5 day course of Molnupiravir effective and safe for non-pregnant, unvaccinated COVID-19 adult patients: Study

Study conducted jointly by Fortis C-DOC, G. D Hospital & Diabetes Institute, Jawaharlal Nehru Medical College & Hospital and Diabetes Foundation

A recent study has revealed that a 5-day course of Molnupiravir could reduce deaths and prove effective and safe at relatively lower costs, in adults and non-pregnant COVID-19 unvaccinated patients at increased risk of severity or needing hospitalization. Molnupiravir is a newer oral antiviral drug that has recently received emergency use authorization (EUA) in several countries including India. The study was conceived by Dr Anoop Misra, Padma Shri, Executive Chairman and Director, Diabetes and Endocrinology, Fortis C-DOC and conducted jointly by G. D Hospital & Diabetes Institute, Jawaharlal Nehru Medical College & Hospital, Fortis C-DOC Hospital for Diabetes & Allied Sciences, National Diabetes, Obesity and Cholesterol Foundation and Diabetes Foundation.

Published in the journal, Diabetes & Metabolic Syndrome: Clinical Research & Reviews, the final results of the study revealed that usage of the drug showed a significant reduction in composite risk of hospitalisation or death.

The study objective was to update the recently conducted review of Molnupiravir and to provide practical tips and guidelines for using the drug for COVID-19 patients by raising a few relevant, contemporary questions. Additionally, the evaluation of effectiveness of Molnupiravir compared to other drugs having emergency use authorisation for COVID-19 was also done.

The methodology followed was to assess efficacy and safety of Molnupiravir by studying published results of phase 3 randomised study in 1433 non-hospitalised COVID-19 patients. Additional data available in public domain between October 15, 2021 and January 5, 2022 and prescribing information of the drug and data presented at the FDA AMDAC meeting held on November 30, 2021 was also accessed, while conducting the study.

Key findings:

• A 5-day course of Molnupiravir in adults and non-pregnant unvaccinated COVID-19 patients appears to be effective and safe to prevent further disease progression and hospitalisation requirement.
• The effectiveness of Molnupiravir is competitive to three monoclonal antibodies, remdesivir and nirmatrelvir-ritonavir, with a relatively lower cost.
• No scope of treatment with Molnupiravir was found in cases when treatment was initiated after hospitalisation due to COVID-19.
• Molnupiravir is not authorised for use in patients less than 18 years of age.

Dr Misra said, “From the available evidence, Molnupiravir appears to be a reasonably useful drug in reducing deaths and hospitalization in adult patients with COVID-19 having high risk, with a relatively lower cost. Molnupiravir could be a useful drug in non-pregnant unvaccinated adults with COVID-19 who are at increased risk of severity including hospitalization. These findings are very important in the context of India as the drug can be used in outpatient settings and is also effective against the Omicron variant compared to other drugs. However, it is effective only when used within 5-days of onset of symptoms. Inappropriate use of the drug in too many individuals without assessing risk may pose an unknown long-term risk of public concern.”