Journal of Antivirals & Antiretrovirals
Open Access

Abstract

Adverse Reactions Associated with Antiretroviral Regimens in Adult Patients of a University Teaching Hospital HIV Program in Zaria, Northern Nigeria: An Observational Cohort Study

Obiako O Reginald, Muktar M Haruna, Garko B Sani, Tobi-Ajayi Eric, Olayinka T Adebola, Iyanda Mathew, Irohibe Chigozie, Umar Bilkisu and Abdu-AguyeIbrahim

Background: Highly active antiretroviral therapy (HAART) has reduced the morbidity associated with HIV infection, and prolonged the lifespan of HIV/AIDS patients, but reports of adverse reactions associated with the antiretroviral drugs exist in the literature. The aim of this research was to determine the frequency and pattern of adverse drug reactions (ADRs) in HAART-experienced patients in our facility from January 2000 to December 2009.
Method: Patients on HAART who had a defined temporal relationship between an adverse or noxious reaction and the administration of the drugs at doses normally used in man for the treatment of HIV disease were studied. Patients who developed adverse reactions to non- antiretroviral drugs were excluded.
Result: of 3641 patients, 380 (10.4%) comprising 289 females (76.1 %) and 91 males (23.9%) of respective mean ages, 35.1 ± 7.4 and 43.2 ± 5.9 years, and respective median CD4+ cell counts, 256/ μL and 124/ μL, had various forms of ADRs. Zidovudine/lamivudine/nevirapine (43.2%), stavudine/lamivudine/nevirapine (26.3%), zidovudine/lamivudine+efavirenz (12.4%), truvada+ nevirapine (9.5%), zidovudine + truvada + ritonavir-boosted lopinavir (8.2%) and truvada/efavirenz (0.5%) were responsible. Mean onset of ADR was 34 days, and there was a female predisposition. The common ADRs were: nausea/hypersalivation/ vomiting (124, 34%), skin rash (100, 26.3%), Steven-Johnson syndrome (27, 7.1%) and anemia (27, 7.1%). Significant risk factors were: baseline CD4+ cell counts > 250/μL, on –therapy CD4+ cell counts > 250/μL, female gender, and type of regimen.
Conclusion: Current antiretroviral regimens are associated with various forms of ADRs, thus the need to strengthen pharmacovigilance and proper education of patients on the side effects and possible adverse reactions of ARV regimens.