CROI 2024 Abstract eBook

Abstract eBook

Poster Abstracts

Methods: Routinely collected programmatic data from 42 USAID-supported PEPFAR country and regional programs were analyzed for U.S. fiscal year (FY) 2022 Quarter(Q) 3 through FY2023 Q2 (April 2022 - March 2023). We compared trends in the percent and volume of interruptions in treatment (IIT; overall, <3 months on treatment, 3-5 months on treatment, and 6+ months on treatment) among children (0-9 years), adolescents (10-19 years), and young adults (20-29 years). Interruption in treatment is defined as no clinical contact for 28 days after the last expected clinical appointment or medication pick-up date. Results: Comparing FY22Q3 to FY23Q2, the overall %IIT as well as absolute number of IIT decreased for all age groups: children (2.8% vs 2.6%; 3,613 vs 3,303), adolescents (2.8% vs 2.6%; 8,141 vs 7,853), and young adults (3.5% vs 3.4%; 44,721 vs 37,435); however, a peak in %IIT was observed for all ages in FY23Q1 (3.2%, 3.1% and 4.1%, respectively). Though overall %IIT is highest for young adults in all quarters, in FY22Q4 through FY23Q2 the highest rates of %IIT occurred in adolescents who have been on treatment for <3 months (12.1%, 14.9% and 11.9%) followed by adolescents who have been on treatment for 3-5 months (11.2%, 12,7% and 8.0%). %IIT among those who have been on treatment for 6+ months is greatest for young adults across all four quarters. For all age groups between FY22Q4 and FY23Q2, the absolute number of IIT is largest at 6+ months, however, compared to overall %IIT, higher rates of % IIT are observed within the first three months on treatment (ranging from 2.7 - 4.8 times more often) followed by 3-5 months (ranging from 2.1 - 4.8 times more often). Conclusion: Overall rates of IIT among children, adolescents, and young adults in USAID-supported PEPFAR programs between FY22Q3 and FY23Q2 remain high. The pattern of markedly high rates of IIT in individuals, particularly adolescents, on treatment <3 months and 3-5 months, highlights the need for targeted interventions and support for new initiators to ensure continuity of treatment. Dolutegravir and Growth in Pediatric Populations With HIV-1: IMPAACT P1093 and IMPAACT 2019 Michael McKenna 1 , Zrinka Lulic 1 , Ann M. Buchanan 2 , Cynthia Brothers 2 , Lionel Tan 3 , Marcia Wang 4 , Sean Brummel 5 , Lauren Ziemba 5 , Theodore Ruel 6 , Patricia M. Flynn 7 , Helena Rabie 8 , Andrew Wiznia 9 1 GlaxoSmithKline, Brentford, United Kingdom, 2 ViiV Healthcare, Durham, NC, USA, 3 ViiV Healthcare, Brentford, United Kingdom, 4 GlaxoSmithKline, Collegeville, PA, USA, 5 Harvard TH Chan School of Public Health, Boston, MA, USA, 6 University of California San Francisco, San Francisco, CA, USA, 7 St Jude Children's Research Hospital, Memphis, TN, USA, 8 Stellenbosch University, Cape Town, South Africa, 9 Albert Einstein College of Medicine, Bronx, NY, USA Background: Weight gain has been associated with dolutegravir (DTG)-based regimens in clinical studies of adults with HIV-1 and in observational studies of children and adolescents using DTG. Data from DTG randomized clinical trials did not show excessive weight gain in children and adolescents living with HIV, but knowledge is limited. We report body mass index (BMI)-based growth parameter changes in pediatric participants from 2 single-arm studies of DTG in IMPAACT 1093 (P1093) and DTG/abacavir/lamivudine in IMPAACT 2019, through 48 weeks of treatment. Methods: Separate descriptive post hoc analyses were performed for each study. Age- and sex-specific BMI-for-age Z-scores (BAZ; standard deviation scores) were calculated per 2006 and 2007 World Health Organization references. BAZ was summarized at each visit from baseline to Week 48 by enrollment weight and age bands, baseline BMI, and sex at birth. Proportions of participants aged ≥2 years who started with BAZ ≤1 (normal BAZ and low BAZ) and became overweight (BAZ >2 but ≤3 for age 2-≤5 years and >1 but ≤2 for age >5 years) or exhibited obesity (BAZ >3 for age 2-≤5 years and >2 for age >5 years) were evaluated. Growth-related adverse events were assessed. Results: Data from P1093 (N=181; aged 4 weeks to <18 years) and IMPAACT 2019 (N=57; aged 6 months to <12 years) were analyzed. Overall mean (SD) BAZ increased from 0.0 (1.4) at baseline to 0.2 (1.3) at Week 48 in P1093 and from −0.7 (1.1) to −0.4 (1.2) in IMPAACT 2019. Similar patterns were seen in subgroups by sex at birth and enrollment weight or age bands (Figure). In a descriptive analysis, mean (SD) BAZ across visits ranged from −0.1 (1.4) to 0.3 (1.3) in P1093 and from −0.7 (1.1) to 0.3 (0.8) in IMPAACT 2019. Mean (SD) BAZ for those with baseline BAZ <−3 and −3 to <−2 improved from baseline to Week 48 in P1093 from −3.6 (0.6) and −2.3 (0.2) to −0.4 (1.1) and −0.6 (1.6), respectively, and in IMPAACT 2019 from −3.1 (0.0) and −2.2 (0.3) to −2.7 (0.7) and −0.8 (0.8), respectively. At Week 48, 6 (6%) P1093 and 2 (4%) IMPAACT

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Global Transition to Dolutegravir-Based ART in Children and Adolescents 0-19 Years Living With HIV Sophie Desmonde 1 , Kim Anderson 2 , Joyeux Bwami 1 , Du tuan Quy 3 , Winstone Nyandiko 4 , Christella Twizere 5 , Marco T. Luque 6 , Renee De Waal 2 , Vohith Khol 7 , Patricia Lelo 8 , Vanessa Rouzier 9 , Frankie Odhiambo 10 , Valeriane Leroy 1 , for IeDEA 1 Institut National de la Santé et de la Recherche Médicale, Toulouse, France, 2 University of Cape Town, Cape Town, South Africa, 3 Children’s Hospital 1 , Ho Chi Minh City, Vietnam, 4 Academic Model Providing Access to Healthcare, Eldoret, Kenya, 5 Centre National de Reference en Matière de VIH, Bujumbura, Burundi, 6 Instituto Hondureño de Seguridad Social, Tegucigalpa, Honduras, 7 National Centre for HIV/ AIDS Dermatology and STDs, Phnom Penh, Cambodia, 8 Kalembe Lembe Pediatric Hospital, Kinshasa, Democratic Republic of Congo, 9 GHESKIO, Port-au-Prince, Haiti, 10 Kenya Medical Research Institute, Kisumu, Kenya Background: Dolutegravir (DTG)-based regimens are recommended as first line antiretroviral therapy (ART) for all children and adolescents living with HIV (CALHIV). We describe transition to DTG in the multiregional IeDEA cohort. Methods: We included all CALHIV enrolled in IeDEA sites where DTG was available from 6 regions (Asia-Pacific, Latin America, Central Africa, West Africa, East Africa, Southern Africa). The observation period of the study was from January 2018 through March 2023. Follow-up (FU) for individual patients began on the date at which their site began to use DTG or at ART initiation, whichever occurred later (i.e., baseline); FU ended at DTG initiation or database closure/ death/loss to FU (LTFU; no visit >7 months), whichever came first. We computed regional cumulative incidence functions (CIF) for DTG initiation. Associated factors were explored in a Cox proportional hazard model adjusted for sex, age, ART regimen and viral load (VL), and stratified by region, using a calendar time scale. Results: Overall, 80% of sites had access to DTG and 61,324 CALHIV were included in our study; 55% were female and 60% were from Southern Africa. At baseline, median age was 12.2 years (IQR: 7.3-16.3), and 37% had VL assessments, of whom 51% were suppressed (<50 copies/mL). Median follow-up was 16.6 months (IQR: 6.0-27.8) during which 711 (1%) CALHIV died and 14,514 (24%) were LTFU. The overall CIF for DTG initiation reached 92% (95%CI: 91-93) and was significantly lower in the Asia-Pacific (44%; 95%CI:41 47) compared to other regions (Figure). In adjusted models, CALHIV <5 years (compared with older CALHIV), those with detectable VL (compared to those with undetectable VL), and those on protease inhibitor-based regimens (compared with non-nucleoside-based regimens) were less likely to initiate or transition to DTG. Additionally, we found in all 4 African regions that female CALHIV were significantly less likely to access DTG than their male counterparts. In other regions, sex was not associated with initiation or transition to DTG. Conclusion: We report an unequal transition to DTG in sites where it has been available. Access to pediatric DTG should be scaled up for younger CALHIV. Moreover, our results highlight the need to promote equitable use of DTG regardless of sex and VL. Continued documentation of treatment practices is required to ensure universal and equal access to DTG for all CALHIV.

Poster Abstracts

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Treatment Interruption Patterns Among Young People in USAID Supported PEPFAR Programs Tishina Okegbe 1 , Lana Lee 1 , Nashiva McDavid 2 , Madeline Schneider 1 1 United States Agency for International Development, Washington, DC, USA, 2 Credence Management Solutions, LLC, Washington, DC, USA Background: Continuity of treatment for people living with HIV is paramount in order to achieve the UNAIDS 95-95-95 targets and reach epidemic control. Treatment disengagement is linked to increases in viral load and onward HIV transmission. To better understand continuity of treatment, we analyzed treatment interruption patterns among children, adolescents, and young adults in USAID-supported PEPFAR countries.

CROI 2024 314