bluuebunny/crossref_metadata_2025 huggingface dataset:
P-441. Gut Permeability Response to Inulin Supplementation in Well-Controlled HIV Patients with Metabolic Syndrome
Authors: vikraman Praveen Kumar , Shamayl Ahmed , Mani Valli , Sohail Rubab , Akerman Meredith , Sison Cristina , Hirsch Bruce
Published: January 2025

Background

HIV infection is known to cause abnormally increased gut permeability resulting in chronic inflammation. Serum levels of Zonulin protein are elevated in persons with increased gut permeability. The objective of this study is to assess whether Inulin (fiber) supplementation will result in a decrease in gut permeability in well-controlled HIV patients with metabolic disorder as measured by baseline and post-intervention Zonulin levels.

Statistical Results

There was a statistically significant increase in median Zonulin levels from baseline to post-intervention (p=0.002)

Methods

10 subjects were selected from patients enrolled in care at the Center for AIDS Research and Treatment (CART) based at North Shore University Hospital. Eligibility criteria included well-controlled HIV patients with evidence of metabolic syndrome. The duration of the study was 6 weeks and the intervention was Inulin supplement use. Bloodwork drawn pre- and post-intervention included Zonulin levels, A1c, Fructosamine, Cholesterol, Triglycerides, HDL, LDL, and non-HDL levels. BMI was also checked. Patients were provided with organic Inulin powder and instructed to take 1 tablespoon once a day for the first week and advance to twice a day for the rest of the study. Every week patients were contacted via telephone to assess compliance and side effects. The primary endpoint was the assessment of baseline and post-intervention Zonulin levels, with the secondary endpoint including baseline and post-intervention BMI, A1c, Fructosamine and Lipids. Descriptive statistics were computed and significance was determined via Wilcoxon signed-rank test.

Pre and Post Intervention Zonulin levels in all 10 subjects

Results

Among the patients enrolled 80% were male, 60% were White, 80% were not Hispanic or Latino, and the median age was 60.5. Flatulence and bloating were the most frequent side effects of inulin reported. The median Zonulin levels at baseline were 177.9µg/mL, and post-intervention were 532.4µg/mL. There was a statistically significant increase in Zonulin levels from baseline to post-intervention (p=0.002). There was no significant difference between baseline and post-intervention for any of the other parameters in the dataset.

Conclusion

Inulin supplementation resulted in a statistically significant increase in Zonulin levels, which goes against our hypothesis. Whether this is due to underlying worsening of pre-existing gut dysbiosis or other factors needs further study.

Disclosures

All Authors: No reported disclosures
P-455. Post-Transplantation Infection and Rejection Outcomes in Kidney Transplant Recipients Living with Human Immunodeficiency Virus (HIV): A Single-Center Experience Over a Decade of Evolving Practices
Authors: Nagam Meghna , Huml Anne , Poggio Emilio , Modi Anita R
Published: January 2025

Background

The development of integrase inhibitor and injectable antiretroviral therapy (ART), use of lymphocyte-depleting induction, and implementation of the HIV Organ Policy Equity (HOPE) Act have revolutionized kidney transplant eligibility, peri-transplantation management, and post-transplantation outcomes for people living with HIV and advanced kidney disease in the last decade. We describe our experience with HIV-positive recipients over this important period.

Methods

We conducted a retrospective chart review of all adults living with HIV and advanced kidney disease who underwent kidney transplantation at our center between 2013-2024. Data was collected on demographics, ART and induction regimens, and post-transplantation outcomes: patient/allograft survival, infections, and rejection episodes within the first year.

Results

Sixteen patients (14 Male, 13 Black, Mean Age 51y) underwent 17 kidney transplantations. Ten transplantations occurred from 2013-2022; seven occurred within 18 months of our center’s implementation of the HOPE Act. HIV-associated nephropathy accounted for all six transplantations from 2013-2017; hypertension and diabetes mellitus accounted for most transplantations in later years. Four patients transplanted prior to 2017 received basiliximab, of whom one experienced rejection within a year; 13 subsequent transplantations were induced with anti-thymocyte globulin (ATG), with three complicated by rejection. Rejection incidence was comparable between recipients of 3 mg/kg and 4.5 mg/kg ATG. Two patients suffered graft loss (rejection, BK nephropathy). Eleven patients had infections within a year, predominantly urinary tract infections and cytomegalovirus viremia. No opportunistic infections were identified. Three out of the four patient deaths in this cohort were due to complications of coronavirus disease 2019.

Conclusion

Recent advancements in HIV care and solid organ transplantation practices converged to facilitate pre-transplantation optimization, increase opportunities for transplantation, and improve post-transplantation outcomes for people living with HIV and advanced kidney disease. When used with integrase inhibitor-based therapy, ATG can prevent rejection without precipitating opportunistic infections.

Disclosures

All Authors: No reported disclosures
P-457. Impact of Switching to Bictegravir- or Dolutegravir-based Antiretroviral Therapy on Weight in People Living with HIV during the COVID-19 Pandemic
Authors: Karam Nardine , Douglas Monica , Moy Stanley
Published: January 2025

Background

Integrase strand transfer inhibitors (INSTIs) have been associated with weight gain with dolutegravir (DTG) and bictegravir (BIC) potentially carrying a higher risk than raltegravir (RAL) and elvitegravir (EVG). The COVID-19 pandemic has also been linked to weight gain. However, there are limited data that contextualize the impact of the COVID-19 pandemic on weight in people living with HIV (PLWH) receiving INSTIs. This study aims to evaluate weight change in PLWH who switched to DTG- or BIC-based antiretroviral therapy (ART) compared to those who remained on non-INSTI-based ART during the COVID-19 pandemic.

Methods

This retrospective cohort study included virologically-suppressed PLWH seen at an HIV clinic between January 1st, 2020 to December 31st, 2023. Patients aged > 18 years were included if they switched from RAL- or EVG-based to DTG- or BIC-based regimens (Group 1), from non-INSTI-based to DTG- or BIC-based regimens (Group 2), or remained on non-INSTI-based regimens (Group 3). Pregnant and ART-naïve PLWH were excluded. The primary outcome was absolute weight change from index date to 6 and 12 months. The index date was defined as the switch date in Groups 1 and 2 and was based on the first weight available in the study period in Group 3. Secondary outcomes were absolute change in body mass index (BMI) at 6 and 12 months and in A1c and LDL at 12 months. Mixed linear models, adjusted for sex, age, and baseline BMI, were used to analyze the outcomes.

Results

A total of 200 patients were included (n=45 in Group 1, n=26 in Group 2, and n=129 in Group 3). Baseline characteristics are presented in Table 1. Absolute changes in outcomes are summarized in Table 2. Groups 1 and 2 experienced a median weight increase of 0.9 kg and 0.5 kg, respectively, from index to 12 months, while Group 3 experienced a median weight decrease of 1.1 kg from index to 12 months. Model-generated means for outcome measurements are presented in Tables 3 and 4. Using mixed linear models, there were no significant changes in adjusted mean weight, LDL, and A1c between groups from index to 6 and 12 months (Table 3).

Conclusion

Switching to BIC- or DTG-based ART during the COVID-19 pandemic was not associated with weight gain in treatment-experienced, virologically-suppressed PLWH in this single-center study.

Disclosures

All Authors: No reported disclosures
P-469. Evaluation of the HIV biobehavioral surveillance system for key populations in the Kyrgyz Republic, 2024
Authors: Kubatova Akylai , Kemelbek kyzy Nasyat , Kubatova Aisuluu , Nabirova Dilyara , Horth Roberta , Otorbaeva Dinara
Published: January 2025

Background

New HIV infections are growing in Kyrgyzstan. Key populations (KP), including men who have sex with men (MSM), sex workers (SW), people who inject drugs (PWID), transgender people (TG), and labor migrants (LM) are disproportionately burdened by HIV. Biobehavioral surveillance is essential because routine HIV testing and treatment data in Kyrgyzstan does not adequately capture KP data due to stigma. A surveillance evaluation had not been conducted to identify system gaps and strengths.Table 1.Summary of HIV biobehavioral surveys among key populations in the Kyrgyz Republic

Methods

Using U.S. Centers for Disease Control and Prevention published guidelines for evaluating public health surveillance systems, we conducted an evaluation of Kyrgyzstan’s biobehavioral surveillance system from February to April 2023. We reviewed protocols, survey tools, data and reports from 2003 to 2023.

Results

Biobehavioral surveys are conducted every 3 years. From 2003-2023, 34 studies were completed which included 1,806 MSM in 10 studies, 6331 SW in 11 studies, 8,772 PWID in 11 studies, 56 TG in 1 study and 945 migrants in 1 study. Population size estimations, which are useful for strategic planning, were 16,900 MSM, 7,100 SW, and 25,000 PWID. Protocols and tools were revised and sampling strategies updated before each survey. This helped ensure high quality standards and demonstrates the systems’ flexibility but limits the usefulness of data for comparing trends over time. Recent surveys for each KP failed to reach desired sample size; the TG study reached just 72% of target. Under-sampling, coupled with inherent bias introduced from the quasi-random sampling strategies used, may result in the data not being fully representative. Stability and timeliness were weaknesses; no surveys were conducted 2016-2021 due to funding shortages and the COVID-19 pandemic. Data quality was high. The recent SW survey (n=520) had high completeness of data (91%) and low error measured as invalid/not logical responses to questions (2%).

Conclusion

The biobehavioral surveillance system for key populations in the Kyrgyz Republic is useful, flexible and of high quality. Important gaps in timeliness, stability, and representativeness could be addressed through stable financing for more surveys conducted at regular intervals.

Disclosures

All Authors: No reported disclosures
P-480. Improving HIV Screening Rates among US Veterans: A Quality Improvement Project
Authors: Shah Khushbu , Martin Matthew , Fisher Lisa , Modi Viraj , Lier Audun J
Published: January 2025

Background

Fifteen percent of the 1.2 million people living with human immunodeficiency virus (HIV) in the United States are unaware of their infection, which increases risk of onward transmission and negative sequalae from untreated HIV. To improve early detection of HIV infection, the US Preventive Services Task Force recommends one-time HIV testing for all adults aged 15 to 65. The goal of this quality improvement project is to understand the rate of HIV testing in US Veterans (USV) who seek care at the Northport Veterans Affairs Medical Center (NVAMC) primary care setting and assess the efficacy of a quality improvement strategy to improve HIV screening rates.Table 1:HIV, HCV, and STI screening rates, and demographic variables identified in Veterans at NVAMC primary care setting.NVAMC, Northport Veterans Affairs Medical Center; HIV, Human Immunodeficiency Virus; HCV, Hepatitis C Virus; STI, Sexually Transmitted Infections; USV, United States Veterans

Methods

We conducted a prospective study of USV aged 15 to 65 from three Primary Care provider panels at NVAMC. Demographics, sexual history, injection drug use (IDU), prior hepatitis C virus (HCV), and sexually transmitted infection (STI) testing rates were obtained from chart review. USV without prior HIV screening were telephoned to obtain informed HIV testing consent and testing was ordered for USV who agreed.

Results

We identified 368 USV, with mean age of 60 years. The majority of this cohort were male (n=366, 99.4%) and White (n=262, 72.3%). Seventy-five (20.4%) USV did not have sexual orientation screening charted, no USV were identified as men who have sex with men (MSM), and 4 (1.1%) USV were identified with IDU history. Two hundred twenty (59.8%) USV had received prior HIV testing. Sixty-eight (18.5%) USV with no prior testing gave consent to obtain an HIV test, 29 (42.6%) USV underwent testing and 29 (100%) tested negative for HIV. Prior HCV testing was common (n=262, 71.2%); 2 (0.8%) USV had prior HCV infection and were treated. Sixty-two (16.8%) USV received testing for gonorrhea, 63 (17.1%) for chlamydia, and 138 (37.5%) for syphilis; one USV was identified with chlamydia infection history. We identified patient barriers to HIV testing (refusal, provider outside VA system) and provider factors (testing not offered).

Conclusion

Implementation of a telephone strategy improved HIV testing rates at NVAMC. HIV screening is cost effective as early identification improves survival due to linkage to care and access to treatment. Consequently, this may prevent forward transmission of HIV.

Disclosures

All Authors: No reported disclosures
P-486. Current Trends in Hospitalization Among People Living with HIV at an Inner City Hospital in Newark, N.J
Authors: Prince Monique A , Owolabi Modupeoluwa , Aiman Wajeeha , Attilus Beatrice , Mbenga Kelly , Slim Jihad
Published: January 2025

Background

As HIV disease is becoming a chronic outpatient condition, we were interested in understanding what is driving high-cost hospitalization in people living with HIV (PLWH) at our inner city hospital in Newark, New Jersey. We sought to examine the trends in admissions over the last two years.Table 1compares the causes of hospitalization between 2022 and 2023 [n = 110]

Methods

A retrospective study was performed on electronic medical records of PLWH >18 years old admitted for at least 24 hours to the medical, intensive care, or psychiatry unit of Saint Michael's Medical Center from 2022-2023. The reason for hospitalization was determined to be the main diagnosis related to the symptoms on admission upon chart review. We calculated the standardized mortality ratios using observed deaths and expected deaths compared to mortality in the general inpatient population. We used R software to compare the causes of hospitalization between the two years using the Welch two-sample t-test.Figure 1demonstrates the breakdown of causes by infectious diseases over the 2 years

Results

We identified 110 HIV-positive adults admitted to the hospital. The mean age was 55.8 +/- 12.7 in 2022 and 53.6 +/- 16.3 in 2023. The causes of hospitalization are illustrated in Table 1, p=0.2438. Infections were the top cause of admissions with the most common infections from the respiratory system over two years as demonstrated in Figure 1. AIDS-defining infections were only 4.5% with a decreasing trend during the study period. Overall inpatient mortality in PLWH was 10% in 2022 and 7.14% in 2023. The mortality rate decreased from 4.06 (95% CI 2.20 - 6.91) in 2022 to 1.91 (95% CI 0.89 - 4.06) in 2023. The length of stay (LOS) among PLWH was 26% shorter than the LOS of the general inpatient population in 2022 (n = 4.475) and the same in 2023 (n = 5.34). The mean LOS in PLWH increased by 19.32% over the two years.

Conclusion

Infections are the most common cause of hospitalization in PLWH with stable trends over the last two years. Average mortality rates and length of stay were lower in PLWH compared to the general hospital admissions.

Disclosures

Jihad Slim, MD, FACP, AbbVie: Grant/Research Support|AbbVie: Honoraria|AbbVie: Speaker Bureau|Gilead Sciences, Inc.: Grant/Research Support|Gilead Sciences, Inc.: Honoraria|Gilead Sciences, Inc.: Speaker Bureau|Merck: Grant/Research Support|Merck: Honoraria|Merck: Speaker Bureau|Theratechnologies: Advisor/Consultant|Theratechnologies: Honoraria|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Grant/Research Support|ViiV Healthcare: Speaker Bureau
P-488. Factors associated with the first-time HIV testing among priority populations in Kentucky
Authors: Soria Jaime , Collins Jana , Wilburn Amanda B , Thacker James , Hoven Ardis , Van Sickels Nicholas , Thornton Alice C
Published: January 2025

Background

The Kentucky Income Reinvestment Program (KIRP), a statewide program funded through the Ryan White HIV/AIDS Program, provides comprehensive early intervention services targeting persons at the highest risk for HIV infection. Conducting first-time HIV testing in high-risk populations represents a crucial and proactive approach to mitigating the impact of HIV/AIDS, plays a pivotal role in reducing onward transmission within communities, and provides critical data for public health planning.

Methods

We conducted a cross-sectional study in Kentucky from January 2022 to March 2024. We compared the demographic characteristics and factors associated with first-time HIV testing in high-risk populations. Study data were collected and managed using a REDCap database. The statistical analyses, including logistic regression, were performed with Stata 17 (College Station, TX: Stata Corp LLC).

Results

In the study period, 27,574 subjects were tested for HIV, and 10,268 (37.2%) of them reported not having had an HIV test before. The median age for the first-time tested was 33 (IQR 13 – 83) years; 4,305 (41.9%) were female, 162 (1.58%) were transgender, and 5,321 (51.8%) lived in Rural Counties. (Table 1) In a multivariate analysis, first-time HIV test was associated significantly with younger age, transgender population, and living in rural counties. (Table 2)

Conclusion

The study underscores the critical importance of reaching high-risk populations for initial HIV testing. Around 40% of the subjects tested did not have a previous HIV test, even though they belonged to a high-risk group. The findings reveal several key demographic factors associated with first-time HIV testing, including the younger population, transgender identity, and rural residents, who were more likely to undergo their initial HIV test through the KIRP interventions to address demographic and geographic disparities.

Disclosures

All Authors: No reported disclosures
P-496. Trajectory of Veterans Aging Cohort Study Index Score in People Living with HIV
Authors: Syue Lingshan , Ko Wen-Chien , Ko Nai-Ying , Li Chung-Yi
Published: January 2025

Background

HIV infection weakens human immunity and also causes chronic inflammation. Effective antiretroviral therapy (ART) restores cellular immunity but its ability to reverse chronic inflammation is limited. The Veterans Aging Cohort Study (VACS) is a longitudinal, prospective observational cohort study and used routinely obtained generic data during clinic follow to generate the VACS index which was correlated with poor outcomes. The present study aims to describe the long-term VACS index trajectory pattern of PLWH and to identify the possible factors associated with the unfavorable trajectory of PLWH.

Trajectories of the VACS index and the confidence intervals over up to 7 years of follow-up (n=1677)

Methods

This was a retrospective cohort study enrolling adult PLWH who received HIV care regularly for more than one year in a single medical center and data were retrieved from the electronic medical system. The VACS index for each patient every half year was calculated during 2016∼2022 and collected for group-based trajectory analysis (GBTA). All these analyses were done using the SAS software (9.4 version, SAS Institute Inc., Cary, NC, USA).

Multivariate odds ratio with 95% confidence intervals of factors associated with unfavorable trajectory in PLWH by the logistic regression method (n=1677)

Results

A total of 1677 PLWH with 13366 VACS index records were analyzed through GBTA and categorized into three trajectories: consistently low VACS index with a median VACS index score of 0 points (40.4%), consistently medium scores (median score, 16) of the VACS index (48.2%), and consistently high scores (median score, 52 ) of the VACS index (11.4%) The medium score distribution of the VACS index in the three groups remained unchanged even though the proportion of ART prescriptions increased during the entire follow-up. Age, HIV exposure other than male-to-male sexual contact, baseline CD4 count, Hb level, renal function, FIB-4, and HCV co-infection were significantly associated with the unfavorable trajectory in the multivariate model.

Conclusion

The present study showed that the VACS index is a relatively stable indicator and could be used as an outcome indicator and also provided physicians with an understanding of the long-term trajectories of the VACS index in PLWH. Physicians could identify the high-risk PLWH quickly by using the VACS index. For the PLWH with the consistently high VACS index, physicians need to consider more evaluations or interventions to assure drug adherence to address HIV control.

Disclosures

All Authors: No reported disclosures
P-504. Disparities in PrEP Coverage by Sex Among Individuals Diagnosed with Bacterial STIs in a Large Municipal Healthcare System
Authors: Kaplan-Lewis Emma , Casey Eunice , Gala Kruti , Li Zeyu , Dai Xingyu , Cohen Gabriel
Published: January 2025

Background

Nationally almost 20% of new HIV diagnosis are in females. Females carry 53% of sexually transmitted infection (STI) disease burden in the US, yet nationally represent only 10% of individuals on Pre-Exposure Prophylaxis (PrEP). The US Preventive Services Task Force and CDC include females diagnosed with bacterial STIs as one of the populations to be considered for PrEP. However, females are often not the focus of HIV PrEP campaigns, resulting in knowledge gaps, bias and stigma that further challenge PrEP access for women. As part of efforts to improve sexual health services and access within NYC's municipal healthcare system, we designed a sexual health dashboard (SHD) that included a “PrEP Eligible” metric focused on federal PrEP guidelines related to bacterial STIs.

Methods

All alive patients aged 13-75 years old with a primary care or women’s health clinic visit within a NYC Health and Hospitals facility during April 2023-March 2024 were included in the SHD. The SHD displays testing and positivity rates for Chlamydia, Gonorrhea, and Syphilis, in addition to PrEP eligibility and PrEP active status. PrEP eligibility is based on high frequency of HIV or STI tests (3+ in 1 year), an abnormal STI lab or STI diagnosis and ‘PrEP Active’ is defined as an active prescription for PrEP within the preceding 6-months.

Results

Females represented 82% of PrEP eligible patients but only 13.2% (162) of PrEP Active patients (1,223). Among all people with Chlamydia, 0.2% of females were PrEP Active compared to 16% of males. For Gonorrhea, 2.6% of females were PrEP Active compared to 44.3% of males. For Syphilis, 1.9% of females were PrEP Active compared to 18.6% of males (Figure 1).

Conclusion

According to the CDC, 6% of sexually acquired HIV can be attributed to bacterial STIs, however PrEP usage remains low among eligible females within a municipal healthcare system in NYC. Dedicated efforts are being made within NYC Health and Hospitals to expand PrEP to primary care and women’s health, with the hopes that diversifying care settings for PrEP will reach populations not currently accessing PrEP services. Lack of recognition of the connection between HIV risk and STIs may disproportionately impact females and contribute to underutilization of PrEP.

Disclosures

Emma Kaplan-Lewis, MD, Gilead Pharmaceuticals: Grant/Research Support
P-515. Enhancing Sexual Wellness: A Novel Approach to Screening and Prevention in an Urban Health Center
Authors: Caponi Mitchell , Bonano Miriam , Bayter Eduardo , Keneipp Kathryn , Bhat Sandeep
Published: January 2025

Background

The Family Health Centers at NYU Langone (FHC) is a network of Federally Qualified Health Centers that serves a largely marginalized, diverse, and low-income patient population in Brooklyn, NY. In 2023, the FHC provided care for over 112,000 patients, with 52% being on Medicaid or Medicare and 28% being uninsured. We identified 44 HBSAG positive patients as well as 25 newly diagnosed HIV patients.

Patients as well as providers are often reluctant to have conversations around sexual health. Identifying risk factors for HIV, infectious hepatitis, and other infections is an area critical for providing excellent primary care to end the epidemic and curb Hep and STI rates.

Methods

The FHC had no standardized approach to collecting HIV and Hep B risk history being followed by providers. Our approach aimed to standardize risk screening processes while raising provider awareness of the significance of Hepatitis screening and HIV prevention.

A Sexual Wellness Screening Tool was developed and integrated into the EPIC My Chart system. The screening tool is answered by patients ahead of an initial/annual appointment through the patient portal and updated annually.

Patients with high-risk responses trigger an EPIC Best Practice Alert (BPA). The BPA recommends elements of care and prepopulates a Hepatitis B lab orders and/or referrals to the HIV prevention team. For provider buy-in and education, learning sessions were held across the network.

Results

During Q1 of 2024, 866 patients completed the tool, 525 patients screening positive for risk factors. Of the 525 patients, 88% reported having sex without a condom in the past 12 months. 65% of patients had multiple risk factors. All patients at risk, were offered testing, however 26 HBV tests were actually ordered and 5 completed. For HIV prevention, 26 referrals were generated and contacted by Prevention Navigators, leading to 2 patients beginning PrEP.

Risk Responses

Conclusion

Having patients fill out the tool ahead of appointments allows for a provider to review the tool with the patient and can help guide the conversations patients and providers have; maximizing the finite time providers have with patients and empowering patients to have their questions answered. Continued education and laboratory process refinement are necessary to streamline the work.

Disclosures

All Authors: No reported disclosures
P-536. Real-world Virologic and Safety Outcomes in People Living with HIV-1 Using Dolutegravir (DTG) + Lamivudine (3TC) in Asia Stratified by Viral Load (VL), Including in Individuals with High VLs
Authors: Doblado-Maldonado Andrés , Reen Ooi Adrian Yit , Chen Jun , Letang Emilio
Published: January 2025

Background

DTG + 3TC was effective for achieving virologic suppression (VS) in ART-naive adults living with HIV-1 with VL ≥ 100,000 c/mL in the GEMINI-1/-2 and STAT trials. Guidelines recommend DTG + 3TC as first-line ART in people with VL < 500,000 c/mL, but in real-world settings, people have initiated this regimen with higher VLs. To support treatment decisions, we summarize real-world evidence for DTG + 3TC in ART-naive people with high VL in Asia.

Methods

Databases and congresses were searched (Jan 2013-Mar 2023) for non-interventional studies of DTG + 3TC use in N ≥ 10 people. Post hoc targeted searches were done to add recent (to Dec 2023) and non-English studies. Publications were screened for effectiveness/safety in ART-naive individuals in Asia, stratified by baseline (BL) VL. Results were summarized using lead study data by cohort to avoid overlap. High VL was ≥ or > 100,000 c/mL and very high VL ≥ or > 500,000 or 1,000,000 c/mL.

Results

Of 283 publications, 21 were included, with ART-naive people using DTG + 3TC in China (n=551, 6 cohorts) and Türkiye (n=56, 1 cohort). Median age ranged from 37 to 66.5 years; 59% to 93% were male. When lead study n/N were pooled by VL, 149/262 (57%) people had high VL and 147/353 (42%) had very high VL (≥ 500,000 c/mL, 113/353; ≥ 1,000,000 c/mL, 40/152) at BL. VS (primarily VL < 50 c/mL) rates in lead studies in people with VL ≥ 100,000 vs < 100,000 c/mL were 52% vs 64% at Week (W)4 and 60% vs 93% at W12; corresponding rates in those with VL ≥ 500,000 vs < 500,000 c/mL were 5% vs 20% and 50% vs 75%. W48 VS rate was 92% for high VL (1 study; all had VL > 100,000 c/mL) and ranged from 64% to 96% for very high VL (vs 90%-92% with VL < 500,000 c/mL; 3 studies). In 1 study, 2 people with high VL had virologic rebound at W48 (resuppressed at W72). Outcomes were generally consistent between lead and non-lead within-cohort studies. One virologic failure was reported in a person with very high VL, due to non-adherence. Studies reported no discontinuations (n=1) or no discontinuations due to adverse events (AEs; n=7), drug-related AEs (n=1), or drug-related serious AEs (n=1). Few serious AEs occurred.

Conclusion

Similar to clinical trials, real-world evidence in ART-naive individuals initiating DTG + 3TC in Asia demonstrated high VS rates and favorable safety outcomes, even when VL was high or very high at ART initiation.

Disclosures

Andrés Doblado-Maldonado, PhD, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Adrian Yit Reen Ooi, MBBS, MS, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Emilio Letang, MD, MPH, PhD, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee
P-554. Anxiety and Depression are Associated with Poor Antiretroviral Adherence in People Living with HIV: A Real-World Survey in Europe
Authors: Hennessy Fritha , Ambler Will , Holbrook Tim
Published: January 2025

Background

High adherence to antiretrovirals (ARV) is vital for people living with HIV (PWH) to ensure undetectable viral load and prevent viral transmission. Various factors can affect adherence, including mental health, although little is known about the impact of anxiety and depression in Europe. Therefore, we aimed to assess adherence to ARV based on PWH’s self-reported level of anxiety or depression.Figure 1.PWH response to “How often do you forget to take your ARV because…”

Methods

Data were drawn from the Adelphi HIV Disease Specific Programme™, a real-world, cross-sectional survey with retrospective medical chart data collection of PWH in Europe (France, Germany, Italy, Spain, United Kingdom) between November 2022 and June 2023. PWH self-completed surveys, reporting ARV adherence via the Adelphi Adherence Questionnaire (ADAQ), a 0 to 4 scale, with lower scores indicating greater adherence. Analyses were descriptive.

Results

Of the 501 PWH included, mean (standard deviation, SD) age was 42.2 (13.8) years and 74% were cisgender male (Table 1). PWH (n=482) self-reported being not (ND, n=226), mildly (MD, n=147), or moderately/severely/extremely (ED, n=109) anxious or depressed. PWH with ED had a notably low mean CD4+ count (Table 2). Levels of viral suppression ranged from 75.5% of MD PWH to 54.2% of ED. Worrying about forgetting to take HIV medication was reported by many ED and MD PWH. These PWH also reported that taking their ARV was an uncomfortable reminder of their HIV status (Table 3).

PWH with MD and ED had a mean (SD) ADAQ score of 0.28 (0.37) and 0.38 (0.50), respectively, compared to 0.20 [0.31] for ND. ED PWH reported lack of adherence due to being in a different routine (48%), of not wanting others to see them taking it (39%), or side effects (23%), this was 39%, 29%, 18% for ND PWH (Figure 1).

Conclusion

Anxiety and depression impact PWH’s adherence to their treatment. Higher levels of anxiety and depression are associated with low treatment adherence in PWH. Suitable mental health support, or other targeted support for PWH with anxiety or depression, may improve adherence and outcomes.

Disclosures

Fritha Hennessy, PhD, Adelphi Real World: Employee|ViiV Healthcare: The Adelphi Real World Disease Specific Programme is wholly owned by Adelphi Real World; ViiV healthcare is one subscriber and paid for the analysis Will Ambler, PhD, Adelphi Real World: Employee|ViiV Healthcare: The Adelphi Real World Disease Specific Programme is wholly owned by Adelphi Real World; ViiV healthcare is one subscriber and paid for the analysis Tim Holbrook, BSc, Adelphi Real World: Employee|ViiV Healthcare: The Adelphi Real World Disease Specific Programme is wholly owned by Adelphi Real World; ViiV healthcare is one subscriber and paid for the analysis
P-557. Weight Change After Switching from Bictegravir/emtricitabine/tenofovir alafenamide in Persons Living with HIV: A Retrospective Cohort Study
Authors: Abdessamad Hilal , Kurop Margaret , McKelvy Jane , Dandachi Dima
Published: January 2025

Background

Antiretroviral Therapy (ART) has revolutionized the management and outcomes of persons with HIV (PWH). However, ART has undesirable effects such as weight gain, that lead to non-compliance or medication switch. The combination Bictegravir (BIC)/emtricitabine (FTC)/tenofovir alafenamide (TAF) has been associated with weight gain, though most of the data regarding this is not comprehensive.Figure 1:Study Flowchart

Methods

A retrospective cohort study was performed on 125 patient records to assess the changes in weight, lipid panel and glycosylated hemoglobin (HBA1C) measurements in PWH who were taking BIC/FTC/TAF for at least 1 year then switched to a different combination, compared to those who remained on this regimen, over a period of 3 years (Figure 1).

Table 1

M: Male, DMII: Type 2 Diabetes Mellitus, DL: Dyslipidemia, GLP-1: Glucagon-like Peptide-1, VL: Viral Load, NA: Not Applicable

Results

Out of the 125 records reviewed, 98 (78%) continued BIC/FTC/TAF for 3 years and 27 (22%) were switched to another combination after 1 year, whether cabotegravir/rilpivrine (69%), dolutegravir/lamivudine (18%) or others (13%). The 2 groups had similar baseline mean age, sex, race, metabolic profile, viral load and CD4 counts (Table 1). There was a median weight gain of 1.3 kg after 1 year of treatment with BIC/FTC/TAF. By year 2, there was a median weight loss of 0.8kg in the group who continued the same ART and 0.2 kg in the group who switched treatment (p=0.441). However, by year 3, there was a median weight gain of 0.5 kg in those who continued the same ART and 0.2 kg in those who switched to another combination; p=0.477 (Figure 2). 25/98 (25%) patients who kept same ART experienced weight loss after 2 years, in comparison to 9/26 (34%) of patients who switched treatment (p=0.497). Low-density lipoprotein and HBA1C readings had minimal mean variations between the 2 groups.Figure 2:Change in median weight between the two patient groups after a 3-year follow-up.

Conclusion

Our data, although of small sample size, shows that while there appears to be no significant weight change while continuing BIC/FTC/TAF as compared to switching to a different regimen. Hence, switching to treatment combinations did not result in weight loss or lower LDL and HBA1C levels. To our knowledge, this is among the few studies to provide real world data on weight change after switching from B/FTC/TAF, which highlights its significance.

Disclosures

Dima Dandachi, MD, MPH, Gilead Sciences: Grant/Research Support|ViiV Healthcare: Grant/Research Support|ViiV Healthcare: Honoraria
P-568. Transmitted Drug Resistance to Antiretroviral Therapy in Chile: Preliminary Results from a Cross-Sectional Study
Authors: Ceballos Maria Elena , Ruiz-Tagle Cinthya , Castañeda Felipe , Ferrés Marcela , Palma Carlos , de Landa Angelica Domínguez , Espinoza Manuel , Afani Alejandro , Balcells María Elvira
Published: January 2025

Background

The use of antiretroviral therapy (ART) has reduced HIV morbi-mortality and its transmission. However, treatment failure can occur when acquiring a strain with mutations conferring resistance to antiretrovirals. Transmitted resistance to antiretroviral drugs (TDR) reported nationally was 10.45% in 2018 and is increasing worldwide. We aimed to determine the percentage of global TDR and the relevance of incorporating the genotyping study in naïve people living with HIV in Chile.

Methods

Observational, cross-sectional study conducted in 11 healthcare centers located in 7 regions of Chile. Individuals ≥18 years old with an HIV diagnosis in the last 12 months and without prior ART were invited to participate. Individuals with an HIV viral load < 1000 ARN copies/mL were excluded. ARN genotyping of the reverse transcriptase, protease and integrase genes were carried out using a nested PCR with subsequent Sanger sequencing. The percentage of individuals with TDR was determined and mutations associated with TDR were identified according to the HIV Drug Resistance Database, Stanford University.

Results

Between February 2023 and April 2024, 117 participants have been sequenced (final sample size 164). The average age is 35.2 years (18-78), with 90.6% belonging to the Chilean population. 87.2% are male, of which 74.4% have sex with men. Most common viral strain was subtype B (70.1%). Overall TDR (TDR to any ART family) was 17.9% (n=21). TDR for each family and mutations are shown in Table 1 and Figure 1. In addition, other mutations were found, but they were not included in the percentage for TDR because they are not in WHO TDR list (Table 2). Three participants presented resistance to more than one ART family; one to NRTI and NNRTI, one to NRTI and INSTI and one to NNRTI and INSTI.

Conclusion

In Chile, an increase is observed in the percentage of TDR to ART compared to what has been historically reported. The main families affected are the NNRTIs and the INSTIs (mostly first generation). Considering these preliminary results, it is considered pertinent to incorporate the baseline genotyping study in patients starting ART with both NNRTI efavirenz or rilpivirine and first-generation INSTI.

Disclosures

All Authors: No reported disclosures
P-569. Changes in lipid profile in people living with HIV on stable protease inhibitors (PIs)-based regimens as second-line ART regimens switch to dolutegravir (DTG)-based regimens
Authors: Kiatkangwanchon Natthapol , Sophonphan Jiratchaya , Avihingsanon Anchalee , Gatechompol Sivaporn , Putcharoen Opass
Published: January 2025

Background

Antiretroviral therapy (ART) for human immunodeficiency virus (HIV) infection is associated with metabolic changes, including dyslipidemia and cardiovascular risk. Switching from protease inhibitor (PIs)-based regimens to dolutegravir (DTG)-based regimens offers potential benefits, but its impact on metabolic parameters requires investigation. This study aimed to assess the change in low-density lipoprotein cholesterol (LDL-C) levels, a risk factor for cardiovascular disease, in people living with HIV (PLWH) who switched from stable PIs-based second-line ART regimens to DTG-based regimens.Table 1Baseline characteristics of participants

Methods

We conducted a prospective cohort study evaluating lipid profile, renal function, and other metabolic parameters in PLWH who switched from PIs-based to DTG-based regimens. The DTG-based regimens comprised two nucleotide reverse transcriptase inhibitors (NRTIs), specifically tenofovir alafenamide (TAF) and emtricitabine (FTC), along with DTG in a single-tablet regimen once daily. The study was conducted at HIV-NAT, and data were collected over 24 weeks.Table 2Comparison of BMI and laboratory tests between PIs-based and 24 weeks after switching to DTG-based regimens

Results

Among 144 PLWH participants, switching to DTG-based regimens resulted in significant reductions in triglycerides (TG) and improvements in high-density lipoprotein cholesterol (HDL-C), while LDL-C and total cholesterol (TC) remained stable. Post-switching, participants experienced weight gain and increases in body mass index (BMI). Renal function, assessed by estimated glomerular filtration rate (eGFR), showed a decline. Despite these changes, virological suppression was maintained, and depressive symptoms remained stable. Notably, depression scores assessed using the Patient Health Questionnaire-9 (PHQ-9) at 24 weeks post-switching primarily indicated normal (68.3%) and mild depression (19.8%), with only one participant reporting severe depression.

Conclusion

Switching to DTG-based regimens in PLWH offers benefits in lipid profile and pill burden reduction, with modest increases in weight and LDL-C attributed primarily to the transition from TDF to TAF. Further research is needed to assess long-term effects, particularly on renal function and cost-effectiveness in diverse settings. These findings contribute to optimizing HIV care and treatment strategies globally.

Disclosures

All Authors: No reported disclosures
P-606. A Single-round Infectious Virus with Codon-deoptimized Genome: A Powerful Tool for Regulating Pathogenicity of WT/Live-Attenuated Viruses
Authors: Noguchi Takafumi , Miyamori Anju , Sugimoto Takeshi , Miyazato Paola , Sasaki Ryo , Komatsu Sayuri , Ebina Hirotaka
Published: January 2025

Background

Coxsackievirus B3 (CVB3) is a ssRNA(+) virus of the Picornaviridae family associated with myocarditis and type I diabetes. Prevention of mother-to-child transmission is important, especially since the outcomes of neonatal infection can be fatal. However, vaccines have not yet been developed. In this study, we revealed that CVB3 codon-deoptimized in the nonstructural proteins’ region (CVB3cd) can be used as live-attenuated vaccines (LAVs). Furthermore, we showed that in co-infection experiments, a CVB3cd-based single-round infectious virus induces interference, significantly reducing the pathogenicity of viruses.

Methods

CVB3cd were designed to be enriched in CpG-containing rare codons in the 3CD region of the viral genome. Viral proliferation was evaluated based on plaque size and growth curve; and their pathogenicity in mice was determined by weight loss and survival after infection. Defective viral particles (DVPs) were generated by packaging WT or CVB3cd replicons with a trans-expressed viral capsid protein. To evaluate the effect of viral interference with DVPs, WT or CVB3cd were co-administered with the DVPs, and their pathogenicity in mice was monitored.

Results

A decrease in viral replication was observed in correlation with the number of deoptimized codons, in addition to an increase in the survival rate of animals infected with the codon-deoptimized viruses. Among vaccination methods, intramuscular injection of the attenuated virus emerged as the least pathogenic option, effectively inducing neutralizing antibodies and providing protection against challenge by the WT virus. In addition, simultaneous infection of CVB3 with DVPs revealed that CVB3cd replicon-based DVP (DVPcd), reduced the pathogenicity of CVB3 in mice and improved the safety of LAVs without compromising immunogenicity.

Conclusion

Our data suggest that viral pathogenicity can be modulated by a combination of codon-deoptimization, route of administration, and viral interference. This approach could be a powerful strategy to develop effective and safe LAVs in a short period of time. Moreover, DVPcd could be used as therapeutic tools against viruses due to their efficient virus-interfering effects.

Disclosures

Anju Miyamori, Master of Medicine, The research foundation for microbial diseases of Osaka university: Grant/Research Support Hirotaka Ebina, Doctor of Medicine, The research foundation for microbial diseases of Osaka university: Grant/Research Support
P-621. The association between pediatric vaccine-limiting and non-completion of the combined 7-vaccine series among US military families, 2010–2019
Authors: Burrell Monica , Romano Celeste , Bukowinski Anna , Hall Clinton , Gumbs Gia , Conlin Ava Marie , Ramchandar Nanda
Published: January 2025

Background

Recent work reported gaps in completion of the pediatric combined 7-vaccine series among US military families. To determine the role of vaccine hesitancy as a contributing factor to undervaccination, we examined the prevalence of vaccine-limiting patterns and measured the association between these patterns and vaccine non-completion.

Methods

Department of Defense Birth and Infant Health Research program data were used to identify children born at military facilities, 2010–2019. Immunizations were identified through age 2 years using vaccine administered and Current Procedural Terminology codes from military facility immunization records and health care encounter records, respectively. Consistent vaccine limiters received < 3 antigens at each vaccine visit (ie, all limited visits). Episodic vaccine limiters had ≥1 limited vaccine visit and only 3 visits with ≥3 antigens. Non-limiters had no limited visits or ≥4 visits with ≥3 antigens. Modified Poisson regression models estimated associations between vaccine-limiting patterns and non-completion of the combined 7-vaccine series by age 2 years.

Results

Overall, 271,510 children were identified for analysis. The prevalence of consistent vaccine-limiting was 0.3% (n=758); episodic vaccine-limiting was 13.6% (n=36,879). Each group was disproportionately represented among the population non-complete for the 7-vaccine series (1.1% and 27.5%, respectively). Consistent vaccine limiters had 5.6 (95% confidence interval [CI]: 5.5-5.7) times the risk and episodic vaccine limiters had 3.0 (95% CI: 2.9-3.0) times the risk of non-completion compared with non-limiters.

Conclusion

Although few US military families consistently limited pediatric vaccinations, episodic vaccine-limiting throughout the first 2 years of life was common, and both vaccine-limiting patterns were associated with higher risk for vaccine series non-completion. Findings suggest greater attention to vaccine-limiting is needed in this population.

Disclosures

All Authors: No reported disclosures