CROI 2025 Abstract eBook

Abstract eBook

Poster Abstracts

VL < 50 cpm. CVF was observed in 15 (1.6%) individuals, of whom, 8 (53%) had >2 mo follow-up on a subsequent regimen, with re-suppression observed in 6 individuals (75%). Injection delays were observed in 4 (27%) individuals with CVF (delay range: 2-11 days). Of 314 PWH with HIV genotype data prior to initiation, 6 (2%) had resistance to ≥1 INSTIs, and 61 (19%) had resistance to ≥1 NNRTIs. Among 15 PWH with CVF, HIV genotype at CVF was available for 5 (33%); RPV resistance was identified in 3 PWH (Y181C + G190S; K101E; Y181C), 1 of whom also had CAB resistance (S147G + N155H). Conclusions: High rates of viral suppression were seen among PWH initiating CAB+RPV, including those with prior NNRTI/INSTI resistance. CVF with emergent INSTI resistance was rare. These results are consistent with previous studies reporting low rates of emergent INSTI resistance and higher rates of NNRTI resistance among failures.

CAB+RPV LA. Among 340 women (89%) with known dosing schedules and ≥1 maintenance injection, 148 (43%) received all maintenance injections on-time, while 125 (37%) had ≥1 delayed maintenance injection and 42 (12%) had ≥1 missed maintenance injection. Among 372 women (98%) with ≥1 VL over follow-up, most maintained suppression (94% at last VL, 82% at all VLs) and 7 (2%) experienced CVF. Median absolute change in CD4 cell counts over follow up was 40 cells/µL (IQR: -91, 152). Conclusions: A diverse population of women with HIV was able to receive CAB+RPV LA on-time and remain suppressed in this real-world study. Confirmed virologic failure was infrequent in these antiretroviral experienced women.

Poster Abstracts

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Long-Acting Cabotegravir and Rilpivirine in Older People With HIV in the GEPPO Cohort Andrea Calcagno 1 , Maria Vittoria Cossu 2 , Samuele Gardini 3 , Stefania Arsuffi 4 , Stefano Calza 4 , Jovana Milic 5 , Benedetto Maurizio Celesia 6 , Giancarlo Orofino 7 , Andrea De Vito 8 , Giuseppe Vittorio De Socio 9 , Federica Barrera 1 , Maria Mazzitelli 10 , Agostino Riva 2 , Emanuele Focà 4 , Giovanni Guaraldi 5 , for the GEPPO Study Group 1 University of Turin, Turin, Italy, 2 Luigi Sacco University Hospital, Milan, Italy, 3 University of Padova, Padova, Italy, 4 University of Brescia, Brescia, Italy, 5 University of Modena and Reggio Emilia, Modena, Italy, 6 University of Catania, Catania, Italy, 7 Azienda Sanitaria Locale "Città di Torino", Turin, Italy, 8 University of Sassari, Sassari, Italy, 9 Hospital Santa Maria della Misericordia, Perugia, Italy, 10 Azienda Ospedaliera di Padova, Padua, Italy Background: The association of intramuscularly administered Long-acting cabotegravir and rilpivirine (LA CAB+RPV) has been proven to be effective and safe in the maintenance treatment of people with HIV (PWH). The study aimed to assess LA CAB+RPV efficacy and safety in Older PWH (OPWH). Methods: PWH in the GEPPO cohort (age >65 years) who started LA CAB+RPV were included. Duration of LA CAB+RPV administration, reasons for drug preference and discontinuation, and HIV RNA/CD4 cell count at the last available observation were recorded together with geriatric variables, including multimorbidity (defined as the presence of ≥3 comorbidities) and polypharmacy (defined as the use of ≥5 medications other than antiretroviral therapy). Baseline (BL) was defined as the time when participants started LA CAB+RPV. Results: Seventy-eight PWH were included. They were mostly male (75.9%) and aged 66.7 years (65-70) at BL. A long time since HIV diagnosis [20 (14-28.5) years] and of ART [19 (13-22) years] as well as moderately low nadir CD4+ T cells [270 (105-410) cell/mm 3 ] were observed. Only three participants had an HIV RNA >50 copies/mL (55, 234, and 945 copies/mL) at the time of the switch. The pre-switch regimen was mainly based on a three-drug combination in 53.5% of study participants (mostly bictegravir or rilpivirine-based) or two-drug combinations by 45.1% (mostly dolutegravir/rilpivirine and dolutegravir/ lamivudine). Multimorbidity (61.9%) and polypharmacy (31.9%) were prevalent. A history of NNRTI resistance-associated mutations, an A1/A6 genotype, and a body mass index >30 Kg/m 2 were observed in 2 (2.7%), 6 (19.3%), and 10 (14.3%) participants, respectively. After a median follow-up of 17.4 months (14.1-18.9), 72 participants (92.3%) were still receiving LA CAB+RPV. No virological failure was observed, and HIV RNA remained <50 copies/mL in all PWH; CD4 cell count at the last available observation was 656 (519-964) cells/mm 3 . The reasons for discontinuation

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Clinical Outcomes Among Virologically Suppressed Women Receiving CAB+RPV LA in the OPERA Cohort Brooke Levis 1 , Jessica A. Altamirano 2 , Cindy Markarian 3 , Quateka Cochran 4 , Courtney Sherman 5 , Mona-Gekanju Toeque 3 , Laura Armas 6 , Gayathri Sridhar 7 , Vani Vannappagari 7 , Kimberley Brown 7 , Jennifer S. Fusco 1 1 Epividian, Inc, Durham, NC, USA, 2 CAN Community Health, Fort Lauderdale, FL, USA, 3 AIDS Healthcare Foundation, Los Angeles, CA, USA, 4 AIDS Healthcare Foundation, Fort Lauderdale, FL, USA, 5 CAN Community Health, Arlington, TX, USA, 6 Human Centered Consulting & Care, McKinney, TX, USA, 7 ViiV Healthcare, Durham, NC, USA Background: Women represent ~20% of people with HIV in the US and may experience unique challenges with HIV treatment. Cabotegravir + rilpivirine long-acting (CAB+RPV LA) injectable, indicated for treatment experienced individuals with viral loads (VL) <50 copies/mL, is the first complete LA antiretroviral regimen approved for HIV-1 treatment. This study assessed clinical outcomes among virologically suppressed women receiving CAB+RPV LA in the OPERA cohort. Methods: Women ≥18 years old with HIV who were virologically suppressed (VL <50 copies/mL) and received ≥1 CAB+RPV LA injection between 21JAN2021-31AUG2023 were followed from first injection until discontinuation, death, loss to follow-up or study end (29FEB2024). Individuals on monthly (Q1M) or every 2-month (Q2M) injection schedules were included. Complete initiation was defined as first 2 injections received ≤67 days apart. For Q1M schedules, on-time maintenance injections were 23-37 days after last injection, delayed were 38-52 days, missed were 53-67 days, and discontinuation was ≥68 days. For Q2M schedules, on-time maintenance injections were 53-67 days after last injection, delayed were 68-112 days, missed were 113-127 days, and discontinuation was ≥128 days. Confirmed virologic failure (CVF) was defined as 2 consecutive VLs ≥200 copies/mL or 1 VL ≥200 copies/mL followed by discontinuation within 4 months. Results: Of 415 women observed, 264 (64%) were Black, 81 (20%) were Hispanic, 52 (13%) were transgender, 200 (48%) had a BMI of ≥30 kg/m 2 , median age was 43 (IQR: 34, 54), and median years since HIV diagnosis was 9 (IQR: 4, 18). A total of 381 (92%) completed initiation (293 [77%] on Q2M injections and 75 [20%] on Q1M injections at initiation) and were followed for a median of 12.4 (IQR: 7.2, 19.0) months (Table). At study end, 297 (78%) were on

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