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Article ; Online: Therapeutic HIV vaccines and broadly neutralizing antibodies.

Sobieszczyk, Magdalena E

2020 Volume 27, Issue 4, Page(s) 97–101

Abstract: ... sites. This article is based on a presentation by Magdalena E. Sobieszczyk, MD, MPH ...

Abstract	Therapeutic vaccines and broadly neutralizing antibodies (bNAbs) represent potential approaches to antiretroviral-free treatment of HIV. Although therapeutic vaccines have been able to produce transient reductions in viral load during analytic treatment interruptions (ATIs), thus far none has been able to induce long-term remission. Pairing with latency reversal agents and immune modulators may improve vaccine efficacy. The bNAbs are investigated as a promising approach to achieving durable virologic control in the absence of antiretroviral therapy. Combinations of antibodies are necessary for increasing overall breadth and potency of coverage and preventing emergence of resistance. The next generation of antibodies includes engineered bispecific and trispecific antibodies that target 2 or 3 independent viral sites. This article is based on a presentation by Magdalena E. Sobieszczyk, MD, MPH, at the International Antiviral Society-USA (IAS-USA) continuing education program held in New York in March 2019.
MeSH term(s)	AIDS Vaccines/administration & dosage ; AIDS Vaccines/immunology ; Animals ; Broadly Neutralizing Antibodies/immunology ; HIV Infections/drug therapy ; HIV Infections/immunology ; HIV Infections/virology ; Humans ; Viral Load ; Virus Latency
Chemical Substances	AIDS Vaccines ; Broadly Neutralizing Antibodies
Language	English
Publishing date	2020-03-19
Publishing country	United States
Document type	Journal Article
ZDB-ID	2656632-1
ISSN	2161-5853 ; 2161-5861
ISSN (online)	2161-5853
ISSN	2161-5861
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Article: Am I Positive? Improving Human Immunodeficiency Virus Testing in the Era of Preexposure Prophylaxis and Immediate Antiretroviral Therapy Using Machine Learning.

Zucker, Jason / Carnevale, Caroline / Gordon, Peter / Sobieszczyk, Magdalena E / Rai, Alex J

Open forum infectious diseases

2022 Volume 9, Issue 7, Page(s) ofac259

Abstract: Background: Human immunodeficiency virus (HIV) testing is the first step in the HIV prevention cascade. The Centers for Disease Control and Prevention HIV laboratory diagnostic testing algorithm was developed before preexposure prophylaxis (PrEP) and ... ...

Abstract	Background: Human immunodeficiency virus (HIV) testing is the first step in the HIV prevention cascade. The Centers for Disease Control and Prevention HIV laboratory diagnostic testing algorithm was developed before preexposure prophylaxis (PrEP) and immediate antiretroviral therapy (iART) became standards of care. PrEP and iART have been shown to delay antibody development and affect the performance of screening HIV assays. Quantitative results from fourth-generation HIV testing may be helpful to disambiguate HIV testing. Methods: We retrospectively reviewed 38 850 results obtained at an urban, academic medical center. We assessed signal-to-cutoff (s/co) distribution among positive and negative tests, in patients engaged and not engaged in an HIV prevention program, and evaluated changes in patients with multiple results. Classification and regression tree (CART) analysis was used to determine a threshold cutoff, and logistic regression was used to identify predictors of true positive tests. Results: Ninety-seven percent of patients with a negative HIV test had a result that was ≤0.2 s/co. For patients tested more than once, we found differences in s/co values did not exceed 0.2 s/co for 99.2% of results. CART identified an s/co value, 38.78, that in logistic regression on a unique validation cohort remained associated with the likelihood of a true-positive HIV result (odds ratio, 2.49). Conclusions: Machine-learning methods may be used to improve HIV screening by automating and improving interpretations, incorporating them into robust algorithms, and improving disease prediction. Further investigation is warranted to confirm if s/co values combined with a patient's risk profile will allow for better clinical decision making for individuals on PrEP or eligible for iART.
Language	English
Publishing date	2022-05-18
Publishing country	United States
Document type	Journal Article
ZDB-ID	2757767-3
ISSN	2328-8957
ISSN	2328-8957
DOI	10.1093/ofid/ofac259
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Article ; Online: Predictors of missed HIV screening opportunities among newly diagnosed individuals at an urban medical center in New York City, 2018-2022.

Paer, Jeffrey / Ratcliffe, Judy / Chang, Michelle / Carnevale, Caroline / Quigee, Daniela / Gordon, Peter / Olender, Susan / Sobieszczyk, Magdalena E / Zucker, Jason

PloS one

2023 Volume 18, Issue 9, Page(s) e0290414

Abstract: Objective: To identify demographic and clinical factors predictive of having a missed opportunity (MO) for HIV screening.: Design: Retrospective cohort study.: Methods: Electronic medical records were queried for individuals newly diagnosed with ... ...

Abstract	Objective: To identify demographic and clinical factors predictive of having a missed opportunity (MO) for HIV screening. Design: Retrospective cohort study. Methods: Electronic medical records were queried for individuals newly diagnosed with HIV in different sites within a large urban academic medical center in New York City between 2018 and 2022. The primary outcome was having one or more MO for HIV screening within the institution, defined as any encounter at which screening was not performed in the 365 days preceding the HIV diagnosis. Results: Over one third of new diagnoses had at least one MO in the preceding year. Older individuals, cisgender women and those assigned female sex at birth, and heterosexual individuals were more likely to have at least one MO. An initial CD4 < 200 cells/ul was more likely among men who have sex with women specifically. Most MOs occurred in the emergency department and outpatient settings, with minimal HIV prevention discussions documented during each MO. Conclusions: These findings suggest that populations perceived to be at lower risk for HIV are more likely to have MOs and possibly late diagnoses, and that universal HIV screening must be implemented into the workflows of emergency department and outpatient settings to facilitate early diagnosis and reduce the incidence of HIV.
MeSH term(s)	Infant, Newborn ; Male ; Humans ; Female ; New York City/epidemiology ; Retrospective Studies ; Hospitals ; Health Facilities ; HIV Infections/diagnosis ; HIV Infections/epidemiology
Language	English
Publishing date	2023-09-07
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0290414
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Article ; Online: The Index of Engagement in PrEP Care: Evaluation of Psychometric Properties and Predictive Potential.

Meyers, Kathrine / Quigee, Daniela / Zucker, Jason / Carnevale, Caroline / Klein, Joshua / Kim, Tae Y / Sobieszczyk, Magdalena E

Journal of acquired immune deficiency syndromes (1999)

2023 Volume 94, Issue 3, Page(s) 214–219

Abstract: Background: The Index of Engagement in HIV Care is a psychometrically valid 10-item self-report measure with predictive power to classify individuals to higher and lower odds of disengaging from HIV care. Given high rates of disengagement from ... ...

Abstract	Background: The Index of Engagement in HIV Care is a psychometrically valid 10-item self-report measure with predictive power to classify individuals to higher and lower odds of disengaging from HIV care. Given high rates of disengagement from preexposure prophylaxis (PrEP) care, we adapted the HIV Index to PrEP. Methods: We evaluated the psychometric properties of the PrEP-Index in a cross-sectional validation among PrEP-eligible persons seen in an HIV Prevention Program and conducted exploratory analysis to assess its potential utility as a prognostic tool. The PrEP Index contains 10 items with answers ranging from (1) not at all to (5) extremely. Possible PrEP-Index scores ranged from 10 to 50, with higher sum scores representing higher levels of engagement. Results: Study participants were cisgender men who have sex with men, and racially and ethnically diverse (non-Hispanic White = 39.2%). Factor analyses supported the 1-factor structure. Among 347 respondents, 118 individuals (34.0%) were available for predictive validity analysis. The PrEP Index score was positively associated with visit constancy at 6 months ( = 0.2261; 95% confidence interval: 0.0363 to 0.4051). Finally, a patient scoring 45 on the PrEP-Index will be classified as not returning within 6 months (sensitivity = 0.73, specificity = 0.65). Conclusions: The PrEP-Index is a psychometrically valid and reliable scale that demonstrates potential utility in identifying individuals at elevated risk of falling out of PrEP care by 6 months, the time point by which the majority of PrEP discontinuations occur. The PrEP-Index could be a useful clinical prognostic tool to allow for efficient resource targeting by clinics to improve engagement in PrEP care.
MeSH term(s)	Male ; Humans ; HIV Infections/diagnosis ; HIV Infections/prevention & control ; HIV Infections/drug therapy ; Homosexuality, Male ; Anti-HIV Agents/therapeutic use ; Cross-Sectional Studies ; Psychometrics ; Sexual and Gender Minorities ; Acquired Immunodeficiency Syndrome/drug therapy ; Pre-Exposure Prophylaxis
Chemical Substances	Anti-HIV Agents
Language	English
Publishing date	2023-10-17
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	645053-2
ISSN	1944-7884 ; 1077-9450 ; 0897-5965 ; 0894-9255 ; 1525-4135
ISSN (online)	1944-7884 ; 1077-9450
ISSN	0897-5965 ; 0894-9255 ; 1525-4135
DOI	10.1097/QAI.0000000000003246
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Article ; Online: Estimating vaccine efficacy during open-label follow-up of COVID-19 vaccine trials based on population-level surveillance data.

Moore, Mia / Zhu, Yifan / Hirsch, Ian / White, Tom / Reiner, Robert C / Barber, Ryan M / Pigott, David / Collins, James K / Santoni, Serena / Sobieszczyk, Magdalena E / Janes, Holly

Epidemics

2024 Volume 47, Page(s) 100768

Abstract: While rapid development and roll out of COVID-19 vaccines is necessary in a pandemic, the process limits the ability of clinical trials to assess longer-term vaccine efficacy. We leveraged COVID-19 surveillance data in the U.S. to evaluate vaccine ... ...

Abstract	While rapid development and roll out of COVID-19 vaccines is necessary in a pandemic, the process limits the ability of clinical trials to assess longer-term vaccine efficacy. We leveraged COVID-19 surveillance data in the U.S. to evaluate vaccine efficacy in U.S. Government-funded COVID-19 vaccine efficacy trials with a three-step estimation process. First, we used a compartmental epidemiological model informed by county-level surveillance data, a "population model", to estimate SARS-CoV-2 incidence among the unvaccinated. Second, a "cohort model" was used to adjust the population SARS-CoV-2 incidence to the vaccine trial cohort, taking into account individual participant characteristics and the difference between SARS-CoV-2 infection and COVID-19 disease. Third, we fit a regression model estimating the offset between the cohort-model-based COVID-19 incidence in the unvaccinated with the placebo-group COVID-19 incidence in the trial during blinded follow-up. Counterfactual placebo COVID-19 incidence was estimated during open-label follow-up by adjusting the cohort-model-based incidence rate by the estimated offset. Vaccine efficacy during open-label follow-up was estimated by contrasting the vaccine group COVID-19 incidence with the counterfactual placebo COVID-19 incidence. We documented good performance of the methodology in a simulation study. We also applied the methodology to estimate vaccine efficacy for the two-dose AZD1222 COVID-19 vaccine using data from the phase 3 U.S. trial (ClinicalTrials.gov # NCT04516746). We estimated AZD1222 vaccine efficacy of 59.1% (95% uncertainty interval (UI): 40.4%-74.3%) in April, 2021 (mean 106 days post-second dose), which reduced to 35.7% (95% UI: 15.0%-51.7%) in July, 2021 (mean 198 days post-second-dose). We developed and evaluated a methodology for estimating longer-term vaccine efficacy. This methodology could be applied to estimating counterfactual placebo incidence for future placebo-controlled vaccine efficacy trials of emerging pathogens with early termination of blinded follow-up, to active-controlled or uncontrolled COVID-19 vaccine efficacy trials, and to other clinical endpoints influenced by vaccination.
Language	English
Publishing date	2024-04-15
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2467993-8
ISSN	1878-0067 ; 1755-4365
ISSN (online)	1878-0067
ISSN	1755-4365
DOI	10.1016/j.epidem.2024.100768
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Article ; Online: Prioritizing clinical research studies during the COVID-19 pandemic: lessons from New York City.

Gulick, Roy M / Sobieszczyk, Magdalena E / Landry, Donald W / Hollenberg, Anthony N

The Journal of clinical investigation

2020 Volume 130, Issue 9, Page(s) 4522–4524

MeSH term(s)	Antiviral Agents/therapeutic use ; Betacoronavirus ; COVID-19 ; Clinical Protocols ; Coronavirus Infections/epidemiology ; Coronavirus Infections/therapy ; Humans ; Immunization, Passive ; Immunologic Factors/therapeutic use ; New York City/epidemiology ; Pandemics ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/therapy ; Randomized Controlled Trials as Topic ; SARS-CoV-2 ; Safety ; COVID-19 Serotherapy
Chemical Substances	Antiviral Agents ; Immunologic Factors
Keywords	covid19
Language	English
Publishing date	2020-07-21
Publishing country	United States
Document type	Journal Article
ZDB-ID	3067-3
ISSN	1558-8238 ; 0021-9738
ISSN (online)	1558-8238
ISSN	0021-9738
DOI	10.1172/JCI142151
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Article ; Online: Bacterial Pneumonia and Respiratory Culture Utilization among Hospitalized Patients with and without COVID-19 in a New York City Hospital.

Weidmann, Maxwell D / Berry, Gregory J / Zucker, Jason E / Huang, Simian / Sobieszczyk, Magdalena E / Green, Daniel A

Journal of clinical microbiology

2022 Volume 60, Issue 7, Page(s) e0017422

Abstract: COVID-19 is associated with prolonged hospitalization and a high risk of intubation, which raises concern for bacterial coinfection and antimicrobial resistance. Previous research has shown a wide range of bacterial pneumonia rates for COVID-19 patients ... ...

Abstract	COVID-19 is associated with prolonged hospitalization and a high risk of intubation, which raises concern for bacterial coinfection and antimicrobial resistance. Previous research has shown a wide range of bacterial pneumonia rates for COVID-19 patients in a variety of clinical and demographic settings, but none have compared hospitalized COVID-19 patients to patients testing negative for severe acute respiratory syndrome coronavirus (SARS-CoV-2) in similar care settings. We performed a retrospective cohort study on hospitalized patients with COVID-19 testing from March 10th, 2020 to December 31st, 2020. A total of 19,219 patients were included, of which 3,796 tested positive for SARS-CoV-2. We found a 2.6-fold increase (
MeSH term(s)	COVID-19 ; COVID-19 Testing ; Coinfection/epidemiology ; Hospitals, Urban ; Humans ; Methicillin-Resistant Staphylococcus aureus ; New York City/epidemiology ; Pneumonia, Bacterial/epidemiology ; Retrospective Studies ; SARS-CoV-2
Language	English
Publishing date	2022-06-01
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
DOI	10.1128/jcm.00174-22
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Article ; Online: Serum levels of anti-PF4 IgG after AZD1222 (ChAdOx1 nCoV-19) vaccination.

Cohen, Taylor S / Kelly, Elizabeth J / Nylander, Sven / Bansal, Himanshu / Jepson, Brett M / Bhuyan, Prakash / Sobieszczyk, Magdalena E / Falsey, Ann R

Scientific reports

2022 Volume 12, Issue 1, Page(s) 7961

Abstract: Rare cases of thrombosis with thrombocytopenia syndrome (TTS) have been reported after AZD1222. Anti-platelet factor-4 (PF4) antibodies were observed in patients following presentation of TTS, however it is unclear if AZD1222 was responsible for inducing ...

Abstract	Rare cases of thrombosis with thrombocytopenia syndrome (TTS) have been reported after AZD1222. Anti-platelet factor-4 (PF4) antibodies were observed in patients following presentation of TTS, however it is unclear if AZD1222 was responsible for inducing production of anti-PF4. Paired samples (baseline and day-15) from a phase 3 trial of AZD1222 vs placebo were analyzed for anti-PF4 levels; 19/1727 (1.1%, AZD1222) vs 7/857 (0.8%, placebo) participants were anti-PF4-IgG-negative at baseline but had moderate Day-15 levels (P = 0.676) and 0/35 and 1/20 (5.0%) had moderate levels at baseline but high Day-15 levels. These data indicate that AZD1222 does not induce a clinically relevant general increase in anti-PF4 IgG.
MeSH term(s)	COVID-19 ; ChAdOx1 nCoV-19 ; Humans ; Immunoglobulin G ; Immunologic Factors ; Platelet Factor 4 ; Thrombocytopenia/etiology ; Thrombosis ; Vaccination
Chemical Substances	Immunoglobulin G ; Immunologic Factors ; Platelet Factor 4 (37270-94-3) ; ChAdOx1 nCoV-19 (B5S3K2V0G8)
Language	English
Publishing date	2022-05-13
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, N.I.H., Extramural
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-022-11623-9
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Article ; Online: Cabotegravir in the treatment and prevention of Human Immunodeficiency Virus-1.

McPherson, Tristan D / Sobieszczyk, Magdalena E / Markowitz, Martin

Expert opinion on investigational drugs

2018 Volume 27, Issue 4, Page(s) 413–420

Abstract: Introduction: Human Immunodeficiency Virus (HIV) is a chronic infection that depletes the immune system of essential components causing those infected to be at risk for multiple life-threatening infections. Worldwide, millions live with this infection, ... ...

Abstract	Introduction: Human Immunodeficiency Virus (HIV) is a chronic infection that depletes the immune system of essential components causing those infected to be at risk for multiple life-threatening infections. Worldwide, millions live with this infection, the vast majority attributable to HIV-1. Transmission persists with hundreds of thousands of new infections reported yearly. Implementation of combination antiretroviral therapy (cART) has been effective in improving outcomes and decreasing transmission. Newer co-formulated agents have provided simpler medication regimens, fewer side effects, and, in some cases, a higher barrier to the emergence of medication resistance. Areas covered: Here, we review trials of cabotegravir (CAB) as treatment of HIV-1 infection and its potential use as pre-exposure prophylaxis (PrEP) in high risk individuals, including issues around oral lead in and potential resistance emergence. Expert opinion: CAB is efficacious when used in combination therapy orally or given intramuscularly every 4 to 8 weeks. Its availability in a long-acting injectable formulation (CAB-LA) makes it a valuable, novel drug to treat HIV-1 infection when combined with long-acting injectable rilpivirine (RPV-LA). Moreover, pre-clinical and early Phase 2a studies support its testing as monotherapy as PrEP. Studies are underway comparing the efficacy of every 8 week CAB-LA to tenofovir disoproxil fumarate/emtricitabine (TDF/FTC).
MeSH term(s)	Administration, Oral ; Animals ; Anti-HIV Agents/administration & dosage ; Anti-HIV Agents/adverse effects ; Anti-HIV Agents/pharmacology ; Drug Resistance, Viral ; Drug Therapy, Combination ; HIV Infections/drug therapy ; HIV Infections/prevention & control ; HIV Infections/virology ; HIV-1/isolation & purification ; Humans ; Injections, Intramuscular ; Pre-Exposure Prophylaxis/methods ; Pyridones/administration & dosage ; Pyridones/adverse effects ; Pyridones/pharmacology
Chemical Substances	Anti-HIV Agents ; Pyridones ; cabotegravir (HMH0132Z1Q)
Language	English
Publishing date	2018-04-10
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1182884-5
ISSN	1744-7658 ; 0967-8298 ; 1354-3784
ISSN (online)	1744-7658
ISSN	0967-8298 ; 1354-3784
DOI	10.1080/13543784.2018.1460357
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Article ; Online: Correlates of psychological distress among undergraduate women engaged in remote learning through a New York City college during the COVID-19 pandemic.

Heck, Craig J / Theodore, Deborah A / Sovic, Brit / Austin, Eloise / Yang, Cynthia / Rotbert, Joshua / Greissman, Samantha / Zucker, Jason / Autry, April / Catallozzi, Marina / Sobieszczyk, Magdalena E / Castor, Delivette

Journal of American college health : J of ACH

2023 , Page(s) 1–10

Abstract: Objective: The study's objective is to explore psychological distress (PD) among remote learners during COVID-19.: Participants: Female undergraduates matriculated at an NYC college in Winter 2020.: Methods: Using the Kessler-6 scale, we defined ... ...

Abstract	Objective: The study's objective is to explore psychological distress (PD) among remote learners during COVID-19. Participants: Female undergraduates matriculated at an NYC college in Winter 2020. Methods: Using the Kessler-6 scale, we defined PD as no/low (LPD), mild/moderate (MPD), and severe (SPD) and assessed if residing in/near NYC modified associations. Results: PD was common (MPD: 34.1%, SPD: 38.9%). Students identifying as Other/Multiracial had lower MPD odds (aOR = 0.39 [0.17-0.88]). SPD was associated with identifying as White (aOR = 2.02 [1.02-3.99]), unbalanced meals (aOR = 2.59 [1.06-6.30]), violence experience (aOR = 1.77 [1.06-2.94]), no social support (aOR = 3.24 [1.37-7.64]), and loneliness (aOR = 2.52 [1.29-4.95]). Among students in/near NYC, moderate/high drug use (aOR = 2.76 [1.15-6.61]), no social support (aOR = 3.62 [1.10-1.19]), and loneliness (aOR = 2.92 [1.11-7.63]) were SPD correlates. Conclusions: PD was high and associated with food insecurity, violence experience, no social support, and loneliness. Living in/near NYC modified drug use, loneliness, and social support associations. Mental health initiatives should address modifiable risk factors to ameliorate pandemic-associated PD.
Language	English
Publishing date	2023-01-17
Publishing country	United States
Document type	Journal Article
ZDB-ID	604907-2
ISSN	1940-3208 ; 0744-8481
ISSN (online)	1940-3208
ISSN	0744-8481
DOI	10.1080/07448481.2022.2156797
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