Merck says COVID-19 pill reduces risk of death and hospitalization

In a potential leap forward in the global fight against the pandemic, drugmaker Merck said on Friday that its experimental pill for people with COVID-19 was halving hospitalizations and deaths.

If cleared by regulators, it would be the first pill shown to treat COVID-19, adding a whole new, easy-to-use weapon to an arsenal that already includes the vaccine.

The company said it would soon ask health officials in the United States and around the world to authorize the use of the pill. A decision by the United States Food and Drug Administration could be made in the weeks to come, and the drug, if approved, could be distributed quickly soon after.

All other COVID-19 treatments now authorized in the United States require an intravenous or injection. A pill taken at home, on the other hand, would ease the pressure on hospitals and could also help curb epidemics in the poorest and most remote corners of the world that lack access to the most expensive infusion therapy.

“It would allow us to treat a lot more people a lot faster and hopefully a lot cheaper,” said Dr William Schaffner, an infectious disease expert at Vanderbilt University who was not involved in the research. .

Merck and its partner Ridgeback Biotherapeutics said initial results showed that patients who received the drug, molnupiravir, within five days of COVID-19 symptoms had about half the hospitalization and death rate they those who received a dummy pill.

The study followed 775 adults with mild to moderate COVID-19 who were considered at high risk for serious illness due to health conditions such as obesity, diabetes or heart disease. The results were not reviewed by external experts, the usual procedure for monitoring new medical research.

Of the patients on molnupiravir, 7.3% were hospitalized or died after 30 days, compared with 14.1% of those on the dummy pill. After that period, there were no deaths among those who received the drug, compared to eight in the placebo group, according to Merck.

The results were so strong that an independent group of medical experts overseeing the trial recommended stopping it early.

Company executives said they plan to submit the data to the FDA in the coming days.

Even with the announcement of a potentially effective new treatment, experts have stressed the importance of vaccines in controlling the pandemic, as they help prevent transmission and reduce the severity of the disease in those who are infected. .

White House coronavirus coordinator Jeff Zients said vaccination would remain the government’s main strategy to control the pandemic. “We want to prevent infections, not just wait to treat them when they arise,” he said.

Dr Anthony Fauci, the government’s leading infectious disease authority, called Merck’s results “very good news.”

Merck has only studied its drug in unvaccinated people. But FDA regulators may consider clearing it for wider use in vaccinated patients who show groundbreaking COVID-19 symptoms.

Andrew Pekosz of Johns Hopkins University predicted that vaccines and antiviral drugs would eventually be used together to protect against the worst effects of COVID-19.

“These should not be viewed as substitutes for vaccination – both should be viewed as two strategies that can be used together to dramatically reduce serious disease,” said Pekosz, a virology specialist.

Patients take four molnupiravir tablets twice a day for five days. Side effects were reported by both groups in the Merck trial, but they were slightly more common in those who received a dummy pill. The company did not specify the problems.

Results from previous studies showed that the drug did not benefit patients who were already hospitalized with serious illness. This is not surprising, given that antiviral drugs are most effective when used before the virus takes hold in the body.

The United States has approved an antiviral drug, remdesivir, for COVID-19, and has authorized the emergency use of three antibody therapies that help the immune system fight off the virus. But all drugs are expensive and have to be given intravenously or by injection in hospitals or clinics, and stocks have been depleted by the latest wave of the delta variant.

Antibody-based drugs have been shown to reduce hospitalizations and deaths by about 70% when given to high-risk patients, about 20 percentage points more than the Merck pill. But experts cautioned against comparing the results of the two, given the preliminary nature of Merck’s data.

Health experts, including Fauci, have long called for a convenient pill that patients could take when symptoms of COVID-19 first appear, much like Tamiflu is given to help speed recovery from the flu.

Like other antivirals, the Merck pill works by interfering with the virus’s ability to copy its genetic code and to reproduce itself.

The U.S. government has committed to purchasing enough pills to treat 1.7 million people, assuming the FDA clears the drug. Merck said it could produce pills for 10 million patients by the end of the year and has contracts with governments around the world. The company has not announced a price.

Several other companies, including Pfizer and Roche, are studying similar drugs and may release results in the weeks and months to come.

Merck had planned to enroll more than 1,500 patients in its advanced stage trial before independent board terminated it prematurely. The results reported on Friday included patients from Latin America, Europe and Africa. Executives estimated 10% of patients studied were from the United States

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This story has been updated to correct that patients take eight tablets per day, not two.

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