CROI 2025 Abstract eBook

Abstract eBook

Poster Abstracts

(p=0.1). New users of GLP-1RAs were significantly more likely to achieve ≥5% weight loss compared to sulfonylureas (adjusted hazard ratio [aHR]=2.06; 95%CI: 1.69–2.52) and DPP-4i (aHR=1.64; 95%CI: 1.25–2.14), but not compared to SGLT2is (aHR=1.09; 95%CI: 0.86–1.38). Conclusions: Among PWH, both GLP-1RAs and SGLT2is significantly reduced weight, with GLP-1RAs showing the greatest percent change overall compared to other antidiabetic medications.

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The Projected Impact of Post-ART BMI Maintenance on Diabetes Risk: A Modeling Study Parastu Kasaie 1 , Yao Zhao 1 , Kendall Reid 1 , Elizabeth Humes 1 , Katherine Kurgansky 1 , Lucas Gerace 1 , Yanxun Xu 2 , Catherine Lesko 1 , Kelly Gebo 3 , Kristine M. Erlandson 4 , Keri N. Althoff 1 1 The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA, 2 The Johns Hopkins University, Baltimore, MD, USA, 3 The Johns Hopkins University School of Medicine, Baltimore, MD, USA, 4 University of Colorado Anschutz Medical Campus, Aurora, CO, USA Background: Weight gain following ART initiation has been linked to an increased risk of diabetes among persons aging with HIV (PAH). We aimed to assess the impact of a hypothetical BMI maintenance program, implemented in the first 2 years after ART initiation, on cumulative diabetes risk over 7 years post-ART initiation. Methods: The PEARL model is an agent-based simulation of comorbidities burden among PAH who have initiated ART in the US. We simulated the effects of a BMI maintenance intervention, where BMI remained stable for those who would otherwise gained it. Individuals starting ART between 2013–2017 with a normal or overweight BMI (18.5–30) and no prior diabetes diagnosis were eligible. The study was implemented at ART initiation via two arms: (1) a hypothetical intervention arm where eligible agents participated in the BMI maintenance program, and (2) a control arm receiving a placebo. Both arms were followed for five years after the intervention. Incidence of diabetes was estimated as new diagnoses per 1,000 person-years (pys) at risk over 7 years post-ART initiation, with effects analyzed by sex, race/ethnicity, and HIV risk factor categories. Results: The model estimated a median of 171,000 PAH initiating ART in the US between 2013–2017, with 73% (n=126,000) meeting the study’s eligibility criteria. In the control arm, 66% of participants were expected to experience BMI increases, with 12% becoming obese within two years post-ART initiation. The projected diabetes risk was 10.7 (per 1,000 pys), resulting in a median of 9,500 new diagnoses over 7 years. The intervention (vs. placebo) reduced diabetes risk by 19%, preventing an estimated 1,800 new diagnoses over 7 years post-ART initiation. The number needed to treat to avert one diabetes diagnosis was 71. In subgroup analyses, the largest relative risk reduction was projected among Hispanic heterosexual men, and the greatest absolute reduction in diagnoses was among Black MSM and Black heterosexual women (Figure). Conclusions: Maintaining BMI in the first two years post-ART initiation could significantly reduce diabetes risk among PAH in the 7 years post-ART initiation, indicating an urgent need for effective weight maintenance programs to be implemented at ART initiation and continued through the subsequent two years. The projected heterogeneity in impact of such intervention across subgroups underscores the importance of tailoring such interventions to address disparities in diabetes risk among PAH.

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Liraglutide for Obesity in HIV (LIROH): A Single-Arm, Open-Label Clinical Trial in South Africa Ngundu Behuhuma 1 , Gugulethu Gasa 1 , Anne Derache 1 , Buhle Nhlapo 1 , Sfundo Khumalo 1 , Nomathemba Chandiwana 2 , Megan Lam 3 , Kristien Bird 1 , Henrik Kloverpris 1 , Janet Lo 3 , Mohammed K. Ali 4 , Francois Venter 2 , Mark J. Siedner 3 , Limakatso Lebina 1 , Jennifer Manne-Goehler 5 1 Africa Health Research Institute, Mtubatuba, South Africa, 2 Ezintsha, Johannesburg, South Africa, 3 Massachusetts General Hospital, Boston, MA, USA, 4 Emory University, Atlanta, GA, USA, 5 Brigham and Women's Hospital, Boston, MA, USA Background: Obesity is a common complication of treated HIV, especially among Black Women. Yet, perceptions of optimal body weight among people living with HIV (PLWH) may influence interest in anti-obesity medical therapies. We conducted a pilot clinical trial to assess the acceptability, tolerability, and preliminary efficacy of liraglutide for obesity management in virologically suppressed PLWH in rural KwaZulu-Natal, South Africa. Methods: In this open-label, Phase IV trial, single arm clinical trial of liraglutide in PLWH (n=40) in South Africa (NCT06438146), we enrolled people ≥18 years old, virologically suppressed on dolutegravir-based ART for ≥6 months, with a BMI ≥30 kg/m 2 . We excluded individuals on another weight loss agent and those with a history of diabetes. All participants received liraglutide for 12 weeks, with dose escalation from 0.6mg SC daily to 3.0mg daily over the first 4 weeks, plus diet and exercise counseling. The primary outcome is acceptability, assessed by enrollment fraction and retention at 12 weeks. The secondary outcomes include changes in weight, blood pressure, lipids, HbA1c, and key safety measures. Depressive symptoms are being assessed using the Patient Health Questionnaire-9 (PHQ-9). Results: We screened 51 PWH from May 5, 2024 to September 17, 2024. Of these, 43 (84%) were eligible and among those, 40 (93%) consented for enrollment. Baseline characteristics of the enrolled population are shown in Table 1. As of September 30, 2024, 12 (30%) had completed treatment, 1 (2%) person had discontinued participation in the study, and 27 (68%) were still on-treatment. Among those who completed treatment, there was a 2.5 kg (95% confidence interval [CI]: 0.98-4.09] decrease in mean body weight [100.9 kg to 98.4 kg, p=0.002]. There have been 26 reports of gastrointestinal side effects (Grade 1-2) in 14/40 participants, 2 of which required a pause in dose escalation, and one injection site reaction (Grade 1) to date. The mean depressive symptom score as assessed by the PHQ-9 decreased by 1.33 (CI: 0.02-2.64) points among those who completed treatment to date [1.75 to 0.42, p=0.023]. Conclusions: These preliminary results indicate that liraglutide is highly acceptable and well-tolerated among PLWH with comorbid obesity in South Africa. The findings demonstrate the potential of anti-obesity medications as a treatment strategy in PLWH and motivate larger trials for efficacy in diverse populations with HIV.

Poster Abstracts

CROI 2025 265