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Two new oral medicines for treating COVID-19 are stirring up excitement—and a slew of questions.
The US Food and Drug Administration (FDA) green lighted Pfizer's Paxlovid for emergency use on December 22, while Merck's molnupiravir got the nod a day later, giving doctors two new options for treating at-risk COVID patients before they land in the hospital.
The prospect of prescribing pills to outpatients marks "a watershed moment in the pandemic," Jacob Lemieux, MD, PhD, instructor in medicine at Harvard Medical School, told reporters during a December 27 briefing led by the Massachusetts Consortium on Pathogen Readiness. At present, though, these drugs are not yet widely available. And, as Dr. Lemieux pointed out, certain logistical challenges lie ahead, namely the current shortage of COVID tests needed to confirm SARS-CoV-2 infections.
So how do the new antiviral medications fight the virus? Who can take them? And what are the potential benefits and risks? Here's what experts are saying about the latest additions to clinicians' COVID-19 toolbox porn.
New-COVID-Antivirals-GettyImages-450742185
GETTY IMAGES / DESIGN BY JO IMPERIO
Who is eligible for Paxlovid and molnupiravir?
Pfizer's Paxlovid is for adults and children 12 and older (who weigh at least 40 kilograms, or just over 88 pounds). Merck's molnupiravir is for adults only, ages 18 and older.
Each medicine may be prescribed for COVID patients with "mild-to-moderate" coronavirus disease and who are at "high risk" of developing severe disease, meaning possible hospitalization or death.
While people of any age can become severely ill with COVID, older adults and those with underlying medical conditions may be at greater risk, notes the US Centers for Disease Control and Prevention (CDC). Likewise, people from certain racial and ethnic minorities and individuals with disabilities are more likely to have poorer outcomes, per the CDC.
One other caveat: the emergency use authorization (EUA) for Merck's molnupiravir stipulates that it's for people "for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate."
Peter Anderson, PharmD, professor in the Department of Pharmaceutical Sciences at the University of Colorado's Skaggs School of Pharmacy and Pharmaceutical Sciences, interprets that language to mean that the drug might be prescribed, say, if someone doesn't have access to monoclonal antibody therapy or cannot take Paxlovid because of a drug interaction. "The next-in-line is the Merck drug; that's kind of the way I see it," Anderson tells Health.
Rajesh Gandhi, MD, professor of medicine at Harvard Medical School and an infectious disease specialist at Massachusetts General Hospital, told reporters he thinks the FDA made "the right call" by positioning molnupiravir as an alternative to other treatments, such as Pfizer's Paxlovid, Gilead Sciences' infusion therapy remdesivir, and GlaxoSmithKline's monoclonal antibody therapy sotrovimab. That "seems right," he said, citing the drug's lower efficacy and certain safety concerns.
Here's How Monoclonal Antibody Treatments Fight COVID-19, Plus How to Know If You're Eligible
What are the benefits of Paxlovid and molnupiravir?
Until now, the options for treating COVID outside of the hospital have been quite limited. The antiviral drug remdesivir, an FDA-approved intravenous (IV) medication for hospitalized patients, (marketed by Gilead Sciences as Veklury) may be given to outpatients "off label."
A few monoclonal antibody treatments, namely Regeneron Pharmaceuticals' REGEN-COV (casirivimab and imdevimab), Eli Lilly and Company's bamlanivimab plus etesevimab, and GlaxoSmithKline's sotrovimab, are cleared for emergency use. While these lab-made antibodies can help a person's immune system recognize and respond to the virus, they're mostly delivered by intravenous infusion, and sometimes by injection, which makes them much less convenient than popping a pill.
What's more, federal health officials recently announced a pause on shipments of bamlanivimab, etesevimab, and REGEN-COV to health care providers. Citing FDA data, the US Department of Health and Human Services said these treatments are unlikely to be effective against the Omicron variant. Only sotrovimab "appears to retain activity" against the variant.
No wonder the recently announced EUAs for drugs that may be prescribed to non-hospitalized COVID patients come as welcome news. Pfizer's Paxlovid is the very first oral pill for treating the coronavirus infection, while Merck's molnupiravir gives doctors a backup alternative. Beyond expanding the pool of potential treatments, these oral medicines will make it easier to treat people at home.
"The fact that there's a pill that can be administered is much more convenient that having to administer infusions," Tom Gallagher, PhD, professor of microbiology and immunology at Loyola University Chicago in Maywood, Illinois, tells Health. "I would imagine compliance would be high because it's only a five-day course."
Along with vaccines, these new oral treatments have enormous potential to allow us to hopefully get back to normal life, Dr. Lemieux observed.
The US Food and Drug Administration (FDA) green lighted Pfizer's Paxlovid for emergency use on December 22, while Merck's molnupiravir got the nod a day later, giving doctors two new options for treating at-risk COVID patients before they land in the hospital.
The prospect of prescribing pills to outpatients marks "a watershed moment in the pandemic," Jacob Lemieux, MD, PhD, instructor in medicine at Harvard Medical School, told reporters during a December 27 briefing led by the Massachusetts Consortium on Pathogen Readiness. At present, though, these drugs are not yet widely available. And, as Dr. Lemieux pointed out, certain logistical challenges lie ahead, namely the current shortage of COVID tests needed to confirm SARS-CoV-2 infections.
So how do the new antiviral medications fight the virus? Who can take them? And what are the potential benefits and risks? Here's what experts are saying about the latest additions to clinicians' COVID-19 toolbox porn.
New-COVID-Antivirals-GettyImages-450742185
GETTY IMAGES / DESIGN BY JO IMPERIO
Who is eligible for Paxlovid and molnupiravir?
Pfizer's Paxlovid is for adults and children 12 and older (who weigh at least 40 kilograms, or just over 88 pounds). Merck's molnupiravir is for adults only, ages 18 and older.
Each medicine may be prescribed for COVID patients with "mild-to-moderate" coronavirus disease and who are at "high risk" of developing severe disease, meaning possible hospitalization or death.
While people of any age can become severely ill with COVID, older adults and those with underlying medical conditions may be at greater risk, notes the US Centers for Disease Control and Prevention (CDC). Likewise, people from certain racial and ethnic minorities and individuals with disabilities are more likely to have poorer outcomes, per the CDC.
One other caveat: the emergency use authorization (EUA) for Merck's molnupiravir stipulates that it's for people "for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate."
Peter Anderson, PharmD, professor in the Department of Pharmaceutical Sciences at the University of Colorado's Skaggs School of Pharmacy and Pharmaceutical Sciences, interprets that language to mean that the drug might be prescribed, say, if someone doesn't have access to monoclonal antibody therapy or cannot take Paxlovid because of a drug interaction. "The next-in-line is the Merck drug; that's kind of the way I see it," Anderson tells Health.
Rajesh Gandhi, MD, professor of medicine at Harvard Medical School and an infectious disease specialist at Massachusetts General Hospital, told reporters he thinks the FDA made "the right call" by positioning molnupiravir as an alternative to other treatments, such as Pfizer's Paxlovid, Gilead Sciences' infusion therapy remdesivir, and GlaxoSmithKline's monoclonal antibody therapy sotrovimab. That "seems right," he said, citing the drug's lower efficacy and certain safety concerns.
Here's How Monoclonal Antibody Treatments Fight COVID-19, Plus How to Know If You're Eligible
What are the benefits of Paxlovid and molnupiravir?
Until now, the options for treating COVID outside of the hospital have been quite limited. The antiviral drug remdesivir, an FDA-approved intravenous (IV) medication for hospitalized patients, (marketed by Gilead Sciences as Veklury) may be given to outpatients "off label."
A few monoclonal antibody treatments, namely Regeneron Pharmaceuticals' REGEN-COV (casirivimab and imdevimab), Eli Lilly and Company's bamlanivimab plus etesevimab, and GlaxoSmithKline's sotrovimab, are cleared for emergency use. While these lab-made antibodies can help a person's immune system recognize and respond to the virus, they're mostly delivered by intravenous infusion, and sometimes by injection, which makes them much less convenient than popping a pill.
What's more, federal health officials recently announced a pause on shipments of bamlanivimab, etesevimab, and REGEN-COV to health care providers. Citing FDA data, the US Department of Health and Human Services said these treatments are unlikely to be effective against the Omicron variant. Only sotrovimab "appears to retain activity" against the variant.
No wonder the recently announced EUAs for drugs that may be prescribed to non-hospitalized COVID patients come as welcome news. Pfizer's Paxlovid is the very first oral pill for treating the coronavirus infection, while Merck's molnupiravir gives doctors a backup alternative. Beyond expanding the pool of potential treatments, these oral medicines will make it easier to treat people at home.
"The fact that there's a pill that can be administered is much more convenient that having to administer infusions," Tom Gallagher, PhD, professor of microbiology and immunology at Loyola University Chicago in Maywood, Illinois, tells Health. "I would imagine compliance would be high because it's only a five-day course."
Along with vaccines, these new oral treatments have enormous potential to allow us to hopefully get back to normal life, Dr. Lemieux observed.
