Remarks

• In the absence of credible tools to predict risk for hospitalization in people infected with SARS-CoV-2, typical characteristics of people at highest risk include those that lack COVID-19 vaccination, with older age, immunosuppresion and/or chronic diseases (e.g. diabetes).
• The benefit will be trivial in absolute terms except in those at highest risk for hospitalization, for which the intervention should be reserved and given early on in disease.
• The panel identified a risk beyond 10% of being hospitalized for COVID-19 to represent a threshold at which most people would want to be treated with molnupiravir.
• The longer-term harms of molnupiravir remain unknown in the absence of clinical evidence, both for individual patients and at the population level. These include genotoxicity, emergence of resistance, and emergence of new variants (see Mechanism of Action).
• The conditional recommendation reflects the concern for widespread treatment with molnupiravir before more safety data become available.
• Use of molnupiravir should be accompanied by mitigation strategies such as avoiding the drug in younger adults, active pharmacovigilance programmes, and monitoring viral polymerase and spike sequences (see Justification).
• Alternative effective treatments with different safety profiles recommended by WHO, such as neutralizing monoclonal antibodies, like sotrovimab, may be preferable or antivirals (currently under WHO assessment) if available.

Practical Info Route, dosage and duration: Additional considerations are available in a linked summary of practical issues (accessible here). Here follows a brief summary of the key points:

• The recommended dose for molnupiravir is 800 mg tablet every 12 hours daily for 5 days, as per the regimen evaluated in large trials informing the recommendation.
• Administration should be as early as possible in the time course of the disease. In the included studies, molnupiravir was administered within 5 days of disease onset.