There are experimental and clinical data regarding the activity of favipiravir against the SARS-CoV-2 virus. The is evidence of significant variability in pharmacokinetics and associated achievement of the required inhibitory concentration of the drug. The evidence base for the effectiveness of use in patients with mild to moderate COVID-19 is limited to open-label randomized clinical trials. The use of the drug, given the limited experience of using favipiravir, requires special attention to the safety of its prescription (pregnancy test, contraception compliance, control of uric acid, transaminases, ECG). At present, the prescription of the drug can be considered by the attending physicians if the expected benefits of its use prevail over the possible risks in accordance with the approved instructions for medical use and the temporary guidelines of the Ministry of Health of Russia.
Background
A systematic review showed the accuracy of Mycobacterium tuberculosis antigen-based skin test (TBST) for tuberculosis (TB) is similar to interferon-gamma release assays, but its safety has not been systematically reviewed.
Methods
We searched for studies reporting injection site reactions (ISR) and systemic adverse events. We searched Medline, Embase, e-library, the Chinese Biomedical Literature Database, and the China National Knowledge Infrastructure database for studies until 30 July 2021, which was updated on 22 November 2022. We conducted a random-effects meta-analysis.
Results
We identified seven studies for Cy-Tb (Serum Institute of India, India), seven (including two found through the updated search) for C-TST (Anhui Zhifei Longcom, China), and 11 for Diaskintest (Generium, Russia). The pooled risk of any injection site reactions (ISR) due to Cy-Tb (N = 2931, 5 studies) was not significantly different from TST (RR 1.05; 95%CI 0.70-1.58). Over 95% of ISR were reported as mild or moderate; common ISR included pain, itching and rash. In one randomised-controlled study (RCT), 49/153 (37.6%) of participants given Cy-Tb developed any systemic adverse events (e.g. fever and headache) compared with 56/149 (37.6%) in those given TST (RR 0.85 95%CI 0.6-1.2). In an RCT in China (n = 14,579), the frequency of systemic adverse events in participants given C-TST was similar to TST, and that of ISR was similar to or lower than the TST. Reporting of the safety data on Diaskintest was not standardised, precluding meta-analysis.
Conclusion
The safety profile of TBST appears similar to TST and is associated with mostly mild ISR.
There exist some theoretical premises for the use of colchicine in patients with COVID-19, and clinical trials are underway. There is currently no published evidence confirming effectiveness and safety of colchicine in COVID-19 and allowing to recommend it for general practice. If prescribing colchicine, the one should perform clinical and hematological monitoring and avoid drug interactions.
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