bluuebunny/crossref_metadata_2025_split huggingface dataset:
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

Abstract

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

Abstract

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

Abstract

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 &lt; 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 &gt;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

Abstract

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 &lt; 1000 copies/ml on non-INSTI antiretroviral therapy (ART) for &gt; 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 &lt; 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

Abstract

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 &lt; 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 &lt; 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

Abstract

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 (&lt; 50 copies/ml for &gt;6 months) patients on bictegravir/emtricitabine/tenofovir alafenamide(B/F/TAF) for &gt;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 &lt; 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
1599. Real-World Efficacy of Long-Acting Cabotegravir and Rilpivirine in an Urban HIV Clinic
Authors: Perez Sarah , Petersen Elizabeth , Huhn Gregory 
Published: November 2023

Abstract

Background
Long-Acting cabotegravir/rilpivirine (LA-CAB/RPV) is the first FDA-approved, complete, long-acting injectable antiretroviral therapy (ART) regimen. In clinical trials, LA-CAB/RPV has proven to be highly effective in maintaining virologic suppression in people living with HIV (PLWH) with virologic suppression, on a stable ART regimen, and no resistance to either agent. There is limited published real-world data regarding the efficacy, adherence, and discontinuation rates of LA-CAB/RPV, especially in populations underrepresented or excluded from clinical trials. The purpose of this study is to evaluate the real-world efficacy of LA-CAB/RPV in achieving and maintaining virologic suppression in PLWH.

Methods
We conducted a single-center retrospective chart review of HIV-1 positive adults receiving care at the Ruth M. Rothstein CORE Center, a safety-net system in Chicago. Patients were included if they received at least one dose of LA-CAB/RPV between January 1, 2022 and October 31, 2022.

Results
A total of 96 patients met inclusion criteria and were included in the study. Of these patients, the median age was 42.5, 79.2% were Black/African American, 54.2% were cisgender men, and 46.9% had a BMI of ≥ 30 kg/m2. Baseline HIV viral load was &lt; 50 copies/mL in 97.9% of patients. Additional baseline characteristics are described in Table 1. Most (86.5%) patients initiated direct-to-inject LA-CAB/RPV with 98% solely initiating every 2-month dosing schedule. The median number of LA-CAB/RPV doses received was 4 (range, 1-15). Virologic suppression was defined as HIV viral load &lt; 50 copies/mL. Of the 96 patients, 79 had HIV viral load data at week 4 with 99.7% of those being undetectable, 37 had data at week 12 with 100% of those being undetectable, and 62 had data at week 24 of which 96.8% were undetectable. Adherence rates to injections were high, with 96.3% given on-time and the discontinuation rate was 18.8%

Conclusion
LA-CAB/RPV was highly effective in achieving and maintaining virologic suppression among a large number of patients at an urban HIV clinic. This study is limited by short follow-up time during the program's initial scale-up phase. Additional long-term data are needed to determine long-term real-world efficacy, adherence, and discontinuation rates.

Disclosures
Gregory Huhn, MD, MPHTM, Clinical Care Options: Advisor/Consultant|Eli Lilly: Grant/Research Support|Gilead: Advisor/Consultant|Gilead: Grant/Research Support|Janssen: Advisor/Consultant|Janssen: Grant/Research Support|Medscape: Advisor/Consultant|Merck: Advisor/Consultant|Practice Point Communications: Advisor/Consultant|Ridgeback: Grant/Research Support|Trio Health: Advisor/Consultant|Viiv: Advisor/Consultant|Viiv: Grant/Research Support
1600. Long-Acting Antiretroviral Injectable: Who Would Benefit?
Authors: Pogorzelski Karolina , Dandachi Dima , Hitchcock Nicole M , Fabricius Michela 
Published: November 2023

Abstract

Background
People with HIV (PWH) face many challenges in obtaining HIV care. Long-acting (LA)-injectable antiretroviral therapies (ART) can address some of these barriers. This project aimed to determine the percentage of patients who could receive the LA-injectable ART cabotegravir/rilpivirine (CAB/RPV) as an alternative to an oral daily pill regimen based on clinical indications.

Methods
We retrospectively reviewed medical records of adult PWH seen at the University of Missouri Health Care (MUHC) HIV outpatient clinic in Columbia, MO. We collected demographics, CD4 counts, hepatitis B status, HIV viral load, and HIV genotype resistance data. The primary endpoint was the percentage of PWH who would qualify to receive the LA-injectable ART CAB/RPV based on an undetectable HIV viral load, no documented chronic hepatitis B status, and no resistance to either CAB or RPV based on the Stanford University HIV Drug Resistance Database.

Results
Six hundred and twenty-five unique PWH were receiving care at MUHC with a median age of 49 years old, 20% female, 27.5% Black/African American, 4.8% Hispanic and/or Latino, and 9.1% with AIDS (CD4 count &lt; 200 cells/uL). 17.9% of PWH were not eligible for the LA-injectable ART CAB/RPV due to a detectable HIV viral load (defined as &gt; 50 copies/mL on the last HIV viral load result). An additional 7.2% did not qualify due to having a genotype resistance to CAB or RPV and 1.8% did not qualify due to having chronic hepatitis B. Altogether, 151 PWH (24.2%) had one or more clinical contraindications for the LA-injectable ART CAB/RPV based on current guidelines. Genotype resistance testing was not available for 59.6% of PWH. However, out of the 474 PWH who are eligible to receive the LA-injectable ART CAB/RPV, only 76 (16.1%) are currently in care and on this regimen.

Conclusion
In this study, we identified a high percentage of patients with no available genotype and a low uptake of the new LA-injectable ART CAB/RPV. To optimize the use of the the LA-injectable ART CAB/RPV and to make it accessible to PWH who could benefit from it, further research needs to be done using both quantitative and qualitative measures to identify barriers and facilitators at the patient, provider, and system level and to develop effective implementation strategies.

Disclosures
Dima Dandachi, MD, MPH, ContraFect Corporation: Grant/Research Support|Missouri Foundation for Health: Grant/Research Support|ViiV healthcare: Grant/Research Support|ViiV healthcare: Honoraria
1601. Transmitted Drug Resistance in Treatment-Naïve People Living with HIV in Costa Rica
Authors: Ramirez-Cardoce Manuel , Lopez-Bolanos Viviana 
Published: November 2023

Abstract

Background
Transmitted drug resistance (TDR) occurs in people living with HIV infection (PLWH) who are not exposed to antiretroviral drugs but who are infected with a virus with mutations associated with resistance. In Costa Rica, HIV genotyping is performed in PLWH failing their first-line ART regimen, but it is not routinely done for all treatment-naïve PLWH before ART initiation, therefore, little is known about TDR prevalence.

Methods
The aim of this study was to determine the prevalence of TDR and the HIV mutation patterns. During 2020, 162 cases of newly diagnosed treatment-naïve PLWH from all of the country’s HIV clinics were included for a genotyping study. Viral ARN was extracted from plasma samples obtained from the HIV National Reference Laboratory and protease (PR), reverse transcriptase (RT), and integrase (IN) regions were amplified and sequenced. The HIV database Program (Stanford University) and the World Health Organization (WHO) 2009 TDR surveillance mutation list were used for interpretation of resistance-associated mutations.

Results
The overall prevalence of TDR was 36% (N=59/162). According to ART class, TDR was 22% in the nucleoside reverse transcriptase inhibitors (NRTI), followed by 13% in the non-nucleoside reverse transcriptase inhibitors (NNRTI); for the protease inhibitors (PI) and the integrase inhibitors (INI), TDR was 8% and 3%, respectively. (Figures 1-3). Most common mutations were: in NRTI, M41L (9.9%), and M184I (6.8%); in NNRTI, K103N (7.4%); in PI, M46I (4.3%); in INI, T97A (1.9%). (Table 1). The median age was 32 years-old (range: 16-71), and 91% were male. Median CD4 count was 420 cells/uL (range: 11-1670) and median viral load was 588337 copies/mL (range: 1220-10000000). According to CDC classification, 20% were stage C-3.
Source: local database
Source: local database

Source: local database

Conclusion
This study population has a moderate level of HIV drug resistance (HIVDR) in ART-naïve PLWH and strongly implies the need to introduce HIVDR surveillance in Costa Rica. These findings confirm the TDR and highlight the need for systematic viral load monitoring and drug resistance testing at diagnosis. Continuous surveillance of newly infected individuals is required to help strategize the best ART regimen for these patients, and should prompt a change in current local recommendations for starting ART.
Source: local database

Disclosures
All Authors: No reported disclosures