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Safety and Tolerability of Antiretroviral Therapy Among HIV-Infected Children And Adolescents In UGANDA

Tukei, Vincent J. MBChB, MMed, MPH*; Asiimwe, Alice MBChB, MSc*; Maganda, Albert BStat, MStat*; Atugonza, Rita MBChB*; Sebuliba, Isaac BStat, MStat*; Bakeera-Kitaka, Sabrina MBChB, MMed; Musoke, Phillipa MBChB, FAAP†,‡; Kalyesubula, Israel MBChB, MMed, DTCH*; Kekitiinwa, Adeodata MBChB, MMed, DPPM*

JAIDS Journal of Acquired Immune Deficiency Syndromes: March 1st, 2012 - Volume 59 - Issue 3 - p 274–280
doi: 10.1097/QAI.0b013e3182423668
Clinical Science

Background: Antiretroviral therapy (ART) is known to cause a number of adverse effects. The objective of this study was to determine the frequency and outcome of ART-related adverse events among patients aged 6 weeks to 18 years.

Methods: We followed up a cohort of 378 HIV-infected children and adolescents who started ART at the Baylor-Uganda Clinic during the period July 2004 to July 2009. Patients were started on zidovudine or stavudine, plus lamivudine, and efavirenz or nevirapine. Adverse events were recorded as they occurred. Descriptive analyses and Kaplan–Meier survival analysis were carried out.

Results: Of 126 adverse events reported among 107 (28.3%) patients, dizziness (17.5%), diarrhea (13.5%), and nausea and vomiting (14.3%) were the most frequent. Anxiety/night mares, skin rashes, nail discoloration, and lipodystrophy each contributed between 5% and 10%; whereas anorexia, abdominal pain, hepatitis, and somnolence contributed 1%–5%. Amnesia, lactic acidosis, gynaecomastia, cardiomyopathy, and peripheral neuropathy were rare, each contributing less than 1% of the total events. The overall probability of remaining free of adverse events was 77.1% (95% confidence interval: 72.38 to 81.13) at month 6 of ART.

Among infants and young children, neurologic events could not be determined. Laboratory abnormalities were present at baseline and during follow-up, and hemoglobin levels increased significantly during the first 6 months of ART. There was no association between adverse events and baseline patient characteristics.

Conclusion: Close to one-third of children on ART experience adverse events. Most events occur within the first 3 months of ART and are not associated with baseline patient characteristics.

*Research Unit, Baylor College of Medicine Bristol Myers Squibb Children's Clinical Center of Excellence at Mulago Hospital, Kampala, Uganda

Department of Pediatrics and Child Health, Makerere University College of Health Sciences, Kampala, Uganda

Makerere University, Johns Hopkins University Research Collaboration Clinic, Kampala, Uganda.

Correspondence to: Vincent J. Tukei, MBChB, MMed, MPH, Block 5 Mulago hospital, PO Box 72052, Kampala, Uganda (e-mail: vtukei@baylor-uganda.org).

Supported by Cooperative agreement Number 5U2GPS000942 from Centers for Disease Control and Prevention (CDC). Abbott Fund provided the test kits used in this program; Clinton Foundation and Ministry of Health of Uganda provided the drugs used; and Baylor International Pediatric AIDS Initiative (BIPAI) provided technical support. Bristol Myers Squibb supplied the antiretroviral drugs to the Uganda ministry of health and provided the funds for the construction of the office block that houses the clinic.

Presented at the 2011 Sub-Saharan Africa Center for AIDS Research (CFAR) conference, May 25th to 27th, 2011, Kampala, Uganda.

The contents of this article are solely the responsibility of the authors and do not necessarily represent the views of CDC.

None of the authors received a stipend or salary from Bristol Myers Squibb or Abbott Fund.

The authors have no conflicts of interest to disclose.

Received August 18, 2011

Accepted November 15, 2011

© 2012 Lippincott Williams & Wilkins, Inc.