The World Health Organisation (WHO) on Tuesday updated its therapeutic guidelines for Covid-19 to include the antiviral drug molnupiravir for patients with non-severe Covid-19 who are at highest risk of hospital admission.
The drug is conditionally recommended, said the WHO Guideline Development Group of international experts in The British Medical Journal (BMJ), set to be published in the early hours of Wednesday.
Patients who are at highest risk of hospitalisation typically include those who are unvaccinated, are of old age and have a weak immune system or suffer from certain chronic diseases.
The expert panel, however, warned against giving the drug to young and healthy patients, including children, and pregnant and breastfeeding women due to potential harms.
While the Indian drugs regulator granted molnupiravir restricted emergency use authorisation in December, the national Covid-19 task force is still deliberating whether to include it in standard Covid-19 treatment protocol due to safety concerns. The lack of a WHO guideline on it till Tuesday was also a factor.
According to people familiar with the matter, it was unlikely that the drug is going to make it to the list of approved drugs for Covid-19 treatment in India anytime soon since a combination of baseline immunity and wide vaccination coverage meant there were fewer hospital admissions in the third wave earlier this year. Molnupiravir stops the Sars-CoV-2 from thriving in the body in the early stages of infection by introducing errors in its replication process. Like most antivirals, it has shown promise when used early after infection, potentially stopping a case from becoming severe. The latest WHO recommendations is based on new data from six randomised controlled trials involving 4,796 patients, the largest dataset on this drug so far.
But there have been concerns.
“This ninth version of the WHO living guideline addresses the use of molnupiravir in non-severe Covid-19. It follows the availability of new data from six trials. These trials were included in an update to the living network meta-analysis on drug treatments for Covid-19…,” said the expert panel in the article.
Moderate certainty evidence from these trials suggests that molnupiravir reduces the risk of hospital admission (43 fewer admissions per 1,000 patients at highest risk) and time to symptom resolution (average 3.4 fewer days), while low certainty evidence suggests a small effect on mortality (6 fewer deaths per 1,000 patients), said a BMJ press statement on the guidelines.