International Journal of Statistics in Medical Research, 2020, 9, 10-19 10 E-ISSN: 1929-6029/20 © 2020 Lifescience Global Adverse Event Risk Assessment on Patients Receiving Combination Antiretroviral Therapy in South Africa Bernard Oguna Omolo 1,2,* and Peter Mungai Njuho 3 1 Division of Mathematics & Computer Science, University of South Carolina-Upstate, Spartanburg, USA 2 School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 3 Department of Statistics, University of South Africa, Johannesburg, South Africa Abstract: Purpose: To determine the risk factors for the development of serious adverse events (AEs) in black adult patients on combination antiretroviral therapy (cART). Methods: This prospective cohort study consisted of 368 adult black HIV positive patients receiving cART at the Grey’s Hospital, KwaZulu-Natal, South Africa. Patients were intensively monitored for incidence of adverse events and the factors associated with their development, under the Antiretroviral Cohort Adverse Event Monitoring in KwaZulu-Natal (ACADEMIK). Multiple logistic regression models were used to identify the risk factors for AEs. Results: A total of 406 AEs were reported across the 13 patient hospital visits in the study. Peripheral neuropathy was the most prevalent adverse event (16%), followed by hypercholesterolaemia (14%), lipoatrophy/lipodystrophy (13%) and skin reaction (11%). Cluster differentiation (CD4) counts (p = 0.0280), age (p = 0.0227) and weight (p = 0.0017) were identified as the significant predictors for hypercholesterolaemia, while sex (p = 0.0309) was significant with respect to skin reaction. CD4 counts (p=0.0200) was also significant for lipoatrophy/lipodystrophy. Skin reaction (23%), diarrhea (18%), hypercholesterolaemia (15%), thrombocytopenia (15%) and peripheral neuropathy (13%) were the top five most incident AEs. Overall, about 46% of the regimens administered were tenofovir-based and 31% zidovudine-based. Conclusions: To enhance the prevention of hypercholesterolaemia, lipoatrophy/lipodystrophy and skin reaction among black adult HIV positive patients on cART, we recommend that CD4 counts and weight be closely monitored and documented during clinic visits. Keywords: Adverse events, cohort event monitoring, combination antiretroviral therapy, pharmacovigilance, risk factors, South Africa. INTRODUCTION With the cure of HIV/AIDS still elusive, antiretroviral therapy (ART) remains the treatment of choice. Lives of many HIV-infected persons under ART have been prolonged, indicating a reduction in mortality. Whilst cART has significantly reduced morbidity and mortality among HIV-infected persons, side effects are still common and can be serious. The World Health Organization (WHO) defines an AE as any untoward medical occurrence that may present during treatment with a medicine but which does not necessarily have a causal relationship with the treatment [1]. Adverse events to cART are common and can potentially affect patients’ adherence to treatments, resulting in poor treatment outcomes and increased resistance [2]. These adverse drug events (ADEs) could sometimes be life threatening as well [2]. Monitoring AEs, therefore, becomes more important and could result in increased life expectancy of HIV positive patients. Improved access to HIV-related medicines should be *Address correspondence to this author at the Division of Mathematics & Computer Science, University of South Carolina – Upstate, 800 University Way, Spartanburg, SC 29303, USA; Tel: +1 864 503 5362; E-mail: bomolo@uscupstate.edu matched by commensurate attention to the safe use of these products. Ensuring that drugs do not cause harm but actually promote the health and well-being of patients is a responsibility shared by patients, health care providers and governments. The goal of ACADEMIK was to establish a surveillance system that would support patient safety and patient adherence to lifelong ART and enhance the quality of patient care in ARV treatment programs [3]. Adverse drug reactions (ADRs) have been shown to negatively affect treatment outcomes in many infectious diseases, including HIV/AIDS and tuberculosis (TB) [2, 4, 5]. Pharmacovigilance is important for detecting rare or unexpected adverse reactions, chronic toxicity, effects in understudied populations, and determining interactions with other products and diseases. As a result, post-approval safety data collection and risk assessment based on observational data are critical to evaluating and minimizing a medicine's risk profile over its life cycle and to guide the best use of drugs. Adverse events to cART are common and can potentially affect a patient’s adherence to treatment, resulting in poor treatment outcomes and increased resistance. It is therefore