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

Tafireyi Nemaura

doi:10.4172/2155-6113.1000203

Abstract

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

Highlights

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
This study has simultaneously evaluated major ADRs associated with the use of anti-retroviral drugs (ARVs) and anti-TB drugs
Our results show a significant number of patients have central nervous system side-effects (CNS) side effects on efavirenz containing anti-retroviral therapy (ART) regimens, efavirenz containing ART regimens + TB treatment and TB treatment only regimens compared to patients on non EFV (43% vs. 17%, p

Summary

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. Sub-Saharan Africa carries the heaviest burden of the HIV and AIDS pandemic. Zimbabwe is within the epicentre of this pandemic with an HIV infection prevalence of 14.3% in the ≥ 15years age group [1]. SubSaharan African populations were late in receiving anti-retroviral therapy (ART) resulting in high mortality rates among HIV and AIDS patients. Since 1985, HIV and AIDS overtook malaria as the leading cause of death in Africa [4]. High mortality rates due to HIV and AIDS declined in resource rich countries with the discovery and access to anti-retroviral drugs (ARVs), starting with zidovudine in 1985 [5]. Given the recent evidence that ART reduces mortality rates and reduces transmission rates [8], ART holds the promise to halting the spiral spread of the HIV pandemic

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Discussion

Conclusion