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Review of the impact of NNRTI-based HIV treatment regimens on patient-reported disease burden
Authors:Kit N. Simpson  Gale Harding  Seema Haider  Margaret Tawadrous  Alexandra Khachatryan
Affiliation:1. Department of Healthcare Leadership and Management, Medical University of South Carolina, Charleston, SC, USA;2. Outcomes Research, Evidera, Bethesda, MD, USA;3. Outcomes Research, Specialty Care Business Unit, Pfizer Inc., Groton, CT, USA;4. Clinical Affairs, Specialty Care Business Unit, Pfizer Inc., Groton, CT, USA;5. Outcomes Research, Pharmerit, Bethesda, MD, USA
Abstract:While the burden of HIV disease is well documented, the value of non-nucleoside reverse transcriptase inhibitor (NNRTI)-based therapy regimens in reducing patient burden is not well understood. The purpose of this study was to examine patient-reported health among those receiving NNRTI-based regimens to understand their incremental value in reducing the burden of HIV. We conducted a structured literature review using PubMed to identify NNRTI trials utilizing validated patient-reported outcome (PRO) instruments during 2005–2011. The search strategy included a PubMed search to identify relevant studies based on disease, instrument, PRO, and NNRTI medication terms; and a manual search of bibliographies of identified papers. Data abstracted from each study included study type, treatment regimen(s), and PRO results. Of 11 trials identified, 8 (73%) reported significance of changes in a PRO over time and 10 (91%) reported significance of PRO changes between groups. Several domains were assessed, with significant findings (between or within groups) observed in: physical health/well-being (n = 5), emotional status/well-being (n = 2), symptoms (n = 2), anxiety (n = 2), gastrointestinal upset (n = 2), psychological health (n = 1), functional and global well-being (n = 1), fatigue/energy (n = 1), depression (n = 1), change in body appearance (n = 1), pain (n = 1), headache (n = 1), bad dreams/nightmares (n = 1), problems having sex (n = 1), and general health perception (n = 1). In conclusion, NNRTIs have been observed most frequently to improve patient-reported physical health and well-being. Treatments are needed that can also reduce patient burden in areas of emotional well-being, cognitive functioning, and overall symptom profile.
Keywords:HIV  patient-reported outcome (PRO)  instrument  burden  NNRTI
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