: Incidence and Predictors of Adverse Drug Reaction among HIV-Positive Adults on Anti-Retroviral Therapy in Government Hospitals of Kaffa Zone: A Retrospective Cohort

  • Viral hepatitis and HIV
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Background: An adverse drug reaction(ADR) is a noxious and unintended response to the correct use of antiretroviral therapy(ART) for HIV positive patients. Its incidence varies from 11-73.3%; between developed and developing countries, with limited information from Kaffa Zone. The aim was to determine incidence and identify predictors of ADR in adult HIV positive patients on ART.
Methods: We conducted a retrospective cohort study between June-August 2018 in government hospitals of Kaffa Zone. We included 592 clinical records of adult HIV positive patients started on ART between July 2006 and August 2017. We defined ADR as ≥1 noxious and unintended responses: anemia, fever, neuropathy, skin rash, immunologic failure and others to ART. We use a standardized form to extract data from medical records, intake forms, and treatment databases. We ran cox proportional hazard analysis and summarized Results: using adjusted hazard ratio(AHR).
Results: Totally, 106(18%) patients report ADR and its incidence was 4.1 per 100 person-years(95%
CI:3.4,5.0). ADRs were reported 121 times; Anemia 24(20%), neuropathy 17(14%) and immunological failure 16 (13%) were more frequent. Rural patients had higher adverse drug reactions than urban patients [AHR:1.9 (95%CI:1.2, 3.2)]. Patients on Stavudine(D4T)-Lamivudine(3TC)-Nevirapine(NVP) [AHR:1.8(95%CI:1.0-3.1)]; Zidovudine (AZT)-3TC-NPV [AHR:2.3 (95% CI:1.2-4.6)]; AZT-3TC-EFV [AHR:2.2(95%CI:1.2-3.9)]; D4T-3TC-EFV [AHR:2.9 (95% CI:1.4-6.0)] reported significantly higher ADR than those on Tenofovir disoproxil(TDF)-based treatments. Patients at WHO clinical stage III [AHR:2.5 (95%CI:1.2-5.0)] or stage IV [AHR:4.3 (95%CI:1.9, 9.9)] reported higher drug reactions than stage I.
Conclusions: The overall incidence of ADR was considerable, and higher among patients from rural areas, at WHO stage III/IV, and on AZT- or D4T-based regimens than urban, stage I and TDF based treatment respectively. Due to reported ADR, AZT-based regimens may not be a good TDF alternative and clinicians should be aware of adverse reactions among rural and WHO clinical stage III/IV patients.

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