title: 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.
abstract: OBJECTIVE
  To illustrate an approach to compare CD4 cell count and HIV-RNA monitoring strategies in HIV-positive individuals on antiretroviral therapy (ART).
  
  
  METHODS
  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.
authors.affiliation: 1Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA; 2University College London, London, United Kingdom; 3Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA; 4Sorbonne Universités, UPMC Univ Paris 06, INSERM, Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP UMRS 1136), Paris, France; 5Assistance Publique-Hopitaux de Paris (AP-HP), Hopital Antoine Béclère, Service de Médecine Interne, Clamart, France; 6University of Alabama at Birmingham, Birmingham, AL; 7Université Paris Sud, INSERM CESP U1018, and AP-HP, Hopital de Bicêtre, Service de Santé Publique, le Kremlin Bicêtre, France; 8Division of Allergy and Infectious Diseases, School of Medicine, University of Washington, Seattle, WA; 9Bordeaux University, ISPED, INSERM U897 CHU de Bordeaux, Bordeaux, France; 10INSERM U897, Centre Inserm Epidémiologie et Biostatistique, Université de Bordeaux, and Department of Internal Medicine, Bordeaux University Hospital, Bordeaux, France; 11School of Medicine, Johns Hopkins University, Baltimore, MD; 12Stichting HIV Monitoring, Amsterdam, Netherlands; Academic Medical Center, Department of Global Health and Division of Infectious Diseases, University of Amsterdam, and Amsterdam Institute for Global Health and Development, Amsterdam, Netherlands; 13Stichting HIV Monitoring, Amsterdam, Netherlands; 14Internal Medicine, Johns Hopkins University, Baltimore, MD; 15National Centre of Epidemiology, Instituto de Salud Carlos III, Madrid, Spain; Consorcio de Investigación Biomédica de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain; 16Ramón y Cajal Hospital, IRYCIS, Madrid, Spain, University of Alcalá de Henares, Madrid, Spain; 17Positive Health Program, San Francisco General Hospital, San Francisco, CA; 18Servei de Medicina Interna, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Spain; 19Fenway Health, Boston, MA; 20Hospital Universitari d
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mesh_terms: D000386:AIDS-Related Complex / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality*; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D019049:Developed Countries; D005060:Europe / Q000453:epidemiology; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality*; D006801:Humans; D011446:Prospective Studies; D012367:RNA, Viral / Q000032:analysis*; D014481:United States / Q000453:epidemiology; D019562:Viral Load / Q000187:drug effects*
chemical_list: D019380:Anti-HIV Agents; D012367:RNA, Viral