The analysis of pharmacovigilance results of adverse reactions of antiretroviral drugs used in the treatment of HIV-positive people in Ukraine
DOI:
https://doi.org/10.24959/sphhcj.24.340Keywords:
antiretroviral drugs, HIV, AIDS, medicines adverse reactions, pharmacovigilance, pharmaceutical provision for the populationAbstract
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.
References
The path that ends AIDS: UNAIDS global AIDS update 2023. https://www.unaids.org/en/resources/documents/2023/global-aids-update-2023
Deeks, S. G., Archin, N., Cannon, P., Collins, S., Jones, R. B., de Jong, M. A. W. P., Lambotte, O., Lamplough, R., Ndung’u, T., Sugarman, J., Tiemessen, C. T., Vandekerckhove, L., & Lewin S. R. (2021). Research priorities for an HIV cure: International AIDS Society Global Scientific Strategy 2021. Nat Med, (27), 2085-2098.
Govender, R. D., Hashim, M. J., Khan, M. Ab., Mustafa, H., & Khan, G. (2021). Global Epidemiology of HIV/AIDS: A Resurgence in North America and. J Epidemiol Glob Health, 11(3), 296–301. https://doi.org/10.2991/jegh.k.210621.001
Global Burden of Disease 2021: Findings from the GBD 2021 Study (2024). / Institute for Health Metrics and Evaluation (IHME). IHME https://surl.li/wwowug
The Global Health Observatory. Data on the size of the HIV epidemic. https://www.who.int/data/gho/data/themes/hiv-aids/data-on-the-size-of-the-hiv-aids-epidemic
Epidemiological fact sheet. HIV statistics, globally and by WHO region, 2023. https://cdn.who.int/media/docs/default-source/hq-hiv-hepatitis-and-stis-library/j0294-who-hiv-epi-factsheet-v7.pdf
Tsentr hromadskoho zdorovia MOZ Ukrainy. Statystyka z VIL/SNIDU. Epidemichna sytuatsiia z VIL-infektsii v Ukraini stanom na 01.10.2024. https://phc.org.ua/kontrol-zakhvoryuvan/vilsnid/statistika-z-vilsnidu
HIV/AIDS surveillance in Europe 2022 data 2023. https://surl.li/pfqrux
Reyes-Urueña, J., Marrone, G., Noori, T., Kuchukhidze, G., Martsynovska, V., Hetman, L., Basenko, A., Bivol, S., J van der Werf, M., & Pharris A. (2023). HIV diagnoses among people born in Ukraine reported by EU/EEA countries in 2022: impact on regional HIV trends and implications for healthcare planning. Euro Surveill, 28(48), 2300642. https://doi.org/10.2807/1560-7917.ES.2023.28.48.2300642
Yefremova, V., Panfilova, H. L., Lebedyn, A. M., Iurchenko, G. N., Okseniuk, О. E., Chernukha, V. M., Tereshchenko, L. V., & Chebernina I. (2022). The results of a comparative analysis of the population of the population of Ukraine and countries of the European region for HIV as a rationale for improving the pharmaceutical provision of patients with socially dangerous pathologies. ScienceRise: Pharmaceutical Science, 1(35), 4-13. https://doi.org/10.15587/2519-4852.2022.253507
Sazonova, Y., Kulchynska, R., Sereda, Y., Azarskova, M., Novak Y., Saliuk, T., Kornilova, M., Liulchuk, M., Vitek, C., & Dumchev K. (2020). HIV treatment cascade among people who inject drugs in Ukraine. PLoS One, 15(12), e0244572 https://doi.org/10.1371/journal.pone.0244572
Dumchev, K., Dvoryak, S., Chernova, O., Morozova, O., & Altice, F. L. (2017). Retention in medication-assisted treatment programs in Ukraine – Identifying factors contributing to a continuing HIV epidemic. International Journal of Drug Policy, (48), 44-53 https://www.sciencedirect.com/science/article/abs/pii/S0955395917301184
Mody, A., Sohn, A. H., Iwuji, C., Tan, R. K. J., Venter, F., & Geng, E. H. (2024). HIV epidemiology, prevention, treatment, and implementation strategies for public health. The Lancet, 403(10425), 471-492. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01381-8/abstract
Guidelines on the public health response to pretreatment HIV drug resistance. (2017). World Health Organization. http://www.who.int/hiv/pub/guidelines/hivdr-guidelines2017/en
Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. (2nd ed.) (2016). World Health Organization. http://www.who.int/hiv/pub/arv/arv2016/en
Dybul, M., Attoye T., Baptiste, S., Cherutich, P., Dabis, F., Deeks, S. G., Dieffenbach, C., Doehle, B., Goodenow, M. M., Jiang, A., Kemps, D., Lewin, S. R., Lumpkin, M. M., Mathae, L., McCune, J. M., Ndung’u, T., Nsubuga, M., Peay, H. L., Pottage, J., … Sikazwe, I. (2021). The case for an HIV cure and how to get there. Lancet HIV, 8(1), e51-e58.
Consolidated guideline on sexual and reproductive health and rights of women living with HIV. (2017). World Health Organization. https://surl.li/yhwwpf
Pharmacovigilance for antiretrovirals in resource-poor countries. (2007). World Health Organization. https://surl.li/kfaovj
Bakare, N., Edwards, I. R., Stergachis, A., Pal, S., Holmes, C. B., Lindquist, M., Duncombe, C., Dodoo, A., Novendstern, J., Nwokike, J., Kuchenbecker, R., Aberg, J. A., Miller, V., & Strobos, J. (2011). Global Pharmacovigilance for Antiretroviral Drugs: Overcoming Contrasting Priorities. PLoS Medicine, 8(7), e1001054. https://doi.org/10.1371/journal.pmed.1001054
Kunene, K. N., & Teo, S. P. (2021). The Importance of Antiretroviral Pharmacovigilance International Journal of Infection, 9(1), e11475. https://doi.org/10.5812/iji.114751
Schneider, M. T., Birger, M., Haakenstad, A., Singh, L., Hamavid, H., Chapin, A., Murray, C. J. L., & Dieleman, J. L. (2016). Tracking development assistance for HIV/AIDS: the international response to a global epidemic. AIDS, 30(9), 1475–9. https://doi.org/10.1097/QAD.0000000000001081
Rather, Z. A., Chowta, M. N., Prakash Raju, G. J. K., & Mubeen, F. (2013). Evaluation of the adverse reactions of antiretroviral drug regimens in a tertiary care hospital. Indian J Pharmaco, 45(2), 145–148. https://doi.org/10.4103/0253-7613.108294
Sindie, R., Mwakilama, E., Chizala, P., & Namangale, J. (2023). A retrospective study on side effects of first-line antiretroviral drugs on HIV patients based on 1A, 2A, and 5A regimen records at Zomba Central Hospital, Malawi. Afr Health Sci, 23(3), 468–480. https://doi.org/10.4314/ahs.v23i3.54
Birbal, S., Dheda, M., Ojewole, E., & Oosthuizen, F. (2016). Adverse drug reactions associated with antiretroviral therapy in South Africa. Afr J AIDS Res, 15(3), 243-8. https://doi.org/10.2989/16085906.2016.1191519
Zash, R., Holmes, L., Diseko, M., Jacobson, D. L., Brummel, S., Mayondi, G., Isaacson, A., Davey, S., Mabuta, J., Mmalane, M., Gaolathe, T., Essex, M., Lockman, S., Makhema, J., & Shapiro, R. L. (2019). Neural-Tube Defects and Antiretroviral Treatment Regimens in Botswana. N Engl J Med, 381(9), 827-40. https://doi.org/10.1056/NEJMoa1905230
Cai, J., Xiao, J., & Zhang, Q. (2014). Side effects and tolerability of post-exposure prophylaxis with zidovudine, lamivudine, and lopinavir/ritonavir: a comparative study with HIV/AIDS patients. Chinese Medical Journal, 127(14), 2632–2636.
Finkelstein, J. L., Gala, P., Rochford, R., Glesby, M. J., & Mehta, S. (2015). HIV/AIDS and lipodystrophy: implications for clinical management in resource-limited settings. J Int AIDS Soc, 18(1), 19033. https://doi.org/10.7448/IAS.18.1.19033
Dupont, E., Yombi, J. C. (2023). Antiretroviral therapy and weight gain in antiretroviral treatment-experienced HIV patients: A review. AIDS Rev, 25(1), 54-64. https://doi.org/10.24875/AIDSRev.22000026
Zalis’ka, О., Maksymovych, N., Zaliskyy, O. (2013). Analysis of Adverse Reactions of Medicine in Ukraine. Valuein Health Journal, 16(7), PHP63. https://surl.li/abfrke
Matvieieva, O. V., Antoniak, S. M., & Hetman, L. I. (2014). Rozpovid pro nevdachu antyretrovirusnoi terapii, a ne vidsutnist efektyvnosti antyretrovirusnykh likarskykh zasobiv. Ratsionalna farmakoterapiia, 2(31), 11-16. https://rpht.com.ua/uploads/issues/2014/2(31)/52111412.pdf
Matvieieva, O. V. (2014). Farmakonahliad: holovni rezultaty 2013 roku. Ratsionalna farmakoterapiia, 1(39), 18-21. https://rpht.com.ua/uploads/issues/2014/1(30)/58827182.pdf
Osnovni pokaznyky roboty farmakonahliadu za 2023 rik. (23.02.2024) / DP “Derzhavnyi ekspertnyi tsentr MOZ Ukrainy”. https://www.dec.gov.ua/doctors/rezultati-diyalnosti-z-pitan-bezpeki-likarskih-zasobiv/?role=doctors
Nakaz MOZ Ukrainy “Pro zatverdzhennia novoho Klinichnoho protokolu iz zastosuvannia antyretrovirusnykh preparativ dlia likuvannia ta profilaktyky VIL-infektsii” No. 1292 (2019, Chervnia 05). https://surl.li/uxxuda
Nakaz MOZ Ukrainy “Pro zatverdzhennia Standartiv okhorony zdorov᾿ia dokontaktnoi ta postkontaktnoi medykamentoznoi profilaktyky VIL-infektsii” No. 189 (2021, Liutyi 05). https://surl.li/jzbuay
Derzhavne pidpryiemstvo “Derzhavnyi ekspektnyi tsentr MOZ Ukrainy”. (2022). VIL-infektsiia. Klinichna nastanova, zasnovana na dokazakh. https://www.dec.gov.ua/wp-content/uploads/2022/11/2022_2092_kn_vil_1.pdf
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