Longitudinal assessment of health related quality of life of HIV infected patients treated for tuberculosis and HIV in a high burden setting
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Assessment of patients receiving treatment for human immunodeficiency virus (HIV) and tuberculosis (TB) using a Health Related Quality of Life (HRQoL) instrument is important to get the subjective view of the patients’ wellbeing.
We used the Functional Assessment of HIV Infection (FAHI) HRQoL instrument to collect perceived wellness information at baseline, month 3, 6 and 12 from patients enrolled in a pharmacokinetic study between March 2007 and April 2008. Composite domain scores at each time point and their relationship with the rate of adverse events (AEs) and serious adverse events were compared between treatment arms.
Out of the 82 patients enrolled, 76 were analysed. There was a significant increase in total score in all groups between baseline, month 3, 6 and 12 (all p values < 0.0001), and over time (p < 0.001). Adjusting for baseline total score, baseline CD4 count had a significant effect on the total score over time (p = 0.002) and the rate of change in total score over time, that is; interaction effect (p < 0.001). There was no difference in each domain scores between participants that received ART with TB treatment and those that received TB treatment only. Respiratory AEs had a significant effect on HRQoL.
We found that assessment of HRQoL of participants in TB–HIV treatment using the FAHI instrument was useful in evaluating treatment responses. It showed improvement consistent with decrease in adverse events and signs and symptoms of TB. Number and type of AEs was related to lower HRQoL in spite of TB cure.
KeywordsHealth Related Quality of Life Tuberculosis HIV Adverse events
The study was sponsored by the Special Programme for Research and Training in Tropical Diseases, World Health Organization and United States Agency for International Development (USAID, Umbrella Grant no. AAG-G-00-99-00005). The European & Developing Countries Clinical Trials Partnership (EDCTP) supplied supplementary funding of the PhD (training grant). The Medical Research Council of South Africa (SAMRC) provided additional finances for the study. We also acknowledge the generous donations of antiretroviral drugs from two major pharmaceutical companies, GlaxoSmithKline (UK) and Merck (USA), without which the study would not have been conducted. These sponsors had nothing to do with study conduct. We would also like to thank the study staff for their hard work and patients for their involvement in this study.
TM participated in design, managed the study and drafted the manuscript. RR, KD and AP participated in the design and management of the study, TR performed the statistical analysis, SM helped draft the manuscript and assisted with its final edit. All authors read and approved the manuscript.
Compliance with ethical standards
Conflict of interest
There were no competing interests declared by any of the authors.
The study was approved by the Biomedical Research Ethics Committee (BREC) of the University of KwaZulu-Natal (KZN), reference numbers E294/05 and BFC 037/08. All procedures performed in the study were in accordance with ethical standards of the national and institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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