With questions being raised on the safety of the only available approved oral antiviral pill for COVID-19 – Molnupiravir, health experts of the country have pointed out that the benefits of the drug outweigh the potential risks it may have in the case of high risk patients.
Molnupiravir is one of the two recent oral antiviral pills approved by the USFDA for COVID-19 and the first oral antiviral to receive approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of mild-to-moderate COVID-19 in adults with a high risk of progression to severe disease, mainly those with pre-existing (co-morbid) conditions. It is the only one currently available in India and has been approved for the treatment of adult patients with Covid-19, with SpO2 > 93% and who have a high risk of progression of the disease including hospitalization or death.
While the drug has been approved by the CDSCO, a recent statement by a National Task Force Member raised concerns pointing to some of the drug’s potential side effects, putting physicians who prescribe it, on a back foot.
Medical Experts, on the other hand, have pointed out that the benefits of the drug outweigh the potential risks it may have in the case of high-risk patients.
At a recent scientific discussion held on “COVID 19: NEW TREATMENT THERAPIES TO TACKLE PRESENT CRISIS”, led by Dr Deepak Talwar, an eminent Respiratory Medicine Expert & attended by other leading Pulmonologists of the country unanimously agreed that there are very limited options of medicines used to treat COVID patients and hence the new approved medicines should be given a try under strict treatment regime protocols and ‘daggers should not be drawn so quickly’ unless we have enough data to raise any serious red flags!
“Physicians have to keep in mind their patient profiles while prescribing any drug. If the patient is high-risk that is more than 60 years of age, is obese or having cardiovascular disease, hypertension, and/or has Chronic lung or kidney or liver disease, then not treating when the disease is mild or moderate can take extreme turns, putting the patient in risk of hospitalisation and as we have seen at the time of Delta variant, even possible death. We have to use the available therapy rather than counting its side-effects, that too which are potential, but not known” said Dr Deepak Talwar, MBBS, MD, DNB, DM, Fellow, National College of Chest Physicians (India); Fellow, American College of Chest Physicians (USA); Senior Consultant & Chairman – Metro Respiratory Centre, Pulmonology & Sleep Medicine.
“While giving approval, the FDA as well as DCGI have gone through the safety data of the drug. Only once satisfied this drug has been approved. Even in the phase-3 clinical trials Molnupiravir, which demonstrated a significant reduction in the risk of hospitalisation or death with no observed safety concerns when compared to the placebo group,” added Dr Dhruva Chaudhry, MD (Medicine), DNB (Medicine) D. M. (Pulmonary & Chest Medicine), FICP, FICCM, President Elect ISCCM, Editor in Chief, Critical Care Communications, a Nodal Officer for COVID-19 at PGIMS Rohtak and Head of the Pulmonary & Critical Care Medicine.
Dr Vasant Nagvekar, MBBS, MD, an infectious diseases consultant at Lilavati Hospital and member of the COVID task force, said, he has prescribed it to 30 patients since its availability in the market. Symptoms with fever (>60 yrs.) and if fever persists 48-72 hrs then Molnupiravir 5 days’ therapy is also receptive. Molnupiravir should be administered as soon as possible after a diagnosis of COVID-19 has been made, and within five days of symptom onset. Molnupiravir is basically to be used in people of >50 years of age and in people with multiple co-morbidities.
Molnupiravir is FDA approved and has shown to reduce hospitalisation and death in 1/3rd of people, however it shouldn’t be used indiscriminately. Side-effects of mutagenicity does not matter, if the drug is indicated for certain patient profiles, for a treatment course of 5 days. It is a remote possibility, which is a potential concern but unknown said Dr. S.K. Jindal, MBBS, MD (Medicine), FAMS, FCCP, FNCP, with an illustrious experience of more than 4 decades, is the Medical Director and Sr. Consultant Pulmonology at Jindal Clinics Chandigarh; Former HOD, Pulmonology Medicine, PGIMER, Chandigarh.
“Molnupiravir is restricted to situations where other FDA-authorized treatments for COVID-19 are inaccessible or aren’t clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death,” said Patrizia Cavazzoni, M.D., director of the FDA’s Centre for Drug Evaluation and Research. “As new variants of the virus continue to emerge, it is crucial to expand the country’s arsenal of COVID-19 therapies using emergency use authorization, while continuing to generate additional data on their safety and effectiveness.”
More robust studies and further research is required in the future for the effectiveness and safety of Molnupiravir.