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.