Bamlanivimab efficacy in older and high BMI outpatients with Covid-19 selected for treatment in a lottery-based allocation process
et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab546, Nov 2021
25th treatment shown to reduce risk in
May 2021, now with p = 0.00049 from 22 studies, recognized in 11 countries.
Efficacy is variant dependent.
No treatment is 100% effective. Protocols
combine treatments.
6,200+ studies for
200+ treatments. c19early.org
|
Retrospective database analysis of 1257 PCR+ outpatients with age ≥65, BMI≥35, 191 receiving bamlanivimab via lottery. Authors note that the alpha variant was most common during the study period, and that efficacy against other variants can be much lower. Authors note confounding due to prioritization in the lottery and differential reporting in the database.
Standard of Care (SOC) for COVID-19 in the study country,
the USA, is very poor with very low average efficacy for approved treatments6.
Only expensive, high-profit treatments were approved for early treatment. Low-cost treatments were excluded, reducing the probability of early treatment due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.
This study is excluded in the after exclusion results of meta
analysis:
significant unadjusted confounding possible.
|
risk of death, 44.2% lower, RR 0.56, p = 1.00, treatment 1 of 191 (0.5%), control 10 of 1,066 (0.9%), NNT 241.
|
|
risk of hospitalization, 65.3% lower, RR 0.35, p = 0.04, treatment 16 of 191 (8.4%), control 121 of 1,065 (11.4%), odds ratio converted to relative risk, IPTW weighted logistic regression.
|
| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Conflicts of interest:
research funding from the drug patent holder, consulting for the pharmaceutical industry.
1.
Liu et al., Striking Antibody Evasion Manifested by the Omicron Variant of SARS-CoV-2, bioRxiv, doi:10.1101/2021.12.14.472719.
2.
Sheward et al., Variable loss of antibody potency against SARS-CoV-2 B.1.1.529 (Omicron), bioRxiv, doi:10.1101/2021.12.19.473354.
3.
VanBlargan et al., An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by several therapeutic monoclonal antibodies, bioRxiv, doi:10.1101/2021.12.15.472828.
4.
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.
Rubin et al., 3 Nov 2021, retrospective, USA, peer-reviewed, 7 authors, study period 9 December, 2020 - 25 February, 2021, average treatment delay 6.0 days.
Bamlanivimab Efficacy in Older and High-BMI Outpatients With COVID-19 Selected for Treatment in a Lottery-Based Allocation Process
Open Forum Infectious Diseases, doi:10.1093/ofid/ofab546
Background. Given the challenges associated with timely delivery of monoclonal antibody (mAb) therapy to outpatients with coronavirus disease 2019 (COVID-19) who are most likely to benefit, it is critical to understand the effectiveness of such therapy outside the context of clinical trials. Methods. This was a case-control study of 1257 adult outpatients with COVID-19, ≥65 years of age or with body mass index (BMI) ≥35, who were entered into a lottery for mAb therapy. Results. Patients who were called to be offered mAb therapy had a statistically significant 44% reduction in the odds of hospitalization within 30 days of a positive severe acute respiratory syndrome coronavirus 2 test compared with those who were not called (odds ratio [OR], 0.56; 95% CI, 0.36-0.89; P = .01). Patients who actually received bamlanivimab had a statistically significant 68% reduction in the odds of hospitalization compared with those who did not receive bamlanivimab (OR, 0.32; 95% CI, 0.11-0.93; P = .04). Conclusions. This study supports the effectiveness of bamlanivimab in reducing COVID-19-related hospitalizations in patients ≥65 or with BMI ≥35.
Author contributions. Dr. Rubin had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
References
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DOI record:
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