Abstract:
BACKGROUND: Of the 1.6 million South African people infected with human immunodeficiency virus (HIV), approximately 970,000 (55%) have
been initiated on HAART. Despite these numbers, very little has been published about the safety profile of antiretroviral (ARV) medicines in the
country. This study was performed at the Medunsa National Pharmacovigilance Centre and aimed to describe the demographic characteristics of
patients enrolled in the pharmacovigilance surveillance study; highly active antiretroviral therapy (HAART) initiation regimen patterns; reasons for
regimen changes; and adverse effects of ARV medicines. METHODS: A cohort study of HIV-infected individuals aged 15 years or older who were on
ARV medicines was conducted at four sentinel sites. RESULTS: After HAART initiation, with an average lapse of 17.8 months (range: 0 – 83.8
months), 2,815 patients were enrolled into the study. Results show that patients were observed for 1,606.2 person-years for pharmacy visits
(collection of ARV medicines) and 817.1 person-years for clinical visits (consultation with the doctor). Females constituted 69.6% (1,958/2,815) of
the study population. Almost all patients initiated HAART on first-line regimens (2,801/2,815). Some patients (6.7%, 190/2,815) dropped out of
the study after HAART initiation. Reasons for regimen changes were not recorded for 2.5% (22/891) of the patients who changed regimens. The
primary reason for regimen changes was drug-related toxicity (76.1%, 678/891), mostly evident in patients taking first-line regimens. Adverse
effects experienced by patients were polyneuropathy (24.0%, 163/678); lipodystrophy (23.9%, 162/678); neuropathy (10.6%, 72/678); and
suspected lactic acidosis (3.8%, 26/678). CONCLUSION: The majority of prescribers complied with the HAART guidelines and initiated most patients
on first-line regimens. However, adverse effects are evident in patients taking first-line regimens. We recommend that the Department of Health
should introduce less toxic first-line ARV regimens. Future efforts will aim to initiate patients on HAART and enrol them into the study
simultaneously to determine early risk profiles of ARV medicines.
