Molnupiravir, an antiviral drug which recently got emergency use authorisation from the Drugs Controller General of India (DCGI) for mild to moderate cases, is safe for use in adults, a new study has revealed. According to the study, a five-day course for adults who are non-pregnant and unvaccinated Covid-19 patients, is effective and safe and can prevent further disease progression and hospitalisation requirements.

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, Fortis Healthcare said Monday in a release. 

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 assessed the efficacy and safety of Molnupiravir by analysing published results of phase 3 randomised study in 1,433 non-hospitalised COVID-19 patients. Additional data available in the public domain between October 15, 2021 and January 5, 2022 and prescribing information of the drug and data presented at the US FDA AMDAC (Antimicrobial Drugs Advisory Committee) meeting held on November 30, 2021 was also accessed, according to the Fortis Healthcare release.

“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,” Fortis said. 

“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 without assessing the risk may pose an unknown long-term risk of public concern,” Dr Misra said. 

“This drug has to be used only by those who are at high risk. The problem with this drug is that the data which we have right now only relates to unvaccinated people. We have no idea whether it will work in those who are vaccinated. It is yet to be ascertained,” Misra told BusinessLine.

“It has to be used while taking all precautions. Men and women in the reproductive age group should also use contraception for the duration of treatment. And it should not be used by those who are above 18 years. These are the two major concerns in the usage of this drug. 

It may be recalled that the drug got embroiled in a big controversy after the Indian Council of Medical Research (ICMR) raised concerns over its usage among those in the reproductive age group. On a BusinessLine query in a press conference, whether Molnupiravir is part of Covid treatment or not, Balram Bhragava, the Director General of ICMR had said, “WHO has not included it.. We are still concerned about issues of pregnancy, lactation, children, soft tissue injury, reproductive age group history of infection and vaccination. Whatever benefit was there in those 1,433 patients was on unvaccinated individuals and only three per cent from mild to moderate diseases.”

Related Topics