COVID-19 Treatments
Johanna Taylor Katroscik, PharmD
Treatment options for COVID-19 infections have expanded over the past year, and so has the confusion around which treatments to use and when. While the use of ritonavir-boosted nirmatrelvir (Paxlovid) has been established as a preferred therapy option for preventing patients with a high risk of developing severe COVID-19 infection, there is growing debate over whether this treatment should be extended to low-risk populations.
Background
Paxlovid is one of the two currently available oral antiviral medications used to treat COVID-19 infections. It works by inhibiting replication of the SARS-CoV-2 (COVID-19) virus; in December of 2021 it was granted an EUA for use in patients who have a high risk of progressing to severe COVID-19 infection. The EUA was granted based on data from the EPIC-HR trial, a Phase 2–3 double-blind, randomized, controlled trial.
The trial consisted of 2,246 patients who had tested positive for COVID-19, were displaying symptoms, had not been vaccinated, were not hospitalized, and were at high risk for developing severe infection.
Patients either received 300 mg nirmatrelvir plus 100 mg ritonavir or only a placebo every 12 hours for 5 days. The study looked at safety, viral load, death, and hospitalization of patients infected with COVID-19; ultimately, the study demonstrated that patients who received Paxlovid had an 89% lower risk of progressing to severe COVID-19 when compared to patients who received placebo.
At the time of publication, NIH COVID-19 Treatment Guidelines recommend either remdesivir or Paxlovid as the two preferred therapy options for nonhospitalized patients with COVID-19.
Of the two, Paxlovid is the orally available option. It is authorized for use in patients who are at least 12 years old, have mild to moderate COVID-19, and are at high risk of progressing to severe COVID-19 infection. Common risk factors for progression to severe infection include cancer, chronic kidney disease, chronic lung diseases, diabetes, cystic fibrosis, HIV, and patients with immunodeficiencies.
While this list is not all-inclusive, practitioners can look up a full list of conditions that qualify a patient to be considered at high risk of progression by looking at CDC’s Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19: Information for Healthcare Profes-sionals webpage (www.cdc.gov/coron avirus/2019-ncov/hcp/clinical-care/underlyingconditions.html).
Use in low-risk populations
Although use has not been authorized for patients who have a low risk of developing severe COVID-19 infection, health care professionals have started discussing whether it could be beneficial to this patient population.
In a recent NEJM Journal Watch blog post, Paul E. Sax, MD, discussed his opinion on the potential benefits of recommending Paxlovid to patients who have a low risk of progression to severe COVID-19.
According to his blog post, the benefits of Paxlovid include that it has activity against all variants of COVID-19, has a “relatively good safety profile,” and that a pill is more convenient for patients than receiving I.V. therapy.
In the post, Sax posed the question of whether it could be used in lower-risk populations once an adequate supply is available. He pointed out that people who have a low risk of progressing to severe infection may still become severely infected and have the potential to develop long-COVID symptoms—both of which may be prevented if patients with a low risk of progression have access to an oral antiviral.
In April, Sax went as far as to pose the question as a survey on his Twitter account to see what other prescribers think; his results show a fairly even split of yes and no responses. While Sax believes that Paxlovid should be considered as an option for patients with low risk COVID-19, he welcomes an open dialogue and discourse in his blog post.
Conclusion
As of publication, Paxlovid was still only authorized for use in patients who have a high risk of developing severe COVID-19 infections. The supply of Paxlovid is also not unlimited, nor is it easily available to all patient populations. While health care providers continue to discuss the potential benefits of prescribing Paxlovid to expanded populations, a larger supply is needed, and more data should be collected before its use could be expanded to a broader patient population. ■