Effectiveness of Sotrovimab in Preventing COVID-19-Related Hospitalizations or Deaths Among US Veterans During Omicron BA.1.

Background: The real-world clinical effectiveness of sotrovimab in preventing coronavirus disease 2019 (COVID-19)-related hospitalization or mortality among high-risk patients diagnosed with COVID-19, particularly after the emergence of the Omicron variant, needs further research.
Method: Using data from the US Department of Veterans Affairs (VA) health care system, we adopted a target trial emulation design in our study. Veterans aged ≥18 years, diagnosed with COVID-19 between December 1, 2021, and April 4, 2022, were included. Patients treated with sotrovimab (n = 2816) as part of routine clinical care were compared with all eligible but untreated patients (n = 11,250). Cox proportional hazards modeling estimated the hazard ratios (HRs) and 95% CIs for the association between receipt of sotrovimab and outcomes.
Results: Most (90%) sotrovimab recipients were ≥50 years old, and 64% had ≥2 mRNA vaccine doses or ≥1 dose of Ad26.COV2. During the period that BA.1 was dominant, compared with patients not treated, sotrovimab-treated patients had a 70% lower risk of hospitalization or mortality within 30 days (HR, 0.30; 95% CI, 0.23-0.40). During BA.2 dominance, sotrovimab-treated patients had a 71% (HR, 0.29; 95% CI, 0.08-0.98) lower risk of 30-day COVID-19-related hospitalization, emergency room visits, or urgent care visits (defined as severe COVID-19) compared with patients not treated.
Conclusions: Using national real-world data from high-risk and predominantly vaccinated veterans, administration of sotrovimab, compared with contemporary standard treatment regimens, was associated with reduced risk of 30-day COVID-19-related hospitalization or all-cause mortality during the Omicron BA.1 period.
Competing Interests: Potential conflicts of interest. V.C.M. reports research grants from the CDC, Gilead Sciences, NIH, Veterans Affairs, and ViiV Healthcare; reports honoraria from Eli Lilly and Company; has served as an advisory board member for Eli Lilly and Company and Novartis; and has participated as a study section chair for the NIH. Y.Y.X., G.Z., and C.K. report receiving grants from the US Food and Drug Administration through an interagency agreement with the Veterans Health Administration and from the US Department of Veterans Affairs Office of Rural Health. Y.Y.X., G.Z., and J.S. also report receiving funding from Vir Biotechnology to the US Department of Veterans Affairs for other research projects outside the submitted work. Y.Y.X. and V.C.M. are supported by VA/BLRD VA SEQCURE (821-SD-ID-42403). V.C.M. received support from the Emory Center for AIDS Research (P30 AI050409). A.A.G. received COVID-19 research project funding from the National Institutes of Health, Department of Defense, Centers for Disease Control and Prevention, AbbVie, and Faron Pharmaceuticals, outside the submitted work. M.M.C., C.R., and S.S. are employees of and shareholders of Vir Biotechnology. M.D. is employee of and shareholder of GSK. All other authors report no potential conflicts.
(Published by Oxford University Press on behalf of Infectious Diseases Society of America 2023.)