Inferior clinical outcome of the CD4+ cell count-guided antiretroviral treatment interruption strategy in the SMART study: Role of CD4+ cell counts and HIV RNA levels during follow-up

The Strategies for Management of Antiretroviral Therapy (SMART) Study Group

Research output: Contribution to journalArticlepeer-review

174 Citations (Scopus)

Abstract

Background and methods. The SMART study compared 2 strategies for using antiretroviral therapy - drug conservation (DC) and viral suppression (VS) - in 5472 human immunodeficiency virus (HIV)-infected patients with CD4+ cell counts >350 cells/μL. Rates and predictors of opportunistic disease or death (OD/death) and the relative risk (RR) in DC versus VS groups according to the latest CD4+ cell count and HIV RNA level are reported. Results. During a mean of 16 months of follow-up, DC patients spent more time with a latest CD4+ cell count <350 cells/μL (for DC vs. VS, 31% vs. 8%) and with a latest HIV RNA level >400 copies/mL (71% vs. 28%) and had a higher rate of OD/death (3.4 vs. 1.3/100 person-years) than VS patients. For periods of follow-up with a CD4+ cell count <350 cells/μL, rates of OD/death were increased but similar in the 2 groups (5.7 vs. 4.6/100 person-years), whereas the rates were higher in DC versus VS patients (2.3 vs. 1.0/100 person-years; RR, 2.3 [95% confidence interval, 1.5-3.4]) for periods with the latest CD4+ cell count ≥350 cells/μL - an increase explained by the higher HIV RNA levels in the DC group. Conclusions. The higher risk of OD/death in DC patients was associated with (1) spending more follow-up time with relative immunodeficiency and (2) living longer with uncontrolled HIV replication even at higher CD4+ cell counts. Ongoing HIV replication at a given CD4+ cell count places patients at an excess risk of OD/death. Trial registration. Clinical Trials.gov identifier: NCT00027352.

Original languageEnglish
Pages (from-to)1145-1155
Number of pages11
JournalJournal of Infectious Diseases
Volume197
Issue number8
DOIs
Publication statusPublished - 15 Apr 2008

Bibliographical note

Funding Information:
Potential conflicts of interest: J. Lundgren and A. Phillips have received honoraria, fees for speaking, consultancy fees, and/or funds for research from various pharmaceutical companies, including Abbott, Bristol-Myers Squibb (BMS), Roche, GlaxoSmithKline (GSK), Gilead, Boehringer Ingelheim (BI), Pfizer, Tibotec, and Janssen-Cilag. S. Emery has received honoraria and consultancy fees from and has received research grants from or been an investigator in clinical trials sponsored by Abbott, BI, BMS, Chiron, Gilead Sciences, GSK, Merck Sharp and Dohme, Roche, Sanofi-Aventis, Tibotec, and Virax Holdings. All other Writing Group members report no potential conflicts.

Funding Information:
Financial support: National Institute of Allergy and Infectious Diseases, National Institutes of Health (grants U01AI042170 and U01AI46362).

Fingerprint

Dive into the research topics of 'Inferior clinical outcome of the CD4+ cell count-guided antiretroviral treatment interruption strategy in the SMART study: Role of CD4+ cell counts and HIV RNA levels during follow-up'. Together they form a unique fingerprint.

Cite this