Merck's experimental COVID-19 treatment pill
(Via Merck)
COVID 2022

Merck says its experimental pill cuts COVID-19 hospitalizations and deaths by half

Drugmaker Merck says its experimental COVID-19 pill reduced hospitalizations and deaths by half in people recently infected with the coronavirus.

In findings likely to open a new front in the treatment of COVID-19, the drugmaker Merck on Friday announced that its antiviral pill, molnupiravir, cut rates of severe disease in half when it was taken by newly infected people at high risk of becoming seriously ill.

If it is authorized for emergency use by the Food and Drug Administration, molnupiravir would become the first effective treatment for COVID-19 that can be taken in pill form.

When it is started soon after a person has developed symptoms of COVID-19, the drug appears to shorten the duration of illness and reduce the severity of symptoms that can lead to hospitalization and death.

Merck, which has developed the drug in collaboration with Florida-based Ridgeback Biotherapeutics, said in a statement that it would seek emergency use authorization from the FDA, and expects to produce 10 million courses of treatment by the end of 2021. In June, the U.S. government locked in the purchase of 1.7 million courses of the drug.

In addition to striking sales agreements with governments across the globe, Merck has said it would license the production of molnupiravir by established generic-drug manufacturers “to accelerate availability” of the drug in more than 100 low- and middle-income countries.

If cleared by the FDA and other drug-safety agencies worldwide, molnupiravir could plug a yawning gap between prevention strategies — masking, social distancing and vaccination — and currently available treatment, all of which requires skilled medical care and facilities to deliver.

For non-hospitalized patients infected with the SARS-CoV-2 virus, two antibody treatments are available. But each must be administered intraveneously, requiring a trip to a hospital or infusion center. Only one FDA-approved antiviral, remdesivir, has been recommended as treatment for COVID-19. But it is used only in hospitalized patients, whose illness has already progressed.

If molnupiravir’s safety and effectiveness meets the FDA’s standards for use during the pandemic, the antiviral could become a take-home treatment for those who have tested positive for infection. If the drug were targeted to people with conditions that make them vulnerable to becoming severely ill, it could cut deaths and reduce strain on hospitals.

“Nothing is as easy as giving people a prescription to take home, so I think it has extraordinary potential,” said Dr. Jeanne Marrazzo, who directs the infectious diseases division at the University of Alabama Medicine.

Among those who have declined vaccination, Marrazzo said that pills, including the malaria drug hydroxychloriquine and the anti-parasitic medication ivermectin, seem to hold special appeal. With so many patients clinging to pills that have no track record of helping, “it would be my prayer” to have one that had been shown to be safe and effective, she added.

In a press release issued early Friday, Merck and its partner, Ridgeback Biotherapeutics, said that the enrollment of participants in a clinical trial of molnupiravir had been halted early because molnupiravir had shown such promising early results. The early results showed that patients who received the drug, called molnupiravir, within five days of COVID-19 symptoms had about half the rate of hospitalization and death as patients who received a dummy pill. The study tracked 775 adults with mild-to-moderate COVID-19 who were considered higher risk for severe disease because of underlying health problems such as obesity, diabetes and heart disease.

Among patients taking molnupiravir, 7.3% were either hospitalized or died at the end of 30 days, compared with 14.1% of those getting the dummy pill. There were no deaths in the drug group after that time period compared with eight deaths in the placebo group, according to Merck. The results were released by the company and have not been peer-reviewed by outside experts, the usual procedure for vetting new medical research. Merck said it plans to present them at a future medical meeting.

An independent group of medical experts monitoring the trial recommended stopping it early because the interim results were so strong. That is typical when early results so clearly show a treatment works that there is no need for further testing before applying for authorization. Company executives said they plan to submit the data for review by the Food and Drug Administration in coming days.

Once the submission is complete, the FDA could make a decision within weeks — and, if approved, the drug could be on the market soon after. Merck studied its drug only in people who were not vaccinated. But FDA regulators may consider authorizing it for broader use in vaccinated patients who get COVID-19 symptoms.

“It exceeded what I thought the drug might be able to do in this clinical trial,” said Dr. Dean Li, vice president of Merck Research Laboratories. “When you see a 50% reduction in hospitalization or death, that’s a substantial clinical impact.”

Patients take eight pills a day for five days. Side effects were reported by both groups in the Merck trial, but they were slightly more common among the group that received a dummy pill. The company did not specify the problems.

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Earlier study results showed that the drug did not benefit patients who were already hospitalized with severe COVID-19.

The U.S. has approved one antiviral drug, remdesivir, specifically for COVID-19, and allowed emergency use of three antibody therapies that help the immune system fight the virus. But all the drugs have to be administered by IV or injection at hospitals or medical clinics, and supplies have been stretched by the latest surge of the Delta variant.

Health experts including the top U.S. infectious disease expert, Dr. Anthony Fauci, have long called for a convenient pill that patients could take when COVID-19 symptoms first appear, much the way the decades-old Tamiflu helps fight influenza. Such medications are seen as key to controlling future waves of infection and reducing the impact of the pandemic.

Vaccines remain the most effective way of protecting against COVID-19, but effective drugs are critical given that billions of people around the world remain unvaccinated.

Merck’s pill works by interfering with an enzyme the coronavirus uses to copy its genetic code and reproduce itself. The pill has shown a similar effect on other viruses.

The U.S. government has committed to purchase 1.7 million doses of the drug if it is authorized by the FDA. Merck has said it can produce 10 million doses by the end of the year and has contracts with governments worldwide. The company has not announced prices.

Several other companies, including Pfizer and Roche, are studying similar drugs and could report results in the coming weeks and months.

Merck had planned to enroll more than 1,500 patients in its late-stage trial before the independent board stopped it early. The results reported Friday included patients enrolled across Latin America, Europe and Africa. Executives estimated about 10% of patients studied were from the U.S.

This story originally appeared in Los Angeles Times.