bluuebunny/crossref_metadata_2025 huggingface dataset:
1019. Healthcare Resource Utilization and Cost of People Living with HIV (PLWH) in US Commercial and Medicare Advantage Health Plans
Authors: Priest Julie , Hulbert Erin , Gilliam Bruce L , Burton Tanya
Published: January 2021

Background

The goal of HIV treatment is to achieve and maintain virologic suppression to prevent disease progression. Patients with uncontrolled HIV and decreasing CD4 counts can experience more health problems and increased health care resource utilization (HCRU) and cost. The objectives were to describe the clinical characteristics, HCRU and cost of PLWH in US Commercial and Medicare Advantage health plans by CD4 count.

Methods

A retrospective cohort study of PLWH aged 18+ between 01/01/2014-03/31/2018 in the Optum Research Database was conducted. Patients were continuously enrolled 6 months before (baseline) and 12 months after (unless evidence of death) the first identified antiretroviral (ARV) therapy (follow-up). Patients were classified as heavily treatment-experienced (HTE) if their regimen indicated an ARV therapy used to treat multi-drug resistant (MDR) virus, Non-HTE if treatment did not include an HTE regimen, or Treatment-Naïve if they were not treated with any ARV medication during baseline. All variables were summarized descriptively by the CD4 count closest to the first ARV regimen and compared using chi-square or F-test/ANOVA.

Results

5,522 patients met the inclusion criteria including 18% with a CD4 count < 200, 70% 200-500, and 12% > 500 cells/mm3. Patients in the lowest CD4 group were more likely to be HTE or Naïve, African-American, female, living in the South, earn less and have at least one AIDS defining condition (Table 1). Patients in the lowest CD4 group also had the highest mortality rate, (6% in the < 200, 2% 200-500, 1% in the > 500 group; p-value < 0.001) and the highest rates of emergency room visits and inpatient stays (Figure 1). All-cause total cost among patients with CD4 counts < 200 was 51% higher than those with CD4 > 500, and medical cost was 207% higher driven primarily by inpatient health care cost. Similar trends were seen for HIV-related care. Among the lowest CD4 group, average total cost was highest in the HTE group followed by Naïve patients.

Table 1. Baseline Characteristics by CD4 count group, cells/mm3

Figure 1. Percentage of Patients with All-cause and HIV-related Healthcare Utilization by CD4 Group

Conclusion

There are still PLWH with CD4 counts < 200 cells/mm3 which can result in more AIDS defining conditions, higher mortality risk, and higher HCRU and cost. These results suggest interventions may be needed to diagnose and treat patients sooner and closely monitor the health of more advanced patients for worsening outcomes.

Disclosures

Julie Priest, MSPH, GlaxoSmithKline (Employee, Shareholder) Erin Hulbert, MS, Optum (Employee)ViiV (Grant/Research Support) Bruce L. Gilliam, MD, ViiV Healthcare (Employee)
1022. Impact of Hospitalization on Antiretroviral Therapy for People Living with HIV
Authors: Ladak Amber , Young Henry N , Tang Emily , Curtis Jessica , Chastain Daniel B
Published: January 2021

Background

Persons living with HIV (PLWH) are frequently hospitalized for reasons often unrelated to HIV. Transitioning of antiretroviral therapy (ART) while inpatient may not always be an immediate priority due to lack of knowledge, formulary restrictions, and patient status. This could lead to medication errors and gaps in therapy, which can persist at discharge, and could lead to viral rebound and disease progression. The purpose of this study was to identify effects of hospitalization on ART for PLWH.

Methods

This was an IRB approved, multi-center, retrospective cohort study of patients with HIV and/or AIDS based on ICD codes. Patients were included if they were at least 18 years old, receiving outpatient ART prior to admission, and hospitalized between March 2016 and March 2018. Patients were excluded if they were pregnant and only received intravenous zidovudine during their hospitalization. The primary objective was to determine the rate of ART restarted during hospitalization. Secondary objectives included rate at which inpatient ART was modified compared to outpatient regimen, and risk factors associated with regimen modification.

Results

Of 400 patients screened, 295 (74%) patients were on an outpatient ART regimen and were included in the study. Approximately half, 51%, were on a single tablet regimen (STR) outpatient. This population was majority male (59%) and of black race (87%). Median age was 49 years. Median CD4 count was 160 cells/mm3, while median HIV RNA for those with detectable viral load was 57,095 copies/mL.

236 of 295 patients (80%) received ART during their inpatient stay. However, 70 (30%) of these patients received a regimen that differed from their outpatient ART regimen. 69% of regimens were modified for reasons other than to optimize therapy. Patient sex, place of admission, and receipt of a STR or multi-tablet regimen (MTR) as an outpatient did not significantly impact rate of regimen modification.

Conclusion

Ensuring appropriate transition of ART during hospitalization remains an area in need of improvement. No one specific factor was associated with whether outpatient ART was appropriately and accurately restarted during hospitalization. Thus, there are many opportunities to improve transitions of care and antiretroviral stewardship.

Disclosures

All Authors: No reported disclosures
1023. Impact of Physical Therapy in the Management of Musculoskeletal Pain in HIV Patients
Authors: Sebanayagam Vinoja , Chakur Nichole , Weinberger Jarrett , Twardy Brandon S , Veltman Jennifer
Published: January 2021

Background

Musculoskeletal (MSK) pain is common in HIV patients in the ambulatory setting. Healthcare providers tend to prescribe opioids to control MSK pain in HIV patients, which increases the risk of opioid misuse. An interdisciplinary approach that includes physical therapy has been successful in managing MSK pain in various healthcare settings. Therefore, we sought to find the impact of recruiting a physical therapist (PT), on the number of opioid prescriptions and physical therapy referrals made by resident physicians to manage MSK pain in HIV patients.

Methods

We performed a retrospective chart review of all patients seen by Internal Medicine (IM) residents in an HIV clinic in Detroit, before (01/17-05/17; 2017 dataset) and after (01/18-05/18; 2018 dataset) recruiting a physical therapist to the healthcare team. We collected demographic and clinical data from both datasets. We also surveyed the residents to assess how the PT addition influenced their comfort and knowledge in treating MSK pain in HIV patients. IRB waiver was obtained.

Results

Results showed that of all HIV patients seen at the clinic, 28/249 (11%) and 37/178 (21%) had chronic MSK pain in the 2017 and 2018 datasets, respectively. In 2017, all 28 patients with MSK pain were prescribed opioids. This number significantly decreased in 2018 after the PT addition (10/37 patients; p< 0.0001). Moreover, the number of physical therapy referrals made by residents significantly increased after the PT addition (2017: 5/28 patients; 2018: 17/37 patients; p=0.03). Residents also recommended non-opioid interventions including orthopedics referrals (7/37 patients), braces/orthotics (3/37 patients) and non-opioid analgesics (26/37 patients) to patients after the PT addition. Survey responses showed that 7/9 residents (78%) felt that the physical therapist was helpful in improving their examination skills or developing a treatment plan for patients.

The effect of recruiting a physical therapist on the number of opioid prescriptions and physical therapy referrals made by resident physicians

Conclusion

In conclusion, our results show that the addition of a physical therapist to the team encourages physicians to utilize non-opioid management of MSK pain in HIV patients. We also find that physicians are satisfied with taking an interdisciplinary approach to pain management in HIV patients.

Disclosures

All Authors: No reported disclosures
77. Out of Sight, Out of Mind: Impact of an Antimicrobial Stewardship Bundle on Fluoroquinolone Utilization
Authors: Black Blade W , Harding Stephanie , Beadle Kathy
Published: January 2021

Background

Fluoroquinolones are broad spectrum antimicrobials associated with a growing list of adverse effects, such as Clostridioides difficile infection, arrhythmias, central nervous system effects, tendon rupture and aortic aneurysm. Due to increasing concerns regarding adverse events and growing resistance, the antimicrobial stewardship team at Wesley Healthcare implemented a bundle aimed at reducing fluoroquinolone usage beginning in June 2017. The components of this bundle included suppression of fluoroquinolone susceptibility in Enterobacteriaceae isolates, removal of fluoroquinolones as first line options on order sets, and introduction of a respiratory specific antibiogram.

Methods

The objective was to evaluate the impact of the stewardship bundle on fluoroquinolone utilization. The primary outcome was ciprofloxacin and levofloxacin usage in days of therapy per 1000 inpatient days (DOT) collected at monthly intervals for 24 months before and after intervention. Overall antimicrobial usage in DOT served as a control variable. The secondary outcomes were E. coli and P. aeruginosa susceptibility to ciprofloxacin measured at the same time points as the primary outcome. An interrupted time-series analysis using segmented regression was performed for all variables.

Results

The mean monthly levofloxacin usage was reduced from 14.1 (95% CI, 12.7 - 15.4) to 8.4 (95% CI, 7.6 - 9.3) DOT. The mean monthly ciprofloxacin usage was reduced from 26.9 (95% CI, 24.6 - 29.4) to 15.8 (95% CI, 14.0 - 17.5) DOT. The trend in levofloxacin usage was reduced (p=0.035), while a pre-existing downward trend in ciprofloxacin usage was unchanged (p=NS). Overall antimicrobial usage increased, likely due to increasing hematology/oncology populations during the study period. There were no differences in E. coli or P. aeruginosa susceptibilities observed.

Conclusion

This antimicrobial stewardship bundle may be a useful intervention to reduce fluoroquinolone usage. The bundle may be of particular utility in reducing levofloxacin usage, as our results demonstrated a change in both its usage and trend in usage.

Disclosures

All Authors: No reported disclosures
1035. Patient-Reported Outcomes on Long-Acting Cabotegravir + Rilpivirine as Maintenance Therapy: FLAIR 96-Week Results
Authors: Chounta Vasiliki , Bernal Enrique , Lombaard Johan , Katner Harold P , Walmsley Sharon , Dorey David , Spreen William , Griffith Sandy , Margolis David
Published: January 2021

Background

In the phase 3 FLAIR study, switching to monthly injectable long-acting (LA) cabotegravir (CAB) + rilpivirine (RPV) was noninferior to continued daily oral dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) for the maintenance of virologic suppression over 96 weeks in adults with HIV-1. Key patient-reported outcomes (PROs) through Week 96 are presented.

Methods

In FLAIR, ART-naive adult participants received induction therapy with oral DTG/ABC/3TC for 20 weeks. Those with HIV-1 RNA < 50 c/mL at 16 weeks were randomized (1:1) to continue DTG/ABC/3TC or receive monthly CAB + RPV LA injections after a 4-week lead-in with daily oral CAB + RPV through Week 96. Treatment satisfaction (HIV Treatment Satisfaction Questionnaire status version [HIVTSQs]) and acceptability of injections (Perception of Injection [PIN] Questionnaire) up to Week 96 were secondary endpoints.

Results

A total of 566 participants were randomized (median age, 34 years; 22% female); baseline characteristics were similar between treatment groups. At Week 96, significantly greater improvement from baseline in total treatment satisfaction score was observed in the CAB + RPV LA vs DTG/ABC/3TC treatment group (adjusted mean difference, 2.3 [95% CI, 1.1-3.5]; P< 0.001), further increasing from Weeks 24 (2.1 [0.9-3.3]) and 44 (0.7 [−0.4, 1.9]). Key drivers for the difference in HIVTSQs between treatment groups were items assessing convenience, flexibility, and satisfaction to continue with LA therapy. In participants receiving CAB + RPV LA, mean score for the “Acceptability of ISRs” dimension of PIN (scale, 1-5) significantly decreased (improved) from Week 5 to Weeks 41, 48, and 96 (2.08 to 1.71, 1.66, and 1.71, respectively; P< 0.001 for all). In addition, 82% and 85% of LA participants, respectively, rated pain and local reactions due to injections as “totally” or “very acceptable” at Week 96.

Conclusion

At Week 96, FLAIR participants receiving LA therapy reported greater improvement in treatment satisfaction compared with participants continuing on daily oral medication as well as overall good acceptability of injections with improvement over time. Overall, these results support monthly CAB + RPV LA as an alternative to daily oral regimens for adults with HIV-1.

Disclosures

Vasiliki Chounta, MSc, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Sharon Walmsley, FRCPC, MD, MSC, GSK (Grant/Research Support)ViiV Healthcare (Grant/Research Support) David Dorey, MMATH, GlaxoSmithKline Inc. (Employee, Shareholder) William Spreen, PharmD, ViiV Healthcare (Employee, Shareholder) Sandy Griffith, PharmD, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) David Margolis, MD, MPH, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee)
1036. Persistence of Guideline-Recommended Antiretroviral Therapy Regimens among Persons Living with HIV Newly Initiating Treatment in the US
Authors: Cohen Joshua P , Wang Xingzhi , Wade Rolin L , Cuervo Helena Diaz , Dionne Dionne M
Published: January 2021

Background

Discontinuation of first-line antiretroviral therapy (ART) may lead to poor outcomes for persons living with HIV (PLWH). While single-tablet regimens (STRs) have been associated with greater persistence compared to multi-tablet regimens (MTRs), few real-world studies have assessed persistence with current guideline-recommended ART regimens. The study aims to assess persistence among treatment-naïve PLWH initiating guideline-recommended ART regimens

Methods

Longitudinal pharmacy claims were extracted from IQVIA’s US LRx database for PLWH initiating ART between Jan 1, 2016 - Jul 31, 2019 (index period), with the observational period up to Jan 31, 2020. Index date was defined as the date of the first ART claim for STRs, or the date of the last filled drug of 1st set of claims for MTRs. Persistence was measured as the number of days until treatment discontinuation (≥ 90-day gap in therapy) and presented via Kaplan-Meier curves. Risk of discontinuation was assessed via Cox proportional hazards models, with BIC/FTC/TAF used as the reference ART regimen.

Results

Overall, 90,949 PLWH initiated STRs and 20,737 initiated MTRs. Average (SD) age was 43 (14) years, 75% were male, and 75% had commercial insurance. At 6 months of follow-up, 71% of PLWH initiating STRs and 56% initiating MTRs remained on their ART regimen. The proportion remaining on their index regimen at 6 months of follow-up was 79% for BIC/FTC/TAF, 73% for EVG/COBI/FTC/TAF, 71% for DTG/ABC/3TC, 69% for DTG + FTC/TAF, 67% for EFV/FTC/TDF, 62% for EVG/COBI/FTC/TDF, and 38% for DTG + FTC/TDF. Risk of discontinuation was higher for MTRs compared to STRs (hazard ratio [HR]: 1.63, 95% CI: 1.61 - 1.66). Compared to the referent BIC/FTC/TAF, risk of discontinuation was higher for EVG/COBI/FTC/TAF (HR: 1.54, 95% CI: 1.48 - 1.60), DTG/ABC/3TC (HR: 1.58, 95% CI: 1.52, 1.65), DTG + FTC/TAF (HR: 1.83, 95% CI: 1.74 - 1.93), EFV/FTC/TDF (HR: 2.31, 95% CI: 2.21 - 2.41), EVG/COBI/FTC/TDF (HR: 2.58, 95% CI: 2.47 - 2.70), and DTG + FTC/TDF (HR: 6.20, 95% CI: 5.83 - 6.59).

Table 1. Persistence with ART by regimen for STR and MTR

Figure 1. Forest Plot of Hazard Ratios for Treatment Discontinuation

Conclusion

Among US adult PLWH, STRs were associated with longer persistence on first-line therapy compared to MTRs. Among STRs, persistence was highest for BIC/FTC/TAF.

Disclosures

All Authors: No reported disclosures
1038. Rapid Start: A Changing Algorithm for the Management of HIV Infection
Authors: Gudipati Smitha , Jaziri Miriam , Tancer Stephanie , Vahia Amit T , Brar Indira
Published: January 2021

Background

Initiating combination antiretroviral therapy (cART) as early as the day of HIV diagnosis is a strategy of increasing interest to control the HIV epidemic and optimize the health of people living with HIV. Pilot studies have shown that starting cART immediately after diagnosis has led to earlier linkage to care and HIV-1 RNA suppression. However, there is some evidence from observational studies that starting cART on the same day as HIV diagnosis may increase the risk of loss to follow-up. Consequently, there is a need for additional data for immediate cART initiation.

Methods

A Retrospective cohort study was conducted from 2016 to 2018 to identify clinical characteristics and risk factors in patients that were diagnosed with HIV-1 with a 4th generation assay using electronic medical records. Rapid start was defined as offering cART prior to or on the first clinic visit. Categorical variables were analyzed using chi-sq test and continuous variables were analyzed using t-test. Data analysis was done using SAS 9.4.

Results

In the study period, 188 patients were identified as HIV-1 positive and cART naïve: 152 males and 34 females. Risk factors included men who have sex with men (N = 86), heterosexual transmission (N = 88), intravenous drug use (N = 18) and multiple partners (N = 15). Of the 188 patients, 40 patients were rapidly started on cART on average within 6 days of diagnosis vs 42 days in the standard of care patients (P > 0.0001), with a shorter duration to clinic follow up over time (P = 0.3103). 50% patients that were rapid started on cART maintained an undetectable viral load vs 77% of the standard of care group (P = 0.3174). 90% of the rapid start patients were retained in care at 12 months vs 78% of the standard of care patients (P = 0.4950). 126 patients were started on single tablet regimens (P = 0.0001) with a trend favoring bictegravir, emtricitabine & tenofovir alafenamide (P = 0.0001).

Conclusion

Our study adds to the growing data that rapid ART initiation within seven days of HIV diagnosis could reduce loss to follow-up, improve virological suppression rates, and reduce mortality. The percentage of patients with undetectable HIV-1 viral load and retained in care was comparable to that in standard of care, indicating that starting cART immediately after diagnosis was well accepted by patients.

Disclosures

Indira Brar, MD, Gilead (Speaker’s Bureau)janssen (Speaker’s Bureau)ViiV (Speaker’s Bureau)
1039. Real World Community-Based HIV Rapid Start Antiretroviral with BFTAF Versus Conventional HIV Antiretroviral Therapy Start – The RoCHaCHa Study, a Pilot Study
Authors: Zuppelli Ashley R , Mancenido Michael , Scutaru Jacob , Danforth Alexandra , Biernbaum Robert , Corales Roberto , Valenti William M
Published: January 2021

Background

Trillium Health (TH) is a FQHC in Rochester, NY providing primary and specialty care, including HIV prevention and treatment. Rapid Start ART (RSA) has been shown to decrease time to virologic suppression while increasing linkage to and retention in care. However, data on BFTAF with these benefits is limited. We aim to prove RSA with BFTAF is advantageous in time to viral load suppression, linkage to and retention in care, and patient satisfaction and acceptance.

Methods

We included data from ART-naive newly diagnosed PLWH enrolled between October 2018 and March 2020 with baseline assessment and started BFTAF. Follow up visits were done per protocol though 48 weeks. The primary study endpoints include median times from: diagnosis to clinic presentation, clinic presentation to ART, and ART to undetectable viral load (VL), < 200 copies/mL and < 50 copies/mL. Linkage to and retention in care were measured at 3 months. Study results were compared with non-RSA historical control data. Patient reported outcomes were evaluated at study completion.

Results

Of the 27 eligible, 25 participants enrolled. Thirteen received their diagnosis at TH: screening for PrEP (6), community-based HIV/STI/HCV testing (3), community outreach (1), or routine patient screening in primary care (3). Twelve were diagnosed externally: university health centers (2), other health clinic (9), or at-home rapid HIV test (1). All accepted the RSA treatment with BFTAF; two eligible patients declined the study, but accepted RSA. 73.9% of participants were seen within 14 days of Day 84, compared with 50% of historical control group. 12 of 25 completed the primary endpoint of which 100% were highly satisfied with RSA. There were no regimen changes or virologic failures through 48 weeks.

RoCHaCHa Study Results

Conclusion

RSA with BFTAF reduced time to virologic suppression in all participants newly diagnosed with HIV-1 compared with historical non-RSA model.

Disclosures

Ashley R. Zuppelli, PHARMD, BCACP, AAHIVP, Gilead Sciences, Inc. (Grant/Research Support)Gilead Sciences, Inc. (Advisor or Review Panel member, Research Grant or Support) Michael Mancenido, DO, AAHIVS, Gilead Sciences, Inc. (Grant/Research Support) Jacob Scutaru, MD, Gilead Sciences, Inc. (Grant/Research Support) Alexandra Danforth, PHARMD, BCACP, AAHIVP, Gilead Sciences, Inc. (Grant/Research Support) Robert Biernbaum, DO, MS, FAAEM, AAHIVS, Gilead Sciences, Inc. (Grant/Research Support, Advisor or Review Panel member, Speaker’s Bureau) Roberto Corales, DO, AAHIVS, Gilead Sciences (Employee) William M. Valenti, MD, FIDSA, Gilead Sciences, Inc. (Grant/Research Support, Speaker’s Bureau)
1040. Real-World Implementation of Dolutegravir-Lamivudine to Achieve and Maintain HIV-1 Viral Suppression at an Academic Medical Center
Authors: Hiryak Kayla , Kludjian Geena , Samuel Rafik , Bettiker Robert , Koren David E
Published: January 2021

Background

Two-drug antiretroviral (ARV) regimens to achieve and maintain HIV viral suppression may lead to decreases in associated drug interactions, adverse events, and pill burden. Dolutegravir-lamivudine (DTG-3TC) has been established as safe and effective in treatment naïve and experienced adults. Further research is warranted to assess insertion into real-world practice.

Methods

This descriptive retrospective cohort consisted of all patients at an academic medical center HIV practice with a confirmed order of DTG-3TC between April 2019 and March 2020. Patients who were not linked to care by the site’s practices were excluded. The primary endpoint was number of patients initiated on DTG-3TC to determine uptake. Secondary endpoints included demographics and viral outcomes. Descriptive measures of central tendencies and variability were used for analysis.

Results

DTG-3TC was initiated in 49 patients. Sixty-nine percent were male (34/49), 90% carried publicly funded insurance (44/49), median age at DTG-3TC initiation was 55 years (IQR 46-60), and mean years since HIV diagnosis was 14 (SD ±8). The largest racial/ethnic category represented was Black (45%, 22/49). Forty-seven patients with a mean CD4 of 753 cells/mm3 (±413) and viral load of 88.2 copies/mL (±525) were switched from alternative regimens, mostly containing an integrase inhibitor (41/47, 87%), and with the primary rationale of medication modernization (27/47, 58%) followed by avoidance of adverse drug reactions (15/47, 32%). From 42 assessed patients, 62% had previous ARV exposure length of over 10 years. No patients were found to have significant resistance mutations to the involved agents. After initiation, 6% (3/49) of patients reported side effects. Among switch patients with follow up lab values, median CD4 (n=20) and viral load (n=21) deltas were -10 cells/mm3 (-59-67) and 0 copies/mL (0-0) respectively. Overall median length of therapy through April 1, 2020 was 110 days (71-156).

Conclusion

Initial implementation of DTG-3TC was successful in a northeast academic HIV practice primarily among virally suppressed treatment switch patients with long exposures to ARV and time since diagnosis. No clinically relevant change in CD4 or Viral Loads were immediately seen.

Disclosures

David E. Koren, PharmD, BCPS, AAHIVP, Gilead Sciences (Advisor or Review Panel member)Janssen Pharmaceuticals (Advisor or Review Panel member)Thera Technologies (Advisor or Review Panel member)
1041. Tenofovir alafenamide associated weight change in persons living with HIV
Authors: Crowder Carlysle E , Bouchard Jeannette , Weissman Sharon , Derrick Caroline
Published: January 2021

Background

Persons living with human immunodeficiency virus (PLWH) have a higher incidence of developing obesity, diabetes, and cardiovascular disease. TAF, a newer formulation of tenofovir, has favorable effects on renal function and bone mineral density compared to TDF. However, recent evidence suggests TAF may have a higher propensity for weight gain over TDF. The purpose of this study is to evaluate weight change in patient switched from TDF to TAF, keeping constant the other components of their antiretroviral therapy.

Methods

This retrospective observational cohort study evaluated adult PLWH who were followed for 12 months pre and post TDF to TAF therapy switch holding all other ART constant. Patients were excluded if not on TDF or TAF therapy for a minimum of 12 months, if there were additional changes to their ART, or if there was inadequate documentation of weight defined as less than 2 weight records pre and post TAF switch. Data collected included height, weight, HIV RNA, CD4 count, and presence of any current opportunistic infections or chronic comorbid conditions. The primary endpoint was change in weight after TAF switch. All variables were evaluated using linear mixed effect models over time.

Results

466 patient charts were reviewed and 55 patients met study criteria and were included in the analysis. The median age (SD) of patients included was 45.9 (12.6) years with most patients being male (67%) and black (73%). Patients had an HIV diagnoses for a mean (SD) of 10 (6.6) years with a mean (SD) CD4 count of 544 (246.8). Full baseline characteristics are recorded in Table 1. Notably, most patients had either an INSTI or PI in their baseline ART regimen (Table 1). The estimated overall marginal mean weight gain was 1.91 kg (95% CI 0.25-3.57, p=0.024). The estimated overall gain in BMI was 0.63 kg/m2 (95% CI 0.08-1.18). Significant predictors of weight gain included female gender (3.09, 95% CI 0.54 – 5.65) and use of both integrase and protease inhibitors at baseline (6.97 kg, 95% CI 3.02 – 10.92).

Conclusion

In a predominantly black, male population, there was a statistically significant change in weight after a TAF switch.

As this is the only data highlighting weight changes following tenofovir formulation change, more data is needed to elucidate the extent of weight-gain in patients on TAF-based regimens.

Disclosures

All Authors: No reported disclosures
1043. The impact of integrase strand transfer inhibitors (InSTIs) on weight gain among adults with HIV in clinical care
Authors: Thatipelli Sneha , Achenbach Chad , Galvin Shannon
Published: January 2021

Background

Integrase strand transfer inhibitors (InSTIs) as ART for HIV has been associated with clinically significant weight gain, in addition to the “return to health phenomenon”.

Methods

We conducted a cohort study on adults over 18 with HIV, who had baseline weights and an additional weight at least 6 months later. Individuals with malignancies, thyroid disorders, and disseminated tuberculosis or mycobacterium avium complex were excluded. To understand the impact of InSTIs on chronic vs. recently infected persons, we divided the cohort into four groups: (1) well-controlled on non-InSTI ART [WN] (2) well-controlled on InSTI ART [WI] (3) uncontrolled on non-InSTI ART [UN], and (4) uncontrolled on InSTI ART [UI]. Well-controlled persons (viral load < 2000) were proxies for chronic infection on long-term ART and uncontrolled for recently infected and initiated on ART. New diagnoses of diabetes, hyperlipidemia, and hypertension were determined by ICD10 codes. Participants with a weight change more than 10 kg in 6 months were excluded.

Results

612 of the initial 910 participants in the cohort met the inclusion criteria. Comparing those who remained on the designated regimen throughout the study led to 86 WN, 153 WI, 166 UN, and 145 UI. Mean weight change at 6 months for WN was +0.22 kg (95% CI [-0.86, 1.3]), at 1 year was -0.86 kg (95% CI [-2.94, 1.22]), and at 2 years was +0.026 kg (95% CI [-2.347, 2.399]). For WI, mean weight change at 6 months was +0.21 kg (95% CI [-0.79, 1.21]), at 1 year was -0.50 kg (95% CI [-2.02, 1.04]), and at 2 years was +0.43 kg (95% CI [-1.35, 2.21]). UN gained weight until the first year (+1.74 kg at 6 mo (95% CI [0.24, 3.24]) and +3.84 kg at 1 year (95% CI [1.57, 6.11])), but plateaued at 2 years (+2.42 kg (95% CI [-0.44, 5.28])). At 6 months mean weight gain for UI was +0.78 kg (95% CI [-0.15, 1.71]), at 1 year was +2.33 kg (95% CI [1.02, 3.64]), and at 2 years was +3.04 kg (95% CI [1.2, 4.85]). WI had a higher incidence of diabetes (37% vs. 32%, p=0.40), hyperlipidemia (32% vs. 29%, p=0.66), and hypertension (34% vs. 26%, p=0.19) compared to WN.

Conclusion

InSTIs may confer a larger and more sustained weight gain among individuals in the first two years after ART initiation. Well controlled individuals did not have statistically significant weight change, but those on Insti-based ART had more metabolic diseases.

Disclosures

All Authors: No reported disclosures
1048. Weight Gain after Initiation of Anti-Retroviral Therapy in Acute HIV-1
Authors: Kaur Harmanpreet , Utay Netanya S , Lake Jordan , Arduino Roberto , Hongyu Miao
Published: January 2021

Background

Background: Excess weight gain with integrase strand transfer inhibitors (INSTIs) has been reported in some people with chronic HIV. In antiretroviral therapy (ART)-naïve people, greater weight gain over 18 months was reported with dolutegravir than other agents. We hypothesized that initiating an INSTI-based regimen during acute HIV infection (AHI) would result in more weight gain than a non-INSTI-based regimen, and INSTIs other than elvitegravir (EVG) would be associated with greater weight gain than EVG.

Methods

Methods: We performed a retrospective, observational, single center chart review analysis of adults with AHI (Feibig Stages 1-5) who were initiated on ART and followed for 48 (+/- 12) weeks. Changes in weight between people on INSTI- vs non-INSTI regimens were compared, and in a subgroup analysis, EVG vs non-EVG and tenofovir alafenamide (TAF) vs non-TAF were compared. Chi-square, t-test, or Wilcoxon Rank Sum test were used, when appropriate.

Results

Results: Baseline characteristics of the 61 participants are shown in Table 1. Overall median (IQR) weight change was 4.53 (1.22-8.36; within-group P< 0.0001) kg (Figure 1). Median weight change in 58 people initiated on INSTI was 4.66 (1.22-8.43; P< 0.0001) kg vs 1.64 (-3.08-6.57; P=0.75) kg in 3 people not on INSTI (between-group P= 0.33). Median weight change on EVG was 4.40 (0.91-6.71; P< 0.0001) kg vs 7.10 (4.97-13.15; P= 0.0001) kg for non-EVG INSTIs (between-group P= 0.008, Figure 2). Median weight change on TAF (n=33) was 2.66 (0.81-7.53; P= 0.002) kg vs 5.31 (3.72-9.34; P < 0.0001) kg in non-TAF (n=25) recipients (between-group P= 0.06). Lower baseline CD4+ T cell count correlated with greater weight gain (P= 0.012). No association between weight gain and race (P= 0.930) or gender (P= 0.379) was noted.

Baseline characteristics and median weight change (kg) from baseline

Weight change in elvitegravir vs non-elvitegravir integrase inhibitor regimen.

Overall weight gain seen over 48 weeks after initiation of antiretroviral therapy calculated using the Wilcoxon Rank Sum test.

Conclusion

People initiating ART during AHI gained weight over 48 weeks, with persons taking INSTIs gaining more weight, though this finding did not reach statistical significance due to small sample size. Amongst INSTI-treated persons, those not on EVG gained more weight than those on EVG. While the benefits of starting ART during AHI on immune system preservation and reservoir should not be underscored, risk and consequences of weight gain following ART initiation should be discussed when initiating ART during AHI.

Disclosures

Jordan Lake, MD, Gilead Sciences (Grant/Research Support, Scientific Research Study Investigator)
1052. Serologic vs. molecular testing for screening for hepatitis C virus infection in patients with hematologic malignancies with and without prior hematopoietic cell transplant recipients
Authors: Torres Harrys A , Angelidakis Georgios , Jiang Ying , Economides Minas , Yibirin Marcel , MD Robert Orlowski , Champlin Richard , Verstovsek Srdan , Raad Issam I , Raad Issam I
Published: January 2021

Background

The prevalence of chronic hepatitis C virus (HCV) infection in patients with cancer in the U.S. has been reported to be 1.5% overall and up to 10.6% in specific subgroups. Testing for antibody to HCV (anti-HCV) is a low-cost diagnostic method in widespread use worldwide; however, the optimal screening test for HCV in cancer patients has not been established. We sought to identify the optimal screening test for HCV in patients with hematologic malignancies and/or prior hematopoietic cell transplant (HCT).

Methods

New patients who were seen at the Lymphoma/Myeloma, Leukemia, and Stem Cell Transplant clinics at MD Anderson Cancer Center (02/11/2019-11/5/2019) were simultaneously screened for HCV with serologic (antibody to HCV [anti-HCV]) and molecular (HCV RNA) assays. Anti-HCV testing was performed by using the ARCHITECT Anti-HCV assay and HCV RNA testing was performed by using the Cobas HCV test. The agreement between the two tests was evaluated using Cohen’s kappa statistic and McNemar’s test. All tests were two-sided with a significance level of 0.05.

Results

A total of 214 patients were enrolled in the study, of whom 127 (59%) were men (Table), One hundred forty-nine patients (70%) had a lymphoid neoplasm, 65 (30%) had a myeloid neoplasm, and 15 (7%) underwent HCT. Ninety-three patients (43%) had progressive disease. Three patients (1.4%) had positive anti-HCV, and two (0.9%) had positive HCV RNA. The overall percentage agreement was 99.5% (95% CI, 97.4% to 99.9%). Of the 3 patients with positive anti-HCV, 2 had positive and 1 had negative HCV RNA. There were no cases of seronegative HCV infection. The positive percentage agreement was 66.7% (95 CI, 20.8% to 93.9%), and the negative percentage agreement was 100.0% (95% CI, 98.2% to 100.0%). Cohen’s Kappa coefficient was 0·80 (95% CI, 0.41 to 1.00, p < 0·0001), indicating substantial agreement between anti-HCV and HCV RNA tests for diagnosis of HCV infection.

Conclusion

The diagnostic yield for screening for chronic HCV infection in heavily immunocompromised cancer patients is similar for serologic and molecular testing. The use of anti-HCV, a diagnostic method with low cost, in patients with cancer would contribute to the World Health Organization’s goal of HCV elimination worldwide.

Table. Characteristics of the study population (n=214)

Disclosures

Harrys A. Torres, MD, Merck & Co., Inc. (Grant/Research Support) Issam I. Raad, MD, Citius (Other Financial or Material Support, Ownership interest)Cook Medical (Grant/Research Support)Inventive Protocol (Other Financial or Material Support, Ownership interest)Novel Anti-Infective Technologies (Shareholder, Other Financial or Material Support, Ownership interest)
1053. The Ecological Relationship Between County-Level HCV Case Rates and Office-Based Buprenorphine in Ohio
Authors: Brook Daniel L , Chettri Shibani , Hetrick Angela , Sibley Adams L , Schalkoff Christine , Lancaster Kathryn , Go Vivian , Kline David , Miller William
Published: January 2021

Background

The United States is experiencing an epidemic of hepatitis C virus (HCV) infections due to injection drug use, especially in rural areas. Counties may be expanding access to buprenorphine, an evidence-based treatment that has been shown to reduce injection drug use, to control the HCV epidemic. We assessed the county-level relationship between HCV rates in 2013-2015 and office-based buprenorphine prescribing in 2018 in Ohio. We also assessed if this relationship varied between rural and urban counties.

Methods

We fit crude and adjusted negative binomial models to assess the relationship between HCV incidence rates in 2013-2015 and office-based buprenorphine prescribing capacity and frequency in Ohio in 2018. We examined effect measure modification of this relationship by rural-urban status using an interaction term.

Results

We found that a 1% higher acute HCV rate was associated with an 18% (95% Confidence Interval [CI]: -3%, 44%) higher office-based buprenorphine prescribing capacity and an 22% (95% CI: -4%, 55%) higher office-based buprenorphine prescribing frequency. We found that a 1% higher total HCV rate was associated with a 239% (95% CI: 179%, 317%) higher office-based buprenorphine prescribing capacity and a 273% (95% CI: 183%, 405%) higher office-based buprenorphine prescribing frequency. We found no evidence of effect measure modification by rural-urban status.

Conclusion

Counties across Ohio may have expanded access to office-based buprenorphine in response to high rates of total HCV. Expansion of office-based buprenorphine may be less associated with acute HCV rates due to the low frequency with which these cases are seen in outpatient settings.

Disclosures

All Authors: No reported disclosures
79. Outcomes Associated with the Utilization of the Methicillin-Resistant Staphylococcus aureus (MRSA) Nasal Polymerase Chain Reaction (PCR) Assay to De-escalate Vancomycin Therapy in Patients with Suspected Pneumonia at a Rural Community Hospital
Authors: Tirupathi Raghavendra , Kyner Mackenzie , Logsdon Jarett
Published: January 2021

Background

Vancomycin is often added to standard inpatient community acquired pneumonia therapy, but the incidence of MRSA pneumonia is relatively low. The MRSA nasal PCR assay is used to detect if a patient’s nares are colonized with MRSA. Studies have found that this test has an excellent negative predictive value at ruling out MRSA pneumonia. In practice, there is reluctance to utilize this data to de-escalate vancomycin, possibly because little data exists investigating clinical outcomes associated with this intervention. The purpose of this study was to evaluate how this assay, in combination with antimicrobial stewardship, impacts de-escalation of vancomycin and consequently, length of stay, days of therapy, readmission, and mortality.

Methods

We performed a cohort study of patients who received vancomycin for pneumonia during the period 2017–2019. In July 2018, we implemented a pharmacy-led process to de-escalate vancomycin in pneumonia patients based on the results of the nasal MRSA PCR. Patient were excluded if they had concomitant skin/skin structure infection, osteomyelitis, were transferred to another facility, signed out against medical advice, or required mechanical ventilation. Data on patient characteristics, disease severity, length of stay, days of therapy, readmission, and mortality were compared between the groups.

Figure 1: Patient disposition with reasons for exclusion from study

Results

101 and 107 patients were included in the before and after group, respectively. The average length of stay was 5.31 (before group) vs 4.33 days (after group), resulting in a 0.98 day decrease (p=0.0095). Days of therapy was 3.16 (before group) vs 1.96 days (after group), resulting in a 1.2 day reduction (p< 0.0001). 30-day mortality was significantly higher in the before group (19.8%) than the after group (9.3%) (RR 0.47, 95% CI 0.23–0.96). 30-day readmission was similar between the two groups (21.8% pre-intervention vs 19.6% post-intervention, p=0.7).

Figure 2: Length of Stay and Duration of therapy reductions between the pre- and post-intervention groups.

Figure 3: 30-day readmission rate and 30-day mortality rate in the pre- and post-intervention groups.

Figure 4: Vancomycin days of therapy per 1000 patient days from July 2017 to May 2020

Conclusion

Use of the MRSA nasal PCR to deescalate vancomycin therapy appears to significantly reduce length of stay and days of vancomycin therapy. Use of this assay did not negatively impact readmission but, may have a positive impact on mortality. Further research is needed to determine the impact of this intervention on length of stay and mortality.

Disclosures

All Authors: No reported disclosures
1055. Assessing the Impact of the Routine Childhood Hepatitis B Immunization and the Need for Hepatitis B Vaccine Birth Dose in Sierra Leone, 2018
Authors: Breakwell Lucy , Marke Dennis , Kaiser Reinhard , Tejada-Strop Alexandra , Pauly Matthew , Stewart Brock , Kabore Hyacinte J , Sesay Tom , Samba Thomas , Hayden Tonya , Kamili Saleem , Jambai Amara , Drobeniuc Jan , Singh Tushar , Tohme Rania A , Wasley Annemarie
Published: January 2021

Background

All African countries recommend 3 doses of hepatitis B vaccine (HepB3), most at 6, 10, and 14 weeks of age, but few recommend a HepB birth dose (HepB-BD). To evaluate the role of mother to child transmission (MTCT) of hepatitis B virus (HBV) with the 3 dose HepB schedule, we conducted a serosurvey in Sierra Leone among 4–30 month old children and their mothers, and 5–9 year old children.

Methods

We conducted a multi-stage cluster survey in 3 districts. Enumeration areas (EA) were selected by probability proportional to size, followed by random selection of eligible households to identify 1901 children per age group. We tested all participants for HBV surface antigen (HBsAg) by rapid test and collected children’s HepB vaccination history. Serum from all HBsAg+ mothers and 1 HBsAg- mother per EA was tested for total antibodies to HBV core antigen (anti-HBc), HBsAg, HBV e antigen (HBeAg), and HBV DNA. We assessed the association of HBsAg prevalence with HepB vaccination and maternal HBV markers.

Results

Among 1889 children aged 4–30 months, 20 (1.3%; 95% CI:0.8%–2.0%) were HBsAg+; HepB3 coverage was 85%. Among 2025 children aged 5–9 years, 32 (1.6%; 95% CI:1.1%–2.3%) were HBsAg+; HepB3 coverage was 77%. Of HBsAg+ children, 70% (14/20) of younger and 56% (18/32) of older children received HepB3. Among 1776 mothers of younger children, 169 (9.8%; 95% CI:8.1%–11.7%) were HBsAg+. HBsAg prevalence for children with HBsAg+ mothers was 5.9% (10/169) and 0.7% (6/1605) for those with HBsAg- mothers (adjusted OR=10.6 [95% CI:2.8–40.8]). Of 139 HBsAg+ mothers, 13 (9%) were HBeAg+ and 126 (91%) had detectable HBV DNA. Maternal HBsAg (p=0.026), HBeAg (p< 0.001), and HBV DNA levels ≥ 200,000 IU/mL (p< 0.001) were associated with HBsAg positivity in younger children (Table 1).

Table 1: Association of maternal HBV serological and molecular markers with HBsAg positivity in 4–30-month old children — Sierra Leone hepatitis B serosurvey, 2018

Conclusion

HBsAg prevalence was much lower among children than among mothers, for whom HepB would not have been available, indicating that routine infant HepB vaccination has substantially lowered HBV burden. Increasing HepB3 coverage could further reduce HBsAg prevalence among children. As HBsAg positivity in young children was strongly associated with having a mother with active HBV infection and > 50% of HBsAg+ children received HepB3, HepB-BD is needed to prevent MTCT of HBV and chronic HBV infections in children.

Disclosures

All Authors: No reported disclosures
1057. CpG-adjuvanted Hepatitis B vaccination improves seroprotection rates in Veterans with HIV
Authors: Deming Meagan , Kottilil Shyam , Wilson Eleanor
Published: January 2021

Background

Hepatitis B virus (HBV) remains a global health issue, leading to complications including cirrhosis and hepatocellular carcinoma. Individuals co-infected with Human Immunodeficiency Virus (HIV) and HBV have increased liver-related morbidity and mortality compared to those with HBV mono-infection. Vaccination can effectively prevent HBV infection, but certain critical populations including people living with HIV (PLWH) are less likely to achieve seroprotection (antibody to hepatitis B surface antigen (HBsAb) titer ≥ 10 IU/mL) after vaccination; seroprotection rates (SPR) in PLWH range from 34 to 88% in clinical trials, with improved SPR in those with immunologic reconstitution and viral suppression. With improved immunologic status, SPR have dramatically improved in our Veteran Infectious Disease clinic population. However, a subset of patients remain HBV vaccine nonresponders despite re-vaccination attempts, perhaps due to intrinsic immunologic anergy. We hypothesized that Veterans with HIV who were nonresponders to prior HBV vaccines may respond to a more immunogenic vaccine. Heplisav-B is a 2-dose series, with improved SPR in other classically difficult to vaccinate groups (including the elderly and those with diabetes), but has not yet been studied in individuals with HIV.

Methods

HBV vaccine nonresponders who had previously been vaccinated and boosted with median 3 and up to 8 doses of alum-adjuvanted HBV vaccines were re-vaccinated with Heplisav-B. HBsAb titers were assessed at days 0, 30, and 60 to follow vaccine responses.

Results

Participants had a median age of 65 (range 44 to 83) and were virologically suppressed on antiretroviral therapy. Enrollment and vaccination was interrupted by the COVID-10 pandemic, but 8 of 10 (80%) enrolled participants had seroprotective titers at day 60, with 6 having titers > 1000 IU/mL. Of the 8 additional participants who had available serologies after the first dose, all were seroprotected, and 3 had titers > 1000 IU/mL.16 of 18 (89%) participants achieved seroprotection with Heplisav-B.

Conclusion

Heplisav-B is immunogenic in persons with HIV and should be a reasonable option for HBV vaccination of PLWH who are previous nonresponders.

Disclosures

Shyam Kottilil, MD PhD, Arbutus Pharmaceuticals (Grant/Research Support)Gilead Sciences (Grant/Research Support)Merck Inc (Grant/Research Support, Advisor or Review Panel member)