Effectiveness of Casirivimab-Imdevimab and Sotrovimab During a SARS-CoV-2 Delta Variant Surge

Abstract

DESIGN, SETTING, AND PARTICIPANTSThis study comprised 2 parallel studies: (1) a propensity score-matched cohort study of mAb treatment vs no mAb treatment and (2) a randomized comparative effectiveness trial of casirivimab-imdevimab and sotrovimab. The cohort consisted of patients who received mAb treatment at the University of Pittsburgh Medical Center outpatient infusion centers and emergency departments from July 14 to September 29, 2021. Participants were patients with a positive SARS-CoV-2 test result who were eligible to receive mAbs according to emergency use authorization criteria.EXPOSURE For the trial, patients were randomized to either intravenous casirivimab-imdevimab or sotrovimab according to a system therapeutic interchange policy. MAIN OUTCOMES AND MEASURESFor the cohort study, risk ratio (RR) estimates for the primary outcome of hospitalization or death by 28 days were compared between mAb treatment and no mAb treatment using propensity score-matched models. For the comparative effectiveness trial, the primary outcome was hospital-free days (days alive and free of hospitalization) within 28 days after mAb treatment, where patients who died were assigned −1 day in a bayesian cumulative logistic model adjusted for treatment location, age, sex, and time. Inferiority was defined as a 99% posterior probability of an odds ratio (OR) less than 1. Equivalence was defined as a 95% posterior probability that the OR was within a given bound. RESULTSA total of 3069 patients (1023 received mAb treatment: mean [SD] age, 53.2 [16.4] years; 569 women [56%]; 2046 had no mAb treatment: mean [SD] age, 52.8 [19.5] years; 1157 women [57%]) were included in the prospective cohort study, and 3558 patients (mean [SD] age, 54 [18] years; 1919 women [54%]) were included in the randomized comparative effectiveness trial. In propensity score-matched models, mAb treatment was associated with reduced risk of hospitalization or death (RR, 0.40; 95% CI, 0.28-0.57) compared with no treatment. Both (continued)

Experience with sotrovimab treatment of SARS‐CoV‐2‐infected patients in Denmark

“…Huang et al . 32 used real‐world data to estimate the effects of sotrovimab and found reduced risk of hospitalization or death (relative risk of hospitalization or death: 0.60; 95%CI: 0.37–1.00), which is in accordance with the findings from the COMET‐ICE trial. 3 Nevertheless, studies on immunocompromised patients are scarce.…”

Monoclonal Antibodies for Treatment of SARS-CoV-2 Infection During Pregnancy

“…Although COVID-19–associated outcomes were similar between groups, the event frequency for hospitalization and death were lower than previously reported frequencies for the general population for both mAb-treated and nontreated groups ( 31–33 ). The low event frequency may reflect the younger population with few comorbidities and inclusion of fully vaccinated patients in the cohort.…”

Association between treatment failure and hospitalization after receipt of neutralizing monoclonal antibody treatment for COVID-19 outpatients

“…They provide immediate, passive immunity against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the virus that causes COVID-19. Phase III clinical trials [ 2 – 5 ] and real-world data [ 6 – 8 ] demonstrated the effectiveness of neutralizing mAbs in reducing hospitalization and mortality among early symptomatic COVID-19 patients. Based on the strength of these trials, the US Food and Drug Administration (FDA) currently recommends mAb therapy for non-hospitalized patients when both ritonavir-boosted nirmatrelvir (Paxlovid) and remdesivir are not available, feasible to use, or clinically appropriate [ 9 ].…”