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AIDS. 2008 Oct 18;22(16):2097-106. doi: 10.1097/QAD.0b013e32830f97e2.

Long-term consequences of the delay between virologic failure of highly active antiretroviral therapy and regimen modification.

Author information

  • 1Division of Biostatistics, Berkeley School of Public Health, Berkeley, California 94720, USA. mayaliv@berkeley.edu

Abstract

OBJECTIVES:

Current treatment guidelines recommend immediate modification of antiretroviral therapy in HIV-infected individuals with incomplete viral suppression. These recommendations have not been tested in observational studies or large randomized trials. We evaluated the consequences of delayed modification following virologic failure.

DESIGN/METHODS:

We used prospective data from two clinical cohorts to estimate the effect of time until regimen modification following first regimen failure on all-cause mortality. The impact of regimen type was also assessed. As the effect of delayed switching can be confounded if patients with a poor prognosis modify therapy earlier than those with a good prognosis, we used a statistical methodology - marginal structural models - to control for time-dependent confounding.

RESULTS:

A total of 982 patients contributed 3414 person-years of follow-up following first regimen failure. Delay until treatment modification was associated with an elevated hazard of all-cause mortality among patients failing a reverse transcriptase inhibitor-based regimen (hazard ratio per additional 3 months delay = 1.23, 95% confidence interval: 1.08, 1.40), but appeared to have a small protective effect among patients failing a protease inhibitor-based regimen (hazard ratio per additional 3 months delay = 0.93, 95% confidence interval: 0.87, 0.99).

CONCLUSION:

Delay in modification after failure of regimens that do not contain a protease inhibitor is associated with increased mortality. Protease inhibitor-based regimens are less dependent on early versus delayed switching strategies. Efforts should be made to minimize delay until treatment modification in resource-poor regions, where the majority of patients are starting reverse transcriptase inhibitor-based regimens and HIV RNA monitoring may not be available.

PMID:
18832873
[PubMed - indexed for MEDLINE]
PMCID:
PMC2597677
Free PMC Article

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