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- In his State of the Union Address, President Biden announced a new “test to treat” program to get people medication for COVID-19.
- “One-stop” sites will be opened soon that allow people who test positive to be treated with Food and Drug Administration (FDA) approved antiviral pills almost immediately, and at no cost.
- Antiviral drugs are intended to reduce rates of hospitalization and death in people at risk of developing severe outcomes from COVID-19.
President Biden announced a plan for the next phase of pandemic response at his State of the Union Address in March, which focuses on several goals including a ‘test to treat’ program that makes it easier for people with COVID-19 to get treatment.
The program will be established at locations that include pharmacy-based clinics, community health centers, long-term care facilities, and Department of Veterans Affairs facilities across the country.
Increased access to potent antiviral drugs
“One-stop” sites will open soon that allow anyone who’s tested positive for COVID-19 to be treated with FDA-approved antiviral pills almost immediately and at no cost.
These sites may be up and running “by March,” according to the White House.
Antiviral COVID-19 drugs are intended to reduce rates of hospitalizations and deaths in people with higher chances of developing severe outcomes from COVID-19. But they need to be given within 5 days of symptom onset.
Experts stress they’re not a replacement for vaccination but can help protect against severe disease if a person has COVID-19.
The drugs included in Biden’s plan are Pfizer’s Paxlovid and Merck’s molnupiravir, which were granted emergency use authorization (EUA) late last year.
Biden confirmed that Pfizer would produce 1 million doses in March and double that amount in April.
How antiviral drugs are prescribed
In the new plan, a person will be able to get tested for COVID-19 and then immediately get a prescription for treatment for the disease. Getting early treatment can significantly reduce the risk of developing severe COVID-19 symptoms.
In early research, Pfizer’s COVID-19 antiviral pill reduced the risk of severe symptoms by nearly 90 percent in high risk individuals. Merck’s antiviral pill had more modest effects and reduced the risk of severe symptoms by about 30 percent in high risk individuals.
Dr. Nikhil Bhayani, infectious diseases physician advisor at Texas Health Resources, said there are different circumstances when each antiviral may be given:
- Paxlovid is prescribed for patients with “high risk of progression of symptoms” and is prescribed within 5 days of symptom onset.
- Molnupiravir is used for people who test positive and have at least one risk factor for severe disease.
He emphasized that Paxlovid is only approved for use in people ages 12 and older, while molnupiravir isn’t recommended for those who are pregnant or for children.
The World Health Organization (WHO) recently noted that molnupiravir is a new medication, so there is little safety data.
“Because of these concerns and data gaps, molnupiravir should be provided only to non-severe COVID-19 patients with the highest risk of hospitalization,” said the WHO.
The organization pointed out this includes people who are older, unvaccinated, have immunodeficiencies, and those living with chronic diseases.
How does Paxlovid work?
While vaccines stimulate the body’s immune system to make antibodies and T-cells directed against the COVID virus, antivirals take another approach.
“The drug Paxlovid consists of two components: a molecule called PF-07321332 and an existing drug called ritonavir,” said Dr. Rich Parker, chief medical officer of Arcadia, a healthcare data and software company. “Ritonavir has been used successfully against HIV.”
Both drug components are protease inhibitors, meaning they block an enzyme called a protease.
“PF-07321332 attacks the virus, while ritonavir stops other enzymes from destroying PF-07321332,” said Parker.
Molnupiravir inhibits the virus
“The other antiviral drug molnupiravir is called a polymerase inhibitor that works by stopping the COVID virus’s genetic material from being replicated accurately,” said Parker.
He explained that the drug causes a viral enzyme called a polymerase to insert errors or mutations into the virus’ RNA.
“The mutations get copied repeatedly until there are so many mutations that the virus cannot survive,” he said.
Antiviral pills available at pharmacies
“The test to treat initiative is a start,” said Michael Ganio, PharmD, senior director of pharmacy practice and quality, American System of Health Pharmacists (ASHP). “It recognizes that pharmacies are an important access point for patients to receive COVID-19 treatments.”
According to Ganio, this initiative should ensure that pharmacies with associated urgent care clinics receive supplies of antivirals and streamline the patient’s testing experience for accessing these medications.
“Unfortunately, pharmacies with urgent care clinics are not as widespread and accessible as community pharmacies,” he warned.
That someone with authority to prescribe antiviral drugs must be involved in the process is a potential weakness for the program.
Ganio said the solution is to expand the test to treat initiative to include pharmacists as prescribers of antiviral drugs, “which will leverage the skills and knowledge of pharmacists in neighborhoods and communities across the country.”
Plan includes vaccine development against new variants
The test to treat initiative is just one part of Biden’s plan.
There will also be a vaccine development platform used to produce vaccines against any new variants within 100 days, ways to prevent future school and business shutdowns, and increased efforts toward global vaccine distribution.
“We must prepare for new variants,” Biden said during his State of the Union Address. “If necessary, we’ll be able to deploy new vaccines within 100 days instead of many more months or years.”
“I cannot promise a new variant won’t come,” he continued. “But I can promise you we’ll do everything within our power to be ready if it does.”
The bottom line
The Biden administration has announced a test to treat program that aims to provide rapid, free access to antiviral drugs that reduce the risk of hospitalization and death from COVID-19.
Experts say rapid testing to provide antiviral drug access is an excellent idea but must be expanded so pharmacists can prescribe them directly.
They also say Pfizer’s Paxlovid could interact with many other medications, so you should check with your doctor before using it.