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Experience with sotrovimab treatment of SARS-CoV-2-infected patients in Denmark.
Rasmussen, Line Dahlerup; Lebech, Anne-Mette; Øvrehus, Anne; Poulsen, Birgitte Klindt; Christensen, Hanne Rolighed; Nielsen, Henrik; Johansen, Isik Somuncu; Omland, Lars Haukali; Wiese, Lothar; Helleberg, Marie; Storgaard, Merete; Dalager-Pedersen, Michael; Rasmussen, Thomas A; Benfield, Thomas; Petersen, Tonny Studsgaard; Andersen, Åse Bengård; Gram, Mie Agermose; Stegger, Marc; Edslev, Sofie Marie; Obel, Niels.
  • Rasmussen LD; Department of Infectious Disease, Odense University Hospital, Odense C, Denmark & Research Unit for Infectious Diseases, University of Southern Denmark, Odense, Denmark.
  • Lebech AM; Department of Infectious Diseases, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
  • Øvrehus A; Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.
  • Poulsen BK; Department of Infectious Disease, Odense University Hospital, Odense C, Denmark & Research Unit for Infectious Diseases, University of Southern Denmark, Odense, Denmark.
  • Christensen HR; Department of Clinical Pharmacology, Aalborg University Hospital, Aalborg, Denmark.
  • Nielsen H; Department of Clinical Pharmacology, Copenhagen University Hospital, Copenhagen, Denmark.
  • Johansen IS; Department of Infectious Diseases, Aalborg University Hospital, Aalborg, Denmark.
  • Omland LH; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
  • Wiese L; Department of Infectious Disease, Odense University Hospital, Odense C, Denmark & Research Unit for Infectious Diseases, University of Southern Denmark, Odense, Denmark.
  • Helleberg M; Department of Infectious Diseases, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
  • Storgaard M; Department of Infectious Diseases, Zealand University Hospital Roskilde, Denmark.
  • Dalager-Pedersen M; Department of Infectious Diseases, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
  • Rasmussen TA; Center of excellence for Health Immunity & Infections, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
  • Benfield T; Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.
  • Petersen TS; Department of Infectious Diseases, Aalborg University Hospital, Aalborg, Denmark.
  • Andersen ÅB; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
  • Gram MA; Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.
  • Stegger M; Doherty Institute for Infection and Immunity, University of Melbourne, Australia.
  • Edslev SM; Department of Infectious Diseases, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark.
  • Obel N; Department of Clinical Pharmacology, Copenhagen University Hospital, Copenhagen, Denmark.
Br J Clin Pharmacol ; 89(6): 1820-1833, 2023 06.
Article in English | MEDLINE | ID: covidwho-2318482
ABSTRACT

AIMS:

To evaluate the experience with use of sotrovimab following severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection in high-risk groups.

METHODS:

In a nationwide, population-based cohort study, we identified all individuals treated with sotrovimab (N = 2933) and stratified them by 4 high-risk groups (A) malignant haematological disease, (B) solid organ transplantation, (C) anti-CD20 therapy ≤1 year and (D) other risks. Cox regression analysis was used to calculate hazard ratios for hospitalization, death and associated prognostic factors.

RESULTS:

Of 2933 sotrovimab-treated individuals, 83% belonged to high-risk groups (37.6% haematological malignancy, 27.4% solid organ transplantation and 17.5% treatment with anti-CD20 ≤1 year). Only 17.8% had other risks (11.8% were pregnant, 10.7% primary immunodeficiency, 21.2% other malignancy, 4.3% received anti-CD20 >1 year and 52.0% other/unknown causes). Within 90 days of infusion, 30.2% were hospitalized and 5.3% died. The main prognostic factors were the predefined high-risk groups, mainly malignant haematological disease and age ≥65 years. Number of COVID-19 vaccines (≥3) was associated with a decreased risk of hospitalization. The Delta but not the Omicron BA.2 variant was associated with a higher risk of death compared to the BA.1 variant.

CONCLUSION:

More than 90% of the patients treated with sotrovimab belonged to the very high-risk groups as described in the Danish guidelines. Sotrovimab-treated individuals remained at a high risk of hospitalization and death which was strongly associated with the underlying immunocompromised state and age. Having received >3 COVID-19 vaccines was association with decreased risk of death and hospitalization.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Aged / Female / Humans / Pregnancy Country/Region as subject: Europa Language: English Journal: Br J Clin Pharmacol Year: 2023 Document Type: Article Affiliation country: Bcp.15644

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Aged / Female / Humans / Pregnancy Country/Region as subject: Europa Language: English Journal: Br J Clin Pharmacol Year: 2023 Document Type: Article Affiliation country: Bcp.15644