జర్నల్ ఆఫ్ ఎయిడ్స్ & క్లినికల్ రీసెర్చ్

Evaluation of the Prevalence, Progression and Severity of Common Adverse Reactions (Lipodystrophy, CNS, Peripheral Neuropathy, and Hypersensitivity Reactions) Associated with Anti-Retroviral Therapy (ART) and Anti-Tuberculosis Treatment in Outpatients in Zimbabwe

Abstract

Tafireyi Nemaura, Milcah Dhoro, Charles Nhachi, Gerard Kadzirange, Prosper Chonzi and Collen Masimirembwa

Introduction: The use of many anti-retroviral drugs has been associated with a myriad of adverse drug reactions (ADRs) which could limit successful treatment outcome with respect to patient compliance and quality of life. An additional consideration is the high incidence of HIV infection with tuberculosis (TB) in Southern Africa, including Zimbabwe, and the use of co-treatment regimens.

Methods: The study is a cross sectional, case-control study of 433 out-patients conducted at two hospitals in Zimbabwe. The patients were profiled for adverse reactions namely central nervous system side-effects (CNS), lipodystrophy (LD), skin hypersensitivity (SH), and peripheral neuropathy (PN). Assignment of the case and the control status of a patient was done based on occurrence of these adverse drug reactions in each of the HIV/AIDS only, TB only and HIV/TB co-infection patient groups.

Results: Among the HIV/AIDS only treatment group (n= 240), the incidences of major ADRs were PN (63%), LD (38%), CNS (29%) and SH (21%). In the TB only treatment group (n=92), the major ADRs were PN (49%), CNS (29%), and SH (14%). In the HIV-TB co-treatment group (n=98), the major ADRs were PN (64%), CNS (39%), LD (6%) and SH (18%). A significant number of females were on alternate first line treatment that has no stavudine as compared to males (OR=1.98, CI (1.1, 3.59); p=0.03). Occurrence of CNS adverse drug reactions were more associated with patients on efavirenz than other HIV-drug combinations (43% vs. 17%, p<0.00001).

Conclusion: The use of anti-retroviral drugs and anti-TB drugs is associated with very high incidences of adverse drug reactions. There is therefore need to understand the pharmacokinetic and pharmacodynamic mechanisms of these ADRs so as to identify patients at risk and to provide guidelines for the choice of drug and dosage to ensure safe and efficacious treatment outcomes