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Safety and Efficacy of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies Amubarvimab Plus Romlusevimab in Nonhospitalized Patients With COVID-19

Evering, Teresa H. ; Chew, Kara W. ; Giganti, Mark J. ; [et al.]

American College of Physicians ; 2023

In: Annals of Internal Medicine Vol. 176, No. 5 ( 2023-05), p. 658-666

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In: Annals of Internal Medicine, American College of Physicians, Vol. 176, No. 5 ( 2023-05), p. 658-666

Type of Medium: Online Resource

ISSN: 0003-4819 , 1539-3704

URL: Article

DOI: 10.7326/M22-3428

RVK:

XA 23600

Language: English

Publisher: American College of Physicians

Publication Date: 2023

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Predictors of SARS-CoV-2 RNA From Nasopharyngeal Swabs and Concordance With Other Compartments in Nonhospitalized Adults With Mild to Moderate COVID-19

Moser, Carlee ; Li, Jonathan Z ; Eron, Joseph J ; [et al.]

Oxford University Press (OUP) ; 2022

In: Open Forum Infectious Diseases Vol. 9, No. 11 ( 2022-11-02)

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In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. 11 ( 2022-11-02)

Abstract: Identifying characteristics associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA shedding may be useful to understand viral compartmentalization, disease pathogenesis, and risks for viral transmission. Methods Participants were enrolled August 2020 to February 2021 in ACTIV-2/A5401, a placebo-controlled platform trial evaluating investigational therapies for mild-to-moderate coronavirus disease 2019 (COVID-19), and underwent quantitative SARS-CoV-2 RNA testing on nasopharyngeal and anterior nasal swabs, oral wash/saliva, and plasma at entry (day 0, pretreatment) and days 3, 7, 14, and 28. Concordance of RNA levels (copies/mL) across compartments and predictors of nasopharyngeal RNA levels were assessed at entry (n = 537). Predictors of changes over time were evaluated among placebo recipients (n = 265) with censored linear regression models. Results Nasopharyngeal and anterior nasal RNA levels at study entry were highly correlated (r = 0.84); higher levels of both were associated with greater detection of RNA in plasma and oral wash/saliva. Older age, White non-Hispanic race/ethnicity, lower body mass index (BMI), SARS-CoV-2 immunoglobulin G seronegativity, and shorter prior symptom duration were associated with higher nasopharyngeal RNA at entry. In adjusted models, body mass index and race/ethnicity associations were attenuated, but the association with age remained (for every 10 years older, mean nasopharyngeal RNA was 0.27 log10 copies/mL higher; P & lt; .001). Examining longitudinal viral RNA levels among placebo recipients, women had faster declines in nasopharyngeal RNA than men (mean change, −2.0 vs −1.3 log10 copies/mL, entry to day 3; P & lt; .001). Conclusions SARS-CoV-2 RNA shedding was concordant across compartments. Age was strongly associated with viral shedding, and men had slower viral clearance than women, which could explain sex differences in acute COVID-19 outcomes.

Type of Medium: Online Resource

ISSN: 2328-8957

URL: Article

DOI: 10.1093/ofid/ofac618

Language: English

Publisher: Oxford University Press (OUP)

Publication Date: 2022

detail.hit.zdb_id: 2757767-3

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3

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Safety and efficacy of inhaled interferon-β1a (SNG001) in adults with mild-to-moderate COVID-19: a randomized, controlled, phase II trial

Jagannathan, Prasanna ; Chew, Kara W. ; Giganti, Mark J. ; [et al.]

Elsevier BV ; 2023

In: eClinicalMedicine Vol. 65 ( 2023-11), p. 102250-

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In: eClinicalMedicine, Elsevier BV, Vol. 65 ( 2023-11), p. 102250-

Type of Medium: Online Resource

ISSN: 2589-5370

URL: Article

DOI: 10.1016/j.eclinm.2023.102250

Language: English

Publisher: Elsevier BV

Publication Date: 2023

detail.hit.zdb_id: 2946413-4

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The STOP COVID 2 Study: Fluvoxamine vs Placebo for Outpatients With Symptomatic COVID-19, a Fully Remote Randomized Controlled Trial

Reiersen, Angela M ; Mattar, Caline ; Bender Ignacio, Rachel A ; [et al.]

Oxford University Press (OUP) ; 2023

In: Open Forum Infectious Diseases Vol. 10, No. 8 ( 2023-08-01)

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In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 10, No. 8 ( 2023-08-01)

Abstract: Prior randomized clinical trials have reported benefit of fluvoxamine ≥200 mg/d vs placebo for patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Methods This randomized, double-blind, placebo-controlled, fully remote multisite clinical trial evaluated whether fluvoxamine prevents clinical deterioration in higher-risk outpatients with acute coronavirus disease 2019 (COVID-19). Between December 2020 and May 2021, nonhospitalized US and Canadian participants with confirmed symptomatic infection received fluvoxamine (50 mg on day 1, 100 mg twice daily thereafter) or placebo for 15 days. The primary modified intent-to-treat (mITT) population included participants who started the intervention within 7 days of symptom onset with a baseline oxygen saturation ≥92%. The primary outcome was clinical deterioration within 15 days of randomization, defined as having both (1) shortness of breath (severity ≥4 on a 0–10 scale or requiring hospitalization) and (2) oxygen saturation & lt;92% on room air or need for supplemental oxygen. Results A total of 547 participants were randomized and met mITT criteria (n = 272 fluvoxamine, n = 275 placebo). The Data Safety Monitoring Board recommended stopping early for futility related to lower-than-predicted event rates and declining accrual concurrent with vaccine availability in the United States and Canada. Clinical deterioration occurred in 13 (4.8%) participants in the fluvoxamine group and 15 (5.5%) participants in the placebo group (absolute difference at day 15, 0.68%; 95% CI, −3.0% to 4.4%; log-rank P = .91). Conclusions This trial did not find fluvoxamine efficacious in preventing clinical deterioration in unvaccinated outpatients with symptomatic COVID-19. It was stopped early and underpowered due to low primary outcome rates. Clinical Trials Registration ClinicalTrials.gov Identifier: NCT04668950.

Type of Medium: Online Resource

ISSN: 2328-8957

URL: Article

DOI: 10.1093/ofid/ofad419

Language: English

Publisher: Oxford University Press (OUP)

Publication Date: 2023

detail.hit.zdb_id: 2757767-3

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5

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Oral and Vaginal Tenofovir for Genital Herpes Simplex Virus Type 2 Shedding in Immunocompetent Women: A Double-Blind, Randomized, Cross-over Trial

Bender Ignacio, Rachel A. ; Perti, Tara ; Magaret, Amalia S. ; [et al.]

Oxford University Press (OUP) ; 2015

In: Journal of Infectious Diseases Vol. 212, No. 12 ( 2015-12-15), p. 1949-1956

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In: Journal of Infectious Diseases, Oxford University Press (OUP), Vol. 212, No. 12 ( 2015-12-15), p. 1949-1956

Type of Medium: Online Resource

ISSN: 0022-1899 , 1537-6613

URL: Article

DOI: 10.1093/infdis/jiv317

RVK:

XA 10000

Language: English

Publisher: Oxford University Press (OUP)

Publication Date: 2015

detail.hit.zdb_id: 1473843-0

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Impact of Antiretroviral Therapy on Cancer Treatment Outcomes among People Living with HIV in Low- and Middle-Income Countries: a Systematic Review

Montaño, Michalina A ; Chagomerana, Maganizo B ; Borok, Margaret ; [et al.]

Springer Science and Business Media LLC ; 2021

In: Current HIV/AIDS Reports Vol. 18, No. 2 ( 2021-04), p. 105-116

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In: Current HIV/AIDS Reports, Springer Science and Business Media LLC, Vol. 18, No. 2 ( 2021-04), p. 105-116

Type of Medium: Online Resource

ISSN: 1548-3568 , 1548-3576

URL: Article

DOI: 10.1007/s11904-021-00542-5

Language: English

Publisher: Springer Science and Business Media LLC

Publication Date: 2021

detail.hit.zdb_id: 2179699-3

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7

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Time to knock monoclonal antibodies off the platform for patients hospitalised with COVID-19

Shapiro, Adrienne E ; Bender Ignacio, Rachel A

Elsevier BV ; 2022

In: The Lancet Infectious Diseases Vol. 22, No. 5 ( 2022-05), p. 567-569

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In: The Lancet Infectious Diseases, Elsevier BV, Vol. 22, No. 5 ( 2022-05), p. 567-569

Type of Medium: Online Resource

ISSN: 1473-3099

URL: Article

DOI: 10.1016/S1473-3099(21)00762-3

Language: English

Publisher: Elsevier BV

Publication Date: 2022

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8

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Comprehensive viromewide antibody responses by systematic epitope scanning after hematopoietic cell transplantation

Bender Ignacio, Rachel A. ; Dasgupta, Sayan ; Stevens-Ayers, Terry ; [et al.]

American Society of Hematology ; 2019

In: Blood Vol. 134, No. 6 ( 2019-08-08), p. 503-514

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In: Blood, American Society of Hematology, Vol. 134, No. 6 ( 2019-08-08), p. 503-514

Abstract: Further insight into humoral viral immunity after hematopoietic cell transplantation (HCT) could have potential impact on donor selection or monitoring of patients. Currently, estimation of humoral immune recovery is inferred from lymphocyte counts or immunoglobulin levels and does not address vulnerability to specific viral infections. We interrogated the viral antibody repertoire before and after HCT using a novel serosurvey (VirScan) that detects immunoglobulin G responses to 206 viruses. We performed VirScan on cryopreserved serum from pre-HCT and 30, 100, and 365 days after myeloablative HCT from 37 donor-recipient pairs. We applied ecologic metrics (α- and β-diversity) and evaluated predictors of metrics and changes over time. Donor age and donor/recipient cytomegalovirus (CMV) serostatus and receipt systemic glucocorticoids were most strongly associated with VirScan metrics at day 100. Other clinical characteristics, including pre-HCT treatment and conditioning, did not affect antiviral repertoire metrics. The recipient repertoire was most similar (pairwise β-diversity) to that of donor at day 100, but more similar to pre-HCT self by day 365. Gain or loss of epitopes to common viruses over the year post-HCT differed by donor and recipient pre-HCT serostatus, with highest gains in naive donors to seropositive recipients for several human herpesviruses and adenoviruses. We used VirScan to highlight contributions of donor and recipient to antiviral humoral immunity and evaluate longitudinal changes. This work builds a foundation to test whether such systematic profiling could serve as a biomarker of immune reconstitution, predict clinical events after HCT, or help refine selection of optimal donors.

Type of Medium: Online Resource

ISSN: 0006-4971 , 1528-0020

URL: Article

DOI: 10.1182/blood.2019897405

RVK:

XA 33000

RVK:

XA 10000

Language: English

Publisher: American Society of Hematology

Publication Date: 2019

detail.hit.zdb_id: 1468538-3

detail.hit.zdb_id: 80069-7

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Engagement in HIV Care and Access to Cancer Treatment Among Patients With HIV-Associated Malignancies in Uganda

Low, Daniel H. ; Phipps, Warren ; Orem, Jackson ; [et al.]

American Society of Clinical Oncology (ASCO) ; 2019

In: Journal of Global Oncology , No. 5 ( 2019-12), p. 1-8

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In: Journal of Global Oncology, American Society of Clinical Oncology (ASCO), , No. 5 ( 2019-12), p. 1-8

Abstract: Health system constraints limit access to HIV and cancer treatment programs in sub-Saharan Africa. Limited access and continuity of care affect morbidity and mortality of patients with cancer and HIV. We assessed barriers in the care cascade of comorbid HIV and cancer. PATIENTS AND METHODS Structured interviews were conducted with 100 adult patients with HIV infection and new diagnoses of cancer at the Uganda Cancer Institute. Participants completed follow-up questionnaires after 1 year to assess ongoing engagement with and barriers to care. RESULTS The median time from new-onset cancer symptoms to initiation of cancer care at the Uganda Cancer Institute was 209 days (interquartile range, 113 to 384 days). Persons previously established in HIV care waited less overall to initiate cancer care ( P = .04). Patients established in HIV care experienced shorter times from initial symptoms to seeking of cancer care ( P = .02) and from seeking of care to cancer diagnosis ( P = .048). Barriers to receiving care for HIV and cancer included difficulty traveling to multiple clinics/hospitals (46%), conflicts between HIV and cancer appointments (23%), prohibitive costs (21%), and difficulty adhering to medications (15%). Reporting of any barriers to care was associated with premature discontinuation of cancer treatment ( P = .003). CONCLUSION Patients with HIV-associated malignancies reported multiple barriers to receiving care for both conditions, although knowledge of HIV status and engagement in HIV care before presentation with malignancy reduced subsequent time to the start of cancer treatment. This study provides evidence to support creation and evaluation of integrated HIV and cancer care models.

Type of Medium: Online Resource

ISSN: 2378-9506

URL: Article

DOI: 10.1200/JGO.18.00187

Language: English

Publisher: American Society of Clinical Oncology (ASCO)

Publication Date: 2019

detail.hit.zdb_id: 3018917-2

detail.hit.zdb_id: 2840981-4

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10

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491. Characterizing the Association of Pre-Existing Cytomegalovirus (CMV)-specific Humoral Immunity with CMV Reactivation Risk after Hematopoietic Cell Transplantation (HCT)

Zamora, Danniel ; Krantz, Elizabeth M ; Joncas-Schronce, Laurel ; [et al.]

Oxford University Press (OUP) ; 2022

In: Open Forum Infectious Diseases Vol. 9, No. Supplement_2 ( 2022-12-15)

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In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. Supplement_2 ( 2022-12-15)

Abstract: There is renewed interest in CMV-specific humoral immune protection due to recent murine data suggesting that strain-specific antibodies may inhibit CMV cell-to-cell spread (Science. 2019; 363:288). To characterize the nature of antibody protection against CMV after HCT, we tested pre-HCT sera in a cohort of CMV D-R+ allogeneic HCT recipients from the pre-letermovir era using VirScan, a technology that measures pathogen-specific humoral immunity (IgG) at the epitope level. Methods Patients (age 0-70 years) who received 1st, myeloablative, HCT for acute leukemia or myelodysplastic syndrome and who underwent PCR surveillance and preemptive therapy were included. VirScan was used on sera collected pre-HCT. Cumulative incidence curves and multivariable Cox regression analyses were used to determine the association of pre-HCT CMV antibody epitopes scores with CMV reactivation (any, & gt;150 IU/mL, & gt;500 IU/mL) in the first 8 weeks post-HCT. Results 170 CMV D-R+ HCT recipients were tested a median of 26 days (range 7-37 days) prior to HCT and had a median of 37 CMV antibody epitopes (IQR 29-50 epitopes, range 14-77 epitopes). The cumulative incidence of CMV reactivation was higher in patients with greater pre-HCT CMV antibody epitopes at each evaluated PCR threshold (Figure 1) and the effect appeared more pronounced in adults (Figure 2). High (≥ 4th quartile vs. 1st quartile), pre-HCT CMV antibody epitopes were associated with an increased risk of any CMV reactivation (adjusted Hazard Ratio [aHR]=4.1, 95% confidence interval [CI] 2.1-7.7, p & lt; 0.001) and at & gt;150 IU/mL (aHR=3.0, 95% CI 1.4-6.5 p=0.006) after adjusting for age, HLA-matching, and pre-HCT T-cell depletion ( & gt;150 IU/mL only). Figure 1Figure 2 Conclusion We observed a paradoxically increased risk of CMV reactivation in patients with high pre-HCT CMV VirScan scores. It is possible that pre-HCT CMV-specific humoral immunity as measured by VirScan is reflective of the burden of latent CMV or that CMV-specific antibodies may mediate antibody-dependent enhancement after HCT and thus facilitate reactivation. Future studies are needed to validate our findings in diverse cohorts and to elucidate the underlying mechanism of increased VirScan scores and associated risks of CMV reactivation. Disclosures Rachel A. Bender Ignacio, MD, MPH, Abbvie: Advisor/Consultant|SeaGen: Advisor/Consultant Joshua A. Hill, MD, Allovir: Advisor/Consultant|Allovir: Grant/Research Support|Covance/CSL: Advisor/Consultant|CRISPR: Advisor/Consultant|Deverra: Grant/Research Support|Gilead: Grant/Research Support|Karius: Advisor/Consultant|Karius: Grant/Research Support|Merck: Grant/Research Support|Octapharma: Advisor/Consultant|OptumHealth: Advisor/Consultant|Oxford Immunotec: Grant/Research Support|Pfizer: Advisor/Consultant|Symbio: Advisor/Consultant|Takeda: Advisor/Consultant Geoffrey Hill, M.D., FRACP, FRCPA, Applied Molecular Transport: Grant/Research Support|Compass Therapeutics: Grant/Research Support|Generon Corporation: Advisor/Consultant|Heat Biologics: Grant/Research Support|iTeos Therapeutics: Advisor/Consultant|iTeos Therapeutics: Grant/Research Support|Laevoroc Oncology: Grant/Research Support|NapaJen Pharma: Advisor/Consultant|Neoleukin Therapeutics: Advisor/Consultant|Serplus Technology: Grant/Research Support|Syndax Pharmaceuticals: Grant/Research Support Michael J. Boeckh, MD PhD, Allovir: Advisor/Consultant|Amazon: Grant/Research Support|Ansun Biopharma: Grant/Research Support|EvrysBio: Advisor/Consultant|Gates Ventures: Grant/Research Support|Gilead Sciences: Advisor/Consultant|Gilead Sciences: Grant/Research Support|GlaxoSmithKline: Advisor/Consultant|GlaxoSmithKline: Grant/Research Support|Helocyte: Advisor/Consultant|Janssen: Advisor/Consultant|Janssen: Grant/Research Support|Kyorin Pharmaceuticals: Advisor/Consultant|Merck: Advisor/Consultant|Merck: Grant/Research Support|Moderna: Advisor/Consultant|Moderna: Grant/Research Support|Regeneron: Grant/Research Support|ReViral: Advisor/Consultant|Symbio: Advisor/Consultant|Takeda: Grant/Research Support|Vir Biotechnology: Advisor/Consultant|Vir Biotechnology: Grant/Research Support.

Type of Medium: Online Resource

ISSN: 2328-8957

URL: Article

DOI: 10.1093/ofid/ofac492.549

Language: English

Publisher: Oxford University Press (OUP)

Publication Date: 2022

detail.hit.zdb_id: 2757767-3

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