‘Test-to-treat’ could transform the pandemic

The Biden administration’s “test-to-treat” initiative has the potential to be one of the most significant advances in health care delivery in recent years. It is also a positive example of how the pandemic is encouraging us to reinvent infectious disease protocols.

Early testing and rapid treatment are critical for the best individual health outcomes and to control the spread of the virus. Yet we must ensure that logistical challenges and issues of equitable access don’t hamper the potential of this groundbreaking initiative.                                            

As we move into the third year of the pandemic, fatigue around COVID-19 protocols and interventions, coupled with ongoing surges, means that our public health strategies must focus on local and nimble responses. The strategy behind the test-to-treat initiative is to use pharmacies to quickly identify those who are positive for COVID-19 through free rapid testing and then provide free oral antiviral treatments in the early days of illness when they are most effective. This could reduce the whole process to less than 30 minutes, reducing barriers to care and encouraging more rigorous uptake of testing and treatment among the broader population. 

We now know that the vaccines reduce the risk of severe disease and hospitalization, but they only provide temporary protection, at best, against infection from emerging variants. We need the additional layers of protection that test-to-treat can provide, especially for vulnerable populations.                       

We now have a range of COVID drugs that are powerful tools to improve health outcomes and reduce the burden on hospital systems. A new meta-analysis of oral antiviral therapies found they reduced the risk of hospitalization and death from COVID by nearly 67 percent. The current oral anti-viral drugs included in test-to-treat are Paxlovid and Molnupiravir, which have an advantage over Remdesivir as they don’t require infusion in a specialized facility over several hours.

But they are most effective only if accessed in the early days of infection. In clinical studies, Paxlovid was found to reduce the proportion of people with COVID-19 related hospital admission or death by about 88 percent compared to the placebo treatment arm only if they received the treatment within five days of the onset of symptoms. 

There could also be even more help on the way. New data suggest early use of the antidepressant fluvoxamine reduces the risk of all-cause hospitalization in symptomatic adult outpatients. A second drug, proxalutamide, has also shown promising trial results, lowering hospitalization or mortality in outpatients with mild-to-moderate COVID-19.

In March, the Department of Health and Human Services began distributing Pfizer’s Paxlovid and Merck’s Molnupiravir pills directly to participating test-to-treat pharmacy-based clinics. The Office of the Assistant Secretary for Preparedness and Response has also launched a program for long-term care pharmacies that will facilitate increased access for long-term care residents who are at increased risk for developing severe COVID-19.  

Test-to-treat is intended to eliminate any barriers to accessing testing and treatment in the early days of infection. The intended scenario is for patients to walk into a pharmacy that has a health clinic staffed by nurse practitioners, physician assistants or physicians where they can be tested for COVID-19 at no cost, and if treatment is deemed appropriate be prescribed oral antiviral therapy at no cost. 

Unfortunately, there are some steep disparities with the pharmacies that can offer this scenario. Only 2,800 of the approximately 50,000 retail pharmacies in the U.S. have health clinics staffed by nurse practitioners, physician assistants or physicians, and about a third of them are located in California, Florida, Illinois, Minnesota and Texas.

Additionally, just 12.5 percent of these pharmacies with health clinics are located in medically underserved areas. Not to mention the shortages of doctors and nurses that health systems are already facing in more traditional settings such as hospitals. This leaves much of the country, and especially populations who may be particularly vulnerable to COVID-19, without access to the test-to-treat initiative. 

One approach to resolving these disparities is to authorize pharmacists to prescribe oral antiviral drugs to patients with positive COVID-19 tests who meet the criteria. Not dissimilar to how pharmacists were given broad, national authorization to administer COVID-19 vaccines. Pharmacies are often used to alleviate the problem of health care deserts.

However, this poses problems of potential liability and fear of litigation for pharmacists. The American Medical Association (AMA) has rejected the concept of test-to-treat in pharmacies, whether or not they have a health clinic with nurse practitioners and physician assistants in them. The AMA cited concerns over the complexity of treating COVID and the high number of drug reactions, suggesting they seek care from their primary care physician instead.  

But this position seems to neglect the medical conditions pharmacists already successfully manage, such as heart failure and blood clotting, and the large number of Americans who don’t have access to a primary care physician.   

There also needs to be clear messaging and transparent communication about the effectiveness of oral antiviral drugs and the accessibility through the test-to-treat initiative. The recent launch of COVID.gov provides important tools for the public such as a Centers for Disease Control and Infection (CDC) community risk lookup allowing for situational awareness to determine infection risk. But more works needs to be done to restore trust in the public and encourage them to take advantage.

If we can resolve these disparities, the test-to-treat initiative could have huge potential to mitigate the consequences of future COVID-19 surges, and we could begin to introduce this model to other diseases. 

William Haseltine is president of ACCESS Health International. An infectious disease expert, Haseltine was formerly a Harvard Medical School professor and founder of the university’s cancer and HIV/AIDS research departments.