The analysis of pharmacovigilance results of adverse reactions of antiretroviral drugs used in the treatment of HIV-positive people in Ukraine

Aim. To analyze the results of pharmacovigilance of adverse reactions of antiretroviral drugs (ARVD) used in the treatment of HIV-positive people in Ukraine. Materials and methods. Historical, analytical and comparative, system, graphic, logical, hypothetical-deductive, as well as marketing, and mathematical-statistical methods of analysis were used. The study object was reports on pharmacovigilance of adverse reactions (ARs) of ARVD. Results. During 2017-2023, the number of reports of ARs of ARVD in Ukraine was unstable. In 2017, the number of reports was 732 compared to only 199 cases in 2023. The highest number of reports was typical for the pre-war 2021 (1330 cases). According to the results of the structural analysis of the reports, it was found that the largest number of them occurred with the use of combined ARVD - FTC + TDF + EFV (1261 cases or 40.43 %); TDF + FTC (607 and 19.46 %); DTG (496 and 15.90 %); AZT + lamivudine (312 and 10.00 %). These combined drugs occupy the leading positions in the number of both serious and non-serious adverse reactions. In addition, for five years, it was the combined ARVs that were characterized in time by the nature of receiving reports about ARs. It should be noted that there was a significant range of variation in the number of reports for different drugs. They ranged from 1 (ABC + lamivudine; AZT + lamivudine + NVP) to 1261 reports (FTC + TDF + EFV). The ratio between serious and non-serious ARs in the use of ARVs during 2008-2012 was 1:2, and according to our (2019-2023) studies, this indicator was 1:16. Conclusions. A comprehensive analysis of the ARVP PR in Ukraine for the period from 2007-2013 and 2017-2023 was conducted. The results presented indicate that since 2017, there has been an unstable nature of changes in the number of reports and their structure by year. This fact makes it necessary to conduct further research aimed at analyzing the impact of the volume and composition of state purchases of ARV drugs on the frequency of detection of RP in the case of their use in the treatment of HIV-infected people in Ukraine.