A pill given early after infection with SARS-CoV-2 cuts in half a person’s risk of hospitalization and death from COVID-19, according to results announced today by the pharmaceutical giant Merck & Co. The treatment marks the first oral antiviral that has proved to be effective against SARS-CoV-2, though several others remain in development. In a statement, Merck said it plans to apply soon for emergency use authorization from the U.S. Food and Drug Administration.
“As a researcher deeply involved on outpatient studies to treat mild Covid-19 to reduce progression and hospitalization, the Merck announcement is to me one of the Top Biggest News Stories of the year 2021,” Oriol Mitjà, of the Germans Trias i Pujol University Hospital, wrote to ScienceInsider in a direct message. “Molnupiravir is unquestionably a game changer! The large effect size, and the ease of administration change the paradigm of mild COVID-19 treatment with a potential to reduce COVID-19 death rates.”
Two other antiviral options are already available: remdesivir, which has been shown to reduce hospital stays in some patients, and monoclonal antibodies. Unlike molnupiravir, both of these options must be given intravenously.
The new results stem from data from 775 nonhospitalized patients who joined the study within 5 days of symptoms starting and had at least one risk factor for developing severe disease. The patients received a 5-day course of the medication, which lab studies have shown disrupts the ability of the SARS-CoV-2 virus to replicate its genome. Merck had planned to include 1550 patients, but an independent data monitoring committee halted the study when it became clear the medicine was effective.
A previous study showed the antiviral had little effect when given to patients already hospitalized with severe disease. Some researchers caution that side effects could be a concern and that the new results have yet to be peer reviewed.
The U.S. government has placed an advance order for 1.7 million doses of molnupiravir at $700 for a 5-day course, The New York Times reports. Although less expensive than monoclonal antibodies, molnupiravir’s price is, Mitjà wrote, “not acceptable for a life-saving tablet.”
And Nahid Bhadelia, director of the Center for Emerging Infectious Diseases Policy & Research at Boston University, says oral antivirals could have “an immense impact,” but for that to happen, rapid tests must be available so treatment can be started early in the disease course. She added: “These antivirals are not a replacement for vaccines because it is always better not to get infected in the first place.”
Source: Science Mag