Miranda Kelly started feeling bad enough to be afraid the day after discovering Covid-19 in her system in June. Kelly, a 44-year-old certified nursing assistant who has diabetes and high blood pressure, had difficulty breathing. Her symptoms were so extreme that she was sent to the hospital.
When her husband, Joe, 46, became ill, they prayed to God that they wouldn’t have to utilize ventilators. She remarked, “I hoped to God that we wouldn’t have to utilize ventilators.” ‘Who is going to take care of these kids? We were puzzled.
The Kellys, who lives in Seattle, consented to participate in a clinical trial at the neighboring FHCRC (Fred Hutchinson Cancer Research Center) as part of a global effort to test an antiviral drug that could stop Covid early, immediately after their diagnosis.
The couple was taking four pills twice daily by the following day. Many participants said their symptoms had improved after a week, but they didn’t know if they’d taken an active treatment or a placebo. They were back to normal after fourteen days.
Miranda Kelly stated, “I’m not sure if we got the therapy, but I have a feeling we did.” “With all of these underlying challenges, I expected a speedy recovery.”
The Kellys are working on a short-term regimen of daily treatments that can combat the virus immediately after diagnosis and potentially prevent symptoms from developing after exposure, which could be the world’s next chance to end Covid.
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“Oral antivirals cannot only shorten the duration of one’s Covid-19 syndrome but also reduce transmission to members of one’s household if one is sick,” said Timothy Sheahan, a virologist at North Carolina-Chapel Hill’s University. The latter assisted in the development of the treatments.
Antivirals are used to treat various viral illnesses, including hepatitis C and HIV, among others. Tamiflu, a commonly prescribed medication that can shorten the length of influenza and reduce the risk of hospitalization when given early, is one of the most well-known.
The drugs, which were created to treat and prevent viral infections in humans and animals, work differently depending on the type of infection. They can, however, be tweaked to boost the immune system’s ability to fight infection, block receptors that allow viruses to enter healthy cells, and decrease the amount of active virus in the body.
At least three good antivirals for Covid are being tested in clinical trials, according to Carl Dieffenbach, director of AIDS division at the NIAID (National Institute of Allergy and Infectious Diseases), who is overseeing antiviral development. Results are expected by late fall or winter.
“I believe we will know what these tablets are capable of within the next few months,” Dieffenbach said.
According to Dieffenbach, the front-runner is Molnupiravir, a medication developed by Merck & Co. and Ridgeback Biotherapeutics. In Seattle, the Kellys are putting their product to the test. PF-07321332, a Pfizer candidate, and AT-527, an antiviral developed by Roche and Atea Pharmaceuticals, are two other candidates.
They work by hampering the virus’s ability to replicate in human cells. In the case of molnupiravir, the enzyme that repeats the viral genetic code is driven to generate so many errors that the virus cannot reproduce. As a result, a patient’s viral load is lowered, infection time is reduced, and a potentially fatal immune reaction is averted.
So yet, only remdesivir, an antiviral drug, has been approved to treat Covid. It is, however, only given intravenously to patients who are unwell enough to be hospitalized in a hospital and is not intended for general use. On the other hand, the top competitors under examination can be packaged as pills.
Sheahan led an early study in mice that showed molnupiravir helped lower SARS-CoV-2, the virus that causes Covid, early illness. Sheahan also worked on redelivering in the preclinical stage. After the recipe was discovered at Emory University, Ridgeback and Merck obtained it.
Clinical trials followed, including an early test with 202 people this spring that showed molnupiravir effectively reduced infectious virus levels. Merck CEO Robert Davis said earlier this month that the firm expects results from its larger phase 3 tests in the coming weeks, with the potential of pursuing FDA emergency use authorization “before year’s end.”
On September 1, Pfizer initiated a combined phase 2 and 3 trial of its medication, and Atea officials anticipate phase 2 and phase 3 trial results later this year.
“Distribution may begin quickly” if the results are positive, and any chemical can be used in an emergency.
Millions of patients could soon have access to a daily orally given treatment, ideally one pill, that could be taken for five to ten days after the first confirmation of Covid infection.
“When we get there,” said Dr. Daniel Griffin, an infectious diseases and immunology expert at Columbia University. “It would be amazing to have this all over the country, so patients could receive it the same day they were diagnosed.”
Oral antivirals for treating coronavirus infections, which were previously overlooked due to a lack of interest, are now a source of fierce competition and funding. In June, the Biden administration said that it had agreed to pay $1.2 billion for 1.7 million treatment sessions of Merck’s molnupiravir if it obtained emergency or full approval. In the same month, the administration announced a $3.2 billion investment in the Antiviral Program for Pandemics, which intends to develop antivirals for the Covid issue and beyond, according to Dieffenbach.
According to Sheahan, the pandemic reignited a long-dormant search for efficient coronavirus antiviral medications. Despite the fact that scientists were worried by the SARS virus, which first appeared in 2003 and was followed by the Middle East respiratory disease, or MERS, in 2012, research activities stagnated as the epidemics waned.
“The business push to develop any products simply went down the tubes,” Sheahan explained.
Recruitment of participants is proving tough.
Antiviral drugs would be combined with monoclonal antibody treatment, which is now being used to treat and prevent Covid-related significant illness and hospitalizations. Monoclonal antibodies, which mimic the body’s natural immune response to infection, were easier to make but required intravenous infusions to be administered.
The federal government covers most monoclonal products at $2,000 per dose. It’s too early to say how antivirals will compare in terms of cost.
According to Griffin, antiviral drugs such as monoclonal antibodies are not a substitute for immunization. They’d be yet another weapon in Covid’s arsenal. “It’s good to have another option,” he remarked.
According to Dr. Elizabeth Duke, a Fred Hutch research associate directing the molnupiravir trial, finding enough participants for clinical studies, which require hundreds of people, has been a challenge in quickly producing antiviral drugs.
Participants must be unvaccinated and recruited in the experiment within five days of a positive Covid test. Interns make 100 phone calls per day to newly Covid-positive people in the Seattle region, and the vast majority of them refuse.
“In general, there is a lot of doubt about the scientific approach,” Duke noted. “And some of the interns are being mistreated by some individuals.”
If the antiviral pills prove to be effective, the next stage will be to create a delivery mechanism that would allow them to reach people as soon as they test positive. Griffin compared it to UnitedHealthcare’s Tamiflu initiative, which last year provided Tamiflu kits to 200,000 at-risk patients enrolled in the insurer’s Medicare Advantage plans.
Merck executives predicted that the company would have manufactured more than 10 million courses of medication by the end of the year. Atea and Pfizer have not made similar estimates.
Perhaps even more so? Antivirals are being explored to see whether they can prevent infection after exposure to the virus.
Duke, also in charge of a preventive trial, continued, “Think about it.” “You could give it to every family member or every student at a school,” says the author, “and then we’re talking about a possible return to normalcy.”