Notification on Including Simnotrelvir Tablets/Ritonavir Tablets (Co-Packaged) and Deuremidevir Hydrobromide Tablets in Diagnosis and Treatment Plan for Novel Coronavirus Infection

To the health commissions and traditional Chinese medicine administrations of all provinces, autonomous regions, municipalities directly under the Central Government, and the Xinjiang Production and Construction Corps:

In accordance with the opinion of the National Medical Products Administration on the conditional approval of the marketing applications of simnotrelvir tablets/ritonavir tablets (co-packaged) and deuremidevir hydrobromide tablets for the treatment of COVID-19,  it has been decided to include these two drugs in Diagnosis and Treatment Plan for Novel Coronavirus Infection  (Trial Version 10)), so as to further improve the antiviral treatment plan for COVID-19. The specifics are as follows:

I. Simnotrelvir Tablets/Ritonavir Tablets (Co-Packaged)

(1) Indications

For the treatment of adults with mild and moderate COVID-19 symptoms, it should be used as soon as possible within 3 days of symptom onset.

(2) Dosage

It is recommended to simultaneously take 0.75g simnotrelvir and 0.1g ritonavir on an empty stomach once every 12 hours for  5 consecutive days.

(3) Contraindications and Drug Use in Special Populations

It is contraindicated in patients who have allergies to any active ingredients or excipients of this medicine. It is contraindicated in patients with rare hereditary diseases, such as galactose intolerance, total lactase deficiency or glucose-galactose malabsorption, and this medicine should not be taken during pregnancy.

This medicine should never be used with drugs that are highly dependent on CYP3A for clearance and result in severe and/or life-threatening adverse reactions when plasma concentrations increase.

Patients with severe hepatic insufficiency should not use this medicine, and the ones with a history of liver diseases, abnormal liver enzymes, or hepatitis should use it with caution. It is not recommended to breastfeed during the treatment with this medicine or within 7 days after withdrawal of the treatment.

II. Deuremidevir Hydrobromide Tablets

(1) Indications

For the treatment of adults with mild and moderate COVID-19 symptoms, it should be used as soon as possible within 3 days of symptom onset.

(2) Dosage

It is recommended to take the tablets once every 12 hours for 5 consecutive days on an empty stomach or after a meal. For the first day ( the first two times), 0.6g should be taken each time; and  0.3g each time from the second to the fifth day (from the third to the tenth time).

(3) Contraindications and Drug Use in Special Populations

It is contraindicated in patients who have had severe allergies to any active ingredients or excipients of this medicine, and this medicine should not be taken during pregnancy.

It is not recommended to breastfeed during the treatment with this medicine or within 7 days after withdrawal of the treatment.

III. Precautions

Before using the above two drugs, read the instructions approved by the National Medical Products Administration in detail and use the drugs correctly according to the indications and dosages specified in the instructions. Doctors should be familiar with the contraindications, adverse reactions, and drug interactions before prescribing the drugs. They should also thoroughly inquire about the patients' drug allergy history to avoid use by patients with contraindications and to avoid combined use with drugs that are prohibited from being used together. All regions should strictly follow the requirements of the Provisions for Adverse Drug Reaction Reporting and Monitoring, do a good job in monitoring and reporting adverse reactions, and ensure the safety of drug use.

(This document is actively disclosed to the public)