bluuebunny/crossref_metadata_2025_split huggingface dataset:
1531. Early Real-World Experience of Long-Acting Cabotegravir (CAB) for HIV Pre-Exposure Prophylaxis (PrEP) in a Large Community-Based Clinic Network (CAN Community Health): Utilization and PrEP Persistence
Authors: Altamirano Jessica A , Shukla Prerak , Barnett Steven K 
Published: November 2023

Abstract

Background
Cabotegravir (CAB) is the first long-acting injectable form of HIV pre-exposure prophylaxis (PrEP) approved by the FDA on December 20, 2021. We assessed real-world utilization and adherence to Cabotegravir for PrEP in an outpatient community-based network in the United States (US).

Methods
Electronic medical records were retrospectively reviewed from the CAN Community Health Network of 26 outpatient clinics across six US states to identify HIV-negative persons who received a prescription or injection for CAB for PrEP between December 2021 and April 2023. Demographics including age, race, ethnicity, sex assigned at birth, gender identity and sexual orientation were collected. Two groups were assessed: 1) those who received ≥ 1 Cabotegravir injection following a prescription and 2) those who were prescribed but never received any Cabotegravir injections. Rate of switching from oral PrEP to CAB injections, persistence and discontinuation of CAB injections were studied as well as HIV seroconversion. Discontinuation was defined as either a switch back to oral PrEP or being &gt; 67 days from last CAB injection.

Results
There were 293 HIV-negative individuals prescribed CAB for PrEP with median age of 36 years, 239 male and 54 female sex assigned at birth; 167 same-sex, 53 heterosexual, 48 bisexual; 97 White Non-Hispanics, 86 Black Non-Hispanics, 60 White Hispanics (Tables 1 & 2). There were 155 (52.9%) HIV-negative individuals who were prescribed CAB for PrEP with ≥ 1 injections received. Of these, 126 individuals (81.3%) demonstrated PrEP persistence and no seroconversions. Discontinuation rate was 29 (18.7%) (Table 2). Reasons for discontinuation and switch back to oral PrEP were insurance coverage gaps or cost of copay (7), side effects (6), conflicts with work schedule (2), not documented (1).
Table 1
Table 2
Table 3

Conclusion
Individuals prescribed Cabotegravir for PrEP reflected a diverse population. However, only 52.9% of prescriptions for Cabotegravir for PrEP resulted in at least one injection administered indicating limitations in use and access to injectable CAB for PrEP.
Those who did initiate CAB for PrEP showed a significant PrEP persistence percentage (81.3%) with an 18.7% rate of discontinuation attributed to insurance coverage gaps or side effects and less commonly conflicts with work schedule.

Disclosures
Jessica A. Altamirano, MD, Janssen Pharmaceuticals: Speaker's Bureau
1533. The First Ten Years of HIV Preexposure Prophylaxis Use and Missed Opportunities at an Urban Academic Children’s Hospital
Authors: Christian Elizabeth , Thomas Sanya , Ganapathi Lakshmi , Krakower Douglas 
Published: November 2023

Abstract

Background
HIV preexposure prophylaxis (PrEP) is underprescribed in adolescents, with ∼16% of PrEP-eligible youth receiving prescriptions in 2019. We analyzed trends in PrEP prescribing and quality of care in adolescents at the largest academic pediatric hospital in New England to inform strategies to improve HIV prevention in this group.

Methods
We reviewed charts of all patients prescribed PrEP at Boston Children’s Hospital between July 2012-December 2021 and extracted demographics, lab results and details of PrEP discussions. We extracted data on all patients with new HIV diagnoses to identify missed opportunities for PrEP.

Results
From 2015-2021, 54 patients were prescribed PrEP; none were during 2012-2014. Prescriptions increased annually except for 2020, coinciding with the COVID-19 pandemic. Most PrEP patients (87%) were &gt;18 years old and prescribing for those &lt; 18 years old remained rare despite regulatory approval for this age-range in 2018 (Fig. 1).
Of the 54 PrEP patients,16% never initiated, 28% discontinued within 6 months, 31% had multiple short (median 3.5 months) periods of use, and 13% started once and continued for &gt;6 months (median 12 months, range 7-36 months). (Fig. 2) The most common reason for discontinuing PrEP was loss to follow up (Fig. 3).
Patients initiated PrEP discussions in 78% of cases, and half of PrEP prescriptions were same day starts. Most patients accessed PrEP through adolescent (81%) or gender speciality (11%) clinics with only 4% through General Pediatrics. Nearly all patients (98%) had baseline HIV and Hepatitis B testing; of 41 patients using PrEP for &gt;3 months, all had follow up HIV tests within 4 months.
Of 22 patients newly diagnosed with HIV, none had taken PrEP. The majority of HIV diagnoses were made during routine screening (68%); three were diagnosed at pre-PrEP screening. Most diagnoses (68%) were made by generalists.Figure 1:Number of Patients Prescribed PrEP per YearFigure 2:Duration of PrEP UseFigure 3:Reasons for PrEP Discontinuation

Conclusion
Only 54 patients were prescribed PrEP during the past decade at a large pediatric hospital despite 22 new HIV diagnoses in this period. Non-initiations or discontinuations were common, suggesting a need for strategies to improve PrEP provision and persistence. With youth initiating most PrEP discussions, strategies to engage providers in PrEP are needed, in particular among generalists where most new HIV diagnoses occurred.

Disclosures
Douglas Krakower, MD, Gilead: Grant/Research Support|Merck: Grant/Research Support|U. North Texas Health Sciences Center: Funding for mentoring|UAB: Advisor/Consultant|UpToDate, Inc.: Royalties|Virology Education: Honoraria
1535. Persistence With Human Immunodeficiency Virus Pre-exposure Prophylaxis in an Active-Duty Military Population
Authors: Colver Jacob T , Yabes Joseph , Marcus Joseph 
Published: November 2023

Abstract

Background
There is limited data on Human Immunodeficiency Virus Pre-exposure Prophylaxis (PrEP) use and persistence in the military. Despite universal access to care, there is concern that PrEP persistence may be lower in military populations due to frequent deployments, need for relocations, and perceived stigma. This study evaluated the persistence rates as well as reasons for PrEP discontinuation in a military cohort.

Methods
The Brooke Army Medical Center Infectious Diseases clinic provides PrEP to service members at Joint Base San Antonio. This study evaluated all active-duty service members who received PrEP between 2020-2022. All charts were examined to determine patient demographics and years on PrEP. If a patient stopped PrEP, they were contacted to determine etiology of discontinuation and invited to restart PrEP.

Results
In total, 112 service members received PrEP during the study period. The cohort was predominantly male (99%) with median age 30 [IQR: 26-34] and a median of 2 years [IQR: 0-3] receiving PrEP (Table 1). The most common indication was multiple sexual partners with less than 100% condom use (n=98, 88%). At the end of the study, most (n=88, 79%) patients were still receiving PrEP including 33 (37%) at other military or civilian facilities. Of the 24 service members who were no longer receiving PrEP, 18 (75%), were able to be contacted (Table 2). Two (1%) patients seroconverted while off PrEP with reasons for discontinuation being abstinence and difficulty making appointments. No patients contacted during this study were interested in restarting PrEP.
Demographic Information of 112 Active-Duty Service Members Receiving PrEP at Brooke Army Medical Center 2020-2022
Reasons for PrEP Discontinuation at Brooke Army Medical Center 2020-2022

Conclusion
This is the first study to evaluate PrEP persistence in an active-duty population. In this cohort with universal access to care, PrEP persistence rates and years receiving PrEP were greater than seen in other populations. While the most common reason for discontinuation was changes in sexual behavior, systemic factors still contributed to PrEP discontinuation. Future studies should elucidate the challenges to PrEP care in the military.

Disclosures
All Authors: No reported disclosures
1539. Presence of mental health concerns is associated with poor adherence in people taking pre-exposure prophylaxis in real-world clinical practice in the United States
Authors: Hennessy Fritha , Turner Libby , Higgins Victoria , Piercy James , Holbrook Tim 
Published: November 2023

Abstract

Background
Pre-exposure prophylaxis (PrEP) is used to prevent HIV acquisition and is up to 99% effective when users are fully adherent. Research has shown an inverse relationship between mental health difficulties and PrEP adherence. This analysis aims to understand the real-world impact of mental health on PrEP adherence in the United States (US).

Methods
Data were drawn from the Adelphi PrEP Disease Specific Programme™, a real-world, study with retrospective clinical data and cross-sectional PROs conducted August 2021-March 2022 in the US. Physicians provided data on patient demographics, satisfaction, components of mental health including anxiety/depression and PrEP adherence. Current PrEP users (PU) provided data on satisfaction and adherence via the Adelphi Adherence Questionnaire (ADAQ), scored from 0 to 4 where lower scores indicate greater adherence. Analyses of variance and descriptive analyses were performed.

Results
PU (n=196) were categorized as having no (nMH, n=108), mild (mMH, n=44), or moderate/severe mental health problems (sMH, n=26). Anxiety (38.6% mMH, 32.3% sMH) and depression (25.0% mMH, 61.5% sMH) were the most common mental health-related comorbidities (physician-stated). PU with sMH had significantly poorer patient-reported adherence than nMH (ADAQ mean [standard deviation] nMH, 0.29 [0.54]; mMH 0.64 [0.59]; sMH 0.78 [0.6]; p&lt; 0.01). The most common reason for poor adherence was forgetting to take PrEP (27.3% nMH; 21.9% mMH; 50.0% sMH; physician stated). A higher percentage of PU with sMH were dissatisfied with the ease of use of their PrEP than PU with nMH (Fig 1A), a lower percentage of PU with sMH felt PrEP was easy to access than PU with nMH (Fig 1B). PU stated drivers of poor adherence included forgetfulness, not being in usual routine, stigma (Fig 2), particularly in PU with sMH.

Conclusion
Poorer mental health was associated with lower PrEP adherence, and was a barrier to effective use. Reasons for poor adherence are multi-factorial and not just related to forgetting to take PrEP. Development of PrEP that is easier to use and easier to access will benefit all PrEP users, particularly for people identified as having poorer mental health.

Disclosures
James Piercy, MSc, Adelphi: Salaried Employee
1546. Relationship between Measured Glomerular Filtration Rate and Tenofovir Dried Blood Spot Concentrations among Transgender Adults on Tenofovir Alafenamide/Emtricitabine for Pre-Exposure Prophylaxis
Authors: Patel Nimish , Awdishu Linda , Burke Leah , Morris Sheldon 
Published: November 2023

Abstract

Background
Kidney function can alter drug clearance. This is pertinent for tenofovir-based pre-exposure prophylaxis (PrEP) regimens where drug concentrations confer protection against HIV. Among transgender (TG) individuals whose kidney function is dynamic due to use of gender affirming therapy (GAT), it is unclear if there is a relationship between tenofovir diphosphate dried blood spots (TFV-DP DBS) and direct measures of glomerular filtration rate (mGFR) The objective of this study was to quantify this relationship and compare if mGFR differs between TG persons with perfect/imperfect adherence to tenofovir alafenamide/emtricitabine (TAF/FTC).

Methods
A prospective cohort study was performed among TG individuals on TAF/FTC for PrEP. Inclusion criteria were age ≥18 years old, TG identity, HIV negative, use of PrEP for ≥12 weeks, and willing to receive iohexol for direct measurement of GFR. TFV DBS concentrations were evaluated after being on ≥12 weeks of TAF/FTC. Perfect adherence to TAF/FTC was defined as a TFV-DP DBS of &gt;1800fmol/punch (Yager et al, PMID: 32539288). Iohexol clearance was used for mGFR by subcutaneously administering 0.5ml iohexol. Plasma iohexol concentrations were assayed 3h post-injection. Pearson’s correlation coefficients were computed to quantify the relationship between TFV-DP DBS and iohexol clearance. Median iohexol clearances were compared between those with perfect/imperfect adherence.

Results
Among the 28 individuals included, median (interquartile range, IQR) age was 33.0 (26.3 – 36.8) years. Three quarters were on GAT and over two thirds (67.9%) were assigned male at birth (AMAB). Median (interquartile range, IQR) iohexol clearance and TFV-DP DBS concentrations were 76 (65 – 95)ml/min and 2611 (2114 – 3240), respectively. There was no significant correlation between TFV-DP DBS and iohexol clearance (r2=0.10, 95% confidence interval, CI: -0.29 – 0.45, p=0.62). TFV-DP DBS &gt;1800fmol/punch (perfect adherence) was observed in 22 participants. Median (95% CI) iohexol clearance between those with and without perfect adherence did not reach significance: 78 (68-96) vs 69 (60-83)mL/min, respectively (p=0.26).

Conclusion
No significant relationship was observed between iohexol clearance and TFV-DP DBS among TG individuals taking TAF/FTC for PrEP.

Disclosures
Sheldon Morris, MD, Gilead: Grant/Research Support
1548. Evaluation of rural HIV screening in adults with one or more risk factors
Authors: Pilcher Finlay , Stedman Eleanor , Tompkins Bradley , Hale Andrew , Singh Devika 
Published: November 2023

Abstract

Background
The National HIV/AIDS Strategy aims to end the HIV epidemic in the United States by 2030. However, despite significant medical advances in HIV prevention (specifically treatment as prevention), transmission without knowledge of HIV status remains a significant barrier to reducing new infections. Developing effective and equitable HIV screening methods is an essential step towards HIV elimination.
Individuals residing in rural settings across the U.S. have limited access to HIV-literate providers due to complex and multifactorial barriers including long travel distances to appointments, fewer community support resources, and scarcity of specialized HIV care providers. The opt-out approach to HIV screening may be insufficient to adequately reach people living in rural communities, particularly those with elevated risk of HIV transmission.

Methods
Our study used Vermont-specific data from the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance System (BRFSS) surveys from 2010 to 2012 and 2016 to 2019. We included participants who responded to three questions in the HIV/AIDS section of the BRFSS. BRFSS surveys from 2013 to 2015 omitted one of the three questions and therefore were excluded from the study.
Participants were assigned either a low- or high-risk category based on a question which asked whether they engaged in certain behaviors associated with HIV transmission (e.g., intravenous drug use, condomless anal sex, etc.) over the past year. HIV screening was considered adequate for participants in the low-risk category if they had one or more lifetime HIV test. Participants in the high-risk category were deemed adequately screened if they had been tested for HIV in the past year.

Results
The results of the analysis are shown in Table 1. Pearson’s chi-squared value (χ2) was 5.1 with an associated p-value = 0.024 suggesting that the percentage of adequate screening varies significantly with HIV risk category.

Conclusion
Our results suggest that HIV screening remains suboptimal in Vermont, particularly for those at increased risk of transmission. These findings indicate that more inclusive and expansive strategies including targeted HIV screening may be warranted in rural regions.

Disclosures
All Authors: No reported disclosures
1551. Changes in Glomerular Filtration Rate after Switching from Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide Fumarate for HIV Pre-exposure Prophylaxis
Authors: Rivera Adovich , Mefford Matthew , Pak Katherine J , Hechter Rulin C 
Published: November 2023

Abstract

Background
In October 2019, tenofovir alafenamide fumarate (TAF) was approved for oral pre-exposure prophylaxis (PrEP) for preventing human immunodeficiency virus (HIV) infection. Compared with tenofovir disoproxil fumarate (TDF), TAF-containing regimens have demonstrated high efficacy and favorable changes in markers of renal function in randomized trials. While switching from TDF to TAF has been associated with improved renal function in people with HIV, this has not been assessed in the context of PrEP. Using electronic health records data from Kaiser Permanente Southern California (KPSC), we assessed changes in estimated glomerular filtration rate (eGFR) after switching from TDF to TAF.

Methods
In this retrospective cohort study, KPSC members aged ≥18 years who filled a prescription of TDF for PrEP from October 2019-May 2022 were identified. Eligible individuals (Figure 1) who switched from TDF to TAF use during the study period were matched to 4 TDF users who did not switch at the switching date (index date) using time-varying propensity scores. A Bayesian linear mixed effects model was used to estimate differences in eGFR between switching and non-switching scenarios (i.e., “What would have happened to the eGFR if the switchers in the data did not switch?”) up to 18 months of follow-up. The model included spline terms for time and were adjusted for baseline eGFR and potential confounders. (Figure 2).Figure 1.Eligibility criteriaFigure 2.Steps in Creation and Analysis of the Matched Cohort

Results
Among 5,250 eligible TDF users, 125 switched to TAF during follow-up. A total of 118 TDF to TAF switchers and 472 matched non-switchers were included in the analysis. Compared to non-switchers, switchers had similar baseline weight, lower baseline eGFR, but were more likely to be older age, White, on Medicare or Medicaid, and have hypertension. (Figure 3) Switching to TAF was associated with a higher eGFR compared to staying on TDF in 3-15 months post-switch, but 95% credible intervals cross the null. (Figure 4 and 5) The findings remained similar after excluding eGFR values after TAF switcher switched back to TDF or non-switcher started TAF. (Figure 5)
Figure 3. Comparison of Baseline Characteristics of TDF to TAF Switcher to Matched Non-Switchers. Figure 4. Distribution of Estimated Differences in Estimated Glomerular Filtration Rate between Two Scenarios at Selected Time Points: Switching from TDF to TAF compared to Staying on TDF (Not Switching) Figure 5. Median Estimated Difference in estimated Glomerular Filtration Rate using Full and Limited Data

Conclusion
We found that switching from TDF to TAF may translate to a slightly better eGFR trajectory in the short term, but the difference might not be clinically important. Confirmation with larger datasets or randomized trials are important.

Disclosures
Matthew Mefford, PhD, Merck & Co., Inc.: Grant/Research Support
1555. Evaluating Pre-exposure Prophylaxis Use in a Large Integrated Rural US Health System
Authors: Tabliago Nikko Rowe A , Lowe Robert B , Gowtham Swathi , McBride Darrell 
Published: November 2023

Abstract

Background
The purpose of this analysis was to evaluate pre-exposure prophylaxis (PrEP) use in high-risk patients across a rural health system to establish system-wide interventions for target clinics to improve providers’ knowledge and comfort regarding HIV screening and PrEP provision.

Methods
Retrospective database review was done on total sample of 202,169 participants between the ages of 15 and 40 years, who were seen by a primary care provider (PCP) between November 1st, 2017 and December 31st, 2021. 201,423 participants met inclusion criteria as participants with active HIV and Hepatitis B infections were excluded. High-risk was defined as meeting any of the following criteria: behavioral attributes [multiple partners, men who have sex with men (MSM), and IV drug use], medication use (including prescriptions of ceftriaxone, penicillin and/or azithromycin for STI treatment), positive sexually transmitted infection (STI) test (syphilis, gonorrhea, chlamydia, and trichomoniasis), tested for STIs more than twice and/or tested for HIV more than twice.

Results
Amongst the 201,423 patients, 13.4% (n = 26,972) of the population were identified as high-risk and 174,451 were not considered high-risk. Of the 26,972 patients, only 205 (0.76%) received a PrEP prescription. Those who met the high-risk criteria, were more likely to be female, Black or African American by race, and Hispanic or Latinx by ethnicity. Of those who met the high-risk criteria for PrEP and who received the prescription, they were more likely to be male, MSM, had multiple sexual partners, those that were tested for hepatitis C, hepatitis B, syphilis and HIV infections. Only 2 patients who received PrEP used IV drugs.

Conclusion
Evaluation of the prescribing practices of PCPs in a large integrated rural health system revealed a large opportunity for meaningful change as only 0.76% of those who met high-risk criteria for HIV acquisition were prescribed PrEP. This study shows that in the setting of a PrEP desert, much needs to be done in the education of providers and communities regarding PrEP use. Unless these urban-rural disparities in PrEP use are addressed, ending the HIV epidemic initiative in the US will not be successful.

Disclosures
All Authors: No reported disclosures
1560. Factors Driving Decisions in the use of HIV Pre-Exposure Prophylaxis: Data from a Real-World Study in the United States
Authors: Whiteside Yohance , McMillan Abigail , Hennessy Fritha , Salmon Phoebe , Holbrook Tim , Tadese Bekana K 
Published: November 2023

Abstract

Background
Although pre-exposure prophylaxis (PrEP) is recommended for people at risk of acquiring HIV, usage remains low. Our study used real-world data to characterise the factors driving decision-making in PrEP use, among current PrEP users (PU) and at-risk non-users (NU).

Methods
Data were drawn from the Adelphi PrEP Disease Specific Programme (DSP)™, a real-world, cross-sectional survey of PU, NU, and physicians in the United States between December 2021 and June 2022. PU, NU, and physicians completed distinct questionnaires. Physicians (n=61) reported demographic data and PrEP usage for next 8 PU and 2 NU. These individuals were invited to complete a questionnaire reporting reasons for/against PrEP use (PU n=196; NU n=38).

Results
Mean age [SD] of PU (n=480) and NU (n=121) was 35.3 [10.8] and 32.5 [10.8] years, respectively. Majority were male (PU 87%; NU 79%) and men who have sex with men (MSM) (PU 75%, NU 62%). Overall, 90% PU were taking PrEP daily and reported fear of contracting HIV (79%) and at-risk behaviours as major drivers for PrEP usage (Figure 1). Physicians reported that of the NU who chose not to start PrEP, 49% stated this was due to not wanting long-term medication (Figure 2). PrEP stigma was a concern for both PU (50%) and NU (65%).

Conclusion
This study provides data on unmet needs and potential drivers for PrEP uptake from the healthcare provider, PU and NU perspectives. Understanding factors that influence the decision to use PrEP may highlight the attributes needed in new products to increase uptake.

Disclosures
Yohance Whiteside, PhD, MSPH, Merck & Co., Inc: Employee|Merck & Co., Inc: Stocks/Bonds Bekana K. Tadese, PhD, MPH, Merck and Co Inc: Employee