Compassionate Use of Remdesivir in Pregnant Women With Severe Coronavirus Disease 2019

Author:

Burwick Richard M1,Yawetz Sigal23,Stephenson Kathryn E34,Collier Ai-Ris Y34,Sen Pritha35,Blackburn Brian G6,Kojic E Milunka7,Hirshberg Adi8,Suarez Jose F6,Sobieszczyk Magdalena E9,Marks Kristen M10,Mazur Shawn11,Big Cecilia12,Manuel Oriol13,Morlin Gregory14,Rose Suzanne J15,Naqvi Mariam1,Goldfarb Ilona T35,DeZure Adam16,Telep Laura16,Tan Susanna K16,Zhao Yang16,Hahambis Tom16,Hindman Jason16,Chokkalingam Anand P16,Carter Christoph16,Das Moupali16,Osinusi Anu O16,Brainard Diana M16,Varughese Tilly A17,Kovalenko Olga17,Sims Matthew D18,Desai Samit19,Swamy Geeta20,Sheffield Jeanne S21,Zash Rebecca34,Short William R8

Affiliation:

1. Cedars Sinai Medical Center, Obstetrics and Gynecology, Los Angeles, California, USA

2. Brigham and Women’s Hospital, Department of Medicine, Boston, Massachusetts, USA

3. Harvard Medical School, Boston, Massachusetts, USA

4. Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA

5. Massachusetts General Hospital, Boston, Massachusetts, USA

6. Stanford University, Stanford, California, USA

7. Mount Sinai Morningside and Mount Sinai West, New York, New York, USA

8. Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA

9. Columbia University, New York, New York, USA

10. Weill Cornell Medicine, New York, New York, USA

11. NewYork Presbyterian/Weill Cornell Medical Center, New York, New York, USA

12. Beaumont Hospital, Dearborn, Michigan, USA

13. Lausanne University Hospital, Lausanne, Switzerland

14. Valley Medical Center, Renton, Washington, USA

15. Stamford Health, Stamford, Connecticut, USA

16. Gilead Sciences Inc, Foster City, California, USA

17. Rutgers New Jersey Medical School, Newark, New Jersey, USA

18. Oakland University William Beaumont School of Medicine, Rochester, Michigan, USA

19. Hackensack Meridian, Hackensack University Medical Center, Hackensack, New Jersey, USA

20. Duke University School of Medicine, Durham, North Carolina, USA

21. Johns Hopkins Medicine, Baltimore, Maryland, USA

Abstract

Abstract Background Remdesivir is efficacious for severe coronavirus disease 2019 (COVID-19) in adults, but data in pregnant women are limited. We describe outcomes in the first 86 pregnant women with severe COVID-19 who were treated with remdesivir. Methods The reported data span 21 March to 16 June 2020 for hospitalized pregnant women with polymerase chain reaction–confirmed severe acute respiratory syndrome coronavirus 2 infection and room air oxygen saturation ≤94% whose clinicians requested remdesivir through the compassionate use program. The intended remdesivir treatment course was 10 days (200 mg on day 1, followed by 100 mg for days 2–10, given intravenously). Results Nineteen of 86 women delivered before their first dose and were reclassified as immediate “postpartum” (median postpartum day 1 [range, 0–3]). At baseline, 40% of pregnant women (median gestational age, 28 weeks) required invasive ventilation, in contrast to 95% of postpartum women (median gestational age at delivery 30 weeks). By day 28 of follow-up, the level of oxygen requirement decreased in 96% and 89% of pregnant and postpartum women, respectively. Among pregnant women, 93% of those on mechanical ventilation were extubated, 93% recovered, and 90% were discharged. Among postpartum women, 89% were extubated, 89% recovered, and 84% were discharged. Remdesivir was well tolerated, with a low incidence of serious adverse events (AEs) (16%). Most AEs were related to pregnancy and underlying disease; most laboratory abnormalities were grade 1 or 2. There was 1 maternal death attributed to underlying disease and no neonatal deaths. Conclusions Among 86 pregnant and postpartum women with severe COVID-19 who received compassionate-use remdesivir, recovery rates were high, with a low rate of serious AEs.

Funder

Gilead Sciences

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Microbiology (medical)

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