MATTHEW PERRONE / AP Health Writer
In a potential leap forward in the global battle against the pandemic, drug maker Merck said Friday that its experimental pill cut hospital stays and deaths in half for people suffering from COVID-19.
If cleared by regulators, it would be the first pill proven to treat COVID-19 and add an entirely new, easy-to-use weapon to an arsenal that already contains the vaccine.
The company said it would soon be asking health authorities in the U.S. and around the world to approve the pill’s use. A decision by the U.S. Food and Drug Administration could be made within weeks, and the drug, if OK, could be distributed quickly soon thereafter.
All other COVID-19 treatments now approved in the US require an IV or injection. A pill taken at home, on the other hand, would take the pressure off hospitals and could also help contain outbreaks in poorer and more remote corners of the world that do not have access to the more expensive IV therapies.
“This would allow us to treat people much faster and, as we trust, far fewer people,” said Dr. William Schaffner, an infectious disease expert at Vanderbilt University who was not involved in the research.
Merck and partner Ridgeback Biotherapeutics said initial results showed that patients who received the drug molnupiravir within five days of symptoms of COVID-19 were hospitalized and died about half as often as those who received a dummy pill.
The study tracked 775 adults with mild to moderate COVID-19 who were classified as high risk for serious illness because of health problems such as obesity, diabetes, or heart disease. The results were not verified by outside experts, the standard procedure for reviewing new medical research.
Of the patients taking molnupiravir, 7.3% were either hospitalized or died after 30 days, compared with 14.1% of those taking the dummy pill. After that period, there were no deaths among those who received the drug, compared with eight in the placebo group, according to Merck.
The results were so convincing that an independent group of medical experts who monitored the study recommended that it end early.
Company executives said they plan to submit the data to the FDA in the coming days.
Despite news of a potentially effective new treatment, experts stressed the importance of vaccines in controlling the pandemic, as they help prevent transmission and also reduce the severity of the disease in those who become infected.
White House coronavirus coordinator Jeff Zients said vaccinations will remain the government’s main strategy to fight 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 authority on infectious diseases, called the Merck results “very good news.”
Merck has only studied its drug in unvaccinated people. However, FDA regulators may consider approving it for wider use in vaccinated patients who experience breakthrough COVID-19 symptoms.
Andrew Pekosz of Johns Hopkins University predicted that vaccines and antiviral drugs would ultimately be used together to protect against the worst effects of COVID-19.
“These should not be viewed as a substitute for vaccination – the two should be viewed as two strategies that can be used together to significantly reduce serious illness,” said Pekosz, a virology specialist.
Patients take four tablets of molnupiravir twice a day for five days. Side effects were reported by both groups in the Merck study, but were slightly more common in those who took a dummy pill. The company did not name the problems.
Previous study results showed that the drug was of no benefit to patients who were already hospitalized with a serious illness. This is not surprising as antiviral drugs are most effective when used before the virus builds up in the body.
The US has approved an antiviral drug, remdesivir, for COVID-19 and allowed the emergency use of three antibody therapies that help the immune system fight the virus. But all drugs are expensive and must be administered intravenously or by injection in hospitals or clinics, and supplies have been stretched with the recent surge in the Delta variant.
The antibody drugs have been shown to reduce hospital stays and deaths by about 70% when given to high-risk patients, about 20 percentage points more than the Merck pill. However, experts cautioned against comparing the results of the two as Merck’s data is preliminary.
Health experts, including Fauci, have long called for a convenient pill patients can take when COVID-19 symptoms first appear, similar to how Tamiflu is given to speed recovery from the flu.
Like other antivirals, Merck’s pill works by disrupting the virus’ ability to copy its genetic code and reproduce itself.
The US government is committed to buying enough pills to treat 1.7 million people, provided the FDA approves the drug. Merck said it could make pills for 10 million patients by the end of the year and it has contracts with governments around the world. The company has not disclosed prices.
Several other companies, including Pfizer and Roche, are investigating similar drugs and may have results in the coming weeks and months.
Merck had planned to enroll more than 1,500 patients in its late-stage study before the independent board of directors stopped it prematurely. The results reported on Friday included patients in Latin America, Europe and Africa. Executives estimated that 10% of the patients studied were from the United States
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