Isaac Okoh Abah1, Maxwell Akanbi2, Mercy Enuwa Abah3, Amos Istifanus Finangwai1, Christy W Dady1, Kakjing Dadul Falang4, Augustine Odoh Ebonyi5, Joseph Anejo Okopi6, Oche Ochai Agbaji7, Altiene Solomon Sagay8, Prosper Okonkwo9, John A Idoko10, Phyllis J Kanki11. 1. BPharm, MSc, Pharmacy Department, Jos University Teaching Hospital, Jos, Nigeria. 2. MBBS, MSCI, Department of Medicine, University of Jos, Jos University Teaching Hospital, Jos, Nigeria. 3. BSc, MSc, Department of Psychology, Faculty of Social Sciences, University of Jos, Jos, Nigeria. 4. BPharm, MSc, Department of Pharmacology, Faculty of Pharmaceutical Sciences, University of Jos, Nigeria. 5. MBBS, MSc, Department of Pediatrics, University of Jos, Jos University Teaching Hospital, Jos, Nigeria. 6. BSc, PhD, Department of Microbiology, Faculty of Natural Sciences, University of Jos, Jos, Nigeria. 7. MBBS, Department of Medicine, University of Jos, Jos University Teaching Hospital, Jos, Nigeria. 8. MBBS, Department of Obstetrics and Gynecology, University of Jos, Jos University Teaching Hospital, Jos, Nigeria. 9. MBBS, AIDS Prevention Initiative in Nigeria (APIN) Ltd./Gte., Abuja, Nigeria. 10. MBBS, National Agency for the control of AIDS (NACA), Abuja, Nigeria. 11. DVM, SD, Harvard School of Public Health, Boston, MA, USA.
Abstract
INTRODUCTION: Adverse drug reactions associated with efavirenz (EFV) therapy are poorly described beyond the first year of treatment. We aimed to describe the incidence and predictors of EFV-related adverse drug reactions (ADRs) in a cohort of adult Nigerian HIV-infected patients on antiretroviral therapy (ART). METHODS: This retrospective cohort study utilized clinical data of HIV-1 infected adults (aged ≥15 years), commenced on efavirenz containing-regimen between January 2004 and December 2011. The time-dependent occurrence of clinical adverse events as defined by the World Health Organization was analyzed by Cox regression analysis. RESULTS: A total of 2920 patients with baseline median (IQR) age of 39 (33-46) years, largely made up of men (78%) were included in the study. During 8834 person-years of follow up, 358 adverse drug events were reported; the incidence rate was 40.3 ADRs per 1000 person-years of treatment. Lipodystrophy and neuropsychiatric disorders were the most common ADRs with incidences of 63 and 30 per 1000 patients respectively. About one-third of the neuropsychiatric adverse events were within 12 months of commencement of ART. The risk of neuropsychiatric ADRs was independently predicted for women [adjusted hazard ratio (aHR) 9.05; 95% CI: 5.18-15.82], those aged <40 years (aHR 2.59; 95% CI: 1.50-4.45), advanced HIV disease (WHO stage 3 or 4) [aHR 2.26; 95% CI: 1.37-3.72], and zidovudine [aHR 2.21; 95% CI: 1.27-3.83] or stavudine [aHR 4.22; 95% CI: 1.99-8.92] containing regimen compared to tenofovir. CONCLUSION: Neuropsychiatric adverse drug events associated with efavirenz-based ART had both early and late onset in our clinical cohort of patients on chronic EFV therapy. Continuous neuropsychiatric assessment for improved detection and management of neuropsychiatric ADRs is recommended in resource-limited settings where the use of efavirenz-based regimens has been scaled up.
INTRODUCTION: Adverse drug reactions associated with efavirenz (EFV) therapy are poorly described beyond the first year of treatment. We aimed to describe the incidence and predictors of EFV-related adverse drug reactions (ADRs) in a cohort of adult Nigerian HIV-infectedpatients on antiretroviral therapy (ART). METHODS: This retrospective cohort study utilized clinical data of HIV-1 infected adults (aged ≥15 years), commenced on efavirenz containing-regimen between January 2004 and December 2011. The time-dependent occurrence of clinical adverse events as defined by the World Health Organization was analyzed by Cox regression analysis. RESULTS: A total of 2920 patients with baseline median (IQR) age of 39 (33-46) years, largely made up of men (78%) were included in the study. During 8834 person-years of follow up, 358 adverse drug events were reported; the incidence rate was 40.3 ADRs per 1000 person-years of treatment. Lipodystrophy and neuropsychiatric disorders were the most common ADRs with incidences of 63 and 30 per 1000 patients respectively. About one-third of the neuropsychiatric adverse events were within 12 months of commencement of ART. The risk of neuropsychiatric ADRs was independently predicted for women [adjusted hazard ratio (aHR) 9.05; 95% CI: 5.18-15.82], those aged <40 years (aHR 2.59; 95% CI: 1.50-4.45), advanced HIV disease (WHO stage 3 or 4) [aHR 2.26; 95% CI: 1.37-3.72], and zidovudine [aHR 2.21; 95% CI: 1.27-3.83] or stavudine [aHR 4.22; 95% CI: 1.99-8.92] containing regimen compared to tenofovir. CONCLUSION: Neuropsychiatric adverse drug events associated with efavirenz-based ART had both early and late onset in our clinical cohort of patients on chronic EFV therapy. Continuous neuropsychiatric assessment for improved detection and management of neuropsychiatric ADRs is recommended in resource-limited settings where the use of efavirenz-based regimens has been scaled up.
Entities:
Keywords:
Africa; Efavirenz; adverse drug reaction; antiretroviral therapy; neuropsychiatric
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