OBSERVATIONAL STUDY ON THE INCIDENCE OF ADVERSE DRUG REACTIONS TO FIRST LINE ANTIRETROVIRAL AGENTS IN MELANESIANS ADULT HIV/AIDS PATIENTS

Authors

  • ZAKKY CHOLISOH Faculty of Pharmacy, Universitas Muhammadiyah Surakarta, Central Java, Indonesia https://orcid.org/0000-0003-0357-6999
  • SITI SITATUL MARAH Faculty of Pharmacy, Universitas Muhammadiyah Surakarta, Central Java, Indonesia
  • BURHANNUDIN ICHSAN Faculty of Medicine, Universitas Muhammadiyah Surakarta (UMS), Jalan Ahmad Yani, Sukoharjo-57169, Central Java, Indonesia

DOI:

https://doi.org/10.22159/ijap.2025.v17s2.08

Keywords:

Adverse drug reactions, Antiretroviral, HIV, AIDS

Abstract

Objective: Acquired immunodeficiency syndrome is a disease caused by Human Immunodeficiency Virus (HIV), and antiretroviral combinations are the mainstay therapy for HIV/AIDS patients. Common problems in using antiretroviral drugs (ART) are Adverse Drug Reactions (ADRs), which can affect the treatment of HIV patients. ADRs has strong genetic predisposition. This research was conducted to determine the profile and prevalence of ADRs in Melanesians HIV patients who use first-line ARTs.

Methods: This was observational research, which descriptively present the highest prevalence of adverse drug reactions in Melanesians’ patients with antiretroviral medications. The inclusion criteria were Melanesians adult patients with HIV/AIDS who had high adherence in using first-line ARTs and willing to be interviewed by filling informed consent. Exclusion criteria were patients with unstable conditions. Patients were followed for 1 mo. Data of perceived adverse drug reactions which the patients had experienced in 1 mo was collected through interviews with data collection carried out every week.

Results: Of total 143 Melanesian patients on antiretroviral, the number of patients who experienced adverse drug reactions there were 142 (99.3%) and 1 (0.7%) patient who did not experience ADRs. Of the 645 side effects experienced by patients included dizziness 244 (37.8%), nausea 164 (25.4%), drowsiness 79 (12.2%), hepatotoxicity 56 (8.7%), vomiting 36 (5.6%), difficulty sleeping 36 (5.6%), anemia 15 (2.3%), weight loss 8 (1.2%), itchy spots 3 (0.5%), hallucinations 2 (0.3%), and myalgia 2 (0.3%).

Conclusion: The incidents of adverse drug reactions among Melanesians patients on antiretroviral were prevalent on 99.3% of patients with dizziness, nausea, and drowsiness as the most commonly perceived adverse drug reactions. The results highlight the urgent need for routine monitoring and early detection of ADRs in this population. These findings also suggest the importance of individualized treatment plans and potential pharmacogenetic considerations to improve tolerability and adherence. Clinicians should also be equipped with targeted education and management strategies to mitigate the impact of ADRs on long-term treatment outcomes.

References

World Health Organization. HIV/AIDS; 2024. Available from: https://www.who.int/newsroom/factsheets/detail/hiv-aids. [Last accessed on 14 Apr 2025].

Director General of Disease Control and Environmental Health. Report on the development of HIV-AIDS and sexually transmitted infectious diseases quarter 1 Jan-Mar 2022. Jakarta. RI: Ministry of Health; 2022. p. 1-23.

GBD 2017. HIV collaborators global regional and national incidence prevalence and mortality of HIV, 1980-2017, and forecasts to 2030, for 195 countries and territories: a systematic analysis for the global burden of diseases injuries and risk factors study 2017. Lancet HIV. 2019;6(12):e831-59. doi: 10.1016/S2352-3018(19)30196-1, PMID 31439534.

Ministry of Health of the Republic of Indonesia. National guidelines for clinical management of HIV infection and antiretroviral therapy in adults. Jakarta: Ministry of Health RI; 2011.

Ministry of Health of the Republic of Indonesia. Pedoman nasional pelayanan kedokteran tata laksana HIV. 2019;1(1):1-220.

Utami IT, Prakoeswa FR, Lestari N, Ichsan B. Hubungan tingkat pengetahuan dengan stigma masyarakat terhadap infeksi HIV/AIDS di Indonesia: literature review. J Kedokteran Syiah Kuala. 2023;23(1):99-107.

Nugroho C, Kusumaningrum TA. Keyakinan perilaku dan sikap terhadap VCT pada LSL di Sukoharjo. J Kesehatan. 2020;12(2):102-6. doi: 10.23917/jk.v12i2.9766.

Gaolathe T, Wirth KE, Holme MP, Makhema J, Moyo S, Chakalisa U. Botswanas progress toward achieving the 2020 UNAIDS 90-90-90 antiretroviral therapy and virological suppression goals: a population based survey. Lancet HIV. 2016;3(5):e221-30. doi: 10.1016/S2352-3018(16)00037-0, PMID 27126489.

Oguntibeju OO. Quality of life of people living with HIV and AIDS and antiretroviral therapy. HIV AIDS (Auckl). 2012 Aug 6;4:117-24. doi: 10.2147/HIV.S32321, PMID 22893751.

Nugraheni AY, Amelia R, Rizki IF. Evaluasi terapi antiretroviral pasien HIV/AIDS. Farmasetis. 2019;8(2):45-54. doi: 10.32583/farmasetis.v8i2.567.

Wahyudi A, Cholisoh Z. Compliance profile of the use of antiretroviral drugs in HIV/AIDS patients in a public hospital in central java in 2022. J Kesehatan Medika Saintika. 2023;14(2).

Puspasari D, Wisaksana R, Ruslami R. Adverse drug reactions and compliance with antiretroviral therapy in HIV patients bandung: Hasan Sadikin Hospital 2015. J Sains Dan Kesehatan. 2018;3(4):175-81.

World Health Organization. Safety of medicine: adverse drug reactions; 2018. Available from: https://www.who.int/docs/default-source/medicines/safety-of-medicines-adverse-drug-reactions-jun18.pdf?sfvrsn=4fcaf40_2. [Last accessed on 14 Apr 2025].

World Health Organization. Consolidated guidelines on HIV testing services. Geneva: World Health Organization; 2015. Available from: http://apps.who.int/iris/bitstream/10665/179870/1/9789241508926_eng.pdf.

Micaglio E, Locati ET, Monasky MM, Romani F, Heilbron F, Pappone C. Role of pharmacogenetics in adverse drug reactions: an update towards personalized medicine. Front Pharmacol. 2021 Apr 30;12:651720. doi: 10.3389/fphar.2021.651720, PMID 33995067.

Mallal S, Phillips E, Carosi G, Molina JM, Workman C, Tomazic J. HLA-b*5701 screening for hypersensitivity to abacavir. N Engl J Med. 2008;358(6):568-79. doi: 10.1056/NEJMoa0706135, PMID 18256392.

Rotger M, Colombo S, Furrer H, Bleiber G, Buclin T, Lee BL. Influence of CYP2B6 polymorphism on plasma and intracellular concentrations and toxicity of efavirenz and nevirapine in HIV infected patients. Clin Pharmacol Ther. 2007 Jan;81(3):557-66. doi: 10.1038/sj.clpt.6100100.

Ministry of Health of the Republic of Indonesia. Pedoman Pelayanan Kefarmasian Untuk ODHA. Jakarta: Ministry of Health RI; 2006.

Tariq RA, Vashisht R, Sinha A. Medication dispensing errors and prevention. In: Treasure Island, (FL): StatPearls Publishing; 2024. Available from: https://www.ncbi.nlm.nih.gov/books/NBK519065.

Allard NL, MacLachlan JH, Dev A, Dwyer J, Srivatsa G, Spelman T. Adherence in chronic hepatitis B: associations between medication possession ratio and adverse viral outcomes. BMC Gastroenterol. 2020;20(1):140. doi: 10.1186/s12876-020-01219-w, PMID 32381025.

Ogston SA, Lemeshow S, Hosmer DW, Klar J, Lwanga SK. Adequacy of sample size in health studies. Biometrics. 1991;47(1). doi: 10.2307/2532527.

Mendes JC, Bonolo PF, Ceccato MD, Costa JO, Reis AM, dos Santos H. Adverse reactions associated with first line regimens in patient initiating antiretroviral therapy. Eur J Clin Pharmacol. 2018;74(8):1077-88. doi: 10.1007/s00228-018-2472-y, PMID 29740676.

Liver Tox. Clinical and research information on drug induced liver injury. In: Bethesda: National Institute of Diabetes and Digestive and Kidney Diseases; 2012. Adverse Drug Reaction Probability Scale (Naranjo) in Drug Induced Liver Injury. Available from: https://www.ncbi.nlm.nih.gov/books/NBK548069.

Eluwa GI, Badru T, Agu KA, Akpoigbe KJ, Chabikuli O, Hamelmann C. Erratum to: adverse drug reactions to antiretroviral therapy (ARVs): incidence type and risk factors in Nigeria. BMC Clin Pharmacol. 2012;12(1):14. doi: 10.1186/1472-6904-12-14.

Rukmangathen R, Brahmanapalli VD, Thammisetty DP, Pemmasani D, Gali SD, Atmakuru RB. Study of adverse drug reactions to antiretroviral therapy in a tertiary care hospital Tirupati. Perspect Clin Res. 2020;11(4):158-63. doi: 10.4103/picr.PICR_133_18, PMID 33489833.

Khan K, Khan AH, Sulaiman SA, Soo CT, Akhtar A. Adverse drug reactions in HIV/AIDS patients at a Tertiary Care Hospital in Penang, Malaysia. Japan J Infect Dis. 2016;69(1):56-9. doi: 10.7883/yoken.JJID.2014.246, PMID 26073728.

Tadesse WT, Mekonnen AB, Tesfaye WH, Tadesse YT. Self-reported adverse drug reactions and their influence on highly active antiretroviral therapy in HIV infected patients: a cross sectional study. BMC Pharmacol Toxicol. 2014;15(1):32. doi: 10.1186/2050-6511-15-32, PMID 24957052.

Padua CA, Cesar CC, Bonolo PF, Acurcio FA, Guimaraes MD. High incidence of adverse reactions to initial antiretroviral therapy in Brazil. Braz J Med Biol Res. 2006;39(4):495-505. doi: 10.1590/S0100-879X2006000400010, PMID 16612473.

Kumar A, Girish H, Nawaz A, Balu P, Kumar B. Determinants of quality of life among people living with HIV/AIDS: a cross sectional study in central Karnataka, India. Int J Med Sci Public Health. 2014;3(11):1413. doi: 10.5455/ijmsph.2014.230820142.

Prosperi MC, Fabbiani M, Fanti I, Zaccarelli M, Colafigli M, Mondi A. Predictors of first line antiretroviral therapy discontinuation due to drug related adverse events in HIV-infected patients: a retrospective cohort study. BMC Infect Dis. 2012;12(1):296. doi: 10.1186/1471-2334-12-296, PMID 23145925.

Arisudhana GA, Sofro MA, Sujianto U. Antiretroviral side effects on adherence in PLWHA in central java. Nurse Media J Nurs. 2019;8(2):79. doi: 10.14710/nmjn.v8i2.20742.

Barus T. Evaluation of side effects of ARV drugs and their management at penjaringan health center Jakarta, 2013-2015. Soc Clin Pharm Indo J. 2017;2(1):29-37.

Zosangpuii C, Datta S, Gunindro N, Meena D, Nameirakpam SS. Adverse drug reaction patterns of anti-retroviral drugs: a study in a tertiary care teaching institute of North East India. Asian J Pharm Clin Res. 2022;15(4):38-41. doi: 10.22159/ajpcr.2022.v15i4.44174.

Dua M, Narwat A, Goyal A. Drug induced cutaneous reactions: a pharmacovigilance study. Int J Pharm Pharm Sci. 2024;16(3):26-30. doi: 10.22159/ijpps.2024v16i3.48975.

Adiningsih FF, Wilar R, Pongtuluran OB. Efek samping obat antiretroviral regimen TLE pada ODHA di klinik VCT RSUD Jayapura tahun 2023. J Ilmiah Kesehatan Diagn. 2023;17(3):176-83.

Handayani D, Lestari N, Pasande A. Gambaran efek samping obat antiretroviral pada pasien HIV/AIDS di RSUD undata palu. Pharmacon J Farmasi Indones. 2021;20(2):124.

Published

15-06-2025

How to Cite

CHOLISOH, Z., MARAH, S. S., & ICHSAN, B. (2025). OBSERVATIONAL STUDY ON THE INCIDENCE OF ADVERSE DRUG REACTIONS TO FIRST LINE ANTIRETROVIRAL AGENTS IN MELANESIANS ADULT HIV/AIDS PATIENTS. International Journal of Applied Pharmaceutics, 17(2), 73–77. https://doi.org/10.22159/ijap.2025.v17s2.08

Issue

Section

Original Article(s)

Similar Articles

<< < 2 3 4 5 6 > >> 

You may also start an advanced similarity search for this article.