CROI 2025 Abstract eBook

Abstract eBook

Poster Abstracts

1051 Hospitalization Incidence Among Young Children Living With HIV in the Western Cape, South Africa Kim Anderson 1 , Brian S. Eley 1 , Helena Rabie 2 , Rudzani Muloiwa 1 , James Nuttall 1 , Lisa J. Frigati 2 , David M. le Roux 1 , Thandi Wessels 3 , Jaco Murray 4 , Vanessa Mudaly 4 , Gayathri Sridhar 5 , Leigh Ragone 5 , Vani Vannappagari 5 , Jonathan Euvrard 1 , Mary-Ann Davies 1 1 University of Cape Town, Cape Town, South Africa, 2 Tygerberg Hospital, Cape Town, South Africa, 3 Stellenbosch University, Cape Town, South Africa, 4 Western Cape Department of Health and Wellness, Cape Town, South Africa, 5 ViiV Healthcare, Durham, NC, USA Background: Studies of hospitalization among young children with HIV in resource-limited settings, in the context of early infant diagnosis and antiretroviral therapy (ART), are limited. Methods: We used routinely collected data to describe hospitalization patterns among children diagnosed with HIV (born 2018-2022), in the Western Cape, South Africa. We used logistic regression to examine factors associated with hospitalization pre-ART start, and mixed-effects Poisson models to assess overall hospitalization rates (excluding birth admissions) and hospitalizations post-ART start. Results: We included 2,219 children: 30% were diagnosed with HIV at birth (≤7 days), an additional 41% before age 1 year, and 29% at age ≥1 year. Median follow-up from birth was 38 months (IQR 24-50). Overall, 67% of children were hospitalized, of whom 50% had >1 hospitalization. Compared to those diagnosed with HIV at birth, overall hospitalization rates (excluding birth admissions) increased by 67% (95%CI:39-101%), 74% (95%CI:45-109%) and 29% (95%CI:9-51%) among those diagnosed at age 1 week to 3 months, >3 to 9 months, and >9 months, respectively. Excluding birth admissions, 35% of children were hospitalized pre-ART start (n=781/2219) and 27% of children who started ART were hospitalized at the time of ART start. Compared to children who started ART before 1 month of age (but not at birth or during a birth admission), those who started at age 1-3, >3 to 6, and >6 to 12 months had increased pre-ART admission odds of 6.5 (95%CI:3.6-11.5), 10.7 (95%CI:6.0-19.0) and 14.7 (95%CI:8.2-26.1), respectively. Among children who received ART (96% protease inhibitor-based regimens), 38% had admissions post-ART start (n=747/1990). At 4 and 12 months after ART start, 49% and 47% of children with available results had unsuppressed viral load (VL≥1,000 copies/ ml), respectively. Hospitalization rates post-ART start were twice as high among children who had unsuppressed VL at 4 or 12 months after ART start. Conclusions: High hospitalization rates occur among young children with HIV. Earlier HIV diagnosis and ART initiation is associated with lower overall hospitalization rate, particularly pre-ART hospitalizations, whereas unsuppressed viral load is associated with higher post-ART hospitalization rates. Our study provides real-world evidence of the benefits of HIV testing at birth, a practice that has not yet been adopted globally, and highlights that morbidity among young children with HIV is only partially mitigated by early ART initiation. 1052 Inflammatory Cytokines in ART-Naive Kenyan Children Diagnosed With HIV at Hospital Admission Lasata Shrestha 1 , Irene Njuguna 1 , Elizabeth M. Obimbo 2 , Lisa Marie Cranmer 3 , Emily R. Begnel 1 , Daisy Chebet 2 , Judith Adhiambo 2 , Kenneth A. Tapia 1 , Barbra Richardson 1 , Hellen M. Okinyi 2 , Cheryl Day 3 , Grace John-Stewart 1 , Dalton Wamalwa 2 , Jennifer Slyker 1 1 University of Washington, Seattle, WA, USA, 2 University of Nairobi, Nairobi, Kenya, 3 Emory University, Atlanta, GA, USA Background: A cascade of inflammatory responses begins after HIV infection, prompting cytokine production and leading to a persistent inflammatory state which is associated with an increased risk of adverse outcomes and death. We assessed correlates of baseline serum proinflammatory cytokine levels and their association with hospitalization outcomes in a cohort of severely-ill ART-naïve Kenyan children living with HIV (CLHIV). Methods: Admission serum samples of 104 CLHIV with median age at enrollment of 2.05 years (IQR=0.99, 6.02) from the PUSH Study (NCT02063880) were used to measure levels of IL-1β, IL-2, IL-6, and TNF-α. A priori study endpoints were death within 6-months of admission, combined endpoint of death or continued hospitalization at 15-days, and mean number of days spent in hospital. Potential correlates were assessed using Poisson and linear regression. Models were used to estimate 6-month hazard ratio of death (Cox regression), relative risk of combined endpoint (Poisson regression), and

1050 Infants With HIV Starting ART Within 4 Months of Age Can Achieve Sustained Undetectable HIV-1 DNA Alfredo Tagarro 1 , Kavidha Reddy 2 , Sara Dominguez-Rodriguez 1 , Shaun Barnabas 3 , Kennedy Otwombe 4 , Maria G. Lain 5 , Almoustapha Maiga 6 , Pablo Rojo 7 , Louise Kuhn 8 , Paolo Palma 9 , Nicola Cotugno 9 , Eleni Nastuoli 10 , Carlo Giaquinto 11 , Thumbi Ndung'u 2 , Paolo Rossi 9 , for the EPIICAL Consortium 1 Fundación para la Investigación Biomédica Hospital 12 de Octubre, Madrid, Spain, 2 Africa Health Research Institute, Mtubatuba, South Africa, 3 Family Clinical Research Unit, Tygerberg, South Africa, 4 Perinatal HIV Research Unit, Soweto, South Africa, 5 Fundação Ariel Glaser Contra o SIDA Pediátrico, Maputo, Mozambique, 6 Centre Hospitalier Universitaire du Point G, Bamako, Mali, 7 Hospital Universitario 12 de Octubre, Madrid, Spain, 8 Columbia University Irving Medical Center, New York, NY, USA, 9 Bambino Gesu Children's Hospital, Rome, Italy, 10 University College London, London, UK, 11 University of Padova, Padova, Italy Background: Recent studies have reported on children born with HIV and treated from the first 48 hours of life who achieved undetectable HIV-1 DNA after 2 years of life. In this study, we report five children who started ART within 4 months of age in Sub-Saharan Africa (SSA), who achieved sustained undetectable HIV-1 DNA after 2 years of follow-up. Methods: We enrolled infants who initiated ART at 3 months or younger in Mozambique, South Africa and Mali (EARTH-EPIICAL Cohort). Children were monitored 2, 6, 12 and 24 weeks after enrolment, followed by biannual check ups up to 4 years after enrolment. We identified infants with sustained viral load (VL) suppression, immunological control, and sustained undetectable HIV-1 DNA. All participants had 48 months follow-up. Sustained VL suppression was defined as VL below the level of detection for the last 12 months (at least 3 tests, interval 6 to 9 months). Immunological control was defined as no significant immunosuppression (low CD4 counts or CD4%) during the last 12 months according to WHO definition (3 or more tests, separated 6 to 9 months). Sustained undetectable proviral HIV1-DNA was defined as two consecutive measurements below 1 copy/106 PBMC (minimum, 5 million) with an interval of 6 +/-1 months. DNA was measured by droplet digital PCR. Results: We enrolled 207 participants; 155 (74.9%) had at least 12 months of follow-up. Five participants (3 female and 2 male) (3.2% [5/155]) had two consecutive negative HIV-1 DNA, sustained VL suppression and immunological control. Their median baseline VL was 22 341 copies/mL (IQR, 649 to 5,041,861), baseline CD4 count and % were 1928 (1698 to 3080) and 42% (34% to 48%). They started ART at 27, 32, 32, 59 and 112 days, and 3/5 reached VL undetectable before 1 year of ART. They all received PMTCT and treatment with the standard of care schedule at their country, which was abacavir, lamivudine and lopinavir/ ritonavir. They all remained in WHO Clinical stage I. The adherence (combining self-reported and observed) to ART was recorded as good in 73% to 100% of the visits. Conclusions: Children with ART started within 4 months of life and immediately after diagnosis as per standard of care in SSA can achieve sustained undetectable HIV-1 DNA, VL and high CD4, similar to children treated in the first 48 hours of life. Children with these features may have a greater likelihood of ART-free viral control and represent ideal candidates for future analytical treatment interruption trials targeting HIV cure.

Poster Abstracts

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CROI 2025 337