Is the domestic oral new crown drug Azvudine safe?

Recently, Cen Xiaobo , director of the National Chengdu New Drug Safety Evaluation Center, said: " It is unscientific to talk about the toxicity of drugs or the potential adverse ris.

In June 2022, in the technical review report of the application for marketing given by the Drug Evaluation Center of the State Drug Administration, in the evaluation of drug safety, it was mentioned that Azvudine tablets "Ames test, CHL chromosome aberration test and in vivo tes.

Carcinogenicity is a matter of great concern to the publ.
Generally, which drugs must be studied for carcinogenicity? What is the carcinogenicity risk of Azvudine? According to Cen Xiaobo, drugs that require carcinogenicity research are generally drugs that patients need to take for a long tim.
For example, drugs for the treatment of hypertension and diabetes need to be taken by patients for a long time or even for a lifetime, and the potential carcinogenicity of the drugs needs to be studie.
For short-term (such as within 7 days) use of drugs, such as common cold medicine, generally do not pay attention to the carcinogenicity of these drug.
In addition, if in non-clinical drug studies, including genotoxicity tests or some long-term toxicology experiments, there are carcinogenic signal cues or other similar structure drugs have carcinogenic cues, although the drug is not used for a long period of time, it will be considered carcinogen.
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The State Food and Drug Administration's review report mentioned that Azvudine's "carcinogenicity risk still needs to be evaluated by subsequent carcinogenicity tests.
According to the report, it is planned to be used for a long time in clinical practice, and the treatment period is more than 6 months, and no carcinogenicity test has been carried out ye.
According to ICH S1 and M3 requirements: For drugs developed for the treatment of certain serious diseases, carcinogenicity testing may not be required before marketing approval, but it is required to be conducted after marketing approva.
In this regard, Cen Xiaobo said that this is to follow the international practice, and the benefit-risk ratio of the patient needs to be weighe.
For drugs that are urgently needed in the clinic, although some studies have not been completed, they can be approved for marketing with condition.
Such as the treatment of malignant tumors, AIDS, rare diseases and other drugs, because the drug carcinogenicity test often takes 2 to 3 year.
In this case, the benefits outweigh the risks for the patients, especially those in urgent clinical need, for the conditional approval of the dru.
"At present, the carcinogenicity test of Azvudine is being carried ou.
" Cen Xiaobo revealed that Azvudine is used for the treatment of AIDS, and some people may take it for a long time or even for li.

It is necessary to carry out its carcinogenicity tes.

Cen Xiaobo said that the toxic and side effects of the drug are directly related to the dose of the drug, and the exposure or drug concentration at the clinical therapeutic dose of Azvudine is far lower than the dose causing toxic and side effects in non-clinical trials, and it has a good therapeutic safety wind.