Background: Despite the prevalent nature of adverse drug reactions (ADRs) and its negative impact on treatment outcomes in ... to identify independent predictors of ADRs. The association ...... Page 58 ...... Ellerbrock, T. V. (2016). Outcomes of ...
ADVERSE DRUG REACTIONS TO ANTIRETROVIRAL DRUGS: EFFECT ON VIROLOGIC FAILURE IN A NIGERIAN COHORT OF HIV-INFECTED ADULTS ON FIRST-LINE ANTIRETROVIRAL THERAPY
ISAAC OKOH ABAH A mini-thesis submitted in partial fulfilment of the requirements for the degree of Master of Public Health at the School of Public Health, University of the Western Cape, South Africa
Supervisor: Dr Hazel Bradley Co-supervisor: Nondumiso Ncube
November 2017
KEYWORDS Adverse drug reaction Antiretroviral therapy HIV medicines Side effects Toxicity Pharmacovigilance Treatment failure Viral suppression Regimen durability Resource-limited setting
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ABSTRACT Background: Despite the prevalent nature of adverse drug reactions (ADRs) and its negative impact on treatment outcomes in patients on antiretroviral therapy (ART), the impact of ADRs on HIV treatment outcomes - including virologic failure, at Jos University Teaching Hospital HIV clinic have not been fully explored. Identifying ADRs and understanding their risk factors could aid early management and ultimately improve treatment outcomes. Aim: The aim of the research was to investigate the frequency, types, and risk factors of clinical ADRs to antiretroviral medicines (ARVs) and assess if ADRs increased the risk of virologic failure in patients on ART. Methodology: A retrospective cohort study design was utilized. Data of HIV-1 infected patients, ≥18 years of age, treatment naïve at enrolment and receiving first-line ART at Jos University Teaching Hospital HIV clinic between June 2004 and February 2012 were evaluated. The incidence and spectrum of ART-associated ADRs were described, and factors associated with ADRs were assessed by Chi-square analyses. A multivariate logistic regression model was fitted to identify independent predictors of ADRs. The association between ADRs and virological failure was assessed by multivariate logistic regression. All statistical tests were two-tailed and a p-value 1 of ART; crude incident rate ratio, 2.87 (95% CI: 2.53-3.24)). Compared to other grades of ADRs, the prevalence of severe ADRs was highest (4.5%), while 2.6% ADRs were moderate, and 0.8% were mild. The most common types of ADRs were lipodystrophy (2.6%) attributable mostly to the use of stavudine, and anaemia (1.9%) mainly due to zidovudine use. Others included skin rash and itching (0.7%), peripheral neuropathy (0.5%), and nightmares and insomnia (0.4%). The likelihood of ADRs increased by a factor of 2% for every one-year increment in age (OR, 1.02; iii
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95% CI: 1.01-1.03; p100,000 copies/mL. Other predictors of virologic failure included earlier calendar year of ART initiation (2004 to 2009) which was predictive of early virologic failure, but protective of late virologic failure, and poor adherence to drug refill schedules (
