Outcomes of pregnant women exposed to Sotrovimab for the treatment of COVID-19 in the BA.1 Omicron predominant era (PRESTO)

Abstract

Background Sotrovimab, a monoclonal antibody with efficacy against SARS-CoV-2 including certain Omicron variants, has been used in treatment of mild-moderate COVID-19. Limited data exists regarding its use in pregnant women. Methods Electronic medical record review of pregnant COVID-19 patients treated with sotrovimab from 12/30/21 − 1/31/22 (Yale New Haven Health Hospital System [YNHHS]) was performed. Included were pregnant individuals ≥ 12 years, weighing ≥ 40 kg, with positive SARS-CoV-2 test (within 10 days). Those receiving care outside YNHHS or receiving other SARS-CoV-2 treatment were excluded. We assessed demographics, medical history, and Monoclonal Antibody Screening Score (MASS). The primary composite clinical outcome assessed included emergency department (ED) visit < 24 h, hospitalization, intensive care unit (ICU) admission, and/or death within 29 days of sotrovimab. Secondarily, adverse feto-maternal outcomes and events for neonates were assessed at birth or through the end of the study period, which was 8/15/22. Results Among 22 subjects, median age was 32 years and body mass index was 27 kg/m2. 63% were Caucasian, 9% Hispanic, 14% African-American, and 9% Asian. 9% had diabetes and sickle cell disease. 5% had well-controlled HIV. 18%, 46%, and 36% received sotrovimab in trimester 1, 2, and 3, respectively. No infusion/allergic reactions occurred. MASS values were < 4. Only 12/22 (55%) received complete primary vaccination (46% mRNA-1273; 46% BNT162b2; 8% JNJ-78,436,735); none received a booster. Conclusions Pregnant COVID-19 patients receiving sotrovimab at our center tolerated it well with good clinical outcomes. Pregnancy and neonatal complications did not appear sotrovimab-related. Though a limited sample, our data helps elucidate the safety and tolerability of sotrovimab in pregnant women.

Use of Monoclonal Antibodies in Pregnant Women Infected by COVID-19: A Case Series

“…Our study suggested that sotrovimab was the drug that achieved the greatest efficacy. Although there were no complications during pregnancy or in the prenatal period for all treatments, as demonstrated by other studies [ 42 , 43 , 44 ], sotrovimab obtained negativization of the infection in less time, especially in the group of pregnant women who were up to date with their vaccination schedule. Contrary to what was reported in a large meta-analysis, it does not depend on vaccination status [ 37 ].…”

Maternal and Newborn Outcomes of SARS-CoV-2/COVID-19 and Pregnancy: Parallels and Contrasts with Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome

“…However, promising preliminary findings suggest that sotrovimab may be an effective and well-tolerated treatment option for pregnant COVID-19 patients. 94 In this study, a cohort of 35 pregnant respondents was investigated to evaluate the utilization of nirmatrelvir-ritonavir during pregnancy. The results revealed that 51.4% of the participants were prescribed this medication, and 34.3% actually took it as per the prescription.…”

“…No individuals within the cohort received a booster dose during the study period. 94 The results of a small cohort study that included 30 pregnant and 16 lactating women demonstrated that all participants were immunogenic after receiving COVID-19 messenger RNA. 100…”