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Lancet HIV. 2017 Jun;4(6):e251-e259. doi: 10.1016/S2352-3018(17)30043-7. Epub 2017 Apr 11.

Comparison of dynamic monitoring strategies based on CD4 cell counts in virally suppressed, HIV-positive individuals on combination antiretroviral therapy in high-income countries: a prospective, observational study.

Author information

1
Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA. Electronic address: ecaniglia@mail.harvard.edu.
2
Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA.
3
University College London, London, UK.
4
Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA; Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA, USA.
5
Sorbonne Universités, UPMC Univ Paris 06, INSERM, Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP UMRS 1136), Paris, France; Assistance Publique-Hopitaux de Paris (AP-HP), Hopital Antoine Béclère, Service de Médecine Interne, Clamart, France.
6
Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; UAB Center for AIDS Research, University of Alabama at Birmingham, Birmingham, AL, USA.
7
Université Paris Sud, INSERM CESP U1018, Paris, France; AP-HP, Hopital de Bicêtre, Service de Santé Publique, le Kremlin Bicêtre, France.
8
School of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.
9
Institut de Santé Publique, d'Epidémiologie et de Développement, Université de Bordeaux, Bordeaux, France; Department of Internal Medicine, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France.
10
INSERM U897, Centre INSERM Epidémiologie et Biostatistique, Université de Bordeaux, Bordeaux, France; Department of Internal Medicine, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France.
11
School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
12
Stichting HIV Monitoring, Amsterdam, Netherlands; Academic Medical Center, Department of Global Health and Division of Infectious Diseases, University of Amsterdam, Amsterdam, Netherlands; Amsterdam Institute for Global Health and Development, Amsterdam, Netherlands.
13
Stichting HIV Monitoring, Amsterdam, Netherlands.
14
Internal Medicine, Johns Hopkins University, Baltimore, MD, USA.
15
National Centre of Epidemiology, Instituto de Salud Carlos III, Madrid, Spain; Consorcio de Investigación Biomédica de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain.
16
Ramón y Cajal Hospital, IRYCIS, Madrid, Spain; University of Alcalá de Henares, Madrid, Spain.
17
Positive Health Program, San Francisco General Hospital, San Francisco, CA, USA.
18
Servei de Medicina Interna, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Barcelona, Spain.
19
Fenway Health, Boston, MA, USA.
20
Hospital Universitari de Bellvitge-Bellvitge Institute for Biomedical Research, Hospitalet de Llobregat, Barcelona, Spain.
21
Division of Infectious Diseases, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
22
Yale School of Medicine, New Haven, CT, USA; VA Connecticut Healthcare System, West Haven, CT, USA.
23
Southern Alberta HIV Clinic, University of Calgary, Calgary, AB, Canada.
24
Programa de Computação Científica, FIOCRUZ, Rio de Janeiro, Brazil.
25
Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland.
26
Centre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa; University of Bern, Institute for Social and Preventive Medicine, Bern, Switzerland.
27
Department of Infectious Diseases, Bern University Hospital and University of Bern, Bern, Switzerland.
28
Department of Hygiene, Epidemiology and Medical Statistics, Athens University Medical School, Athens, Greece.
29
Department of Medicine, University of Washington, Seattle, WA, USA.
30
Infectious Diseases, Hospital Clinic-IDIBAPS, Barcelona, Spain.
31
School of Social and Community Medicine, University of Bristol, Bristol, UK.
32
Sorbonne Universités, UPMC Univ Paris 06, INSERM, Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP UMRS 1136), Paris, France.
33
Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
34
Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA; Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA, USA; Harvard-MIT Division of Health Sciences and Technology, Boston, MA, USA.

Abstract

BACKGROUND:

Clinical guidelines vary with respect to the optimal monitoring frequency of HIV-positive individuals. We compared dynamic monitoring strategies based on time-varying CD4 cell counts in virologically suppressed HIV-positive individuals.

METHODS:

In this observational study, we used data from prospective studies of HIV-positive individuals in Europe (France, Greece, the Netherlands, Spain, Switzerland, and the UK) and North and South America (Brazil, Canada, and the USA) in The HIV-CAUSAL Collaboration and The Centers for AIDS Research Network of Integrated Clinical Systems. We compared three monitoring strategies that differ in the threshold used to measure CD4 cell count and HIV RNA viral load every 3-6 months (when below the threshold) or every 9-12 months (when above the threshold). The strategies were defined by the threshold CD4 counts of 200 cells per μL, 350 cells per μL, and 500 cells per μL. Using inverse probability weighting to adjust for baseline and time-varying confounders, we estimated hazard ratios (HRs) of death and of AIDS-defining illness or death, risk ratios of virological failure, and mean differences in CD4 cell count.

FINDINGS:

47 635 individuals initiated an antiretroviral therapy regimen between Jan 1, 2000, and Jan 9, 2015, and met the eligibility criteria for inclusion in our study. During follow-up, CD4 cell count was measured on average every 4·0 months and viral load every 3·8 months. 464 individuals died (107 in threshold 200 strategy, 157 in threshold 350, and 200 in threshold 500) and 1091 had AIDS-defining illnesses or died (267 in threshold 200 strategy, 365 in threshold 350, and 459 in threshold 500). Compared with threshold 500, the mortality HR was 1·05 (95% CI 0·86-1·29) for threshold 200 and 1·02 (0·91·1·14) for threshold 350. Corresponding estimates for death or AIDS-defining illness were 1·08 (0·95-1·22) for threshold 200 and 1·03 (0·96-1·12) for threshold 350. Compared with threshold 500, the 24 month risk ratios of virological failure (viral load more than 200 copies per mL) were 2·01 (1·17-3·43) for threshold 200 and 1·24 (0·89-1·73) for threshold 350, and 24 month mean CD4 cell count differences were 0·4 (-25·5 to 26·3) cells per μL for threshold 200 and -3·5 (-16·0 to 8·9) cells per μL for threshold 350.

INTERPRETATION:

Decreasing monitoring to annually when CD4 count is higher than 200 cells per μL compared with higher than 500 cells per μL does not worsen the short-term clinical and immunological outcomes of virally suppressed HIV-positive individuals. However, more frequent virological monitoring might be necessary to reduce the risk of virological failure. Further follow-up studies are needed to establish the long-term safety of these strategies.

FUNDING:

National Institutes of Health.

PMID:
28411091
PMCID:
PMC5492888
DOI:
10.1016/S2352-3018(17)30043-7
[Indexed for MEDLINE]
Free PMC Article

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