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Association Between the Occurrence of Adverse Drug Events and Modification of First-Line Highly Active Antiretroviral Therapy in Ghanaian HIV Patients

Author

Listed:
  • Raymond A. Tetteh

    (Utrecht University
    Korle Bu Teaching Hospital)

  • Edmund T. Nartey

    (University of Ghana
    University of Ghana)

  • Margaret Lartey

    (University of Ghana)

  • Aukje K. Mantel-Teeuwisse

    (Utrecht University)

  • Hubert G. M. Leufkens

    (Utrecht University
    Medicines Evaluation Board)

  • Barbara A. Yankey

    (Georgia State University)

  • Alexander N. O. Dodoo

    (University of Ghana)

Abstract

Introduction Patients initiated on highly active antiretroviral therapy (HAART) generally remain on medication indefinitely. A modification in the HAART regimen may become necessary because of possible acute or chronic toxicities, concomitant clinical conditions, development of virological failure or the advent of adverse drug events. The study documents adverse drug events of HIV-positive Ghanaian patients with HAART modifications. It also investigates the association between documented adverse drug events and HAART modification using an unmatched case–control study design. Method The study was conducted in the Fevers Unit of the Korle Bu Teaching Hospital and involved patients who attended the HIV Care Clinic between January 2004 and December 2009. Data from 298 modified therapy patients (cases) were compared with 298 continuing therapy patients (controls) who had been on treatment for at least 1 month before the end of study. Controls were sampled from the same database of a cohort of HIV-positive patients on HAART, at the time a case occurred, in terms of treatment initiation ±1 month. Data were obtained from patients’ clinical folders and the HIV clinic database linked to the pharmacy database. The nature of the documented adverse drug events of the cases was described and the association between the documented adverse drug events and HAART modification was determined by logistic regression with reported odds ratios (ORs) and their 95 % confidence interval (CI). Results Among the 298 modified therapy patients sampled in this study, 52.7 % of them had at least one documented adverse drug event. The most documented adverse drug event was anaemia, recorded in 18.5 % of modified therapy patients, all of whom were on a zidovudine-based regimen. The presence of documented adverse drug events was significantly associated with HAART modification [adjusted OR = 2.71 (95 % CI 2.11–3.48), p

Suggested Citation

  • Raymond A. Tetteh & Edmund T. Nartey & Margaret Lartey & Aukje K. Mantel-Teeuwisse & Hubert G. M. Leufkens & Barbara A. Yankey & Alexander N. O. Dodoo, 2016. "Association Between the Occurrence of Adverse Drug Events and Modification of First-Line Highly Active Antiretroviral Therapy in Ghanaian HIV Patients," Drug Safety, Springer, vol. 39(11), pages 1139-1149, November.
    • Handle: RePEc:spr:drugsa:v:39:y:2016:i:11:d:10.1007_s40264-016-0460-7
    DOI: 10.1007/s40264-016-0460-7
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    References listed on IDEAS

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    1. Greenland, S., 1989. "Modeling and variable selection in epidemiologic analysis," American Journal of Public Health, American Public Health Association, vol. 79(3), pages 340-349.
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    1. Raymond A. Tetteh & Barbara A. Yankey & Edmund T. Nartey & Margaret Lartey & Hubert G. M. Leufkens & Alexander N. O. Dodoo, 2017. "Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns," Drug Safety, Springer, vol. 40(4), pages 273-283, April.

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