To deal with "double positive", how to choose among the 6 domestically marketed new coronavirus oral drugs?

Recently, topics related to the novel coronavirus have frequently been on the hot search list, and the number of patients with first- and second-level positive tests has increased significantly. People are also more concerned about the question of "how to choose oral medications for the novel coronavirus."

According to information on the website of the National Medical Products Administration, there are currently a total of 6 oral COVID-19 drugs on the market in China, and these drugs can be used under the guidance of a doctor.

Can children take oral COVID-19 medicine? Are there any contraindications? How effective is it? NetEase Health has compiled and sorted out the issues that people are concerned about!

1. Paxlovid: The once hyped COVID-19 “miracle drug”

On February 12, 2022, my country's National Medical Products Administration conditionally approved the import registration of Paxlovid, making Paxlovid the first oral COVID-19 drug to be marketed in China.

Pfizer conducted an experiment in 2021 - EPIC-HR, which stands for Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients. This experiment selected 2,245 adults over the age of 18 as experimental subjects. These people have some factors that may cause severe COVID-19, such as underlying diseases, no vaccination, first infection, and advanced age.

Among 697 patients using Paxlovid, 5 were hospitalized within 28 days (0.7%) and 0 died, while in another group of patients using placebo, 44 ​​were hospitalized within 28 days (6.5%) and 9 died. Through this experiment, Pfizer proved that Paxlovid can reduce the risk of death and hospitalization by 89%.

2. Monolavir: The world's first oral drug for COVID-19

Monolavin is the world's first approved oral drug for COVID-19. On November 4, 2021, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) approved Monolavin for marketing for the treatment of mild to moderate COVID-19 infection in adults with a high risk of progression to severe illness. On December 29, 2022, my country's National Medical Products Administration conditionally approved the import registration of Monolavin.

Data from the Phase 3 MOVe-OUT clinical trial of Monolavir published in the New England Journal of Medicine in December 2021 showed that early treatment with Monolavir significantly reduced the risk of hospitalization or death in unvaccinated high-risk adult patients with COVID-19. The interim analysis report of the trial showed that compared with the placebo group, the risk of hospitalization or death in the Monolavir group was reduced by approximately 50% by day 29.

3. Azvudine tablets: the first domestically produced oral drug for COVID-19

As early as July 20, 2021, the National Medical Products Administration conditionally approved the use of Azvudine tablets in combination with other reverse transcriptase inhibitors to treat adult HIV-1 infected patients with high viral loads. On July 25, 2022, the National Medical Products Administration conditionally approved the addition of an indication for Azvudine for the treatment of adult patients infected with the common type of novel coronavirus.

On July 15, 2022, the official WeChat account of RealBio released the results of the Phase III clinical trial of Azvudine. The clinical trial results showed:

① Significant improvement of clinical symptoms: Azvudine tablets can significantly shorten the time for symptom improvement in patients with moderate COVID-19 infection, increase the proportion of patients with improved clinical symptoms, and achieve clinically superior results. The proportion of subjects with improved clinical symptoms on the 7th day after the first dose was 40.43% in the Azvudine group and 10.87% in the placebo group (P value <0.001). The median time for clinical symptom improvement in the Azvudine group and the placebo group showed extremely significant statistical differences (P value <0.001).

②Inhibition of the new coronavirus: Azvudine can inhibit the activity of the new coronavirus, and the virus clearance time is about 5 days.

③Safety: Azvudine tablets were generally well tolerated, and there was no statistical difference in the incidence of adverse events between the azvudine group and the placebo group, and there was no increase in risk to the subjects.

4. Senoxin: The first domestically produced 3CL COVID-19 innovative drug

On January 28, 2023, Senoxin received special approval from the National Medical Products Administration and was conditionally launched in China. With the approval, Senoxin became my country's first independently developed 3CL target anti-new coronavirus innovative drug with independent intellectual property rights.

From the perspective of clinical design, the Phase II/III clinical studies of Senoxin included a large sample of Chinese patients and targeted the currently prevalent Omicron strain. According to the clinical study results of Senoxin published on the official website of Innovent Biologics, after a full 5-day course of treatment, the viral load of the Senoxin group decreased by more than 96%.

5. Mindevi: Another breakthrough in domestic oral COVID-19 medicine

On January 28, 2023, the National Medical Products Administration, in accordance with the special drug approval procedure, conditionally approved the launch of the Class 1 innovative drug Mindewei. Mindewei is a new oral nucleoside antiviral drug used to treat adult patients with mild to moderate COVID-19 infection.

On December 28, 2022, the New England Journal of Medicine published online the results of a Phase III registration clinical study comparing VV116 with the combination of namatevir tablets and ritonavir tablets (Paxlovid) for the early treatment of patients with mild to moderate COVID-19 infection who were at high risk of progression to severe disease, including death. The results showed that the primary endpoint of the study achieved non-inferiority, and compared with Paxlovid, patients receiving VV116 performed equally or even better in promoting recovery. The VV116 group had a shorter clinical recovery time and better safety performance.

6. Leruiling: The advantages of monotherapy are obvious

On March 21, 2023, the National Medical Products Administration, in accordance with the relevant provisions of the Drug Administration Law and in accordance with the special drug approval procedures, conditionally approved the marketing of the Class 1 innovative drug Leretevir Tablets (trade name: Leruiling). Leretevir Tablets are oral small molecule drugs for the treatment of COVID-19 infection, used to treat adult patients with mild to moderate COVID-19 infection.

According to existing research data, Leretevir tablets have a good therapeutic effect on mild cases of new coronavirus infection when used alone. Compared with similar products, there is no need to use ritonavir tablets in combination, which can reduce the side effects of combined drugs and reduce the risk of elderly patients with underlying diseases taking drugs.

According to the results of the Phase II clinical trial of Lerestatvir tablets, Lerestatvir tablets can effectively shorten the time it takes for nucleic acid to turn negative and reduce viral load. The viral titer dropped more than 10 times that of the placebo group 72 hours after taking the drug. In the larger Phase III clinical trial, research data showed that after four days of using Lerestatvir tablets alone, the viral load of patients with mild to moderate COVID-19 infection was reduced by an average of nearly 90% compared with the placebo group.

NetEase Health reminds that the above 6 new crown oral drugs are prescription drugs, with strict indications, contraindications, and precautions. It is very important to follow the doctor's orders! If there are elderly people or patients with underlying diseases at home, it is okay to buy a box for backup, but there is no need to stock up on a large amount of drugs. Remember, you cannot take medicine randomly on your own, let alone blindly follow the trend.

References:

1. Package insert for Namatevir tablets/ritonavir tablets combination

2. Monoravir Instructions

3. Instructions for use of Azvudine tablets

4. Package Instructions for Senotegravir Tablets/Ritonavir Tablets Combination

5. Instructions for use of Deuterium Remdevir Hydrobromide Tablets

6. Instructions for use of Leretevir tablets

7. First and only FDA-approved oral treatment for COVID-19 in adults

https://www.paxlovid.com/

8. Diagnosis and Treatment Plan for Novel Coronavirus Infection (Trial Tenth Edition)

http://www.nhc.gov.cn/xcs/zhengcwj/202301/32de5b2ff9bf4eaa88e75bdf7223a65a/files/460b0e7b19bd42f3bba00c1efb9b6811.pdf

9. Jayk Bernal A, Gomes da Silva MM, Musungaie DB, et al. Molnupiravir for oral treatment of Covid-19 in nonhospitalized patients. N Engl J Med 2022;386:509-520.

10. Where to buy? How to use? Here are the authoritative answers to these two oral COVID-19 drugs!

https://wsjk.tj.gov.cn/ZTZL1/ZTZL750/YQFKZL9424/FKZS1886/202212/t20221230_6064699.html

11. The main efficacy indicators of the Phase III clinical trial of Azvudine tablets for the treatment of COVID-19 have reached expectations

https://mp.weixin.qq.com/s/LXaq4p_v0unYoFN0GaRfkw

12. Innovent Biologics official website

http://www.simcere.com/news/detail.aspx?mtt=335

13. VV116 versus Nirmatrelvir–Ritonavir for Oral Treatment of Covid-19

https://www.nejm.org/doi/full/10.1056/NEJMoa2208822