2024 Clinical Practice Guideline Update by the Infectious Diseases Society of America on the Management of COVID-19: Anti-SARS-CoV-2 Neutralizing Antibody Pemivibart for Pre-exposure Prophylaxis

Clinical Infectious Diseases, Год журнала: 2024, Номер unknown

Опубликована: Авг. 23, 2024

Abstract This article provides a focused update to the clinical practice guideline on treatment and management of patients with coronavirus disease 2019, developed by Infectious Diseases Society America. The panel presents recommendation use anti–severe acute respiratory syndrome 2 neutralizing antibody pemivibart as pre-exposure prophylaxis. is based evidence derived from systematic review adheres standardized methodology for rating certainty strength according GRADE (Grading Recommendations, Assessment, Development, Evaluation) approach. Information included in U.S. Food Drug Administration Emergency Use Authorization this agent.

Язык: Английский

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Safety and Efficacy of Pemivibart, a Long-Acting Monoclonal Antibody, for Prevention of Symptomatic COVID-19: Interim Results From the CANOPY Clinical Trial

medRxiv (Cold Spring Harbor Laboratory), Год журнала: 2024, Номер unknown

Опубликована: Ноя. 13, 2024

ABSTRACT Background Pemivibart received emergency-use authorization for prevention of symptomatic COVID-19 in moderate-to-severe immunocompromised individuals based on immunobridging analysis the phase 3 CANOPY trial. We report an interim safety and efficacy pemivibart with (cohort A) or without B) significant immunocompromise over a contemporary variant landscape. Methods Eligible participants (aged ≥18 years; SARS-CoV-2-negative) 2 intravenous 4500-mg infusions blinded placebo (2:1, cohort 90 days apart. Safety was primary endpoint. Composite incidence reverse transcription-polymerase chain reaction (RT-PCR)-confirmed COVID-19, hospitalization, all-cause mortality evaluated through month 6 12 B). Results In September-November 2023, 306 A; 317 162 B. The most common study drug-related adverse event infusion-related reactions A: 11/306 [3.6%]; B: 7/317 [2.2%, pemivibart] 0/162 [placebo]). Four 623 (0.6%) who experienced anaphylactic (2 non-serious; serious) within 24 hours dosing. A, composite endpoint (day 180) 11/298 (3.7%; deaths [suicide unknown cause]) first full dose pemivibart. B, 6/317 (1.9%) group 19/160 (11.9%) group, representing 84.1% standardized relative risk reduction (RRR) (95% CI, 60.9-93.5; nominal P <.0001) Through 12, 15/317 (4.7%; 1 death [cardiac failure]) 29/160 (18.1%) met clinical endpoint, respectively demonstrating 73.9% RRR 52.8-85.6; <.0001). Conclusions provided pre-exposure prophylactic against well-tolerated by immunocompromise. Anaphylaxis important risk. Clinical Trials Registration NCT06039449 Key points Pre-exposure administration doses approximately apart generally protection months

Язык: Английский

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Vaccination in Adults with Diabetes Mellitus: A Position Statement of the Diabetes Mellitus Study Group of the Portuguese Society of Endocrinology, Diabetes, and Metabolism

Deleted Journal, Год журнала: 2024, Номер unknown, С. 1 - 11

Опубликована: Окт. 8, 2024

Diabetes mellitus (DM) is a very prevalent chronic disease worldwide, including in Portugal, and it accompanied by significant morbidity mortality. People with DM must follow the National Vaccination Program. Additionally, Portuguese Society of Endocrinology, Diabetes, Metabolism (Sociedade Portuguesa de Endocrinologia, e Metabolismo, SPEDM) has drawn up position statement to promote speed relevant vaccination coverage people thus prevent infections reduce impact such diseases on population at increased risk. This includes against Streptococcus pneumoniae, influenza, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)/coronavirus disease-2019 (COVID-19), syncytial virus (RSV), herpes zoster (HZ), refers adult outside context pregnancy. In agreement Directorate-General Health (Direcção-Geral da Saúde, DGS), 2020, SPEDM recommended immunization 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13) 23-valent (PPV23) adults due risk invasive disease. Currently, as two more recent vaccines are available, preferentially recommends, this population, use 20-valent (PCV20) or, an alternative, 15-valent (PCV15) followed, interval 12 months, PPV23. Annual influenza should be carried out accordance DGS norms force; among groups greatest clinical risk, regardless age. SPEDM, DGS, also recommends SARS-CoV-2 DM, following proposed schedules. Considering hospitalization RSV infection for aged 60 or older, especially if other factors coexist. Finally, given greater susceptibility developing HZ its complications, 50 years well 18 older immune compromise, factors, personal history HZ. changing nature epidemiological context, will periodically reviewed.

Язык: Английский

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