German pharmaceutical company Merck announced on Friday that trials indicate it has produced the first effective antiviral pill to fight Covid-19.
Its drug, called molnupiravir, will be submitted to authorities for clearance after clinical trials show it reduces the risk of hospitalization and death by 50% when taken by high-risk people soon after their treatment. infection.
This relatively easy treatment might be just the first in a long line of antiviral pills to fight the coronavirus, as such treatments are much easier to perform than the antibody treatments currently used in the United States for these patients.
Dr Robert Shafer, an infectious disease specialist and expert in antiviral therapy at Stanford University, told the New York Times “I think this will translate to several thousand lives saved around the world, where there is less access to monoclonal antibodies, and in this country as well.”
The US-based Pfizer company began work on developing an antiviral pill to fight the coronavirus several months ago; Atea Pharmaceuticals and Roche are also expected to announce the results of the final stage tariffs on their similar pills shortly.
Merck says its pills should be taken twice a day for five days – using four capsules for each dose. The drug molnupiravir prevents the virus from replicating in the body, according to the pharmaceutical giant.
In another encouraging – and relatively unusual – sign, independent experts monitoring the study’s progress have called for the trials to be stopped and results to be announced immediately due to the treatment’s high efficacy. The trial was stopped by the Food and Drug Administration.
Merck Covid-19 pill study stopped due to unexpected positive results
As part of the story, data collected from a total of 775 volunteers in the United States and overseas was collated and compared through early August.
In those who actually received the drug, the risk of hospitalization and death fell by 50% overall, while no side effects were noted, according to Merck.
However, the drugmaker did not include in its announcement all of the data that would be needed to determine exactly how the drug will be used in the general population.
Only seven percent of the volunteers who received the drug – all of whom were at high risk for coronavirus – were hospitalized. None of this group died; this compares extremely favorably with the 14% rate of hospitalization and death among people in the control group, who did not receive the actual drug.
There were a total of eight deaths in this control group.
Monoclonal antibody treatments, in which a patient receives antibodies that closely resemble their own because they fight the virus, must be given intravenously. Although currently administered on an outpatient basis, each treatment lasts one hour, and then patients must wait to be monitored for an additional hour.
Such treatment is of course quite expensive and it has proven to be an additional burden on the already overwhelmed hospitals and clinics in the United States.
The new pill developed by Merck is of course much easier to administer and will be a boon to rural and remote areas of the world once approved, but its effectiveness is lower than monoclonal treatments.
Monoclonal therapy reduces hospitalizations and deaths by 70 to 85 percent in similar high-risk patients, according to studies.
According to Angela Rasmussen, who works as a virologist and research scientist at the Vaccines and Infectious Diseases Organization at the University of Saskatchewan, antiviral pills could have a bigger impact on society, however, simply because they will be so much. more readily available to more people.
She noted “If it holds up to the population scale it will translate into an objectively greater number of potentially saved lives with this drug,” adding “Maybe it doesn’t do the same numbers as the antibodies. monoclonal, but it’s still going to be huge. “
There is already huge interest in the pill, with the US government having pre-ordered a total of 1.7 million doses of the drug from Merck.
The cost of such treatment at this point is $ 700 per patient, which is one third of the current cost of monoclonal antibody treatment.
Merck – which is developing the pill with its partner, Ridgeback Biotherapeutics of Miami – did not specify for which patients it plans to ask the FDA to clear the drug.
It may be initially cleared for the limited group of patients eligible to receive monoclonal antibody treatments: possibly the elderly and those whose medical conditions put them at high risk of poor Covid outcomes. But experts said they expected the drug could eventually be used more widely, in many people who tested positive for the virus.
If approved, Merck’s drug would be the second antiviral treatment for Covid. The first, remdesivir, needs to be infused and has fallen out of favor with clinicians as studies have suggested that it offers only modest benefit for Covid patients.