The U.S. Food and Drug Administration approved the emergency use of the molnupiravir pill for the treatment of mild-to-moderate coronavirus disease 2019 in nonhospitalized adult patients with positive results of direct SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19, including hospitalization or death.

Does molnupiravir prevent infection or severe illness and death?

The study suggested that molnupiravir would help patients who have at least one risk factor (include obesity, older age (>60 years), diabetes mellitus, or heart disease) for severe COVID-19 to avoid hospitalization.

Molnupiravir cut the risk for hospitalization and death in high-risk patients by 30%.

Who is molnupiravir recommended for?

Molnupiravir is authorized for the treatment of mild-to-moderate COVID-19 in adults 18 and older who are at high risk for progressing to severe COVID-19, including hospitalization or death. It is not authorized for children younger than 18 years.

Will molnupiravir work on virus variants, including Delta and Omicron?

Results from the molnupiravir clinical trial, conducted in the U.S. and other countries, suggested the drug would be effective against some variants of concern, including the Delta, Gamma, and Mu mutations.

Scientists are still studying how well the drug works to treat Omicron. In a recent Laboratory research (in vitro) results suggest that antivirals remain effective against the Omicron strain of SARS-CoV-2 virus. Molnupiravir has a mechanism of action that can work against Omicron and any other variant Merck & Co and partner Ridgeback Biotherapeutics said. Molnupiravir is yet to be studied against Omicron in human studies, the companies said.

Can pregnant women use molnupiravir ?

Pregnancy: The use of molnupiravir is not recommended during pregnancy. Advise individuals of childbearing potential to use effective contraception correctly and consistently, as applicable, for the duration of treatment and for 4 days after the last dose of molnupiravir.

Lactation: Breastfeeding is not recommended during treatment and for 4 days after the last dose of molnupiravir. A lactating individual may consider interrupting breastfeeding and may consider pumping and discarding breast milk during treatment and for 4 days after the last dose of molnupiravir.

Clinical considerations:

Health care provider should assess whether patients are pregnant or not before prescribing molnupiravir. If patients are pregnant, the provider should prescribe it only if the potential benefits would outweigh the potential risks.

COVID-19 in pregnancy is also itself associated with adverse maternal and fetal outcomes, including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous
thromboembolic disease, and fetal death.

If the decision is made to use molnupiravir during pregnancy, the prescribing healthcare provider must document that the known and potential benefits and potential risks of using molnupiravir during pregnancy were communicated to the pregnant individual.

Molnupiravir is not authorized:

- for use in patients less than 18 years of age.

- for initiation of treatment in patients requiring hospitalization due to COVID-19.

- for use for longer than 5 consecutive days.

- for pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

Molnupiravir is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.

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