Long-term Use Research Articles

The experience of adults with cystic fibrosis using long-term domiciliary non-invasive ventilation.

Background: The use of non-invasive ventilation (NIV) in patients with advanced cystic fibrosis (CF) has increased in recent years. Research evidence supports its clinical benefits, but less is known about the patients' experience of its long-term use in a domiciliary setting.Objective: To investigate patients' lived experience of using long-term domiciliary NIV.Methods: Semi-structured, qualitative interviews were conducted with adults with CF using long-term domiciliary NIV for respiratory failure. The data collected were subject to thematic analysis.Results: Nine adults (6 female), 5 of whom were awaiting lung transplantation, with a mean age of 39years and mean FEV1 per cent predicted of 28%, were recruited. Data analysis revealed 2 themes: gratitude, and determination despite challenges. Patients identified some troubling side effects from NIV but were grateful for its symptomatic relief and were determined to continue using it to improve their quality of life.Conclusions: Participants reported experiences of NIV to be generally positive in terms of symptom relief and quality of life. These findings provide an initial insight into patients' experience of NIV and have the potential to help guide and improve care.

Anti-Inflammatory and Antioxidant Effects of Gundelia tournefortii Aqueous Extract on the Liver and Kidney of PCOS Mice.

Polycystic Ovarian Syndrome (PCOS) is an endocrine disorder associated with increased risk of kidney and liver damage. Current treatments have shown contradictory outcomes, and their long-term use causes unwanted side effects. G. tournefortii could serve as a complementary medicine to current PCOS treatments. This study evaluates the effect of G. tournefortii in alleviating liver and kidney damage induced by PCOS via the regulation of oxidative stress pathways. PCOS was induced in female Balb/c mice using dehydroepiandrosterone over 21 days. They included a Sham group, a Vehicle group, a group treated with the extract only, and an untreated PCOS mice group. Positive Controls were treated with Metformin. The other PCOS groups were either co-treated while inducing PCOS or treated with the extract post-disease induction. Histological analysis was performed. Serum liver and kidney biochemical markers, levels of oxidative stress, and two pro-inflammatory markers were measured. NLRP3 and its associated genes (caspase-1 and ASC) gene expression was assessed. The extract restored normal kidney and liver histology post-PCOS induction. It decreased ALT and AST levels by 50% and the oxidant marker malondialdehyde (MDA) by 65% (P < .05). Superoxide dismutase (SOD)/catalase (CAT) activities were normalized in PCOS treated group. IL-1β/TNF-α significantly decreased (80% and 68%, respectively, P < .05) in the post-treated group. NLRP3 genes decreased in kidney tissues post-treatment with G. tournefortii extract. G. tournefortii reduced oxidative stress by modifying the ASC/caspase-1/IL-1β signaling pathway, thus protecting livers and kidneys highlighting the herb as a potential preventative and complementary agent in mitigating PCOS associated damage.

Application of cell therapy in rheumatoid Arthritis: Focusing on the immunomodulatory strategies of Mesenchymal stem cells.

Rheumatoid arthritis (RA) is a common chronic autoimmune disease that primarily affects the joints, leading to synovial inflammation and hyperplasia, which subsequently causes joint pain, swelling, and damage. The microenvironment of RA is characterized by hypoxia, high reactive oxygen species (ROS), low pH, and levels of high inflammatory factors. Traditional treatments only partially alleviate symptoms and often cause various adverse reactions with long-term use. Therefore, there is an urgent need for safer and more effective treatments. In recent years, mesenchymal stem cells (MSCs) have shown significant potential in treating RA due to their diverse immunomodulatory mechanisms. MSCs paracrine a variety of soluble factors to improve the inflammatory microenvironment in RA patients by inhibiting T cell proliferation or inducing T cell differentiation to regulatory T cells (Tregs), inhibiting B cell proliferation and differentiation and immunoglobulin production, prompting macrophage polarization toward an anti-inflammatory phenotype, and inhibiting neutrophil recruitment and preventing the maturation of dendritic cells (DCs). This review summarizes the immunomodulatory effects of MSCs in RA and their application in animal models and clinical trials. Although the immunomodulatory mechanisms of MSCs are not yet fully elucidated, their significant potential in RA treatment has been widely recognized. Future research should further explore the immunomodulatory mechanisms of MSCs and optimize their functions in different pathological microenvironments to develop more effective and safer therapeutic strategies.

Hysteresis Behavior of Reinforced Concrete Column Retrofitted and Repaired with Carbon Fiber Sheet

Structures experience damage and deterioration over their life cycle. The recent increase in interest in sustainable development of cities is re-evaluating the long-term use of structures. Therefore, researches on the retrofitting method for existing structures is receiving high attention again. However, there are very few cases where the direct comparison between the repair and retrofitting effects of structures has been experimentally verified. In this study, retrofitting methods and repair methods with carbon fiber sheets for reinforced concrete columns under shear failure were investigated. 10 reinforced concrete columns were tested under reversed cyclic loading. As a result of the experiment, it was found that, when reinforced with CFS strips, the increase in the width of the strip serves to enhance the strength and ductility of the reinforced member by providing confinement against shear cracks occurring in concrete. It was confirmed that as the number of overlaps of CFS increased, a greater strength-enhancing effect and ductility-enhancing effect appeared. However, the two-way reinforcement of CFS did not show a great effect in improving strength and ductility. As a result of evaluating the repair performance of damaged members using CFS, it was found that the strength and ductility of the repaired specimen exceeded the original strength and ductility of the base material as well as the strength and ductility of the reinforced specimen.

Abstract TP391: CGRP Monoclonal Antibody Does Not Exacerbate Stroke Outcomes in Mice

Background: Calcitonin gene-related peptide (CGRP) is a potent vasodilator that plays a role in migraine. Monoclonal antibodies targeting CGRP, such as fremanezumab, is now widely used for migraine prevention. However, inhibition of CGRP system may also lead to vasoconstriction, raising concerns about whether the long-term treatment with these antibodies in migraine patients might increase the risk of stroke or worsen outcomes if a stroke occurs while taking these medications. Here, we aimed to investigate whether fremanezumab exacerbates stroke outcomes in a mouse model of ischemic stroke. Methods: Two middle cerebral artery occlusion (MCAO) models were used: a 12-minute occlusion simulating a transient ischemic attack (TIA) and a 60-minute occlusion representing a conventional stroke model. Fremanezumab was administered intraperitoneally at either 2 days or 7 days before MCAO induction in both models; one cohort received treatment 28 and 7 days before MCAO. On day 2 after reperfusion, brain tissues were harvested for TTC staining to evaluate infarct volume. Neurological function was assessed using a neuro score and corner test. Additionally, an angiogram using black ink was performed to visualize cerebral vasculature, and vessel diameters were measured to determine the impact of fremanezumab on vascular dimensions. Results: Angiographic arterial diameters in the fremanezumab arm did not differ from the saline arm, suggesting that fremanezumab does not cause vasoconstriction. In the TIA model, the fremanezumab group exhibited a trend towards increased infarct incidence and volume and hemorrhagic transformation, although these did not reach statistical significance. Additionally, there were no substantial changes in neurological scores and the corner test. In the 60-minute MCAO model, no significant changes or trends were observed in infarct volume or other outcomes between the two treatment arms. Outcomes were similar when fremanezumab was administered 2 or 7 days before MCAO. Conclusion: Despite previous concerns that long-term use of fremanezumab might exacerbate stroke risk by promoting vasoconstriction, our findings do not support this hypothesis and suggest that fremanezumab does not worsen stroke outcomes in these models. These findings have important implications for the management of stroke risk in patients using fremanezumab for migraine prevention, suggesting that it may be used with confidence regarding its impact on stroke risk.

Towards a dynamic processual model of psychedelic microdosing.

Existing research highlights an increase in psychedelic microdosing, particularly for therapeutic purposes and as a means for self-enhancement. However, we know little about the different routes into and out of microdosing, particularly by those who do not consume other illicit substances, and of the processes involved in the development, maintenance, and cessation of practices. Drawing upon a trans-national interview-based study of 23 participants actively microdosing (n = 19), about to start (n = 3), or who were past users (n = 1), we develop a phased-based analysis of different user pathways. We identify key phases as: 'Awareness/Discovery', where participants became aware of microdosing; 'Research/Reframing', where they researched access, techniques, and undertook 'stigma work' to reframe risks; 'Access/Supply' where they sought reliable and safe sources of psychedelics and cultivated attitudes/practices/substances for longer-term use; 'Experimentation/Differentiation' where participants altered dosing levels/schedules and, inter-relatedly, differentiated 'effects' and 'benefits'; 'Independence/Incorporation' where they stabilised practices into patterns 'right for them'; and 'Expansion/Advocacy' where microdosing was linked to greater inter- and intrapersonal 'expansiveness'. Pathways in and out of microdosing are multilinear and differentiated. Nonetheless, a dynamic processual approach helps highlight the overall structure of changes involved which, we find, can entail a shift towards greater temporal and relational 'expansiveness', greater independence, and more incorporated practices. These shifts necessitated considerable 'work' variously to negate stigma, maintain supply, determine dose, document shifts, and other kinds of material-symbolic 'investment'. We also show the significance of processual/phased-based models beyond psychedelics to better understand drug-use journeys and temporalities which confound conventional dependency-focused paradigms.

Childhood adversity, early school leaving and long-term social benefit use: a longitudinal mediation analysis of a population-wide study

Childhood adversity, early school leaving and long-term social benefit use: a longitudinal mediation analysis of a population-wide study

A one-day acceptance and commitment therapy workshop for the prevention of chronic post-surgical pain and long-term opioid use following spine surgery: Protocol for a pilot feasibility randomized controlled trial.

Back pain is increasingly common, leading to more spine surgeries. While most people experience pain relief and improved function after surgery, many continue to suffer from chronic post-surgical pain (CPSP) with limited functional improvement. CPSP is often treated with opioids, raising concerns about misuse, poor functional outcomes, and broader public health impacts. Therefore, perioperative interventions are needed to enhance outcomes and reduce the risk of opioid misuse after surgery. This article outlines a study protocol evaluating the feasibility, acceptability, and preliminary efficacy of a brief, perioperative Acceptance and Commitment Therapy (ACT) intervention aimed at improving pain and reducing opioid use after spine surgery. In this pilot randomized controlled trial, participants scheduled for spine surgery (anticipated N=100) are assigned to the ACT intervention or a treatment-as-usual group. The ACT intervention is a 5-h, single-session, virtual workshop with a booster call two weeks post-workshop or post-surgery, whichever is later. The primary outcome is patient-reported treatment helpfulness immediately after the intervention. Secondary outcomes include patient-reported treatment credibility and expectancy post-intervention, treatment helpfulness at 1month post-surgery, and pain interference, pain intensity and opioid use at 1, 3, and 6months post-surgery. This pilot trial examines a novel, brief ACT intervention aimed at preventing CPSP and reducing opioid dependence. If successful, feasibility and preliminary efficacy results will be utilized to inform a future, full-scale randomized trial of this intervention.

Can an alteration of the gut microbiome increase risk of gastrointestinal malignancies? Insights from the National Inpatient Sample.

841 Background: The gut microbiome is composed of trillions of microorganisms, inhabiting the lining of the gastrointestinal (GI) tract. The gut microbiome plays multiple roles in upholding human health including maintaining metabolism and regulating immune homeostasis. Dysregulation of the gut flora is known as gut dysbiosis. Studies have shown that gut dysbiosis is linked to the development of malignancies such as colorectal cancer. The purpose of this study is to assess the correlation between an altered gut flora and development of GI malignancies. Methods: The National Inpatient Sample was queried between 2016-2020 for all adult patients with altered gut flora, defined by history of gastrointestinal/bariatric surgeries, history of clostridium difficile infection, long-term antibiotic use, and inflammatory bowel disease. Rates of various cancers were compared between this cohort and all other patients utilizing chi-squared tests. Binary logistic regressions were utilized to calculate odds ratios of developing the various cancers, adjusted for age, sex, Charlson Comorbidity Index (CCI), and smoking status. Results: A total of 7,758,168 hospitalizations with altered gut flora were identified. Esophageal cancer (aOR 3.16, 95% CI 3.08 - 3.24) and colorectal cancer (aOR 3.15, 95% CI 3.11 - 3.18) were observed to have the highest odds of occurring in patients with altered gut flora. Gastric, hepatobiliary, pancreatic, and neuroendocrine cancers also all had significantly higher odds of occurring in patients with altered gut flora. Conclusions: Our study shows that conditions altering the gut flora are associated with increased odds of malignancies of the GI tract. This suggests that the gut microbiome may play an intricate role in regulation of tumor cell proliferation. Optimization of gut health and restoration of gut flora may prove beneficial to patients at high risk for malignancies of the GI tract. Altered Gut Flora (%) Intact Gut Flora (%) Adjusted Odds Ratio (CI) p-value Esophageal 0.4 0.1 3.16 (3.08 - 3.24) &lt;.001 Gastric 0.3 0.1 1.67 (1.64-1.69) &lt;.001 Colorectal 2.5 0.6 3.15 (3.11 - 3.18) &lt;.001 Hepatobiliary 0.4 0.3 1.04 (1.02 - 1.07) &lt;.001 Pancreatic 0.6 0.3 1.34 (1.31 - 1.37) &lt;.001 Neuroendocrine 0.2 0.1 1.38 (1.33 - 1.44) &lt;.001

Chronic Use of Proton Pump Inhibitors Is Associated With Reduced 30-Day Mortality From Acute Pancreatitis.

Proton pump inhibitors (PPIs) decrease pancreatic exocrine secretions. There has been interest in the impact of their short-term in-hospital administration on acute pancreatitis (AP) outcomes. It is unknown whether long-term use affects AP outcomes. We investigated the association between chronic PPI use and short-term AP outcomes. We included all (2308) patients admitted with a primary diagnosis of AP (625 on chronic PPI use) between January 2008 and June 2021 and evaluated any association between chronic PPI use and 30-day all-cause mortality by univariate logistic regression. Compared to non-users, patients on chronic PPIs were older (p < 0.001) and had a higher Charlson Comorbidity Index score (p < 0.001). Mortality rates at 30 days were 1.5% in chronic PPI users and 4.6% in non-users (OR 0.33; 95% CI, 0.16-0.6; p < 0.001).

Facile Fabrication of Binary-Structured Fibrous Membranes with Antifouling and Flame-Retardant Properties for Durable Water/Oil Separation.

Membrane fouling from dispersed droplets during water/oil separation undermines performance and limits long-term use. Additionally, there is an urgent need for flame-retardant fibrous membranes capable of purifying high-temperature polluted oils. Inspired by the binary structure of taro leaves, this study introduces a novel fibrous membrane with both antifouling and flame-retardant properties for water/oil treatment. Eco-friendly cellulose acetate (CA) and multifunctional thermoplastic polyurethane (TPU) were used to construct a microfiber-based substrate membrane via electrospinning. A TPU/ammonium polyphosphate (APP) nanofiber layer with a beads-on-string structure was then electrosprayed onto the substrate as a functional layer. This binary-structured composite membrane leverages the adhesive properties of TPU within both the base microfibers and the functional nanofibers, enhancing stability and structural integrity. The functional layer's re-entrant structure effectively prevents dispersed droplets from adhering under the continuous phase, enabling efficient separation performance in both oil-in-water and water-in-oil emulsions. The membrane demonstrated strong antifouling properties and excellent recyclability, maintaining stable flux and a consistently high separation efficiency (>99.6%) across multiple cycles. Additionally, its flame-retardant properties allowed the membrane to self-extinguish when removed from direct flame. This study presents a novel strategy for fabricating multifunctional separation membranes, with detailed analysis of the underlying mechanisms.

Challenges Surrounding Hemodialysis Initiation Faced by Undocumented Immigrants.

Hemodialysis care in the United States for undocumented immigrants remains a challenging issue. The objective of this study is to evaluate the timeliness of nephrology and vascular surgery care provided to undocumented immigrants with end-stage renal disease (ESRD) compared to their documented counterparts. Additionally, we evaluate catheter-related complications in undocumented patients on hemodialysis (HD). A retrospective chart analysis was performed of patients undergoing first-time arteriovenous access (AVA) creation at a single center from 2012-2018 to compare outcomes between documented and undocumented patients. Additionally, within the undocumented group, we compared outcomes between patients dependent on a central venous catheter (CVC group) to patients with a CVC and transition to an AVA (CAV group). The primary outcomes were time to initial evaluation by nephrology, vascular surgery, and AVA creation, as well as complications associated with long-term CVC use within the undocumented patients. 290 patients underwent first-time AVA creation (62 undocumented, 228 documented). Undocumented patients were younger at the time of surgery and, more commonly, Hispanic. Undocumented patients were more likely to receive their first nephrology evaluation upon HD initiation (59.7% vs 25.4%, p<0.001). Regarding vascular access surgery initial evaluation for AVA creation, undocumented patients were more likely to be evaluated after initiating HD (74.2% vs. 38.6%, p<0.001). After being evaluated for AVA creation, there was no difference in time from vascular surgery evaluation to surgery (25 days vs. 20 days, p=0.95) or from surgery to AVA maturation (77 days vs. 57 days, p=0.31). As a result, undocumented patients were more likely to start dialysis with a CVC (90.3% vs 66.7%, p=0.0004). Undocumented in the CVC group were more likely to experience catheter-related complications compared to their undocumented counterparts in the CAV group (CVC 72.5% vs CAV 45.9%, p=0.032). The CAV patients were found to have an earlier occurrence of their first catheter-related complications, driving an earlier evaluation for AVA creation and subsequent CVC removal. Due to limited access to healthcare, undocumented immigrants with ESRD had a significant delay in evaluation by nephrologists and vascular access surgeons for AVA creation with a higher use of CVC for dialysis initiation. CVC-related complications are highly frequent and avoidable in undocumented patients with an earlier referral for creation of appropriate AVA.

P-93. Contezolid in Patients with Spinal Infections

Abstract Background Methicillin-resistant Staphylococcus aureus (MRSA) is a common cause of spinal infections (SI) requiring long-term use of antibiotic therapy. Linezolid (LZD) is effective in treating MRSA in different clinical scenarios, but its long-term use is limited due to risk of significant thrombocytopenia. Contezolid (CZD) is a new generation of oral oxazolidinone with potentially less myelosuppressive effect. However, data on the use of CZD in patient with SI is currently lacking. This study aims to evaluate the use of oral CZD in patients with spinal infections due to MRSA. Methods Single-center, retrospective study in 7 patients with SI caused by MRSA. All patients experienced platelet count decreased during treatment with LZD and were rapidly switched to CZD (800 mg, po, bid) for &amp;gt; 4 weeks. We evaluated the clinical outcomes (within six months after treatment), adverse reactions and the platelet counts. Results 7 patients met the criteria for this study (median age 58, IQR 56.5-64.5, 14.3% female). With LZD treatment for a median of 14 days ( IQR 12-14 ), platelet count decreased from normal range 125-300 × 109/L to 65–75 × 109/L. After switching to CZD for 2 weeks, the platelet counts recovered to &amp;gt; 100 × 109/L in all subjects. At the time of the switch 5 patients still had increased C-reactive protein. After approximately 2 months of oral CZD treatment(median duration 28 days, IQR 26-31.5 ), all patients improved clinically and CRP levels returned to normal (Table 1). Follow up MRI results also indicated radiologic improvement (Figure 1). Clinical evaluation, CRP and MRI six months after therapy indicated no recurrence in any subjects. During the treatment with CZD, only 2 patients experienced mild nausea, with no serious adverse reported. Conclusion In patients with SI due to MRSA experiencing thrombocytopenia with LZD, This limited study of oral CZD, as a rescue therapy for hematogenous osteomyelitis and thrombocytopenia after treatment with LZD, is encouraging and suggests that CZD may with more study be an excellent option for the treatment of SI due to MRSA. Disclosures All Authors: No reported disclosures

Severe Asthma in School-Age Children: An Updated Appraisal on Biological Options and Challenges in This Age Group

This review examines the growing role of biological therapies in managing severe asthma in children aged 6–11 years. Severe asthma, characterized by persistent symptoms and frequent exacerbations, presents significant challenges in pediatric care. Biologic treatments, including mepolizumab, omalizumab, and dupilumab, provide targeted interventions for patients with high eosinophilic inflammation or allergic asthma (T2-high asthma). Alongside their therapeutic benefits, the review evaluates the safety profiles of these biologics, highlighting potential side effects and the necessity for monitoring during long-term use. Cost considerations and treatment adherence also emerge as important challenges that need to be addressed in clinical practice. Additionally, the review emphasizes the need for identifying patients who would derive the most benefit from biologic therapies, advocating for the development of biomarkers to aid in treatment decisions. Emerging biologics, such as tezepelumab, are introduced as promising alternatives with the potential to target upstream inflammatory pathways, offering hope for treating T2-low asthma forms, which currently lack effective treatment options in children.

Update on Menopause Hormone Therapy; Current Indications and Unanswered Questions.

To provide clinicians involved in managing menopause with a summary of current evidence surrounding menopause hormone therapy (MHT). The authors evaluate and synthesize existing pooled evidence relating to MHT's clinical indications, efficacy, and safety and explore the limitations of existing data. The review focuses on MHT-related outcomes in women with natural-timed menopause captured within observational studies, RCTs, and pooled data from pivotal meta-analyses and reviews. Available published data are scrutinized. Available evidence and notably lacking data from women not adequately represented in published MHT trials, such as those with socioeconomic adversity, significant comorbidities, and minority ethnic backgrounds, are highlighted and deliberated. The impact of MHT differs significantly between demographics. Current consensus recommendations for MHT emphasize the importance of tailoring type, route, dose, and duration of therapy to individual needs and risk/benefit ratio through shared decision-making. MHT impact can change over time. Current MHT data support its benefits for treating menopause symptoms and a potential window of opportunity in midlife to benefit skeletal health. Limitations of current evidence highlight menopause health inequalities and underscores the need for further research. This review recommends tailored use of MHT for well-defined indications, recognizing its value for menopause symptom relief and skeletal benefits for many midlife women. MHT may be used as long as benefits outweigh risks, through shared decision-making. There is insufficient clinical evidence to support the long-term use of MHT in some contemporary cohorts of women accessing MHT in clinical practice.

P-565. A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes with and without Ibalizumab in a Real-World Setting: United States (PROMISE-US) Study Design and Baseline Characteristics

Abstract Background Multidrug resistance arises usually in people with HIV (PWH) with extensive prior exposure to antiretrovirals (ARVs). There is a need for further understanding of factors that impact the maintenance of virologic suppression in heavily treatment experienced (HTE) PWH in a real-world setting.Table 1:Baseline Characteristics PROMISE-US 1/2* Any regimen including the two drugs and may have additional ARVs in the OBR** cGSS was calculated as per Gonzalez-Serna et al. Journal of Antimicrobial Chemotherapy, 2017, P. 496 –503, https://doi.org/10.1093/jac/dkw455. Because commercial resistance testing is not available for ibalizumab, fostemsavir, or lenacapavir, all 3 agents are always considered fully active.*** Adverse events were only collected for subjects in Cohort 2.ARV, antiretroviral; cGSS, combined genotypic sensitivity score; FTR, fostemsavir; IBA, ibalizumab; INSTI, integrase strand transfer inhibitor; LEN, lenacapavir; MVC, maraviroc; NNRTI, non-nucleotide reverse transcriptase inhibitor; NRTI, nucleotide reverse transcriptase inhibitor; OBR, optimized background regimen; PI, protease inhibitor; RNA, ribonucleic acid. Methods PROMISE-US (CT.gov Identifier: NCT05388474) is a phase 4 multicenter, retrospective and prospective, observational, non-interventional registry study. The primary objective is to evaluate the long-term efficacy and durability of ibalizumab in combination with other ARVs by comparing the clinical outcomes of patients receiving ibalizumab treatment (Cohort 2; C2) vs. matched patients not receiving ibalizumab (Cohort 1; C1). This abstract describes the study design and baseline characteristics of the first 100 patients enrolled. Baseline is defined as the date of the latest treatment change event (the start date of ibalizumab in C2; the start date of standard of care in C1). Table 1: Baseline Characteristics PROMISE-US 2/2 *Any regimen including the two drugs and may have additional ARVs in the OBR **cGSS was calculated as per Gonzalez-Serna et al. Journal of Antimicrobial Chemotherapy, 2017, P. 496 –503, https://doi.org/10.1093/jac/dkw455. Because commercial resistance testing is not available for ibalizumab, fostemsavir, or lenacapavir, all 3 agents are always considered fully active. ***Adverse events were only collected for subjects in Cohort 2. ARV, antiretroviral; cGSS, combined genotypic sensitivity score; FTR, fostemsavir; IBA, ibalizumab; INSTI, integrase strand transfer inhibitor; LEN, lenacapavir; MVC, maraviroc; NNRTI, non-nucleotide reverse transcriptase inhibitor; NRTI, nucleotide reverse transcriptase inhibitor; OBR, optimized background regimen; PI, protease inhibitor; RNA, ribonucleic acid. Results By 8-Nov-2023, a total of 114 subjects were enrolled; 70 in 1, 44 in C2. Baseline characteristics, including race, ethnicity, sex, gender, and time since diagnosis, were well matched between both cohorts. The use of ibalizumab and the combination of ibalizumab plus lenacapavir was associated with HTE patients with higher HIV viral loads and declining CD4 T cells (p-values of 0.0629 and 0.0001, respectively, for C2 vs. C1). Combined genotypic sensitivity scores (cGSSs) were comparable between the two cohorts (Table 1). However, since commercial resistance testing is not available for all newer agents, which are considered fully active, this measure may overestimate regimen sensitivity in C2 subjects who were more likely to have these in their regimens. 80% of C2 subjects had been on ibalizumab for greater than 12 months. Ibalizumab was well-tolerated with no infusion reactions reported. Conclusion Ibalizumab was more frequently selected for use in advanced HTE patients with lower CD4 cell counts and higher viral loads than other regimens. Through better understanding of HTE patients’ treatments and long-term use of ibalizumab, this study will help further characterize the efficacy and safety profile of the agents used in combination for this population with high unmet need to help guide treatment selection. Disclosures Princy N. Kumar, MD, Gilead: Advisor/Consultant|Gilead: Grant/Research Support|Gilead: Stocks/Bonds (Public Company)|Johnson &amp; Johnson: Stocks/Bonds (Public Company)|Merck: Advisor/Consultant|Merck: Grant/Research Support|Merck: Stocks/Bonds (Public Company)|Moderna: Stocks/Bonds (Public Company)|Pfizer: Stocks/Bonds (Public Company)|Theratechnologies: Grant/Research Support|ViiV/GSK: Advisor/Consultant|ViiV/GSK: Grant/Research Support|ViiV/GSK: Stocks/Bonds (Public Company) Charlotte-Paige M. Rolle, MD, MPH, Gilead Sciences: Advisor/Consultant|Gilead Sciences: Grant/Research Support|Gilead Sciences: Honoraria|MSD: Grant/Research Support|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Grant/Research Support|ViiV Healthcare: Honoraria Brinda Emu, MD, Genentech/Roche: Advisor/Consultant|Theratechologies: Advisor/Consultant Zachary Henry, MD, gilead: Advisor/Consultant|theratechnology: Advisor/Consultant Claudia Martorell, MD, Gilead Sciences: Grant/Research Support|Theratechnologies: Grant/Research Support|ViiV: Grant/Research Support 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 R Brandon Cash, PharmD, Theratechnologies: Employee Kaitlin Anstett, PhD, Theratechnologies Inc.: Employee

P-550. Efficacy and Safety of B/F/TAF in Black Adults with HIV Who Are Treatment Naïve: 5-Year Follow-Up from Two Phase 3 Studies

Abstract Background Black communities are disproportionately affected by HIV and may have a greater lifetime risk of comorbidities compared with non-Black people with HIV (PWH). Despite this, they have historically been underrepresented in clinical studies. Here, we report efficacy and safety through 5 years of first-line therapy with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in Black PWH. Methods Studies 1489 (NCT02607930; B/F/TAF vs dolutegravir/abacavir/lamivudine [DTG/ABC/3TC]) and 1490 (NCT02607956; B/F/TAF vs DTG+F/TAF) were randomized, double-blind, multicenter, Phase 3 studies in adult PWH. This pooled analysis reports the outcomes of Black and non-Black participants who received B/F/TAF in the 144-week (W) randomization phase and the 96W open-label extension. Baseline demographics and clinical characteristics; proportion of participants with HIV-1 RNA &amp;lt; 50 copies/mL (missing=excluded); adherence; treatment-emergent adverse events (TEAEs); and changes in CD4 count and metabolic and renal parameters are presented. Results Overall, 211 (33.4%) Black and 421 (66.6%) non-Black PWH (91.0% and 54.2% from the US, respectively) received B/F/TAF up to W240. Baseline demographics and clinical characteristics are shown in the Table; 19.9% Black and 18.1% non-Black PWH had HIV-1 RNA &amp;gt; 100,000 copies/mL, 17.5% and 10.0% had CD4 &amp;lt; 200 cells/µL, and 19.4%/8.1% and 13.5%/5.0% had a history of hypertension/diabetes mellitus, respectively. At W240, high proportions of both Black (97.2%) and non-Black PWH (99.3%) had HIV-1 RNA &amp;lt; 50 copies/mL, despite Black PWH being more likely than non-Black PWH to have low (&amp;lt; 85%) adherence (11.2% vs 5.0%; P=0.0074 [Fisher’s exact test]). A smaller proportion of Black vs non-Black PWH experienced study drug–related TEAEs (20.4% vs 31.8%; P=0.0026 [Fisher’s exact test]). Changes in CD4 count, metabolic and renal parameters, and TE hypertension and diabetes were similar between groups (Table). Conclusion At Year 5, B/F/TAF maintained high rates of virologic suppression in Black PWH, despite a greater proportion of Black vs non-Black PWH having low adherence. B/F/TAF was well tolerated, with a smaller proportion of Black vs non-Black PWH with study drug–related TEAEs. These findings further support the long-term use of B/F/TAF in Black PWH. Disclosures Anson K. Wurapa, MD, Gilead: Honoraria|Gilead Sciences, Inc.: Medical writing support provided by Aspire Scientific (Bollington, UK) Jose Ramon Arribas, MD, Alexa: Advisor/Consultant|Gilead Sciences, Inc.: Advisor/Consultant|Gilead Sciences, Inc.: Expert Testimony|Gilead Sciences, Inc.: Grant/Research Support|Gilead Sciences, Inc.: Medical writing support provided by Aspire Scientific (Bollington, UK)|Janssen: Advisor/Consultant|Janssen: Expert Testimony|Lilly: Advisor/Consultant|MSD: Advisor/Consultant|MSD: Expert Testimony|Serono: Advisor/Consultant|Teva: Advisor/Consultant|ViiV: Advisor/Consultant|ViiV: Expert Testimony|ViiV: Grant/Research Support Yazdan Yazdanpanah, MD, PhD, Gilead Sciences, Inc.: Medical writing support provided by Aspire Scientific (Bollington, UK) Chloe Orkin, MBChB, FRCP, MD, AstraZeneca: Grant/Research Support|Gilead Sciences, Inc.: Grant/Research Support|Gilead Sciences, Inc.: Honoraria|Gilead Sciences, Inc.: Medical writing support provided by Aspire Scientific (Bollington, UK)|GSK: Honoraria|MSD: Honoraria|ViiV Healthcare: Grant/Research Support|ViiV Healthcare: Honoraria Hui Liu, PhD, Gilead Sciences, Inc.: Employee; Medical writing support provided by Aspire Scientific (Bollington, UK)|Gilead Sciences, Inc.: Stocks/Bonds (Private Company) Rachel Rogers, Gilead Sciences, Inc.: Employee; Medical writing support provided by Aspire Scientific (Bollington, UK)|Gilead Sciences, Inc.: Stocks/Bonds (Private Company) David Malebranche, MD, MPH, Gilead Sciences, Inc.: Employee; Medical writing support provided by Aspire Scientific (Bollington, UK)|Gilead Sciences, Inc.: Stocks/Bonds (Private Company) Jason Hindman, PharmD, MBA, Gilead Sciences, Inc.: Employee; Medical writing support provided by Aspire Scientific (Bollington, UK)|Gilead Sciences, Inc.: Stocks/Bonds (Private Company) Debbie P. Hagins, MD, FAPCR, AAHIVS, Gilead Sciences, Inc.: Medical writing support provided by Aspire Scientific (Bollington, UK)

P-582. Long-term effectiveness and tolerability of Dolutegravir/Lamivudine in Korea: 3 year follow up

Abstract Background Many studies have revealed the real-world effectiveness and tolerability of Dolutegravir/Lamivudine (DTG/3TC). However, most studies were conducted in Western countries, and data from Asian countries are still lacking; in particular, the results from long-term use have not been reported in Asian countries. As DTG/3TC has been introduced and is becoming increasingly widespread in Asia, it is necessary to investigate the maintenance rate, reasons for discontinuation, long-term effectiveness, and metabolic parameter changes. Methods We performed a retrospective cohort study with adult people with HIV treated with DTG/3TC specific combination at a tertiary hospital in Korea. Among them, those who were followed up for more than 36 months were included. Both treatment-naïve and those who switched from other antiretroviral therapies to DTG/3TC were included. Baseline characteristics, DTG/3TC maintenance rates, effectiveness, and metabolic parameters changes over 36 months were investigated. Results From July 2020 to April 2024, 305 people with HIV started DTG/3TC. Among them, 134 people with HIV followed for more than 36 months were included (16 treatment-naïve and 118 switching). Most were male (N=126, 94%), and the median age was 45.5 years. There were no cases of switching from DTG/3TC to other ARTs during the 36-month follow-up after starting DTG/3TC. All of the treatment-naïve group maintained HIV RNA &amp;lt; 50 copies/mL from 6 to 36 months after starting DTG/3TC. The rate of HIV RNA &amp;lt; 50 copies/mL at the 36 months in the switching group was 99.2% (117/118). In the treatment-naïve group, CD4 cell count increased from a median of 494 cells/uL at baseline to 795 cells/uL at 36 months (p=0.005). During the 36-month follow-up, there were no significant changes in lipid profile and body weight in both treatment-naïve and switching groups except for an increase in HDL cholesterol in the switching group (from median 45 mg/dL at baseline to median 49 mg/dL at 36-month, p=0.001). Effectiveness of Dolutegravir/Lamivudine for the treatments-naive and switching groups Conclusion In our long-term follow-up study conducted in South Korea, DTG/3TC worked effectively in viral suppression and CD4 count maintenance, and no significant adverse effects were observed on lipid profiles and body weight gain in both treatment-naïve and switching groups. Tolerability of Dolutegravir/Lamivudine for the treatments-naive and switching groups Disclosures All Authors: No reported disclosures

Influence of Screen Time on the sleep quality : A cross- sectional study on a Ayurveda college students

Background: The majority of students experience inadequate sleep, which is linked to daytime drowsiness. Long-term screen use is thought to negatively impact sleep through a variety of mechanisms. However, media devices are developing so quickly, the correlation between media device use and poor sleep is not been sufficiently evaluated. Aim: To assess the effect of the screen time on the sleep quality among college students Materials and Methods: An analytical cross-sectional study was carried out on the students of Alva’s Ayurveda Medical College and Hospital, Moodubidire using a self-administered online questionnaire through Google forms. The questionnaire covered student’s personal information, medical history, screen usage including the type of device, duration of screen use, effect of screen use on their sleep quality. Result: A total of 60 students fulfilling the inclusion criteria completed the study questionnaire. Students aged from 19-30 with the mean age of 24.19. Among those, 12 students (20 %) used screen for more than 5 hours on daily basis, 10 students (16.66 %) used screen for 4-5 hrs, 19 students (31.66 %) used screen for 3-4 hours, 17 students (28.33 %) used screen for 2-3 hrs, 2 students (3.33 %) used screen for less than 2 hours.

P-92. Risk factors, Clinical Manifestations and Management of Vertebral Osteomyelitis due to Coccidioides: a 10-year Retrospective Descriptive Study

Abstract Background Vertebral osteomyelitis is a severe manifestation of disseminated coccidioidomycosis with limited published data on clinical presentations and outcomes. The purpose of this study was to describe the epidemiology, risk factors, clinical features, management, and outcomes of coccidioidal vertebral osteomyelitis (CVO) among a cohort of patients in an endemic region. Methods We conducted a retrospective chart review of patients treated for CVO between 2013 and 2022 at an academic health system in Arizona. Demographic and clinical data were extracted. Results Forty-two patients with CVO were identified. The mean age at diagnosis was 36.3 (range, 18.9-73.2 years). Thirty-four (81%) patients were males and 33 (79%) were African American. Nine (21%) had a prior or current history of incarceration. Fifteen (36%) patients had a history of coccidioidomycosis including pulmonary (n=9), skin/musculoskeletal (n=5), and CNS infection (n=1) prior to diagnosis of CVO. Known comorbidities included long-term corticosteroid use (n=2), HIV infection (n=2), and pregnancy at time of CVO diagnosis (n=3 of 8 females). Of the 37 patients with complement fixation titers available at time of presentation, 25 patients had a titer &amp;gt;=1:128. The most frequent imaging findings identified via CT or MRI were paraspinal/epidural abscesses (n=32) or bone lytic lesions/erosions (n=32). All patients received triazole therapy, 32 (76%) received amphotericin B (median 15.5 days) at some point during their treatment course, and 4 (10%) received an investigational drug. Sixteen (38%) patients underwent surgical debridement and spinal fixation hardware was placed in 13 (31%). Thirteen (31%) patients experienced disease progression warranting re-admission. Four (10%) died within 3.5 years of diagnosis and all deaths were secondary to complications associated with CVO. Conclusion There is a high morbidity and mortality due to CVO. Most patients with CVO are African American males and few have predisposing comorbidities. A remarkably high proportion (21%) have a history of incarceration suggesting it may be a risk factor for CVO. A better understanding of the factors that predispose individuals to CVO and better therapies are urgently needed to improve outcomes in this frequently devastating illness. Disclosures Fariba Donovan, MD, PhD, F2G: Advisor/Consultant|F2G Ltd: Advisor/Consultant|F2G Ltd: Grant/Research Support|F2G Ltd: Honoraria