Merck announced that their new antiviral pill for treating COVID-19, molnupiravir, can reduce the risk of hospitalization and death by 50 percent. They are also planning to work with the Food and Drug Administration (FDA) for emergency use authorization (EUA) in the US by the end of the year.
According to data from a late-stage clinical trial, the pill can protect patients treated with it who have begun to show symptoms within the first five days. During the phase 3 trial, 7 percent of the volunteers who received the pill were hospitalized and none died. The placebo group had a rate of 14 percent hospitalizations or deaths.
The 50 percent efficacy is lower than the 85 percent efficacy from the monoclonal antibodies—the treatment currently being used for mild to moderate COVID cases, but the reach that the pill will be able to have in the population may make it more impactful as a treatment option.
Merck’s COVID pill is aimed for people who have COVID but have not been hospitalized. Phase 3 of Merck’s trials were focused on unvaccinated people who were in the high risk category, such as those with medical conditions or who are older in age. The pill is expected to only be available for those in the high risk category when it is first released then eventually become more widely available.
The regimen for treatment is similar to Tamiflu or antibiotic treatment for an infection. It will require a prescription in order to receive the pill at a pharmacy; patients will have to take four pills twice a day for five days to make up a total of 40 pills.
Roche and Atea, as well as Pfizer, are in the works to create their own antiviral as well, their data from clinical trials is expected at the end of the year. Roche/Atea’s drug is said to be similar to Merck’s but with a smaller dosage, while Pfizer’s is said to work differently and use fewer pills but be a combination of two drugs, which has the possibility to lead to complications with other medications.
As far as side effects are concerned, all drugs come with some level of side effects, but Merck would have had to convince officials that the benefits outweighed the risks by the time animal trials concluded. The drug targets the genome of the coronavirus in order to stop it from replicating. In theory, this means that there is the possibility that it could cause problems with cells that are fast-dividing, which would cause complications with pregnant women or put people at risk for cancer. But, the short period of exposure to the drug would minimize this risk, if it becomes a possible side effect at all. There would also be other limitations in place, such as reducing the number of times a person can use the drug within a year. So far though, Merck themselves have not reported any serious side effects.
The federal government is paying $700 for each course of treatment, which is about one-third the cost for monoclonal antibody treatment. The pills are expected to be free for Americans, like the COVID vaccine. Any other out of pocket costs will be determined after the treatment is authorized.