Quyết định 4498/QD-BYT

DECISION

AMENDMENTS TO GUIDELINES ON DIAGNOSIS AND TREATMENT OF COVID-19 CAUSED BY NOVEL CORONA VIRUS (SARS-COV-2)

MINISTER OF HEALTH

Pursuant to Decree No. 75/2017/ND-CP dated June 20, 2017 of the Government on functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Resolution No. 86/NQ-CP dated August 6, 2021 Resolving urgent solutions for COVID-19 epidemic management for implementation of Resolution No. 30/2021/QH15 dated July 28, 2021 of the 15^th National Assembly;

According to remarks of Specialized Council for developing specialized documents, guidelines, and regulations guaranteeing COVID-19 diagnosis and treatment established under Decision No. 4026/QD-BYT dated August 20, 2021 of the Minister;

At request of Director of Vietnam Administration of Medical Services and Ministry of Health,

HEREBY DECIDES:

Article 1. Attached to this Decision are amendments to Sub-section 6.6. Antiviral drugs and Sub-section 6.7. Monoclonal antibody under Part VIII. Treatment, Section 6. Other treatment of “Guidelines on diagnosis and treatment for COVID-19 caused by the novel Corona virus (SARS-CoV-2)” under Decision No. 3416/QD-BYT dated July 14, 2021 of Minister of Health.  

Article 2. This Decision comes into effect from the day of signing.

Article 3. Director of Department of Medical Examination and Treatment; Chief of the Ministry Office, Chief Ministry Inspector, directors of departments and agencies affiliated to Ministry of Health; directors of hospitals and facilities providing hospital beds affiliated to Ministry of Health; Directors of Departments of Health of provinces and central-affiliated cities; heads of medical sector of ministries are responsible for implementation of this Decision.

AMENDMENTS TO GUIDELINES ON DIAGNOSIS AND TREATMENT OF COVID-19 CAUSED BY NOVEL CORONA VIRUS (SARS-COV-2)

(Attached to Decision No. 4498/QD-BYT dated September 21, 2021 of Minister of Health)

VIII. TREATMENT

6. Other treatment methods

Sub-section 6.6. Antiviral drugs under Part VIII. Treatment, Section 6. Other treatment of “Guidelines on diagnosis and treatment of COVID-19 caused by the novel Corona virus (SARS-CoV-2)” attached to Decision No. 3416/QD-BYT dated July 14, 2021 of Minister of Health is amended as follows:

6.6. Antiviral drugs

- Refers to drugs inhibiting virus duplication.

- Oral antiviral drugs are used for all cases of confirmed early SARS-CoV-2 infection.

- Injection and intravenous infusion antiviral drugs are used for inpatients.

- For drugs that have not been recommended for use, not licensed for circulation, and not licensed for emergency use in any country by World Health Organization: use of said drugs must comply with regulations on clinical testing of Ministry of Health.

- For drugs that have been recommended for use, licensed for circulation, or licensed for emergency use in at least 1 country by World Health Organization: said drugs shall be permitted for use according to instruction manuals of manufacturers attached upon import (e.g. Remdesivir, favipiravir, etc.).   

Sub-section 6.7. Monoclonal antibody under Part VIII. Treatment, Section 6. Other treatment of “Guidelines on diagnosis and treatment of COVID-19 caused by the novel Corona virus (SARS-CoV-2)” attached to Decision No. 3416/QD-BYT dated July 14, 2021 of Minister of Health is amended as follows:

6.7. Monoclonal antibody

- Refers to Interleukine 6 inhibitors or virus neutralizers.

- Recommended for treatment for patients at 12 years of age or older with confirmed infection of SARS-CoV-2 from mild to moderate severity, facing risks of worsening in a manner similar to the elderly, overweight persons, persons having cardiovascular diseases, hypertension, chronic pulmonary diseases, type 1 and type 2 diabetes, chronic kidney diseases-including patients who are undergoing dialysis, chronic liver diseases, and immunodeficiency, receiving treatment for cancer, bone marrow transplant or organ transplant, immunodeficiency, HIV, anaemia, sickle cells, thalassemia, and taking drugs that cause immunodeficiency over prolonged period of time.

- For drugs that have not been recommended for use, not licensed for circulation, and not licensed for emergency use in any country by World Health Organization: use of said drugs must comply with regulations on clinical testing of Ministry of Health.

- For drugs that have been recommended for use, licensed for circulation, or licensed for emergency use in at least 1 country by World Health Organization: said drugs shall be permitted for use according to instruction manuals of manufacturers attached upon import (e.g. Tocilizumab, Sarilumab; Casirivimab 600mg + Imdevimab 600mg, Bamlanivimab 700mg + Estesevimab 1400mg, Strovimab; etc.).