A: President Biden announced a “Test to Treat” initiative in his State of the Union address last week.
The program aims to reduce hospitalizations from COVID-19 by providing fast, free, broad access to antivirals. To be eligible, you must have confirmed mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19.
TL;DR
At the heart of the initiative is the creation of “one stop shops” that pair rapid antigen COVID testing with immediate access to antivirals. These “one stop shops” will be rolled out in pharmacies (e.g. CVS or Walgreens, Kroger pharmacy), long term care facilities, and other federally qualified community health centers. All Test to Treat clinics will include access to a qualified health care provider to write the prescription. Pharmacists are not qualified to prescribe antivirals but play a vital role in managing potential drug-drug interactions.
If COVID-19 test results are positive and the patient is eligible for treatment, they will be offered a free course of antiviral pills, either Pfizer’s Paxlovid or Merck’s molnupiravir. Notably, both drugs must be given within five days of symptom onset.
The eligibility criteria are unclear but will likely resemble the “high risk” definition used in the clinical trial for Pfizer’s Paxlovid. This trial included patients with one or more risk factors including: age over 60, overweight/obesity (defined as BMI >25) and a “high risk” medical condition including: chronic lung disease (including asthma), chronic kidney disease, current smoker, immunosuppressive disease or immunosuppressive treatment, cardiovascular disease, hypertension, sickle cell disease, neurodevelopmental disorders, and active cancer.
While the Test to Treat initiative has significant potential to reduce the toll of COVID-19, there is a lot that needs to be worked out to ensure successful implementation. Some of the concerns include the safety of others in the clinic, accuracy of antigen tests, and supply of antivirals, appropriate prescribing, and access to counseling given potential interactions with other medications and health conditions.
THE DRUGS
In clinical trials, Paxlovid was nearly 90 percent effective at preventing hospitalizations or death, versus 30 percent for Merck’s molnupiravir. These trials were done in the Delta surge on unvaccinated patients. It’s not clear yet how effective these medications will be in other populations and contexts. Interim results of trials on vaccinated high-risk adults and unvaccinated standard-risk adults look promising. Both Paxlovid and molnupiravir received FDA Emergency Use Authorization for use in confirmed mild-to-moderate COVID-19 in patients “at high risk for progression to severe COVID-19, including hospitalization or death”. Molnupiravir is less effective and therefore approved for use in patients “for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.”
Paxlovid is actually two different medications packed together, both in tablet form: nirmatrelvir and ritonavir. It can be used in patients aged 12 and up, but is unsafe for patients with certain conditions like liver or kidney disease, or while taking various medications for blood pressure and heart health.
Molnupiravir has fewer interactions with other drugs but is restricted to use in patients 18 and older and is contraindicated during pregnancy due to potential impact on bone and cartilage growth.
A reader asked us our thoughts on the safety of these drugs. There is never a simple answer to “are they safe?” as all interventions carry risks. The key question is whether those risks are smaller than the risk of the alternative. The FDA’s decision to approve these drugs suggests that the benefits of treatment will, on average, outweigh the risks in the eligible population – those at high risk of severe COVID-19 outcomes. It’s certainly possible that there are adverse events we don’t yet understand, but this concern must be weighed against the known risks of untreated COVID-19 in high risk individuals. As with all drugs, their safety will be continually monitored and updated as we learn more.
NEXT STEPS
The program is slated to launch this month (March 2022) at hundreds of sites and to ramp up quickly. We are cheering for its success and hope that all the kinks will be worked out swiftly. As public health geeks, we are also excited for the precedent this program could set for other diseases.
If you’re at high risk for severe COVID-19, we recommend planning ahead and having a chat with your primary care provider to discuss options. The antivirals in the Test to Treat program are not the only authorized treatments for COVID-19. For some patients, monoclonal antibodies or remdesivir may be a more appropriate choice.
Last but not least, don’t forget that prevention and vaccines also help reduce hospitalizations. It doesn’t have to be one or the other. Let’s fight COVID-19 with everything we’ve got!
Links:
US HHS Fact Sheet: Biden Administration Launches Nationwide Test-to-Treat Initiative Ensuring Rapid ‘On the Spot’ Access to Lifesaving COVID Treatments
This local doc says President Biden’s ‘test to treat’ plan is ‘a major milestone.’ Here’s why.
Biden’s ‘test to treat’ covid plan draws praise, questions
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