New Evidence Available

Updated Recommendation

A new evidence synthesis was published:2023, Therapeutics and COVID-19: living guideline, 10 November 2023.

View latest version (2023)

Bibliographic information

GuidelineTherapeutics and COVID-19: living guideline, 13 January 2023.
Year of Publication2023
Issuing InstitutionWorld Health Organization

Recommendation

Retired

For patients with non-severe COVID-19 (excluding pregnant and breastfeeding women, and children) . We suggest treatment with molnupiravir, conditional to those at highest risk of hospitalization

Recommended in favor

Conditional

Notes and Remarks

  • See Section 6.1 f or help t o identify patients at highest risk f or hospitalization.
  • Several therapeutic op tions are available: see decision support t ool that displays benefits and harms o f nirmatrelvir-ritonavir, molnupiravir and remdesivir.
  • The longer-term harms o f molnupiravir remain unknown in the absenc e of clinical evidence, both for individual patients and at the population level. These include g enotoxicity, emergence of resistance, and emer gence of new v ariants (see M echanism o f action).
  • The conditional recommendation reflects the c oncern for widespread treatment with molnupiravir before more safety data become available.
  • Use of molnupiravir should be ac companied by mitigation strategies such as av oiding the drug in younger adults, activ e pharmacovigilance programmes, and monit oring viral polymerase and spik e sequenc es (see J ustification).

Practical Info Route, dosage and duration: Additional considerations are available in three summaries of practical issues (molnupiravir for COVID-19, administration of molnupiravir for COVID-19, safety and monitoring f or patients receiving molnupiravir for COVID-19). Here follows a brief summary o f the key points:

  • The recommended dose f or molnupiravir is 800 mg table t every 12 hours daily f or 5 days, as per the r egimen evaluated in large trials informing the recommendation.
  • Administration should be as early as possible in the time c ourse of the disease. I n the included studies, molnupir avir was administered within 5 da ys of disease onse t.

Resources and other considerations Acceptability and feasibility Molnupiravir is unlikely to be a vailable for all individuals who, giv en the op tion, would choose to r eceive the treatment. This reinforces that molnupiravir should be reserved for those at highest risk. Obstacles to access in LMICs due to c ost and availability are of concern (30). Challenges in shared decision-making and in communicating the harms v ersus benefits of molnupiravir may also be incr eased in LMICs. F or example, those with socioeconomic disadvantages tend to ha ve less ac cess to services, including diagnostic testing and tr eatments, in the first 5 days of symptoms, and thus less ac cess to the in terventions. Therefore, if pa tients at highest risk receive the in tervention this may exacerbate health inequity. It is important that countries integrate the COVID-19 clinical care pathway in the parts of the health s ystem that may provide care for patients with non-se vere COVID-19 (i.e. primary care, community care settings). The recommendations should provide a stimulus to engag e all possible mechanisms to impr ove global access to the intervention. In promoting access, WHO has pr equalified generic versions of Molnupiravir and one g eneric version of Nirmatrelvir-ritonavir. In addition, there are additional applications under review for both products. UN partners procure these products and are making them a vailable to low- and middle-inc ome countries. WHO and UN partners support allocation and procurement mechanisms f or countries to ensure that these medicines are available and integrated into national supply chains. Individual countries may formulate their guidelines considering available resources and prioritize treatment options according. Access to SARS-CoV-2 diagnostics: Since this recommendation emphasizes the need to administer tr eatment with molnupiravir within 5 days of symptom onset; increasing access and ensuring appropriate use o f diagnostic tests is essen tial. Thus, availability and use of reliable and timely COVID-19 diagnostic tests (including the use o f NAAT and Ag-RD Ts) is needed to improve access to drugs, especially those tar geting the early phase o f disease. T he appropriate use o f Ag-RDTs by individuals and trained professionals can improve early diagnosis and earlier ac cess to clinical care, particularly in the community and in primary health car e settings. National programs should op timize their testing s ystems to reflect local epidemiology, response objectives, available resources and needs o f their populations.

Also Featured In

This recommendation also appears in the following guidelines:

Originally Developed
Guideline

Therapeutics and COVID-19: living guideline, 3 March 2022.

Year2022
InstitutionWorld Health Organization
Guideline

Therapeutics and COVID-19: living guideline, 22 April 2022.

Year2022
InstitutionWorld Health Organization
Guideline

Therapeutics and COVID-19: living guideline, 14 July 2022.

Year2022
InstitutionWHO
Guideline

Therapeutics and COVID-19: living guideline, 16 September 2022.

Year2022
InstitutionWorld Health Organization