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Merck announced on Friday that its new pill to treat Covid-19 reduced the risk of hospitalization and death by about 50%. Merck plans to seek emergency authorization for the antiviral pills to be used in the United States.
Here’s what you need to know.
Who will receive the pills?
The pills are intended for people sick with Covid but who are not hospitalized. Merck’s Phase 3 clinical trial recruited only unvaccinated people considered to be at high risk, such as the elderly or people with health conditions like diabetes or heart disease. Initially, the drug may have only been available to these people, but experts expect it to eventually become more widely available.
The pills are designed to be taken as soon as possible after a person shows symptoms of having Covid – a time when the virus is replicating rapidly and the immune system has not yet mounted a defense. In Merck’s trial, volunteers must have exhibited symptoms within the past five days, and some researchers believe the pills need to be taken even earlier to be more effective.
How effective are they?
Merck said the drug halved the risk of hospitalization or death. In the phase 3 trial, 7 percent of volunteers in the drug group were hospitalized and none died. In the group that received a placebo, 14% were hospitalized or died.
The effectiveness of 50% is lower than that of monoclonal antibodies, the intravenous cocktail used to treat high-risk people with mild or moderate Covid. Studies have shown that these antibodies reduce hospitalizations and deaths by up to 85% in these patients.
But experts said the new antiviral pills will most likely have a bigger impact on Covid overall than bulky antibodies because the pills can reach more people.
When will the pills be available?
Merck said Friday it plans to seek emergency clearance from the Food and Drug Administration as soon as possible. Regulators could then clear the drug before the end of this year, if all goes well.
Dr Anthony S. Fauci, President Biden’s senior medical adviser on the coronavirus, said in a White House briefing on Friday that he could not give a specific timeframe for approval.
“The FDA will review the data and in its usual, very efficient and very efficient manner, will review the data as quickly as possible and then it will be pulled out of there,” he said.
Will there be enough pills?
Merck hopes to be able to make enough pills for 10 million people by the end of the year. The US government has already ordered 1.7 million treatments.
This is nowhere near enough for everyone in the United States who becomes ill with Covid to receive the pills.
How much will the treatment cost?
The federal government pays about $ 700 per treatment. This represents about a third of the cost of treatment with monoclonal antibody. The plan is to make the pills free for Americans, like the Covid vaccines. Whether there are any out-of-pocket costs will likely be determined after regulatory agencies have approved the use of the pills.
Are there any concerns about side effects?
Merck did not report any serious side effects in volunteers in its clinical trial. All of the side effects, which usually involve mild complaints like a headache, can be difficult to distinguish from feeling unwell from Covid, the researchers said.
Are there other antiviral pills on the way?
Pfizer is developing a similar pill, as are Atea Pharmaceuticals and Roche. The results of their clinical trials are expected in the coming months. They are unlikely to be available until next year.
What does taking the pill consist of?
The diet is familiar to anyone who has taken Tamiflu for seasonal flu or an antibiotic for a urinary tract infection. People will have to get a prescription and fill it in a pharmacy. Patients will take four capsules twice a day for five days, or 40 capsules during treatment.
How does the pill work?
Antiviral pills are designed to prevent the virus from replicating itself.
Molnupiravir prompts the coronavirus to use the drug to try to reproduce the genetic material of the virus. Once this process is underway, the drug inserts errors into the genetic code.
“If you create enough errors or if you create errors in parts of the virus that are absolutely critical, the virus cannot replicate itself,” said Daria Hazuda, vice president of infectious disease and disease research. vaccines at Merck.
Sheryl Gay Stolberg contributed reporting.
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