A study on adverse drug reactions in patients on antiretroviral therapy in a tertiary care hospital

Authors

  • Praveena Gungam Department of Pharmacology, Osmania Medical College, Koti, Hyderabad, Telangana 500095, India
  • Y. Sunil Kumar Yadav Department of Pharmacology, Osmania Medical College, Koti, Hyderabad, Telangana 500095, India
  • Sunil Junapudi Department of Pharmaceutical Chemistry, Geethanjali College of Pharmacy, Cherryal, Keesara, Medchal, Telangana 501301, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20183917

Keywords:

Antiretroviral, Adverse drug reactions, Human immunodeficiency virus, Tertiary care

Abstract

Background: Besides unparalleled advantages, exceptionally dynamic antiretroviral treatment is additionally connected with extensive variety of potential adverse drug reactions (ADRs), which prevents treatment adherence. The present study is intended to screen and monitor the event of ADRs to different antiretroviral treatment (ART) regimens in a tertiary care ART setup.

Methods: A prospective, longitudinal observational study was done in the outpatient setting of nodal ART center, Osmania General Hospital. A sum of 525 patients on different ART regimens were examined for ADRs more than year and a half. Adverse event history, prescription history and other significant subtle elements were captured. Causality and seriousness of each announced ADR were surveyed.

Results: 37.33% patients of aggregate members gave a sum of 330 ADRs. Patients from zidovudine-based regimens presented with majority of ADRs such as anemia, central nervous system (CNS), and gastrointestinal (GI) side effects. Tenofovir-based regimens were, be that as it may, observed to be somewhat more secure. The blend with Efavirenz was related with significant CNS reactions while that of Nevirapine was related with rash and pigmentation of nails. Atazanavir supported second-line regimens were quite connected with expanded serum lipid levels taken after by other GI and CNS unfavourable impacts. Expanded liver compounds were found in atazanavir-based second-line ART.

Conclusions: The study enables to obtain in sequence on the incidence and pattern of ADRs associated with various antiretroviral regimens, thereby reducing its occurrence and protecting the patient population from avoidable harm. Need of intensive monitoring for ADRs in ARTs along these lines is by all accounts an order.

References

Factsheet 2017. UNAIDS. Available at: http://www.unaids. org/en/resources/campaigns/HowAIDSchangedeverything/ factsheet. [Last accessed on 2018 April 18].

Kulkarni V. A turning point: The new World Health Organization guidelines for treatment of human immunodeficiency virus infection. Ind J Der Venere Leprol. 2016;82(2):125-7.

Mukherjee S, Era N, Saha B, Tripathi SK. Adverse drug reaction monitoring in patients on antiretroviral therapy in a tertiary care hospital in Eastern India. Ind J Pharmacol. 2017;49(3):223-8.

Kumarasamy N, Solomon S, Peters E, Amalraj RE, Purnima M, Ravikumar B, et al. Antiretroviral drugs in the treatment of people living with human immunodeficiency virus: experience in a south Indian tertiary referral centre. The Journal of the Association of Physicians of India. 2000;48(4):390-3.

Rhodes CM, Chang Y, Regan S, Singer DE, Triant VA. Human Immunodeficiency Virus (HIV) Quality Indicators Are Similar Across HIV Care Delivery Models. InOpen forum infectious diseases, Oxford University Press; 2017;4(1).

Luma HN, Choukem SP, Temfack E, Ashuntantang G, Joko HA, Koulla-Shiro S. Adverse drug reactions of Highly Active Antiretroviral Therapy (HAART) in HIV infected patients at the General Hospital, Douala, Cameroon: a cross sectional study. Pan Afri Med J. 2012;12(1).

Abdissa SG, Fekade D, Feleke Y, Seboxa T, Diro E. Adverse drug reactions associated with antiretroviral treatment among adult Ethiopian patients in a tertiary hospital. Ethio Med J. 2012;50(2):107-13.

Severe P, Jean Juste MA, Ambroise A, Eliacin L, Marchand C, Apollon S, et al. Early versus standard antiretroviral therapy for HIV-infected adults in Haiti. New Eng J Medic. 2010;363(3):257-65.

Bonfanti P, Valsecchi L, Parazzini F, Carradori S, Pusterla L, Fortuna P, et al. Incidence of adverse reactions in HIV patients treated with protease inhibitors: a cohort study. Coordinamento Italiano Studio Allergia e Infezione da HIV (CISAI) Group. J Acq Imm Deficie Syndrom (1999). 2000 Mar;23(3):236-45.

Dean GL, Edwards SG, Ives NJ, Matthews G, Fox EF, Navaratne L, et al. Treatment of tuberculosis in HIV-infected persons in the era of highly active antiretroviral therapy. Aids. 2002;16(1):75-83.

Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clinical Pharmacology and Therapeutics. 1981;30(2):239-45.

The use of the WHO‑UMC System for Standardized Case Causality Assessment. Available at: http://www.who-umc.org/Graphics/24734.pdf. [Last accessed on 2016 May 21].

Bailey C, Peddie D, Wickham ME, Badke K, Small SS, Doyle‐Waters MM, et al. Adverse drug event reporting systems: a systematic review. Bri J Clinic Pharmacol. 2016;82(1):17-29.

Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Ame J Health-System Pharm. 1992;49(9):2229-32.

Bhatti AB, Usman M, Kandi V. Current scenario of HIV/AIDS, treatment options, and major challenges with compliance to antiretroviral therapy. Cureus. 2016;8(3).e515.

Mayer KH, Chandhiok N, Thomas B. Antiretroviral pre-exposure prophylaxis: A new opportunity to slow HIV spread in India. Ind J Me Resear. 2016;143(2):125-8.

Dandona R, Rewari BB, Kumar GA, Tanwar S, Kumar SP, Vishnumolakala VS, et al. Survival outcomes for first-line antiretroviral therapy in India’s ART program. BMC infectious diseases. 2016;16(1):555.

Gupta AK, Singh GP, Goel S, Kaushik PB, Joshi BC, Chakraborty S. Efficacy of a new model for delivering integrated TB and HIV services for people living with HIV/AIDS in Delhi–case for a paradigm shift in national HIV/TB cross-referral strategy. AIDS care. 2014;26(2):137-41.

Bartlett JA, Chen SS, Quinn JB. Comparative efficacy of nucleoside/nucleotide reverse transcriptase inhibitors in combination with efavirenz: results of a systematic overview. HIV clinical trials. 2007;8(4):221-6.

Spire B, Carrieri P, Garzot MA, L'henaff M, Obadia Y, The Trt-5 Group. Factors associated with efavirenz discontinuation in a large community-based sample of patients. AIDS care. 2004;16(5):558-64.

Hawkins T, Geist C, Young B, Giblin A, Mercier RC, Thornton K, et al. Comparison of neuropsychiatric side effects in an observational cohort of efavirenz-and protease inhibitor-treated patients. HIV Clinical Trials. 2005;6(4):187-96.

Treisman GJ, Kaplin AI. Neurologic and psychiatric complications of antiretroviral agents. Aids. 2002;16(9):1201-15.

Puzantian T. Central nervous system adverse effects with efavirenz: case report and review. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy. 2002;22(7):930-3.

Young J, Weber R, Rickenbach M, Furrer H, Bernasconi E, Hirschel B, et al. Research article Lipid profiles for antiretroviral-naive patients starting PI-and NNRTI-based therapy in the Swiss HIV Cohort Study. Antiviral therapy. 2005;10:585-91.

Ofotokun I, Lennox JL, Smithson SE, Lu C, Easley KA. Liver enzymes elevation and immune reconstitution among treatment-naive HIV-infected patients instituting antiretroviral therapy. Ame J Med Scienc. 2007;334(5):334-41.

Ejilemele AA, Nwauche CA, Ejele OA. Pattern of abnormal liver enzymes in HIV patients presenting at a Nigerian Tertiary Hospital. Nig Postg Med J. 2007;14(4):306-9.

Miles SA. Hematopoietic growth factors as adjuncts to antiretroviral therapy. AIDS research and human retroviruses. 1992;8(6):1073-80.

Miles SA, Golde DW, Mitsuyasu RT. The use of hematopoietic hormones in HIV infection and AIDS-related malignancies. Hematology/Oncology Clinics. 1991;5(2):267-80.

Maggi E, Romagnani S. Role of T cell derived cytokines in HIV infection. J Bio Regu Homeo Agen. 1995;9(2):37.

Groopman JE. Zidovudine intolerance. Rev Infect Dis 1990;12 (5):S500‑6.

Downloads

Published

2018-09-24

How to Cite

Gungam, P., Yadav, Y. S. K., & Junapudi, S. (2018). A study on adverse drug reactions in patients on antiretroviral therapy in a tertiary care hospital. International Journal of Basic & Clinical Pharmacology, 7(10), 1882–1888. https://doi.org/10.18203/2319-2003.ijbcp20183917

Issue

Section

Original Research Articles