ArticleThe Pan African medical journal2012
A pharmacovigilance study of adults on highly active antiretroviral therapy, South Africa: 2007 - 2011.
Article in The Pan African medical journal, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed, 16 citations in OpenAlex.
- Lipodystrophy diagnosis in people living with HIV/AIDS: prediction and validation of sex-specific anthropometric models.BMC public health · 2018Article
- Coping Strategies for Adverse Effects of Antiretroviral Therapy among Adult HIV Patients Attending University of Gondar Referral Hospital, Gondar, Northwest Ethiopia: A Cross-Sectional Study.AIDS research and treatment · 2018Article
- Association Between the Occurrence of Adverse Drug Events and Modification of First-Line Highly Active Antiretroviral Therapy in Ghanaian HIV Patients.Drug safety · 2016Article
- Confirmation of factors that influence antiretroviral regimen change and the subsequent patient outcomes at a Regional Hospital in rural KwaZulu-Natal.African journal of primary health care & family medicine · 2016Article
- Contemporary issues on the epidemiology and antiretroviral adherence of HIV-infected adolescents in sub-Saharan Africa: a narrative review.Journal of the International AIDS Society · 2015Review
- HIV/AIDS and lipodystrophy: implications for clinical management in resource-limited settings.Journal of the International AIDS Society · 2015Review
- An assessment of adverse drug reactions among HIV positive patients receiving antiretroviral treatment in South Africa.AIDS research and therapy · 2015Article
- Knowledge and attitudes of non-occupational HIV post-exposure prophylaxis amongst first- and second-year medical students at Stellenbosch University in South Africa.African journal of primary health care & family medicine · 2014Article
- A framework for assessing the economic value of pharmacovigilance in low- and middle-income countries.Drug safety · 2014Article
Corrections and comments
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Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOf 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.
methodsA cohort study of HIV-infected individuals aged 15 years or older who were on ARV medicines was conducted at four sentinel sites.
resultsAfter 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).
conclusionThe 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.
Indexed as
Identifiers
22593775PMC3343667W1533681707What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.