Retrospective 34,160 COVID-19 patients in the USA treated with sotrovimab matched to 68,320 untreated patients from May 2021-April 2022, during periods when Delta and early Omicron were predominant. Sotrovimab-treated patients had significantly lower rates of hospitalization, mortality, ICU admission, and need for respiratory support compared to matched untreated patients.
Authors exclude patients using antivirals in the control group but not the treatment group.
Confounding by treatment propensity. This study analyzes a population
where only a fraction of eligible patients received the treatment. Patients
receiving treatment may be more likely to follow other recommendations, more
likely to receive additional care, and more likely to use additional
treatments that are not tracked in the data (e.g., nasal/oral hygiene
c19early.org, c19early.org (B), vitamin D
c19early.org (C), etc.) — either because the physician
recommending sotrovimab also recommended them, or
because the patient seeking out sotrovimab is more
likely to be familiar with the efficacy of additional treatments and more
likely to take the time to use them.
Therefore, these kind of studies may
overestimate the efficacy of treatments.
Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.1 Liu, Sheward, VanBlargan, BA.4, BA.5 Haars, XBB.1.9.3, XBB.1.5.24, XBB.2.9, CH.1.1 Pochtovyi, and no efficacy for BA.2 Zhou, ХВВ.1.9.1, XBB.1.16, BQ.1.1.45, and CL.1 Pochtovyi. US EUA has been revoked.
6.
Pochtovyi et al., In Vitro Efficacy of Antivirals and Monoclonal Antibodies against SARS-CoV-2 Omicron Lineages XBB.1.9.1, XBB.1.9.3, XBB.1.5, XBB.1.16, XBB.2.4, BQ.1.1.45, CH.1.1, and CL.1, Vaccines,
doi:10.3390/vaccines11101533.mdpi.com, doi.org.
|
risk of death, 80.3% lower, RR 0.20, p < 0.001, treatment 52 of 34,160 (0.2%), control 527 of 68,320 (0.8%), NNT 162.
|
|
risk of ICU admission, 29.8% lower, RR 0.70, p < 0.001, treatment 147 of 34,160 (0.4%), control 419 of 68,320 (0.6%), NNT 547.
|
|
risk of hospitalization, 16.4% lower, RR 0.84, p < 0.001, treatment 1,350 of 34,160 (4.0%), control 3,231 of 68,320 (4.7%), NNT 129.
|
|
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
|
Bell et al., 27 Nov 2023, retrospective, USA, peer-reviewed, 6 authors.
Real-world Effectiveness of Sotrovimab for COVID-19: Evidence from United States (US) Administrative Claims Data
MS Christopher F Bell, PhD Tasneem Lokhandwala, PhD Daniel C Gibbons, PhD Myriam Drysdale, MS Jane Wang, MSc Emily Lloyd
Background. This study compared outcomes among COVID-19 patients (pts) treated with the monoclonal antibody (mAb) sotrovimab matched to untreated pts. Methods. Administrative claims (Komodo Health) were used to identify pts (≥ 12 years) diagnosed with COVID-19 (ICD-10: U0.7.1) in an ambulatory setting in the US (26 May 2021-5 April 2022). The sotrovimab cohort included pts meeting sotrovimab's Emergency Use Authorization (EUA) criteria and receiving sotrovimab ≤ 10 days from diagnosis (index date = day of infusion). The untreated cohort included pts with no evidence of early/prophylaxis mAb or antiviral treatments (index date imputed based on the time distribution between diagnosis and sotrovimab infusion for their matched counterpart from the sotrovimab cohort). Pts were required to be continuously enrolled for ≥ 12 months pre-index and ≥ 29 days post-index (excluding death). Exact matching and propensity-score matching (EM/PSM) methods were used to construct 1:2 matched cohorts of sotrovimab-treated and untreated patients (EM; age [≤ 5 years], diagnosis date [≤ 14 days], state: PSM; gender, payor, region,
