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Mortality in well controlled HIV in the continuous antiretroviral therapy arms of the SMART and ESPRIT trials compared with the general population

Rodger, Alison J.a; Lodwick, Rebeccaa; Schechter, Maurob; Deeks, Stevenc; Amin, Janakid; Gilson, Richarda; Paredes, Rogere; Bakowska, Elzbietaf; Engsig, Frederik N.g; Phillips, Andrewa; for the INSIGHT SMART, ESPRIT Study Groups

doi: 10.1097/QAD.0b013e32835cae9c
Epidemiology and Social

Background: Due to the success of antiretroviral therapy (ART), it is relevant to ask whether death rates in optimally treated HIV are higher than the general population. The objective was to compare mortality rates in well controlled HIV-infected adults in the SMART and ESPRIT clinical trials with the general population.

Methods: Non-IDUs aged 20–70 years from the continuous ART control arms of ESPRIT and SMART were included if the person had both low HIV plasma viral loads (≤400 copies/ml SMART, ≤500 copies/ml ESPRIT) and high CD4+ T-cell counts (≥350 cells/μl) at any time in the past 6 months. Standardized mortality ratios (SMRs) were calculated by comparing death rates with the Human Mortality Database.

Results: Three thousand, two hundred and eighty individuals [665 (20%) women], median age 43 years, contributed 12 357 person-years of follow-up. Sixty-two deaths occurred during follow up. Commonest cause of death was cardiovascular disease (CVD) or sudden death (19, 31%), followed by non-AIDS malignancy (12, 19%). Only two deaths (3%) were AIDS-related. Mortality rate was increased compared with the general population with a CD4+ cell count between 350 and 499 cells/μl [SMR 1.77, 95% confidence interval (CI) 1.17–2.55]. No evidence for increased mortality was seen with CD4+ cell counts greater than 500 cells/μl (SMR 1.00, 95% CI 0.69–1.40).

Conclusion: In HIV-infected individuals on ART, with a recent undetectable viral load, who maintained or had recovery of CD4+ cell counts to at least 500 cells/μl, we identified no evidence for a raised risk of death compared with the general population.

aUniversity College London, London, UK

bUniversidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil

cThe University of California, San Francisco, San Francisco, California, USA

dUniversity of New South Wales, Sydney, New South Wales, Australia

eHIV Unit and irsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain

fWojewodzki Szpital Zakazny, Warsaw, Poland

gCopenhagen University Hospital, Copenhagen, Denmark.

Correspondence to Dr Alison Rodger, Research Department of Infection & Population Health, University College London (UCL), Rowland Hill Street, London NW3 2PF, UK. Tel: +44 20 7472 6754; fax: +44 20 7794 1224; e-mail:

Received 23 September, 2012

Revised 1 November, 2012

Accepted 15 November, 2012

© 2013 Lippincott Williams & Wilkins, Inc.