Oklahoma City VA Health Care Professionals Publish Unique COVID-19 Clinical Findings

Research efforts began in May of 2022 between OKCVAHCS experts from Pharmacy and Infectious Diseases Services to write an article titled “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.”  The peer-reviewed manuscript has just been published in Journal of Infection.

Molnupiravir and nirmatrelvir/ritonavir (Paxlovid) were the first two oral antiviral agents to show reductions in hospitalizations or deaths in certain high-risk patients with mild-to-moderate Covid-19 infection compared to placebo in randomized, controlled trials.

However, advanced age of 65 years and over, arguably the single most important high-risk attribute, was not well represented: the mean age for patients in these studies was only 43 and 46 years of age, respectively. In addition, those trials only included patients who had not been vaccinated for Covid-19, so little was known about the drug’s usefulness in patients who had been vaccinated.

Both drugs became available through US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) process early January 2022, right in the middle of the U.S. Covid-19 Omicron variant wave, but there wasn’t enough drug available to meet the need during the first few months.

VA Medical Centers such as the OKCVAHCS distributed as much of the drugs as available to Veterans with mild-to-moderate Covid-19 disease who fit the evidence-based criteria.

This conundrum led the VA team to the realization that they could possibly answer a couple of lingering questions from the randomized clinical trials if they examined data from the first month of availability: do patients aged 65 years and over benefit from treatment, with or without vaccination history? 

Thus, the objective of the study was to characterize and compare clinical outcomes (risk of hospitalization and death within 30 days of Covid-19 diagnosis) of Veterans 65 years of age prescribed molnupiravir or nirmatrelvir/ritonavir in the initial months of availability versus a “propensity-matched set” (similar comparative group) of Veterans that did not receive oral antivirals. OKCVAHCS used the VHA’s clinical administrative database to collect de-identified data nationwide.

This project demonstrated that Veterans aged 65 years and older who were diagnosed with mild-to-moderate Covid-19 infection benefited from treatment with either molnupiravir or Paxlovid, with decreased chances of hospitalization and decreased chances of death, regardless of vaccination status to different extents. 

This data will add to our ever-growing body of evidence to best guide treatment for our Veterans and the general population with Covid-19 infections. The VA team also documented that patients with more health conditions and larger prescription regimen burdens are often selected for molnupiravir therapy over Paxlovid than patients with fewer medical conditions and fewer prescriptions. This is due to a large amount of drugs that are contraindicated to take with Paxlovid due to severe drug interactions.

The VA team plans to continue this project with a second similar focus group evaluating another high-risk population that was also vastly underrepresented in other trials—those with immunocompromising conditions. The data collection for this project begins March 2023.

For more information about the OKCVAHCS research project, visit the Journal of Infection, or see attached article located at the link below.

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 - Journal of Infection

Phillip Ybarra, Public Affairs Specialist

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