Adverse reactions to antiretroviral drugs in patients receiving therapy in a Federal teaching hospital Southwest Nigeria
Sikiru Usman , Ibrahim Oreagba , Olalekan Agede , Awodele Olufunsho, Chioma Ejekam , Akinwunmi Akinyede , Titilope Adeyemo , Oluranti Opanuga , Sunday Olayemi and Sulaimon Akanmu
1 Department of Pharmacology, Therapeutics and Toxicology, College of Medicine, University of Lagos, P.M.B.
12003, Idiaraba, Lagos, Nigeria.
2 AIDS Prevention Initiative in Nigeria (APIN) Clinic, Lagos University Teaching Hospital, Idiaraba, Lagos, Nigeria.
3 Department of Hematology and Blood Transfusion, College of Medicine, University of Lagos, P.M.B. 12003, Idiaraba, Lagos, Nigeria
4 National Pharmacovigilance Centre, National Agency for Food and Drug Administration and Control,
Abuja, Nigeria.
Corresponding Author: Usman Sikiru Olatunji
E-mail: sikiruusman2004@yahoo.com Phone: +2347066263713
ABSTRACT
Background: Antiretroviral drugs have proven efficacy in reducing viral load to undetectable plasma levels. Although, adverse reactions to antiretroviral drugs may cause death, prolongation of hospitalization, non-adherence and treatment failure in HIV infected persons; they are not fully documented in Nigeria. It is therefore necessary to evaluate adverse reactions of patients to antiretroviral drugs in Nigeria.
Objectives: This study aimed to document the adverse reactions to antiretroviral drugs (ARVs) in HIV-positive patients, assess their severity causality and identify the risk factors for the development of the ADRs.
Methods: With the aid of data capture form and interview, information about ADR was obtained prospectively from 51 new patients eligible to commence ARV for a period of 3 months. The retrospective arm made use of information extracted from the case notes of 137 ARV-experienced patients selected using a web-based random method from June 2009 – July 2010).
Results: Dizziness (17.40%) was the most frequently reported adverse event in both arms of the study followed by body weakness (11.85%), anemia (11.11%), rash (9.63%), pruritus (9.63%), nausea and vomiting (7.41%) and fatigue (7.41%). Majority of suspected ADRs were mild (76.5%) while only few were severe (3.9%). Female + 3 gender (p=0.0010), CD4 cells count below 200 cells/mm (p=0.0005) and antiretroviral drug combination of Zidovudine + lamivudine + nevirapine (p=0.0099) were significantly associated with the development of ADRs to ARVs.
Conclusion: The most common adverse event to antiretroviral drugs in this study was dizziness followed by body weakness, anaemia, skin rash, body itching, lipodystrophy, nausea and vomiting. Most of the ADRs were + mild and their development was significantly associated with female gender, CD4 cells count below 2003 cells/mm and antiretroviral drug combination of Zidovudine + lamivudine + nevirapine.
Keywords:Adverse Drug Reactions, Antiretroviral therapy, HIV Patients