%; VL ≥50 to <200: 16%). At the time of the 1st LEN injection, 38 (57%) continued the prior regimen and 13 (19%) simplified their regimen (Table). Among 61 individuals with ≥1 month of follow-up, 18 (30%) experienced ≥1 change in their BR while on LEN (median: 1.5; IQR: 1, 2). Of those 18 with a BR change after starting LEN, 15 (83%) experienced a BR simplification (Table). Conclusions: While LEN is indicated for individuals who are failing their current regimen, this overview of the first year of LEN use in a large US cohort showed a varied but small group of people with HIV receiving LEN injections, most of whom had well-controlled HIV before LEN initiation. A subset of LEN users were able to simplify their ART regimen at LEN initiation or during follow-up in this real-world setting.

the rates of current or past substance use (OR = 1.22, 95% CI 1.11-1.34, p < .001) and unstable housing (OR = 1.11, 95% CI 1.01-1.23, p = .031) were higher than in those with initial VS. PWH with viremia were more likely to have CD4 counts <200 cells/mm3 (OR = 1.22, 95% CI 1.09-1.36, p < .001) at initiation. The median time to achieve VS (<=30 copies/ml) in those with viremia was 32 days (95% CI 30-45; Figure). At 24 weeks, 98.3% of those who started with VS remained suppressed and 94.5% of those with initial viremia achieved VS. The probability of achieving/maintaining VS did not significantly differ between the two groups at 24 weeks (χ² 3.12, p = .077). Conclusions: In a cohort of PWH in San Francisco with high rates of housing instability and substance use, LA ART worked well with high rates of VS either maintained (98.3%) in those initiating ART with VS or achieved (94.5%) in those starting with viremia. CD4 counts were lower in those with initial viremia. There was no difference in the probability of VS at 24 weeks among those who started LA ART with and without VS. This data supports the DHHS and IAS-USA guidelines on using LA ART in those with viremia and adherence challenges at high risk of HIV progression.

Poster Abstracts

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Long-Acting Injectable ART in Persons With HIV-1 Viremia in the South: A Tool to End the Epidemic Jonathan Colasanti 1 , Amalia Aldredge 1 , Larisa Niles Carnes 2 , Bradley L. Smith 2 , Eudiah Ochieng 2 , Erica Anderson 2 , Vickie Robinson 2 , Melissa Washington 2 , Jeri Sumitani 2 , Eric Leue 2 , Della Corbin-Johnson 2 , Priyasha Pareek 1 , Meredith Lora 1 , Wendy Armstrong 1 , Lauren F. Collins 1 1 Emory University, Atlanta, GA, USA, 2 Grady Health System, Atlanta, GA, USA Background: Treatment with long-acting antiretroviral therapy (LA ART) with cabotegravir/rilpivirine (CAB/RPV) +/- lenacapavir (LEN) holds promise to achieve viral suppression (VS) in people with HIV (PWH) for whom oral ART fails. Although supported in certain scenarios by guidelines, scaling this approach in viremic PWH has lagged. Methods: We performed a retrospective review of PWH cared for at a large Ryan White-funded program in the urban South who initiated LA ART (CAB/RPV, LEN, and/or ibalizumab [IBA]) between 4/14/2021–8/31/2024 with follow-up through 12/31/2024. PWH were included if HIV-1 RNA was >50 c/mL (viremia) at time of first LA ART injection with at least 3 months of follow-up time. Primary outcome was achieving HIV-1 RNA <50 cp/mL. Results: Of 361 total PWH receiving LA ART, 81 (22%) initiated with viremia, among whom regimens were CAB/RPV only (n=56), CAB/RPV+LEN (n=23), and CAB/RPV+LEN+IBA (n=2). Of those initiated with viremia, median (IQR) age was 38 (30-49) yrs, median years since HIV diagnosis was 15.5 (8.8-20.5), and nine (11%) had perinatal acquisition. Seventy-five (93%) identified as Black race, 29 (36%) were cis-women (including four initiated in pregnancy) and three (3.6%) were trans-women. Median BMI was 24 (22-30) kg/m 2 . Median income was $25K ($20-33K) and social determinants of health were highly prevalent: 72% had unmet transportation needs, 51% had food insecurity, and 27% had high-risk of financial resource strain. Thirty-six (44%) had prior opportunistic infections, many recent due to ongoing viremia. At LA ART initiation, median VL was log 10 3.97 (2.91-4.80) c/mL and median CD4 was 186 (62-420) cells/mL. A total of 75 PWH (93%) achieved VS after a median of 1 (1-2) injections, resulting in median CD4 rise to 330 (172-483) cells/mL. Of 9 PWH who did not achieve VS, one was lost to follow-up; two had virologic failure with drug resistance; four have ongoing low-level viremia (<200 c/ml);

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Long-Term Virologic Suppression Rates in the Ward 86 HIV Clinic’s Long-Acting ART Program (SPLASH) Nathanael L. Gistand 1 , Matthew A. Spinelli 2 , Megan J. Heise 2 , Jon Oskarsson 2 , Katerina Christopoulos 2 , Matt Hickey 2 , Mary Shiels 2 , Francis Mayorga-Munoz 2 , Janet Grochowski 2 , David Glidden 2 , Monica Gandhi 2 1 San Francisco General Hospital, San Fransisco, CA, USA, 2 University of California San Francisco, San Francisco, CA, USA Background: The Ward 86 HIV Clinic in San Francisco serves publicly-insured people with HIV (PWH) living with multiple concomitant challenges. With the approval of long-acting (LA) cabotegravir/rilpivirine in 2021, Ward 86 started using LA antiretroviral therapy (ART) for those with adherence challenges to oral ART. More than 3.5 years into the program, we now report on and compare the long-term virologic suppression (VS) rates in those who started LA ART with or without initial VS. Methods: Using electronic medical record data verified by clinician review, we compared outcomes in the Special Programs to Stop HIV Using Long-Acting ART (SPLASH) program for those starting LA ART with or without VS. For those starting with initial viremia, the time to VS was calculated by Kaplan-Meier. Chi squared testing compared VS and logistic regression compared characteristics between those starting LA ART with and without viremia. Results: Overall, 370 participants (mean=46.3 years, SD = 11.6) starting LA ART from January 2021-September 2024 were included in the analyses; 80% cisgender male, 14% cis/transgender female, 6% non-binary/ other; 41% White, 28% Latino/a, 23% Black, 8% Asian; 40% housing instability; 46% substance use. Among the 130 PWH (35%) starting LA ART with HIV RNA >30 copies/mL,

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