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Clinical Trial
. 2013 Nov 14;8(11):e78642.
doi: 10.1371/journal.pone.0078642. eCollection 2013.

Symptomatic illness and low CD4 cell count at HIV seroconversion as markers of severe primary HIV infection

Sara Lodi  1 , Martin Fisher, Andrew Phillips, Andrea De Luca, Jade Ghosn, Ruslan Malyuta, Robert Zangerle, Santiago Moreno, Philippe Vanhems, Faroudy Boufassa, Marguerite Guiguet, Kholoud Porter; CASCADE Collaboration in EuroCoord
Collaborators, Affiliations
Clinical Trial

Symptomatic illness and low CD4 cell count at HIV seroconversion as markers of severe primary HIV infection

Sara Lodi et al. PLoS One. .

Abstract

Background: The risk/benefit of initiating ART in primary HIV infection (PHI) is unclear. The benefits are more likely to outweigh the risks in patients with severe PHI. An accepted definition of severe PHI is, however, lacking.

Methods: CASCADE patients with HIV test interval <6 months were classified as severe and non-severe PHI based on whether the following traits were recorded in the first 6 months following seroconversion: severe specific pre-defined symptoms, central nervous system-implicated illness, and ≥1, ≥2 CD4<350 (and <500) cells/mm(3). For each definition, we used Kaplan-Meier curves and Cox survival models to compare time to AIDS/death, censoring at the earlier of last clinic visit or 1/1/1997, when combination antiretroviral therapy (cART) became available.

Results: Among 1108 included patients mostly males (85%) infected through sex between men (71%), 366 were diagnosed with AIDS/died. The risk of AIDS/death was significantly higher for individuals with severe symptoms, those with ≥1 CD4<350 cells/mm(3) or ≥2 CD4 <500 cells/mm(3) in the first 6 months [aHR (95% confidence interval) 2.1 (1.4,3.2), 2.0 (1.5,2.7), and 2.3, (1.5-3.5) respectively]. Median [interquantile range] survival for patients with ≥2, ≥1 and no CD4<350 cells/mm(3) within 6 months of seroconversion was 3.9 [2.7,6.5], 5.4 [4.5,8.4] and 8.1 [4.3,10.3] years, respectively. The diagnosis of CNS-implicated symptoms was rare and did not appear to be prognostic.

Conclusion: One CD4 count <350 or two <500 cells/mm(3) within 6 months of seroconversion and/or severe illness in PHI may be useful early indicators of individuals at high risk of disease progression.

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Conflict of interest statement

Competing Interests: KP has received an honorarium from Tibotec. AP has received fees for consultancy for Gilead Sciences, GSK Biologicals, KP 360; speaker fees from Gilead; funds for research from BMS; Advisory Board membership with Abbvie. JG has received fees for consulting from Gilead Sciences, Bristol Myers Squibb, Merck Sharp Dohme Chibret, Janssen, Merck Sharp Dohme Chibret and Viiv. PV has received consultancy from consulting for Sanofi Pasteur. AdL has received fees for consulting from Gilead, Jansen, Siemens diagnostics, Abbott Virology and ViiV Healthcare. MF has received honoraria, speaker fees, or funding to attend conferences from: AbbVie, Bristol Myers Squibb, Gilead, Janssen, Merck, and Viiv. No other competing interests to declare. This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials.

Figures

Figure 1
Figure 1. Risk of AIDS and/or death after HIV seroconversion by lowest CD4 count recorded in the first 6 months of HIV diagnosis.
The dashed line shows a relative risk of 1 for a CD4 count of 500 cells/mm3. Risk adjusted for sex, exposure category and age at HIV seroconversion.
See this image and copyright information in PMC

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