COVID-19 Outpatient Treatment Recommendations—Maine, 2022 Open Access
Benowitz, Isaac (Spring 2024)
Abstract
Background
Risk factors for severe COVID-19 include older age, certain medical conditions and social behaviors, and inadequate COVID-19 vaccination. Two oral antiviral drugs first became available in 2021 and are highly effective at preventing progression to hospitalization or death in persons at higher risk for severe disease. Clinicians initially received limited guidance on who to treat in outpatient settings. CDC did not provide clinical treatment guidelines for outpatient treatment, including information on age- and vaccination-related risks, until June 2022. Federal allocation of limited supplies of monoclonal antibody and oral antiviral medications to each U.S. state led to clinician concerns about an inadequate supply for all eligible patients. Several health systems in Maine relied on the NIH prioritization tiers to establish who to treat. We sought to identify risk factors for hospitalization or death in COVID-19 patients in Maine in late 2021, develop clinical recommendations for outpatient COVID-19 treatment using antiviral drugs, and estimate the deaths potentially averted by using these local recommendations instead of NIH guidelines.
Methods
We described characteristics of COVID-19 cases reported to Maine CDC during the Delta wave period (October 3 to December 18, 2021). We defined categories by vaccination status, age, and comorbid medical conditions, aligning with the NIH prioritization groups. We used logistic regression to compare a model predicting severe disease from vaccination status, age, and comorbidities against a reduced model predicting severe disease from age alone. We used state-specific risk information to develop clinical treatment recommendations for prioritizing outpatient treatment and communicating severe disease risk. We incorporated information obtained informally from several groups of clinicians in the state. We calculated total COVID-19 cases leading to severe disease during the Delta wave in Maine that would have been treated with outpatient antivirals by following Maine’s top tier category had been treated.
Results
During the Delta wave period, there were 50,860 cases of COVID-19 reported to Maine CDC, including 12,733 cases with complete investigation records. We found an elevated risk of severe disease for some unvaccinated persons and some vaccinated persons, particularly in persons with comorbid conditions. The largest proportion of overall cases with severe disease were among unvaccinated persons age 75+ years old with 1+ risk factors and among fully-vaccinated persons age 75+ years old with 1+ risk factors. The full model statistics suggest the full model has a better fit. We created guidelines for COVID-19 treatment in outpatient settings. These were similar to the NIH tier groups but include some vaccinated persons in higher groups. Early versions of Maine guidelines used numbered tiers and specified which drugs a patient should have access to. Later, after it became clearer that there was a sufficient supply of antiviral medications to offer any available treatment to all eligible patients, Maine revised these guidelines, describing patients at high, higher, and highest risk for severe disease, supporting clinicians’ education to patients at risk. Using Maine Tier 1 would have treated 134% more people than using NIH Tier 1.
Discussion
We found notable levels of severe disease for older persons, including older vaccinated persons. We used case investigation data to develop recommendations for COVID-19 treatment that were more timely and relevant than NIH guidelines that relied on data collected prior to the widespread availability of vaccines. These recommendations supported clinicians in their treatment decisions and provided valuable insights into the risk for severe disease and provided a rational way for the state to encourage a uniform approach to COVID-19 treatment decisions in outpatient settings. There is an ongoing need to support clinicians who educate patients about risk factors for severe disease and make treatment recommendations.
Table of Contents
Chapter 1: Background Literature Review 8
Student Contribution 16
Chapter 2: Journal Article 17
Abstract 17
Background 18
Methods 20
Results 21
Discussion 23
Tables and Figures 26
Chapter 3: Future Directions/Public Health Implications 37
References 38
About this Master's Thesis
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