Although science has made great progress against bacterial disease, our advances against viruses are still in their infancy. Now, potentially good news is being reported in the battle against the current pandemic: An experimental oral drug known as molnupiravir reduces the risk of hospitalization and death in phase III clinical trials.
Molnupiravir, a product of research from Merck Pharmaceuticals and Ridgeback Biotherapeutics, inhibits coronavirus replication inside the body by inserting errors in viral genetic code. The clinical trial consisted of 775 unvaccinated people with lab-confirmed infection and at least one complicating issue that put them at high risk for hospitalization (for example, advanced age, diabetes, obesity, etc.). The drug therapy was instituted within five days of symptom onset and given in the form of four capsules a day for five days.
Results from the study revealed that 14.1 percent of high-risk patients receiving placebo ended up hospitalized after diagnosis. In the oral molnupiravir group, only 7.3 percent of patients were. No deaths were reported in the group that received molnupiravir compared to eight deaths in the placebo group. Adverse reactions, such as headaches, were seen at the same rate for both groups.
The researchers claim that molnupiravir is effective against all strains of the coronavirus, including the Delta variant. They also state that their data shows the drug isn’t capable of causing genetic changes in human cells.
A simple oral treatment like molnupiravir for outpatients, if approved, may change the way viral infections are managed. At present, treatment for pandemic cases such as remdesivir consists of intravenous infusions and are generally given once a patient has been hospitalized.
The manufacturers are in the process of seeking emergency authorization from the FDA. If successful, molnupiravir would become the first approved oral antiviral medication for SARS-CoV2. Having an effective oral at-home therapy is a major advance against the pandemic, easing the burden on our medical infrastructure.
Treatment will be by prescription and given as soon as possible after symptom onset. This strategy is similar to other oral antiviral drugs like Tamiflu (oseltamivir). These drugs decreased the severity of many influenza cases when taken early in the course of the infection. As with Tamiflu, It will be very important for those at risk to be educated in what to look for in terms of symptoms, and to contact medical professionals immediately.
It should be noted that another study currently in Phase III clinical trials is examining molnupiravir for its effectiveness in preventing the infection.
Hopefully, more new antivirals will be developed as time goes on, making viral diseases just a bump on the road, not the end of the road, for our citizens, regardless of their age or health status.
Joe Alton MD
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