CROI 2025 Abstract eBook

Abstract eBook

Poster Abstracts

679

Interim Week 48 Results in Young South Africans on Long-Acting Injectable ART: The AFINAty Study Lauren Jennings 1 , Chantel Schreuder 1 , Nyiko Mashele 1 , Metsekae Madimabe 1 , Millicent Atujuna 1 , Linda-Gail Bekker 1 , Catherine Orrell 2 1 Desmond Tutu HIV Foundation, Cape Town, South Africa, 2 University of Cape Town, Cape Town, South Africa Background: Adolescents and young adults living with HIV (YLHIV) are a population who face antiretroviral therapy (ART) adherence challenges. Long acting injectable (LAI) formulations have the potential to address some of these challenges, including pill fatigue, stigma and disclosure. We conducted a study to determine the acceptability and feasibility of delivering LAI ART to YLHIV in a community setting in Cape Town, South Africa. Methods: We enrolled YLHIV, on or starting first-line ART, aged 12-24 years in 3 cohorts: 1) those who are virally suppressed (<50 copies/mL) and adherent to ART; 2) those who are virally unsuppressed or have evidence of recent adherence challenges, and 3) those who are ART naïve. We allowed for up to 24 weeks of screening during which viral suppression (<50 c/mL) could be achieved on first-line oral ART. When virally suppressed, YLHIV were offered a switch to cabotegravir and rilpivirine LAI administered every 8-weeks, with an optional oral lead-in. Viral load was measured at Week 24 and Week 48 after switching. Qualitative assessments were made through serial individual interviews. Results: We enrolled 179 YLHIV across the 3 cohorts. 134 were switched to LAI (59 in cohort 1 who were virally suppressed at baseline and 75 in cohorts 2 & 3 who achieved viral suppression during screening). The median age was 20 years (IQR 18-22) and 85 (63.4%) identified as female. As of 31 August 2024, 70 participants were expected to have reached Week 48. Sixty-eight of the 70 (97%) attended the Week 48 visit, with one lost to follow-up and one participant transferring out of the study area. Three (4%) participants had a viral load >50 c/mL at Week 48 (60, 251, and 254 c/mL). All re-supressed within 4 weeks, prior to their next injections. There have been no drug-related severe or serious adverse events to date. Qualitative assessments have confirmed this regimen is highly acceptable to YLHIV. Conclusions: High retention and high viral suppression rates at Week 48 have been demonstrated in this community-based cohort of YLHIV in Cape Town, South Africa. Long-acting cabotegravir and rilpirivine LAI are an effective, acceptable and feasible treatment option and should be considered as a priority in national ART programs for adolescents and young adults living with HIV. Impact of Oral Lead-In on PK and Virologic Outcomes in People With HIV Transitioning to CAB+RPV LA Marta Fernández-González 1 , Christian Ledesma 1 , María Losada-Echeberría 2 , Guillermo Telenti 1 , Javier Garcia-Abellan 1 , Sergio Padilla Urrea 1 , Melissa Bello Perez 1 , Enrique Barrajón Catalán 2 , Paula Mascarell 1 , Angela Botella 1 , Daria De Stefano 1 , Daniela D’Urso 1 , Leandro López 1 , Mar Masiá 1 , Felix Gutierrez 1 1 Hospital General Universitario de Elche, Elche, Spain, 2 Universidad Miguel Hernández de Elche, Elche, Spain Background: For people with HIV (PWH) on antiretroviral therapy (ART), transitioning to bimonthly long-acting (LA) injectable cabotegravir (CAB) plus rilpivirine (RPV) can be done either directly (non-OLI) or after an optional one month oral lead-in (OLI). Recent data suggest lower CAB trough concentrations (Ctrough) with non-OLI initiation. This study aimed to assess pharmacokinetics (PK) and virological outcomes based on OLI use in a real-world setting. Methods: We conducted a prospective cohort study of PWH on stable oral ART transitioning to bimonthly CAB+RPV LA. Participants were sequentially assigned to non-OLI (01-04/2023) or OLI (05-12/2023) groups. Plasma HIV-1 viral load (VL) and CAB and RPV plasma levels were measured before each injection over a 9-month follow-up. Virological failure (VF) was defined as 2 consecutive VL≥200 cp/mL or one VL≥1000 cp/mL. Non-sustained viral suppression (non-suppression) was defined as any VL≥20 cp/mL. Statistical analyses were conducted using R v4.2.3 with linear mixed-effects models adjusted for OLI use, age, sex, BMI and smoking status. Models included a random intercept and slope for each patient. Results: A total of 707 plasma samples from 176 PWH were analyzed. The median age was 48 years (IQR: 38-56) with 14.8% female and 77.3% Spanish. The median time since HIV diagnosis was 12 years (IQR: 5-23). Of the participants 46.6% initiated LA therapy directly, while 53.4% used OLI. Baseline characteristics, including age, sex, BMI, CD4 count and smoking status were similar between groups (p>.1). Over the 9-month follow-up, no significant differences were observed in non-suppression rates between non-OLI and

were adverse events (2 subjects: 1 fever/muscular pain and 1 palpitations/ paresthesias), patient’s choice (1), death (1), HBV flare in occult B hepatitis (1), and physician’s choice (1). Conclusions: Our results suggest that the LA CAB+RPV combination is effective and safe in OPWH despite a long history of ART and a high prevalence of multimorbidity and polypharmacy. Older age should not be a barrier to the LA regimen: this study paves the way to evaluate the risk of an ageism attitude when clinicians consider ART choices in older PWH. Long-Acting Cabotegravir/Rilpivirine in Real-Life: Sex-Based Characteristics, PROs and Effectiveness Ana González-Cordón 1 , Berta Torres 1 , Leire Berrocal 1 , Maria Martínez-Rebollar 1 , Ivan Chivite 1 , Alexy Inciarte 1 , Paula Arreba 1 , Juan Ambrosioni 2 , Lorena de la Mora 1 , Alberto Foncillas 1 , Jose L. Blanco 1 , Esteban Martínez 1 , José M. Miró 1 , Josep Mallolas 2 , Montserrat Laguno 1 , for the Cabotegravir-Rilpivirine Research Group 1 Hospital Clinic of Barcelona, Barcelona, Spain, 2 August Pi i Sunyer Biomedical Research Institute, Barcelona, Spain Background: This study aimed to focus on sex-based characteristics, patient reported outcomes (PROs) and effectiveness in people with HIV switching to long-acting cabotegravir-rilpivirine (LA-CAB/RPV) administered Q2M in Hospital Clínic of Barcelona, Spain. Methods: People starting LA-CAB/RPV were invited to participate in an observational, prospective study approved by the local Ethical Committee. Clinical information was routinely collected, PROs were self-administered through electronic questionnaires. Participant characteristics, treatment effectiveness [HIV-RNA <50 copies/mL by on treatment (OT), modified intention-to-treat (mITT), and intention to-treat (ITT)], and PROs were analyzed focusing on sex-at-birth based differences. Results: From 2Feb2023 to 2Jul2024, 611 participants of 6477 in active follow up (9%) started LA-CAB/RPV, and 587 accepted to participate, 547 (93%) men and 40 (7%) women at birth, compared to 4862 (84%) men and 909 (16%) women that continued with other ART (p < 0.001). Women were older, had longer time since HIV diagnosis, longer time on ART, had higher last-CD4 count but lower nadir-CD4, and were more frequently Spanish-born than men both in LA-CAB/RPV group (Table) and in general cohort (not shown). Women had more previous virological failures but no differences in number of historical mutations. Effectiveness by OT, mITT and ITT in the 373 participants on LA-CAB/ RPV who reached week28 of follow up was 100%, 92%, and 90% in women and 97%, 93%, and 90% in men without significant differences. Injections were administered on time in 96% (men) and 97% (women). There were 5 (1%) confirmed virological failures, all in men, and all but one with low level viremia (VL <200 cp/mL). No significant differences in reason for switching to LA-CAB/RPV nor in treatment acceptance (ACCEPT questionnaire) were observed between men and women. No differences in life satisfaction and HIV medication relationship domains of HIV/AIDS-Targeted Quality of Life (HAT-QoL) questionnaire were noted, nonetheless women expressed more frequent disclosure issues than men (p <0.001). No relevant differences were observed in injection site reactions nor in Perception of Injection questionnaire. Conclusions: Compared to our general cohort, proportionally less women than men switched to LA-CAB/RPV. Baseline characteristics could partially explain this difference, although we cannot exclude prescription biases or other barriers.

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Poster Abstracts

680

CROI 2025 192