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Characteristics and outcomes of US Veterans at least 65 years of age at high risk of severe SARS-CoV-2 infection with or without receipt of oral antiviral agents - 28/02/23

Doi : 10.1016/j.jinf.2023.01.018 
Chris A. Gentry a, , Phoi Nguyen b, Sharanjeet K. Thind c, 1 , George Kurdgelashvili d, Riley J. Williams e
a Pharmacy Service, Oklahoma City Veterans Affairs Health Care System, 921 Northeast 13th Street (119), Oklahoma City, OK 73104, USA 
b PGY1 Pharmacy Resident, Pharmacy Service, Oklahoma City Veterans Affairs Health Care System, Oklahoma City, OK, USA 
c Infectious Diseases, Medical Service, Oklahoma City Veterans Affairs Health Care System, Oklahoma City, OK, USA 
d Medical Service, Oklahoma City Veterans Affairs Health Care System, Oklahoma City, OK, USA 
e Infectious Diseases, Oklahoma City Veterans Affairs Health Care System, Oklahoma City, OK, USA 

Corresponding author.

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Highlights

Molnupiravir and nirmatrelvir/ritonavir demonstrated favorable outcomes in randomized, controlled trials for patients at high risk of progression to severe SARS-CoV-2 infection, but data regarding patients 65 years and older were limited. Given the large number of precautions and contraindications to nirmatrelvir/ritonavir, older patients with high levels of comorbidities and high pill burdens may more often be selected for treatment with molnupiravir.
Our study's primary purpose was to compare outcomes of United States (US) Veterans 65 years of age and older who received either molnupiravir or nirmatrelvir/ritonavir with a propensity-matched group of Veterans 65 years of age and older who did not receive an antiviral agent in the first several weeks after emergency use authorization.
Our study also sought to characterize baseline differences between United States (US) Veterans 65 years and older who received molnupiravir, nirmatrelvir/ritonavir, or no antiviral drug.
The composite primary outcome of admission or death within 30 days of diagnosis was reached less often in those receiving either molnupiravir or nirmatrelvir/ritonavir versus those that received no antiviral (65/1370 [4.75%] vs. 139/1370 [10.2%]; odds ratio 0.44, 95% confidence interval 0.32-0.60, p<0.0001).
There were baseline differences between Veterans selected for molnupiravir vs. nirmatrelvir/ritonavir therapy, particularly with the number of concomitant medications with cautions or contraindications with nirmatrelvir/ritonavir.

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Abstract

Objectives

Molnupiravir and nirmatrelvir/ritonavir each became available in the United States (US) through the Food and Drug Administration (FDA) emergency use authorization (EUA) in December 2021 after their respective initial prospective randomized controlled trials demonstrated efficacy for patients with mild-to-moderate SARS-CoV-2 active infection considered to be at high risk for progression of disease and hospitalization. Although sufficiently powered for this wide group, the mean age for patients in these studies was only 43 and 46 years of age, respectively. We sought to compare outcomes of US Veterans 65 years and older who received either of these oral antivirals to those who did not receive oral antivirals for mild-to-moderate SARS-CoV-2 active infection.

Methods

The current project was a retrospective, observational, nationwide propensity-matched analysis comparing outcomes of US Veterans 65 years and older who received either of these oral antivirals to US Veterans 65 years and older who did not receive oral antivirals for mild-to-moderate SARS-CoV-2 active infection.

Results

The composite primary outcome of admission or death within 30 days of diagnosis was reached less often in those receiving either molnupiravir or nirmatrelvir/ritonavir versus those that received no antiviral (65/1370 [4.75%] vs. 139/1370 [10.2%]; odds ratio 0.44, 95% confidence interval 0.32-0.60, p<0.0001). Baseline differences between Veterans selected for molnupiravir vs. nirmatrelvir/ritonavir therapy were noted, particularly in the number of concomitant medications with cautions or contraindications with nirmatrelvir/ritonavir.

Conclusions

Our findings support the use of molnupiravir or nirmatrelvir/ritonavir in patients 65 years of age and older. Patients with higher medication caution and contraindication burdens to nirmatrelvir/ritonavir are selected for molnupiravir therapy, which in the absence of a prospective head-to-head trial, may limit any efforts to compare the effectiveness of the two drugs.

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Keywords : SARS-CoV-2 infection, Molnupiravir, Nirmatrelvir/ritonavir, Vaccination


Plan


 Summary: Patients 65 years of age and older had improved outcomes if given oral antiviral therapy for active SARS-CoV-2 infection. Molnupiravir is selected over nirmatrelvir/ritonavir in patients with multiple cautions or contraindications to nirmatrelvir/ritonavir, which may lead to baseline discrepancies when trying to compare groups receiving these therapies.


© 2023  Publié par Elsevier Masson SAS.
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