The German pharmaceuticals firm 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 placed before the authorities for authorization after clinical trials showed that it cut the risk of hospitalization and death by 50% when taken by high-risk individuals soon after they had become infected.
This comparatively easy treatment might be just the first in a long line of antiviral pills to fight the coronavirus, since such treatments are much more easily accomplished than the antibody treatments that are currently used in the US for such patients.
Dr. Robert Shafer, an infectious disease specialist and expert on antiviral therapy from Stanford University, told the New York Times “I think it will translate into many thousands of lives being saved worldwide, where there’s less access to monoclonal antibodies, and in this country, too.”
The US-based Pfizer corporation started work on developing an antiviral pill to fight the coronavirus many months ago; Atea Pharmaceuticals and Roche are also expected to announce late-stage duty results of their similar pills shortly.
Merck says that its pills must be taken twice a day for five days — using four capsules for each dose. The molnupiravir drug stops the virus from replicating in the body, according to the Pharma giant.
In another hopeful — and relatively unusual — sign, the independent experts monitoring the study’s progress asked that the trials be stopped and the results announced right away because of the great efficacy shown by the treatment. The ceasing of the trial was agreed upon by the Food and Drug Administration.
Merck Covid-19 pill study stopped due to unexpectedly positive results
As part of the story, data gleaned 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, hospitalization and death risk fell by a total of 50 percent, while there were no side effects noted whatsoever, according to Merck.
However, the drugmaker did not include the full array of data in its announcement 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 — who were all at an elevated risk of the coronavirus — were hospitalized. Not one of this group died; this compares extremely favorably with the 14 percent rate of both hospitalization and death in those in the control group, who did not receive the actual medication.
Thee were a total of eight deaths in that control group.
The monoclonal antibody treatments, in which a patient receives antibodies that are much like his own as it fights off the virus, must be administered intravenously. Although given currently at outpatient settings, each treatment takes one hour and then patients must wait to be monitored for an additional hour.
Such treatment is of course fairly expensive and they have proven to be an additional burden on already-overwhelmed hospitals and clinics around the US.
The new pill developed by Merck is of course much easier to administer and will be a boon to rural and remote areas around the world, once authorized, but its efficacy is lower than the monoclonal treatments.
The monoclonal treatment reduces hospitalizations and deaths from between 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 Vaccine and Infectious Disease Organization at the University of Saskatchewan, the antiviral pills might come to have a greater impact on society, however, just because they will be so much more readily available to more people.
She noted “If that holds up at the population scale, that is going to translate to an objectively larger number of lives saved potentially with this drug,” adding “Maybe it isn’t doing the same numbers as the monoclonal antibodies, but it’s still going to be huge.”
There already is an enormous amount of interest in the pill, with the US government ordering a total of 1.7 million courses of Merck’s drug in advance.
The cost of such treatment at this point is $700 per patient — representing one-third of the current cost of the monoclonal antibody treatment.
Merck — which is developing the pill with its partner, Ridgeback Biotherapeutics of Miami — has not said which patients it plans to ask the F.D.A. to authorize the drug for.
It may be initially authorized for the limited group of patients who are eligible to receive monoclonal antibody treatments: possibly older people and those with medical conditions that put them at high risk for bad outcomes from Covid. But experts said they expected that the drug might eventually be used more widely, in many people who test positive for the virus.
If authorized, Merck’s drug would be the second antiviral treatment for Covid. The first, remdesivir, must be infused and has lost favor among clinicians as studies have suggested that it offers only modest benefit for Covid patients.