Everything you need to know about the new pill to treat coronavirus

On Friday, the Merck laboratory announced that its new pill to treat Covid-19 reduced the risk of hospitalization and death by about 50%. The drugmaker now plans to seek emergency authorization for the use of antiviral pills in the United States.

This is what you need to know.

Who will get 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, that is, the elderly or people with medical conditions such as diabetes or heart disease.

Initially, the drug may only be available to these people, but experts hope it will become more widely available over time.

The pills are designed to be taken as soon as possible after a person shows symptoms of Covid – that is, when the virus is replicating rapidly and the immune system has not yet prepared a defense.

In the Merck 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 percent of the participants were hospitalized or died.

The effectiveness of 50% is lower than that of monoclonal antibodies, the intravenous cocktail of drugs used to treat high-risk people with mild or moderate Covid.

Studies have shown that these antibodies reduce hospitalizations and deaths, even in this type of patient, by 85 percent.

But experts said the new antiviral pills could have a bigger impact on COVID than bulky antibodies because the pills can reach more people.

When will the pills be available?

Merck said Friday that it plans to seek emergency clearance from the Food and Drug Administration as soon as possible. If all goes well, the regulators they could authorize the drug before the end of this year.

Anthony Fauci, President Joe Biden’s senior medical adviser for the coronavirus, said in a White House briefing on Friday that he could not give a specific timeline for approval.

“The FDA will analyze the data and, as is usually the case, in a very effective and efficient manner, it will review the data as quickly as possible and after that a decision will be made,” he said.

Will there be enough pills?

Merck hopes to be able to produce enough pills for 10 million people by the end of the year.

The US government has already ordered 1.7 million full treatments.

That number is a far cry from the number of pills needed by everyone in the United States who become ill with the coronavirus.

How much will the treatment cost?

The federal government pays approximately $ 700 for each treatment. This represents about a third of the cost of treatment with monoclonal antibodies. The plan is to make the pills free for Americans, as is the case with COVID vaccines. If there are any additional costs that people have to pay, this will likely be determined after regulators clear the pills for use.

Are there any concerns about side effects?

Merck did not report any serious side effects in volunteers in its clinical trial.

Researchers said any side effects, which typically include mild conditions such as headaches, can be difficult to distinguish from the discomfort of Covid.

Are there other antiviral pills on the way?

Pfizer is developing a similar tablet, as are Atea Pharmaceuticals and Roche.

The results of its clinical trials are expected in the coming months. But they’re unlikely to be available for use until next year.

What does it take to take the pill?

The diet is familiar to anyone who has taken Tamiflu for seasonal flu or an antibiotic for a urinary tract infection.

People will need to get a prescription to buy the drug from 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 cheat the coronavirus to try to reproduce your genetic material when you use the medicine. Once this process is underway, the drug inserts errors into the genetic code.

“If you create enough bugs or bugs in the critical parts of the virus, the virus cannot replicate itself,” said Daria Hazuda, vice president of vaccine and infectious disease research at Merck.

CB