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When to Monitor CD4 Cell Count and HIV RNA to Reduce Mortality and AIDS-Defining Illness in Virologically Suppressed HIV-Positive Persons on Antiretroviral Therapy in High-Income Countries: A Prospective Observational Study

Research output: Contribution to journalArticle

  • Ellen C Caniglia
  • Caroline Sabin
  • James M Robins
  • Roger Logan
  • Lauren E Cain
  • Sophie Abgrall
  • Michael J Mugavero
  • Sonia Hernandez-Diaz
  • Laurence Meyer
  • Remonie Seng
  • Daniel R Drozd
  • George R Seage
  • Fabrice Bonnet
  • Francois Dabis
  • Richard R Moore
  • Peter Reiss
  • Ard van Sighem
  • William C Mathews
  • Julia Del Amo
  • Santiago Moreno
  • Steven G Deeks
  • Roberto Muga
  • Stephen L Boswell
  • Elena Ferrer
  • Joseph J Eron
  • Sonia Napravnik
  • Sophie Jose
  • Andrew Phillips
  • Ashley Olson
  • Amy C Justice
  • Janet P Tate
  • Heiner C Bucher
  • Matthias Egger
  • Giota Touloumi
  • Jonathan A Sterne
  • Dominique Costagliola
  • Michael Saag
  • Miguel A Hernán
  • Center for AIDS Research Network of Integrated Clinical Systems and the HIV-CAUSAL Collaboration
Original languageEnglish
Pages (from-to)214-221
Number of pages8
JournalJournal of Acquired Immune Deficiency Syndromes
Issue number2
Early online date1 Jun 2016
DateAccepted/In press - 22 Dec 2015
DateE-pub ahead of print - 1 Jun 2016
DatePublished (current) - 1 Jun 2016


OBJECTIVE: To illustrate an approach to compare CD4 cell count and HIV-RNA monitoring strategies in HIV-positive individuals on antiretroviral therapy (ART).

DESIGN: Prospective studies of HIV-positive individuals in Europe and the USA in the HIV-CAUSAL Collaboration and The Center for AIDS Research Network of Integrated Clinical Systems.

METHODS: Antiretroviral-naive individuals who initiated ART and became virologically suppressed within 12 months were followed from the date of suppression. We compared 3 CD4 cell count and HIV-RNA monitoring strategies: once every (1) 3 ± 1 months, (2) 6 ± 1 months, and (3) 9-12 ± 1 months. We used inverse-probability weighted models to compare these strategies with respect to clinical, immunologic, and virologic outcomes.

RESULTS: In 39,029 eligible individuals, there were 265 deaths and 690 AIDS-defining illnesses or deaths. Compared with the 3-month strategy, the mortality hazard ratios (95% CIs) were 0.86 (0.42 to 1.78) for the 6 months and 0.82 (0.46 to 1.47) for the 9-12 month strategy. The respective 18-month risk ratios (95% CIs) of virologic failure (RNA >200) were 0.74 (0.46 to 1.19) and 2.35 (1.56 to 3.54) and 18-month mean CD4 differences (95% CIs) were -5.3 (-18.6 to 7.9) and -31.7 (-52.0 to -11.3). The estimates for the 2-year risk of AIDS-defining illness or death were similar across strategies.

CONCLUSIONS: Our findings suggest that monitoring frequency of virologically suppressed individuals can be decreased from every 3 months to every 6, 9, or 12 months with respect to clinical outcomes. Because effects of different monitoring strategies could take years to materialize, longer follow-up is needed to fully evaluate this question.

    Research areas

  • HIV, CD4 cell count, HIV RNA, monitoring, observational studies, mortality

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    Rights statement: This is the author accepted manuscript (AAM). The final published version (version of record) is available online via Wolters Kluwer at . Please refer to any applicable terms of use of the publisher.

    Accepted author manuscript, 768 KB, PDF document


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