First COVID-19 Antiviral Oral Home Treatment Drug Approved

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First COVID-19 Home Treatment Pill Approved – A New Tool Against Global Coronavirus Pandemic

The Food and Drug Administration (FDA) has approved the first antiviral pill to treat COVID-19 at home in an highly expected move, according to a media report.

Dr. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, in describing the authorization as a major step forward in the fight against global coronavirus pandemic, said that the approved drug provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants continue to emerge.

Dr. Cavazzoni also promised to make antiviral treatment more accessible to patients who are at high risk for severe COVID-19 development.

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The Pfizer-made pill, Paxlovid, should be taken twice a day for five days in combination with ritonavir, a universal antiviral.

The approval marks the beginning of an era of treatment for COVID-19 that is in the form of an oral pill. The pill, called Paxlovid, is made by Pfizer. It’s taken twice a day for five days in combination with a second medicine called ritonavir, a generic antiviral.

The Pfizer treatment drug, Paxlovid could help prevent coronavirus patients from getting sick and subsequent infection hospitalization.

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Paxlovid reduced the risk of hospitalization or death by 89%, compared with a placebo high risk cases for developing serious COVID-19

How does the use of Paxlovid work? According to Morning Brew, people ages 12 and up deemed most at risk of hospitalization can take the drug orally at home within five days of developing Covid symptoms. If they do, a visit to the ER will likely be unnecessary: A key study showed that the pill, called Paxlovid, reduced the risk of hospitalization or death by 88% in vulnerable, unvaccinated patients.

The NPR reported that Paxlovid reduced the risk of hospitalization or death by 89%, compared with a placebo, when taken within three days of first symptoms of illness from the analysis of the results from a Pfizer study involving more than 2,200 people at high risk cases for developing serious COVID-19.

The results also found out that when the COVID-19 treatment drug is taken within five days, the drug reduced the risk of hospitalization and death by 88%.

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Paxlovid unlikely to treat people infected with the Omicron variant of the COVID-19

Paxlovid’s efficacy is unlikely to be reduced in treating people infected with the omicron variant of the coronavirus virus as the pill doesn’t target the virus’s spike protein, as the coronavirus vaccines do. This hasn’t been proven yet.

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Pfizer’s Paxlovid vs Merck’s Molnupiravir

As the supply of Paxlovid would be limited, in the next few months, readily available less-effective Merck COVID-19 pill provides another option

Pfizer has said it would have 180,000 course of treatment ready by the end of the year even though the US government has a contract with the company to buy 10 million courses of the treatment for $5.3 billion. But initial supplies of Paxlovid would be limited. The US Food and Drug Administration (FDA) is also weighing a COVID-19 pill from Merck and Ridgeback Biotherapeutics that is also taken twice a day for five days.

There’s more of the Merck drug to go around. Merck says it will have 10 million packs available by the end of the month.

Merck has contracted with the U.S. government to supply at least 3 million courses of its pill, Molnupiravir, which is still awaiting clearance, for $2.2 billion. The FDA declined to comment on Merck’s drug, according to CNBC news report.

But the efficacy of the Merck COVID-19 pill may make it less attractive and a less option. An interim analysis of a clinical study of the drug found that Molnupiravir cut the risk of hospitalization or death in half. However, the final study analysis released a couple of days before a public meeting of advisers to the FDA, found only a 30% reduction in the risk of hospitalization or death, prompting the FDA advisers to raise concern about the possibility of using the drug in place of Paxlovid which could cause birth defects in people administered with it.

Pfizer’s treatment is administered in two 150 milligram tablets along with a 100 milligram tablet of an HIV drug, ritonavir, twice daily. The HIV drug helps slow the patient’s metabolism, which allows Paxlovid to remain active in the body at a higher concentration for a longer period.

Merck’s 800 milligram pill is taken every 12 hours for five days after symptom onset. The drug was developed with Ridgeback Biotherapeutics.

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