Definitions of antiretroviral treatment failure for measuring quality outcomes

HIV Medicine
A SamaranayakeC K Fairley

Abstract

Our aim was to compare three different definitions of treatment failure and discuss their use as quality outcome measures for a clinical service. Data for treatment-naïve patients who attended the Melbourne Sexual Health Centre (MSHC) between 1 January 2000 and 31 December 2008 were analysed. Definition 1 was the strict Food and Drug Administration (FDA) definition of treatment failure as determined using the time to loss of virological response (TLOVR) algorithm. Definition 2 defined treatment failure as occurring in those whose viral load never fell to <400 HIV-1 RNA copies/mL or who developed two consecutive viral loads > or =400 copies/mL on any treatment (switching or stopping treatment with a viral load <400 copies/mL was permitted). Definition 3 was the same as definition 2 except that individuals were also deemed to have failed if they stopped treatment for 6 months or longer. There were 310 antiretroviral-naïve patients who started treatment in the study period. Of these, 156 [50.3%; 95% confidence interval (CI) 42.1-53.3%] experienced treatment failure under definition 1, 10 (3.2%; 95% CI 1.5-5.8%) experienced treatment failure under definition 2, and 16 (4.5%; 95% CI 2.5-7.4%) experienced treatment failure under defi...Continue Reading

References

Dec 9, 2003·International Journal for Quality in Health Care : Journal of the International Society for Quality in Health Care·Jan Mainz
Mar 31, 2004·Lancet·Peter J PronovostHaya Rubin
Dec 1, 2006·The New England Journal of Medicine·UNKNOWN Strategies for Management of Antiretroviral Therapy (SMART) Study GroupC Rappoport
Oct 31, 2007·BMJ : British Medical Journal·Ira B WilsonPaul D Cleary
Nov 29, 2007·HIV Clinical Trials·Michael J KozalUNKNOWN Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA)

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