bluuebunny/crossref_metadata_2025 huggingface dataset:
1524. Racial and Gender Disparities in HIV Mortality: A population-based Retrospective Study in the United States from 1999 to 2020
Authors: Prince Monique A , Tan Min-Choon , Tan Min-Xuan , Prince E’ebony , Nicholas Rick , Shaaban Hamid , Slim Jihad
Published: November 2023

Background

Human Immunodeficiency Virus (HIV) has been historically associated with high mortality however, rates have declined with expanded access to antiretroviral therapy. It is important to identify and dissect inequities that contribute to mortality rates in individuals with HIV, which may help inform targeted interventions to improve treatment access in future decades. This study sought to determine the longitudinal trends in mortality attributed to HIV disease by race and sex.

Methods

We queried the Centers for Disease Control and Prevention's Wide-Ranging Online Data for Epidemiologic Research (CDC WONDER) database and performed serial cross-sectional analyses of national death certificate data for HIV-related mortality. HIV diseases (ICD-10 B20-B24, O98.7, R75) were listed as the underlying cause of death. We calculated age-adjusted mortality rates (AAMR) per 1,000,000 individuals and determined the trends over time by using the Joinpoint Regression Program. Subgroup analyses were performed by sex and race.Figure 1Demonstrates Age-Adjusted HIV Mortality Rate per 100,000

Results

In the 22-year study period, 210 921 HIV-related mortality in the United States were identified between 1999 and 2020. The AAMR from HIV-related mortality decreased significantly from 5.32 per 1,000,000 individuals in 1999 to 1.40 per 1,000,000 individuals in 2020 (p< 0.01). Overall, men recorded a higher AAMR compared to women (4.66 vs. 1.65 per 1,000,000 individuals, p< 0.01). African American individuals had the highest AAMRs (13.46 per 1,000,000 individuals) compared to White, American Indian, and Asian individuals (1.70 vs 1.65 vs 0.47 per 1,000,000 individuals). Similar decreasing trends were seen in all racial groups: African American men from 36.12 to 8.11 per 1,000,000 individuals, African American women from 13.13 to 3.54 per 1,000,000 individuals, White men from 4.91 to 1.36 per 1,000,000 individuals, and White women from 1.00 to 0.27 per 1,000,000 individuals.

Conclusion

The AAMR from HIV-related mortality has decreased significantly over the last two decades with significant racial and gender disparities. Men and African American individuals have higher AAMR from HIV-related mortality. This highlights the effectiveness of antiretroviral medications and emphasizes the need to improve the healthcare access among those underserved population.

Disclosures

Jihad Slim, MD, FACP, ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Grant/Research Support
1525. Evolving Trends in HIV Transmitted Drug Resistance in Eastern North Carolina
Authors: Reddy Srinivas , Pierce Jacob , Bian Hui , Lebron Dora
Published: November 2023

Background

The impact of HIV/AIDS worldwide is an important public health challenge. One factor that contributes to increased HIV transmission is HIV drug resistance. This occurs from the intrinsic nature of HIV to mutate and eventually replicate in the presence of antiretroviral therapy. The effects of this are development of treatment failure and further transmission amongst cohorts in a given population. The problem of propagated drug resistance is further compounded in populations that present with problems of adherence. A previous study conducted at our institution demonstrated no association with race and transmitted drug resistance.

Methods

This is a retrospective study that evaluated treatment-naive HIV patients with genotype results from 2016-2020 at East Carolina University infectious disease clinic in Greenville, NC. We collected data on age, race, sex, HIV risk factor, and genotype. A logistic regression model was fit for transmitted HIV resistance with the following covariates: age, gender, race, year, and men who have sex with men (MSM) status. Individual comparisons were made by chi-squared testing for categorical variables or Wilcox ranked sum test for non-normally distributed continuous variables. All observations are presumed to be independent. All data analysis was performed in SAS (SAS Institute Inc., SAS 9.4, Cary, NC: SAS Institute Inc., 2002-2023).

Results

Of 305 charts reviewed, 245 were included in the analysis. Twenty-six (13.7% African-Americans) versus 14 (25.9% of other races) were found with transmitted drug resistance. Twenty four (16.4%) were MSM. The years with higher transmitted drug resistance detected were 2017-2019 (18.7%, 16.5%, 17.1%, respectively). African American race was found to be protective against transmitted resistance (OR 0.46, 95% CI 0.22-0.98, p = 0.04) when adjusting for MSM status, Sex, Age, and Year. The result was also significant in the unadjusted analysis (χ2 = 4.60, p = 0.03). Non-African Americans were 2.17 times more likely to have transmitted resistance than African Americans.Table 1:Patient Characteristics. Patient characteristics presented as proportion and percentage for categorical variables and median and standard deviation for continuous variables.Table 2:Adjusted logistic regression for variable effect on transmitted antiviral resistance

Conclusion

African American race was found to be protective against transmitted resistance (OR 0.46, 95% CI 0.22-0.98, p = 0.04) when adjusting for MSM status, sex, age, and year. This is a change from the results of our previous study.

Disclosures

All Authors: No reported disclosures
1526. Hospitalized Patients with HIV – Defining the Population and the Impact of Barriers to Care
Authors: Hatlen Timothy , Reynoso Giselle A , Fetters Kirk B
Published: November 2023

Background

Hospitalized people living with HIV (PLWH) with active viremia present a unique opportunity for addressing barriers to care (BTC) and optimizing 1-year outcomes. Large-scale interventions have had limited long-term success. We aimed to evaluate the role of pre-specified BTC to viral suppression at one year to guide local interventions.

Methods

We performed a retrospective cohort study at a safety-net hospital in Los Angeles County evaluating encounters of adult PLWH admitted between 2015 - 2020. We collected demographics, clinical characteristics, and 1-year outcomes based off baseline virologic status.

Results

A total of 361 encounters involving 234 patients were reviewed. Patients viremic at baseline (n=70) were more often Black, cis-men, severely immunocompromised and 73% reported at least one BTC (Table 1, Fig 1). At 1-year follow up, patients with baseline viremia or reporting multiple BTC regardless of baseline viral status were more likely to be viremic or lost to follow up (Table 2, Fig. 2).

Population characteristics based off insurance status and baseline virologic status

Data are n (%) or median (range). Categories may not add to 100% in cases of missing data. a – Based off first encounter; b - Encounters of patients with insurance though Department of Health Services or self-pay that have ability to follow up in the safety-net system included only; c – includes data for all patient encounters; d – other diagnoses include, but not limited to, chest pain, acute coronary syndrome, heart failure, diabetes with hyperglycemia, cerebrovascular event; c – excluding patients that died or discharged on hospice care; Suppressed – HIV-1 RNA < 200 copies, ART – antiretroviral therapy; dx - diagnosis

One Year Outcomes based off Baseline Viral Status in the Insurance Linked Population

a – Encounters of patients with insurance though Department of Health Services or self-pay that have ability to follow up in the safety-net system included only; b – Chi Square suppressed versus viremic baseline; LTFU – lost to follow up; Suppressed – HIV-1 RNA < 200 copies/mm3. Viremic – HIV-1 RNA > 200 copies/mm3

Prevalence of barriers to care amongst PLWH suppressed or viremic at baseline

Conclusion

Hospitalized PLWH experiencing multiple barriers to care, regardless of baseline virologic control, are at higher risk for being viremic at 1-year and lost to follow up. These data can inform local interventions, i.e. enhanced post-discharge follow-up or social work involvement, and advocacy in this population.

LTFU – lost to follow up; 1yr – 1-year; #V – cumulative number of prespecified barriers to care. Suppressed Baseline defined as HIV-1 RNA < 200 copies/mm3

Disclosures

All Authors: No reported disclosures
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

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 > 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

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 >18 years old and prescribing for those < 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 >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 >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

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

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< 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

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 >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 >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

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

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

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

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
1562. Renal Outcomes after Switch from Oral Antiretroviral therapy (ART) to Long-acting injectable Cabotegravir/Rilpivirine (LAI CAB)
Authors: Ayala Alvaro , McNaboe Lukas , Kostka Julia , Chirch Lisa M
Published: November 2023

Background

In previous studies, patients switching from Tenofovir Disoproxil (TDF) to Long Acting Injectable (LAI) Cabotegravir/Rilpivirine demonstrated improvement in renal outcomes. Furthermore, Tenofovir Alafenamide (TAF) has shown improved renal outcomes compared TDF. In this study, we aim to compare Estimated Glomerular Filtration Rate (eGFR) changes in patients who switched from Integrase Inhibitors (INSTI), with and without a TAF based regimen oral therapy, to LAI.

Methods

Demographics, previous antiretroviral therapy regimen, and clinical parameters were collected at the initiation of LAI (T0), 2 months (T1), 6 months (T2), and 12 months before and after the switch to LAI. Patients who remained on TAF-containing regimens only were compared to patients who switched to LAI after they were previously on TAF. eGFR using CKD epi formula was utilized in order to compare these groups. A multiple linear regression adjusted for variables impacting renal outcomes was performed for all patients, and patients previously on TAF.

Results

A total of 22 patients on LAI and 44 on oral INSTI-based regimens were included. There was a difference in age for those who switched to LAI compared to those who remained on oral therapy (Table 1). Demographic data for patients previously on TAF is shown in Table 2. There was no significant difference between eGFR in all patients and the TAF subgroup who switched to LAI at 2 months, 6 months, and 12 months respectively, (Figure 1 & 2). When adjusting for other variables, there was no significant change in eGFR between LAI vs oral in both overall and TAF groups at 12 months, (Tables 3 & 4).

Conclusion

In this retrospective study, there was no significant change in eGFR between patients starting on LAI and those who continued on an oral regimen with and without TAF. Further real-world data assessment for long-term renal outcomes in patients on LAI is needed.

Disclosures

All Authors: No reported disclosures
1565. Antiretroviral Stewardship: Protocol Development and Implementation at an Academic Medical Center.
Authors: Bylsma Tara , Grossman Katlyn , Vindenes Tine
Published: November 2023

Background

1.2 million people are living with HIV (PLWH) in the USA. As this population grows older (47% of PLWH were over age 50 in 2018) and more medically complex, the risk of medication errors increases. This population has not been prioritized for stewardship efforts, but experts have called for ARV stewardship programs to be developed. We developed a protocol to systematically review patients on ARVs during inpatient admissions to reduce and prevent medication errors, improve patient safety, and improve equity of care for PLWH.

Methods

We implemented a pharmacist-driven intervention over a 3-month period and compared it to usual practice in the 3 months prior to launch. Patients with active ARV prescriptions were identified using a novel automated patient report generated within the EMR. Then, a pharmacist reviewed the ARV regimen and opportunistic infection prophylaxis for accuracy, completeness, potential DDIs or administration issues. A standardized consult note was developed to communicate pharmacist recommendations to the care team.

We evaluated qualitative features of the ARV-related interventions and calculated the proportion of hospital days with and without medication errors.

Results

The baseline period included 52 patients with an average age of 52 years and LOS of 6.6 days. The intervention period included 60 patients with an average age of 53 years and LOS of 5.4 days. During the intervention, automated pharmacy review led to medication intervention on 49% of patients, compared with 36% of patients in the baseline period. Similarly, the average time to pharmacy intervention decreased from 3 days after admission in the baseline period to 2.5 days in the intervention period.

The most common interventions were resuming an ARV regimen and management of DDIs. The most common clinical rationales for interventions were DDIs, acute changes in renal function, and non-formulary medication restrictions.

Automated patient identification and pharmacist review reduced the prevalence of medication errors related to ART from 17% of inpatient days to 2% of inpatient days.

Conclusion

There is a need for ARV stewardship. Expanding, automating, and standardizing these capabilities improved patient safety by reducing medication errors and improving continuity of care in the inpatient setting.

Disclosures

All Authors: No reported disclosures
1573. Viral Blips While on Antiretroviral Therapy are Associated with Virologic Failure
Authors: Fleit Madeline , Hsieh Hsing-Chuan , Colombo Rhonda , Schofield Christina , Berjohn Catherine , Lalani Tahaniyat , Blaylock Jason , Yabes Joseph , Joya Christie , Ewers Evan , Crowell Trevor A , Chu Xiuping , Agan Brian , Ganesan Anuradha
Published: November 2023

Background

Blips in HIV viral load (VL) while on antiretroviral therapy (ART) are of unclear clinical significance. In this study, we examined the association between blips and virologic failure (VF).

Methods

We used data from the US Military HIV Natural History Study (NHS) cohort. Included participants were diagnosed with HIV after 2006, had been on ART for ≥ 6months, and had ≥3 VLs recorded and measured using an assay with a lower limit of detection of < 50 copies/mL. VF was defined as two consecutive VLs ≥ 200 copies/mL spanning 90 days or a single VL ≥1000 copies/mL. Blips were defined as VL of 51-999 copies/mL, that were preceded and followed by a VL ≤ 50 copies/mL and were differentiated by magnitude as low-level (VL 51-199 copies/mL) or high-level (200-999 copies/mL). Detectable VLs that did not meet criteria for VF or blips were grouped as low-level viremia (LLV; 51-199 copies/mL), and higher low-level viremia (hLLV; 200-999 copies/mL). Cox proportional hazards models adjusted for demographic characteristics, time updated CD4 counts, ART, and viral load were used. Hazard ratios and 95% confidence intervals are presented.

Results

A total of 988 participants (median age 34.1 years, 96.7% male, 41.7% African American) were included, of which 55 (5.6%) experienced VF (Table 1). While 191 participants (19.3%) experienced blips, it was the highest VL status in 146 (14.8%) (Table 2). Having blips and low-level viremia was associated with increasing hazard of VF, graded by type and level of viremia (low-level blip 1.86 [1.10 – 3.14]; high-level blip 3.56 [1.13 – 11.18]; LLV 4.10 [3.06-5.51]; hLLV 10.51 [6.28-17.61]. Other factors associated with VF were African American race and higher VL at ART initiation. Whereas higher CD4 counts, and use of integrase strand transfer inhibitors (relative to Non-Nucleoside Reverse Transcriptase inhibitors) were protective (Table 3).

Conclusion

Detectable viremia, including blips, are associated with an increased risk of VF. The magnitude of the viremia appears important with dose-response-type impact (i.e., viral loads >200 copies/mL having a greater hazard of VF). These findings suggest that individuals with viral blips at a minimum should undergo evaluation for medication adherence and may benefit from more frequent VL monitoring.

Disclosures

All Authors: No reported disclosures
1586. Impact of Dolutegravir-based Regimen on Metabolic Syndrome and its Components in Adults with HIV in Care at Hospital Roosevelt in Guatemala City
Authors: Farfán Alvaro J Mazariegos , Marroquin Hugo , Ortiz Dean , Parra-Rodriguez Luis , Spec Andrej , Meléndez Johanna , Pinzón Rodolfo , Samayoa Johanna , Mejia-Chew Carlos , O’Halloran Jane
Published: November 2023

Background

Integrase inhibitors (INSTI) are associated with weight gain, elevated glucose and lipid changes. Use of the INSTI dolutegravir (DTG) is increasing in Latin America. We assessed the impact of DTG switch on Metabolic Syndrome (MetS) and its components in people with HIV (PWH) in Guatemala.

Methods

Participants with an HIV RNA < 1000 copies/ml on non-INSTI antiretroviral therapy (ART) for > 6 months who had a study visit between June 2019 and March 2020, and had complete data on MetS criteria were followed prospectively until May 2022. Those who switched to DTG-based regimen during follow up were compared to those who remained on a non-INSTI regimen. Switch participants were required to have remained on DTG for one year. We used the Latin American Diabetes Association criteria for MetS and cut-offs for waist circumference. Rates of MetS and its components were calculated at baseline and follow-up. Covariates included sex, residence, ethnicity, CD4 count, BMI, and ART. Significant covariates (p < 0.05) were included in multivariable logistic regression analyses.

Results

Of 258 participants included, 82% were on efavirenz-based regimens at baseline, 52% switched to DTG (median DTG exposure of 17.5 months, interquartile range [IQR] 14.7-21.7). Overall, 91.5% remained on the same ART backbone. The MetS rate was 29.5% at baseline, and there was no between-group difference in MetS and its components. The non-switch group had a greater proportion of females, indigenous ethnicity, and a higher BMI (Table 1). MetS rate was 39.5% at follow-up (+7.4% switch group vs +13% non-switch group; p=0.39). On multivariable analysis there was no association between DTG switch and MetS (aOR 0.93; IC 0.52,1.6; p=0.78). Participants that switched to DTG were less likely to meet hypertriglyceridemia criteria (aOR 0.53; IC 0.38, 0.90; p=0.02), and more likely to meet HDL cholesterol criteria (aOR 1.93; IC 1.1,3.3; p=0.02) (Table 2).

Conclusion

Overall, MetS increased substantially in the follow-up period in PWH in Guatemala. We found no association between DTG switch and increased MetS. Although hypertriglyceridemia improved following DTG-switch, the potential beneficial effect might be offset by a greater reduction in HDL cholesterol, highlighting the importance of examining individual components of MetS in PWH.

Disclosures

Carlos Mejia-Chew, MD, INSMED: Grant/Research Support|RevImmune: Grant/Research Support
1591. Real-world experiences and outcomes implementing long-acting cabotegravir/rilpivirine at a Ryan White HIV/AIDS Program (RWHAP)-funded clinic in South Florida
Authors: Montalvo Sheila , Sherman Elizabeth , Eckardt Paula A , Bromberg Romina , Poon Kenneth K , Van Ostran Garrett , Cano Cevallos Edison , Savage Angela
Published: November 2023

Background

Long-acting (LA) cabotegravir/rilpivirine (CAB/RPV) may simplify antiretroviral therapy (ART), improve adherence, and reduce pill stigma for people with HIV (PWH). However, real-world implementation is challenged by various barriers. We describe an integrated LA CAB/RPV workflow and the clinical characteristics and outcomes of PWH referred for and initiated on CAB/RPV in a Ryan White HIV/AIDS Program-funded clinic in South Florida (serving more than 1600 PWH).

Methods

The clinic engaged an interdisciplinary team (MD/APRN, PharmDs, RNs) to develop and maintain an infrastructure required to transition virologically suppressed (HIV RNA < 50 copies/mL) PWH from oral ART to LA CAB/RPV (Figure 1). MD/APRN referred pre-screened and interested PWH to PharmDs for eligibility evaluation, medication counseling, and drug acquisition. RNs administered injections, scheduled and tracked clinic appointments to ensure on-time injections, and ordered appropriate labs. PWH followed up with MD/APRN every 4 months to ensure efficacy and safety.

Results

Between January 2022 and March 2023, 83 PWH were referred to PharmDs for initiation of LA CAB/RPV and 30 (36%) initiated LA CAB/RPV. Those not initiated on LA CAB/RPV included those who declined to start (e.g., patient concerns over side effects, convenience) (n=23), clinician adherence concerns (n=9), insurance denial (n=7), and baseline resistance (n=7). Payor source for LA CAB/RPV included 40% RWHAP, 36% private, and 24% Medicare/Medicaid. For those initiated on LA CAB/RPV (Table 1), we observed a mean turnaround time of 23 days from PharmD eligibility evaluation to the first injections. Three PWH discontinued LA CAB/RPV: 2 due to side effects and 1 due to pregnancy. Five PWH experienced low-level viremia (HIV RNA < 200 copies/mL) following the switch, all others maintained viral suppression.

Conclusion

A large number of eligible and interested PWH referred for LA CAB/RPV did not initiate the drug. Those who initiated CAB/RPV tolerated the drug well and maintained viral suppression. Implementation of LA CAB/RPV is enhanced by an interdisciplinary team to provide services, optimize workflows, and maintain infrastructure needed for a successful program.

Disclosures

All Authors: No reported disclosures
1593. Switch to DOVATO in Patients Suppressed on Biktarvy (The SOUND Study), week 48 interim analysis
Authors: Slim Jihad , Fallon James , Abouzeid Wassim , Fadoju-Oloyede Helen , Shafiq Amtus , Muhanna Ala
Published: November 2023

Background

Dolutegravir/lamivudine(DTG/3TC) is a complete regimen, approved by the FDA for the treatment of HIV-1 infection in treatment-naïve or virologically suppressed patients with no prior virologic failure or resistance to DTG/3TC. The SOUND study evaluated virologically suppressed (< 50 copies/ml for >6 months) patients on bictegravir/emtricitabine/tenofovir alafenamide(B/F/TAF) for >24 weeks, with an unknown HIV resistance history who were switched to DTG/3TC.

Methods

SOUND recruited patients from urban clinics in the Northeastern U.S. serving predominately African American or Latinx communities is a prospective open-label, single-center, pilot study with the primary endpoint % of patients with HIV-1 VL ≥ 50 copies/mL at week 48; Secondary endpoints at weeks 48 and 96 include percentage of patients with HIV-1 VL < 50 copies/mL, incidence and severity of adverse events (AEs) and laboratory abnormalities, retrospective pro-viral DNA testing on banked samples at baseline to compare virologic outcome (with or without M184V/I), number and type of resistance-associated mutations in virologic failure.

Results

We enrolled 40 patients suppressed on B/F/TAF, 18 (45%) female, 23 (57.5%) Black, mean time on B/F/TAF 2.75 years (range: 1 – 3.6), mean time since HIV diagnosis 16.4 years (range: 1.2 – 36), mean number of prior antiretroviral regimen before entering the study 5 (range 1 – 14), baseline CD4: 681 cells/ml (range:372-1044). Nadir CD4 mean: 364(range:13-734). At week 48, 37 (92.5%) patients were virologically suppressed. Three patients withdrew informed consent and were virologically suppressed at the time of discontinuation. Five patients experienced serious adverse events none were related to study medications, and no one stopped DTG/3TC due to AE.

Conclusion

This pilot study supports the switch to DTG/3TC in patients virologically suppressed on B/F/TAF, with unknown resistance history.

Disclosures

Jihad Slim, MD, FACP, ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Grant/Research Support