Safety assessment of the use of thioureidoiminomethylpyridinium perchlorate (Perchlozone) in the treatment of drug-resistant tuberculosis in patients with HIV infection

Abstract

An increase in the number of patients with tuberculosis caused by drug-resistant strains of mycobacteria is recorded annually. In this regard, one of the priority areas of modern phthisiology is the search for ways to improve the drug therapy of tuberculosis using new highly effective treatment regimens and drugs.

The aim of the study was to assess the safety of thioureidoiminomethylpyridinium perchlorate (Perchlozone®) for the treatment of drug-resistant tuberculosis in patients with HIV infection.

Material and methods. A retrospective single-center study of a cohort of patients treated with Perchlozone in the city TB hospital for 2019–2021 was carried out. The study included 66 patients with first diagnosed respiratory tuberculosis without HIV infection (group 1) and with HIV infection (group 2). Group 2 patients were stratified into 3 subgroups based on the degree of immunosuppression (IIA, IIB, IIC).

For statistical processing of the obtained data, the IBM SPSS Statistics 22 program was used.

Results and discussion. In the process of treatment with Perchlozone® as part of a complex scheme of anti-tuberculosis therapy, adverse events (AEs) were recorded in 19/45 (42.2%) patients in the first and 9/21 (42.9%) patients in the second group. In the structure of AEs, the largest proportion accounted for changes in the digestive system and hyperthermia. Adverse reactions, as a rule, were of mild to moderate severity and were stopped by symptomatic therapy. Severe AEs that required discontinuation of the drug were detected in 4/45 (8.9%) and 2/21 (9.5%), respectively.

Conclusion. It has been established that the use of thiouridoiminomethylpyridinium perchlorate as part of complex therapy in patients with combined tuberculosis and HIV infection is safe and does not contribute to an increase in the incidence of adverse reactions compared to that in patients with tuberculosis and HIV-negative status.

Keywords:tuberculosis with multi-drug resistance; treatment of tuberculosis; Perchlozone®; HIV infection

Funding. The study had no sponsor support.

Conflict of interest. The authors declare no conflict of interest.

Contribution. The concept and design of the study, text editing – Panteleev A.M., Daynovets A.V.; collection and processing of material, writing the text, responsibility for the integrity of all parts of the article – Shuvalova E.V.; collection and processing of material, statistical data processing – Udaltsova E.V.; approval of the final version of the article – Panteleev A.M.

For citation: Shuvalova E.V., Panteleev A.M., Daynovets A.V., Udaltsova E.N. Safety assessment of the use of thioureidoiminomethylpyridinium perchlorate (Perchlozone) in the treatment of drug-resistant tuberculosis in patients with HIV infection. Infektsionnye bolezni: novosti, mneniya, obuchenie [Infectious Diseases: News, Opinions, Training]. 2023; 12 (1): 69–74. DOI: https://doi.org/10.33029/2305-3496-2023-12-1-69-74 (in Russian)

REFERENCES

1.Belyaeva E.N., Chernokhaeva I.V., Starshinova A.A., et al. The range of adverse reactions in the complex treatment of respiratory tuberculosis with multiple and extensive drug resistance when perchlozon is included to the regimen. Tuberkulez i bolezni lëgkih [Tuberculosis and Lung Diseases]. 2015; (7): 24–5. (in Russian)

2. Grebenkina V.Yu. Study of the pharmacokinetics of the original anti-tuberculosis drug “Perchloson”: Abstract of Diss. Moscow, 2015: 22 p. (in Russian)

3. Ershova E.S., Turik A.L., Pavlova M.V., Revjakin E.A. The effectiveness and the safety of combined tuberculosis treatment regimens using the drug perchlozon. Methods of forecasting, prevention and elimination of adverse events. Tuberkulez i sotsial’no znachimye zabolevaniya [Tuberculosis and Socially Significant Diseases]. 2021; (4): 43–53. (in Russian)

4.Panteleev A.M., Galkin V.B., Gorbanova N.V., Veselov A.A., et al. Information bulletin. Epidemiological situation on tuberculosis in St. Petersburg in 2021. St. Petersburg, 2022: 28 p. (in Russian)

5. Myshkova E.P., Petrenko T.I., Kolpakova T.A. Comparative analysis of effcacy and safety of various anti-tuberculosis therapy regimens in patients with MDR/XDR tuberculosis. Tuberkulez i bolezni lëgkih [Tuberculosis and Lung Diseases]. 2022; 100 (5): 35–40. DOI: https://doi.org/10.21292/2075-1230-2022-100-5-35-40 (in Russian)

6. Nikolaeva S.V. Experience of using the drug of perchlozon in tuberculosis patients with multiple drug resistance in Buryatia Republic. Tuberkulez i bolezni lëgkih [Tuberculosis and Lung Diseases]. 2015; (10): 64 68. (in Russian)

7.Vasilyeva I.A., Balasanyants G.S., Borisov S.E. Tuberculosis in adults: clinical guidelines. Moscow, 2020: 121 p. (in Russian)

8.Tuberculosis: fact sheet on Sustainable Development Goals (SDGs): health targets. WHO/EURO:2017-2388-42143-58059. URL: https://apps.who.int/iris/handle/10665/340885

9.Vasilyeva I.A., Voronin E.E., Pokrovsky V.V. Federal clinical guidelines for the prevention, diagnosis and treatment of tuberculosis in patients with HIV infection. Moscow; 2016: 40 p. (in Russian)

10.Yablonsky P.K., Vinogradova T.I., Pavlova M.V. New prospects for the treatment of respiratory tuberculosis. Meditsinskiy al’yans [Medical Alliance]. 2013; (2): 69–73. (in Russian)

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CHIEF EDITOR
Aleksandr V. Gorelov
Academician of the Russian Academy of Sciences, MD, Head of Infection Diseases and Epidemiology Department of the Scientific and Educational Institute of Clinical Medicine named after N.A. Semashko ofRussian University of Medicine, Ministry of Health of the Russian Federation, Professor of the Department of Childhood Diseases, Clinical Institute of Children's Health named after N.F. Filatov, Sechenov First Moscow State Medical University, Ministry of Health of the Russian Federation, Deputy Director for Research, Central Research Institute of Epidemiology, Rospotrebnadzor (Moscow, Russian Federation)

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