Coronavirus less likely to develop resistance to molnupiravir: Gagandeep Kang

There are some concerns about how early and how mild the disease has to be for the drug to work, says Dr. Kang.

On October 11, just 10 days after Merck announced via a press release the highly encouraging news of an interim analysis of a phase-3 trial using the antiviral drug molnupiravir, the company has submitted an emergency use authorisation application to the FDA. Preliminary data, which is yet to be peer-reviewed, shows molnupiravir can reduce risk of hospitalisation or death by 50% in non-hospitalised adult patients with mild-to-moderate COVID-19 disease. That molnupiravir is an oral drug is a major advantage in treating patients as it would not require hospitalisation. In an email, , Professor of Microbiology at CMC, Vellore, explains the other advantages that the drug will have, if granted an EUA.

Yes, molnupiravir has significant promise. But there are some concerns about how early and how mild the disease has to be for molnupiravir to work. It seems important to treat within the first few days of diagnosis or symptoms and the drug does not work towards the more severe end of the spectrum, including what is considered moderate disease.

The study was designed to include people with at least one risk factor for severe disease, because the goal was to study progression to severe disease. Had completely healthy people been included the study size would have needed to be much larger to get clear outcomes. Merck’s selection strategy of people at risk of severe disease led to a clear answer on efficacy in mild disease, such that the study was stopped for efficacy with data on 775 people.