The World Health Organization (WHO) has updated its living guidelines on COVID-19 therapeutics to include a conditional recommendation on molnupiravir, a new antiviral medicine. The recommendation is based on new data from six randomised controlled trials involving 4,796 patients. This is the largest dataset on this drug so far, WHO said in a statement.
In a statement released today, WHO said that this is the first oral anti-viral drug to be included in the treatment guidelines for COVID-19. As this is a new medicine, there is little safety data. WHO recommends active monitoring for drug safety, along with other strategies, to mitigate potential harms.
Because of these concerns and data gaps, molnupiravir should be provided only to non-severe COVID-19 patients with the highest risk of hospitalisation. These are typically people who have not received a COVID-19 vaccination, older people, people with immunodeficiencies and people living with chronic diseases, it said.
Children, and pregnant and breastfeeding women should not be given the drug. People who take molnupiravir should have a contraceptive plan, and health systems should ensure access to pregnancy testing and contraceptives at the point of care, the statement further mentioned.
Along with a recommendation on molnupiravir, this ninth update of WHO’s living guideline on therapeutics includes an update on casirivimab-imdevimab, a monoclonal antibody cocktail. Based on evidence that this combination of drugs is ineffective against the Omicron variant of concern, WHO now recommends that it is only given when the infection is caused by another variant.
Molnupiravir is not widely available but steps have been taken towards increasing access, including the signing of a voluntary licensing agreement. The Access to COVID-19 Tools Accelerator (ACT-A) is making a limited supply available to countries with access constraints, added the statement.
WHO has also invited manufacturers to submit their products for prequalification, with a number of manufacturers of molnupiravir going through assessment now. WHO evaluates the quality, safety and efficacy of medical products for the United Nations (UN) and other large suppliers to Low- and Middle-Income Countries (LMICs), the statement concluded.