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Observational Study
. 2016 Jun 1;72(2):214-21.
doi: 10.1097/QAI.0000000000000956.

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

Ellen C Caniglia  1 , 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 3rd, 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
Affiliations
Observational Study

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

Ellen C Caniglia et al. J Acquir Immune Defic Syndr. .

Abstract

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.

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Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

FIGURE 1
FIGURE 1
Number of individuals following each monitoring strategy over follow-up, HIV-CAUSAL Collaboration and CNICS.
FIGURE 2
FIGURE 2
Eighteen-month mean CD4 cell curves by monitoring strategy, HIV-CAUSAL Collaboration and CNICS.
See this image and copyright information in PMC

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