bluuebunny/crossref_metadata_2025_split huggingface dataset:
109. Evaluating Predictive Value of Surgical Resected Proximal Bone Margins in Diabetic Foot Osteomyelitis with Clinical Outcomes at One Year
Authors: Weng Bruce , Oskooilar Yasmin , Zakhary Bishoy , Chiu Chiao An , Mulligan Nikki , Wu Patrick , Sutjita Made 
Published: December 2021

Abstract

Background
Diabetic foot osteomyelitis (DFO) remains a significant comorbidity in diabetes and often requires both surgical and medical interventions. Surgical bone resection with proximal margins is performed for treatment at our institution to guide antimicrobial therapy. Optimal antibiotic duration often remains unclear, along with clinical outcomes with negative margins. We evaluate if negative bone margins predict outcomes of DFO at one year in our county hospital.

Methods
A retrospectively cohort study assessed adult patients undergoing DFO amputations between 9/2016 to 9/2019. Patient data collected included demographics, smoking history, hemoglobin A1c (HbA1c), basic labs, microbiology, antibiotic duration, bone margin pathology. Physician review of records determined if intervention was successful. Primary outcome was met if no further amputation at the same site was required in the following 12 months.

Results
Of 92 patients, 57 had negative margins and 35 had positive margins for pathology confirmed osteomyelitis. Smoking history was significant in positive margins (35.1% vs 57.1%; p=0.038). Patients with negative margins had a successful outcome at 12 months compared to positive margins (86% vs 66%; p=0.003), but no significant differences in outcome at 6 months. Antibiotic days was reduced in negative margin individuals (mean 18 vs 30 days; p=0.001). Negative margins also demonstrated significant lower rates of readmission at 12 months (p=0.015). Staphylococcus aureus was notable in positive vs negative margins (57.1% vs 29.8%; p=0.017). MSSA was significantly noted in positive margins (45.7% vs 14%; p=0.001). MRSA was similar regardless of margin results (15.8% vs 11.4%; p=0.399). Initial ESR, CRP and HbA1c were similar between groups.

Conclusion
Our study noted that negative proximal bone margins resulted in more successful outcomes at 12 months and less days of antimicrobial therapy. Patients with negative margins had lower rates of readmission at 12 months for surgical site complications. Negative proximal bone margins results can guide antibiotic therapy and improve outcomes of resections. Presence of S. aureus was significant in positive margins and likely warrant consideration for further aggressive intervention.
Clinical Characteristics of Patients with Diabetic Foot Osteomyelitis

Clinical demographics, antibiotic usage, microbiology and results of patients presenting for diabetic foot osteomyelitis needing surgical amputation intervention. Abbreviations: HbA1c - Hemoglobin A1c; MSSA - methicillin-susceptible Staphylococcus aureus; MRSA - methicillin-resistant Staphylococcus aureus; CRP -C-reactive protein; ESR - erythrocyte sedimentation rate

Disclosures
All Authors: No reported disclosures
895. Impact of Telemedicine on HIV Care and Prevention Services at an Academic Ryan White-Funded Clinic
Authors: Dasigi Jay V , Gupta Nupur , Hadi Christiane 
Published: December 2021

Abstract

Background
Telemedicine (TM) has been seldom used for the care of persons with HIV. However, the COVID-19 pandemic has forced HIV clinics to rapidly scale TM resources. With the increase of TM, the impact on HIV patient care remains uncertain. The purpose of this study is to examine the effects of TM on HIV care and retention at a Ryan White-funded clinic.

Methods
This was a retrospective study of patients seen at an academic clinic in Pittsburgh, PA between 1/1/20 – 12/31/20. Encounter information was extracted from the clinic electronic health record. Primary outcomes were viral load (VL) suppression (&lt; 200 copies/ml) and retention in care for persons seen via TM (phone, video +/- in person) vs those seen in-person. Secondary outcomes included flu vaccination and STI screening rates.

Results
Amongst 1414 patients, 608 patients had at least one scheduled TM visit, with 97 seen exclusively via TM, and 806 were scheduled for only in-person visits. In those with at least one TM visit, 92.72% had a suppressed VL. 89.69% of those with only TM visits were suppressed. 92.43% were suppressed in the in-person group. Average show rate amongst patients who had at least one TM visit was 60.39% (+0.96% from 2019, +1.71% from 2018), vs 64.38% amongst patients who only had in-person visits. Amongst patients who were only scheduled for TM visits, show rate was 83.97%. 40.18% of patients who had at least one TM visit received their flu vaccine in 2020 (-37.45% from 2019, -36.72% from 2018) vs 37.62% who were only seen in-person. Amongst patients who had at least one TM visit, syphilis screening rate was 43.09% (-7.64% from 2019, -8.55% from 2018) vs 43.51% for those seen only in-person. Gonorrhea and chlamydia screening rates were both 42.91% (+9.46% from 2019, +15.27% from 2018 for chlamydia screening; +8.36% from 2019, +14.73% from 2018 for gonorrhea screening). Amongst patients who were exclusively seen in-person gonorrhea screening rate was 48.24% and chlamydia screening rate was 47.57%.
Table 1. Characteristics of Patients Seen in 2020

Table 2. Primary and Secondary Outcomes for Patients Seen in 2020

Conclusion
VL suppression rates were similar across both groups, but retention in care was highest in the TM-only group. Flu vaccination rates and STI screening were lower in the groups that included TM. TM is an effective method for maintaining VL suppression and retention in care but has room for improvement with provision of preventative services.

Disclosures
All Authors: No reported disclosures
897. Trends and Correlation of HIV-1 Reservoir in Acute HIV Infection and Chronic HIV Infection in China
Authors: peng Shuang , wang Ming 
Published: December 2021

Abstract

Background
Among acute HIV infection （AHI）and chronic HIV infection（CHI）,the association of HIV-1 DNA and HIV-1 RNA is currently a hot spot of concern. We studied HIV-1 DNA levels in patients with AHI and CHI before initiation of ART to explore the growth characteristics of the HIV reservoir.

Methods
From 2016/10/31 to 2020/11/23, 97 patients were enrolled in the first hospital of Changsha in China. According to the patient’s epidemiological history, HIV-1 antibody conversion time, presence of opportunistic infection（OI）, to determine whether the patients were in the acute or chronic infection period, and divided into two arms: AHI and CHI. Lleukomonocyte, HIV-1 RNA, and CD4/8 of all patients were collected. The HIV-1 DNA in peripheral blood mononuclear (PBMC) was detected by PCR-Fluorescence Probing. The results were analyzed by SPSS 22.0 and GraphPad Prism 8.0. P-value &lt; 0.05 were statistically significant.

Results
93 of 97 were male and 85 of 97 with sexual transmission. In AHI arm, the mean of HIV-1 RNA was 5.15 log10 copies/ml, and the mean of HIV-1 DNA was 2.83 log10 copies/106 PBMCs. In CHI Arm, the mean value of HIV-1 RNA was 4.90 log10 copies/ml, and the mean value of HIV-1 DNA was 3.19 log copies/106 PBMCs. The HIV-1 DNA of CHI group was higher than that of AHI group (p = 0.002) , but the HIV-1 RNA of CHI group was lower than that of AHI Group (p = 0.183) . There were no significant differences between AHI and CHI in age, sex, body weight, route of infection, ART, other viral infection, leukomonocyte, CD4+ T cell count, CD4+ T cell percentage, CD8+ T cell count, CD8+ T cell percentage and CD4/CD8 ratio (P &gt; 0.05).In Group AHI, HIV-1 DNA was positively correlated with HIV-1 RNA (r = 0.548, p &lt; 0.001), but not in Group CHI (r = 0.14, p = 0.347).

Conclusion
Patients with AHI have lower HIV-1 DNA levels and smaller viral reservoir than those with CHI. These data have illustrates the benefits of rapid treatment. The correlation between HIV-1 DNA and HIV-1 RNA in patients with acute infection is strong,the level of HIV-1 DNA increased with the increase of HIV-1 RNA level, but was not related to CD4 + T cells, CD8 + T cells and CD4/CD8 ratio.

Disclosures
All Authors: No reported disclosures
898. Effectiveness and Tolerability of DTG + 3TC in Clinical Practice: Evidence in PLHIV from Real-world Data
Authors: Evitt Lee A , Kumar Rahul , Kamath Rahul , Jha Diwakar , Parks Daniel , van Wyk Jean A , de Ruiter Annemiek 
Published: December 2021

Abstract

Background
Randomized controlled trials have shown dolutegravir (DTG) + lamivudine (3TC) to be an efficacious, well-tolerated and durable regimen for treatment-naive and treatment-experienced people living with HIV (PLHIV). Several observational studies have also concluded that it is effective in clinical practice. The objective of this meta-analysis was to estimate effectiveness and tolerability of DTG + 3TC in PLHIV by combining real-world evidence from clinical practice.

Methods
A systematic literature review using PubMed and Embase plus 24 regional and international conferences was conducted between January 2013 and December 2020 to identify studies of DTG + 3TC in treatment-experienced and treatment-naive PLHIV in clinical practice. Eligible published articles reporting virologic suppression, virologic failure and discontinuations at Weeks 48 and 96 were identified and extracted. Identified studies were included if they had an acceptable level of publication bias and heterogeneity determined using funnel plots and I2 statistics, respectively. One-arm meta-analyses using the DerSimonian and Laird method were conducted to estimate effect sizes for outcomes of interest for DTG + 3TC.

Results
One study of DTG + 3TC was identified reporting outcomes of interest at time points of interest in treatment-naive PLHIV, hence no meta-analysis was undertaken in this population. Eight studies (N=2366 PLHIV) undertaken in Europe reported data on treatment-experienced, virologically suppressed PLHIV on outcomes of interest at time points of interest (not all endpoints/time points were reported by all studies). The meta-analysis of available data from these 8 studies showed that among PLHIV switching to DTG + 3TC treatment, ≥ 95% maintained virologic suppression (per protocol) with ~1% virologic failures on DTG + 3TC at Weeks 48 and 96. Five of the 8 studies reported resistance data. Among participants with baseline resistance testing, no treatment-emergent integrase strand transfer inhibitor resistance mutations were observed.
Table. Meta-analysis Results in Treatment-Experienced PLHIV: Proportion with Virologic Failure, Virologic Suppression, and Discontinuations at Weeks 48 and 96

Conclusion
DTG + 3TC is an effective, tolerable and durable antiretroviral regimen with low rates of discontinuation in treatment-experienced PLHIV in clinical practice.

Disclosures
Lee A. Evitt, MSc Health Economics, ViiV Healthcare (Employee, Shareholder of GSK) Rahul Kumar, M Pharmacy, GlaxoSmithKline (Employee) Rahul Kamath, PharmD, GlaxoSmithKline (Employee) Diwakar Jha, Masters in Pharmaceutical Sciences, GlaxoSmithKline (Employee) Daniel Parks, PhD, GlaxoSmithKline (Employee, Shareholder) Jean A. van Wyk, MB,ChB, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Annemiek de Ruiter, MBBS FRCP, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee)
899. Use of Dolutegravir/Rilpivirine in Treatment of HIV in PLWH with CKD and ESRD
Authors: Kang Jungwook , Kim Yae Ji 
Published: December 2021

Abstract

Background
Dolutegravir and rilpivirine is a novel two-drug single-tablet regimen for human immunodeficiency virus (HIV) that does not require dose adjustment in patients with chronic kidney disease (CKD) or end-stage renal disease (ESRD). Although there are no studies proving the efficacy and safety of this regimen for patients with CKD and ESRD, there are a few studies that support the use of dolutegravir in hemodialysis.

Methods
A retrospective chart review was performed on patients who received dolutegravir and rilpivirine from November 2017 to July 2020 in the HIV clinic at SUNY Downstate Medical Center. The primary endpoint was the viral load suppression rate (defined as viral load less than 50 copies/ml) at 6 months of therapy compared between two groups of patients with varying kidney function: chronic kidney disease (defined as creatinine clearance (CrCl) under 60 mL/min) and normal kidney function (defined as CrCl higher than or equal to 60 mL/min). Viral load suppression rate was compared using logistic regression. Secondary outcomes were any reported adverse drug events and the discontinuations of the study medication.

Results
Overall viral load suppression at 6 months was achieved in 31 out of 36 patients (86.1%). 13 out of 14 patients (92.9%) with CrCl greater than or equal to 60 mL/min at baseline achieved viral load suppression at 6 months, whereas 18 out of 22 patients (81.8%) with CrCl under 60 mL/min at baseline achieved viral load suppression at 6 months (p=0.367). With adjustments for age, gender, and the history of Acquired Immunodeficiency Syndrome, the result was still insignificant. One adverse event of headache was reported in the group with baseline CrCl under 60 mL/min. Three cases of discontinuation were reported in this group due to resistance, headache, and drug-drug interaction.

Conclusion
The use of dolutegravir and rilpivirine for the treatment of HIV infection in adults with CKD or ESRD on hemodialysis was both safe and effective in African American population.

Disclosures
All Authors: No reported disclosures
901. Integrated Community Health Screening for COVID-19 and HIV Promotes HIV Diagnoses and Linkage to Care
Authors: Rosmarin-DeStefano Corey L , Martin Eugene G , Salaru Gratian , Tempalski Barbara , Finkel Diana , Scarinci Eileen 
Published: December 2021

Abstract

Background
New Jersey experienced a 64% decrease in HIV screening during the COVID-19 pandemic, hampering the Federal “End the Epidemic Initiative”. From March 2020- May 2021, North Jersey Community Research Initiative, a community-based organization in Newark, NJ, noted a HIV seropositivity of 3.1% despite a decrease of 25% in testing. Qualitative interviews conducted virtually with community individuals and focus groups during that time period indicated that COVID-19 suggested clients were taking more risks due to feelings of isolation, depression and anxiety. NJCRI in collaboration with Robert Wood Johnson Medical School in Somerset, NJ and five other community-based partners in NJ wanted to assess if offering community combination COVID-19 screening and HIV screenings during the pandemic would increase community screening for HIV.

Methods
CLIA Waived Screening for COVID-19 from two antigen assays, LumiraDx and BD Veritor was combined with a referenced laboratory based molecular screening from saliva Infinity Biologix under FDA emergency use authorization within CDC guidance with HIV Alere/Determine and INSTI in those individuals that identified as asymptomatic for COVID-19 but with high risk for HIV

Results
NJCRI began the COVID-19 and HIV rapid screening to clients on January 4, 2021.Clients tested for COVID-19 (N=274), 3% tested positive for HIV and &lt; 3% are self-reported HIV+ (94% of the sample tested negative for HIV). Overall, 92% of clients tested negative for COVID-19. Clients testing positive for COVID-19 (N=19), there was a 6% positivity rate utilizing COVID-19 Antigen by nasal swab. Those positive via COVID-19 Molecular (N=19) method, results indicate clients also tested positive 6% of the time using a saliva indicator. Approximately, 5% of the study sample are confirmed COVID-19 positives via both testing methods (separately 1% Antigen and &lt; 2% Molecular). 19% of the sample (N=3) tested positive for both HIV and COVID-19.

Figure 2. Demographics

Figure 3. Social and Economic Risk Factors

Conclusion
Newly diagnosed patients were treated the same day with antiretroviral therapy; linked to medical care, behavioral health and risk reduction services. Combining COVID-19 and HIV screening in a trusted community-based setting improved delivery of HIV care and linkage to care for newly diagnosed individuals in Newark, NJ.

Figure 4. Behavioral Risk Factors

Figure 3. Social and Behavioral Risk Factors

Disclosures
All Authors: No reported disclosures
902. Unreturned Pill Bottles in the 1489 and 1490 Clinical Trials: An Important Measure of Poor Adherence that Is Often Ignored in Pill Count Calculations
Authors: Acosta Rima K , Chen Grace Q , Huang Hailin , Liu Hui , White Kirsten L 
Published: December 2021

Abstract

Background
Adherence to antiretroviral therapy is important for HIV suppression. In clinical trials, adherence is commonly measured by pill count; limitations are that unreturned pills may not have been taken and unreturned pill bottle data are omitted. This analysis focuses on the relationship between unreturned pill bottles as a measure of poor adherence and the overall effect on virologic success rates across all treatment groups.

Methods
Pill bottle return category (all bottles returned or ≥1 bottle unreturned) and return rates for participants across all treatment groups from two treatment-naïve INSTI clinical trials (Studies 1489 and 1490) were calculated. Association of bottle return category or rates with virologic events through week 144, including last on-treatment observation carried forward (LOCF) outcome, was determined; comparisons used Fisher’s exact or Wilcoxon rank sum test.

Results
Virologic suppression with ≥95% adherence by pill count can differ for those with unreturned pill bottles (Figure). In these studies, 60% of participants returned all their pill bottles through week 144; if one visit with ≥1 unreturned bottle was allowed, this percentage increased to 81%. The mean bottle return rate was 94% and did not differ by study, treatment arm, or sex. Failure to return pill bottles was significantly associated with lower suppression rates. Additionally, significant differences in pill bottle return rate (p &lt; 0.01) were observed by week 144 LOCF outcome (95% vs 77% mean return rate for those with HIV RNA &lt; 50 c/mL vs ≥50 c/mL), need for resistance testing (95% vs 77% return rate for those not tested vs tested), confirmed virologic failure (VF) (94% vs 90% return rate for those without VF vs with VF) and blip status (95% vs 92% return rate for those without blips vs with blips).
HIV-1 Viral Loads of Two Participants with ≥95% Adherence by Pill Count through Week 144

Conclusion
In these treatment-naïve INSTI clinical trials, failure to return pill bottles was associated with lower suppression rates. Although the calculated adherence rates in these studies was relatively high (median ≥95%), these calculations did not account for unreturned pill bottles. We believe that assessing adherence by both pill count and pill bottle return rate may provide a more complete picture of adherence in clinical trials.

Disclosures
Rima K. Acosta, BS, Gilead Sciences, Inc. (Employee, Shareholder) Grace Q. Chen, BS, Gilead Sciences, Inc. (Employee) Hailin Huang, PhD, Gilead Sciences, Inc. (Employee, Shareholder) Hui Liu, PhD, Gilead Sciences, Inc. (Employee, Shareholder) Kirsten L. White, PhD, Gilead Sciences, Inc (Employee, Shareholder)
904. Improving Infectious Disease Screening and Hepatitis C Care Cascade Outcomes Among Adults Receiving Medication Assisted Treatment
Authors: Hoehnen Sarah , Blood Audra B , Austermiller Rachel 
Published: December 2021

Abstract

Background
This initiative increased infectious disease (ID) screening in an adult medication assisted treatment (MAT) population at a Federally Qualified Health Center (FQHC) by implementing opt-out screening for HIV, viral hepatitis, and sexually transmitted infections (STIs), and assessed the success of a co-located hepatitis C (HCV) treatment program.

Methods
ID providers maintained a standing lab order for HIV, hepatitis A, hepatitis B, HCV, syphilis, chlamydia/gonorrhea (GC/CT), and trichomoniasis (trich), with reflex to confirmatory for HIV/HCV/syphilis. For all existing and new adult MAT patients, a MAT RN provided education, ensured lab draw on the day of MAT induction, and scheduled an ID follow-up visit. The patient then had an in-person or telemedicine visit with the ID provider to review results, discuss risk reduction, and initiate treatment (HIV PrEP or treatment for STI, HCV, or HIV) as indicated. Data was compiled and monitored by a Prevention RN.
Plan, Do, Study, Act (PDSA) Model

PDSA model demonstrating implementation approach

Results
The rate of testing among MAT patients increased over a one-year period.
HCV treatment uptake in this setting exceeded that documented in published data for people who inject drugs (PWID).
HCV Care Cascade Outcomes

HCV screening and treatment outcomes within HCV Care Cascade model
Screening Outcomes

Screening rates among adult MAT population over a one-year measurement period

Conclusion
This study documents the successful implementation of an opt-out screening program among an adult substance use disorder (SUD) treatment population across urban, mixed, and designated rural environments. HCV treatment uptake in this setting exceeded that documented in published data for people who inject drugs (PWID).
Barriers to implementation included acceptance among patients with long-term MAT participation, acceptance/adoption by behavioral health nursing and provider staff, and functional workflow development – establishment of protocol, lab availability, scheduling, and “tough sticks.”
Modifications that increased effectiveness included an interdisciplinary approach and dedicated staff for monitoring results completion and patient outreach.
Run chart: HIV screening rates over a one-year period

HIV screening change among adult MAT patients over a one-year period
Run chart: HCV screening rates over a one-year period

HCV screening change among adult MAT patients over a one-year period
HCV Care Cascade: HCV screening and treatment outcomes

HCV screening and treatment outcomes presented in HCV Care Cascade for adult MAT population

Disclosures
All Authors: No reported disclosures