title: Implementation and Operational Research: Effects of CD4 Monitoring Frequency on Clinical End Points in Clinically Stable HIV-Infected Patients With Viral Suppression.
abstract: BACKGROUND
  Current treatment guidelines for HIV infection recommend routine CD4 lymphocyte (CD4) count monitoring in patients with viral suppression. This may have a limited impact on influencing care as clinically meaningful CD4 decline rarely occurs during viral suppression.
  
  
  METHODS
  In a regional HIV observational cohort in the Asia-Pacific region, patients with viral suppression (2 consecutive viral loads <400 copies/mL) and a CD4 count ≥200 cells per microliter who had CD4 testing 6 monthly were analyzed. Main study end points were occurrence of 1 CD4 count <200 cells per microliter (single CD4 <200) and 2 CD4 counts <200 cells per microliter within a 6-month period (confirmed CD4 <200). A comparison of time with single and confirmed CD4 <200 with biannual or annual CD4 assessment was performed by generating a hypothetical group comprising the same patients with annual CD4 testing by removing every second CD4 count.
  
  
  RESULTS
  Among 1538 patients, the rate of single CD4 <200 was 3.45/100 patient-years and of confirmed CD4 <200 was 0.77/100 patient-years. During 5 years of viral suppression, patients with baseline CD4 200-249 cells per microliter were significantly more likely to experience confirmed CD4 <200 compared with patients with higher baseline CD4 [hazard ratio, 55.47 (95% confidence interval: 7.36 to 418.20), P < 0.001 versus baseline CD4 ≥500 cells/μL]. Cumulative probabilities of confirmed CD4 <200 was also higher in patients with baseline CD4 200-249 cells per microliter compared with patients with higher baseline CD4. There was no significant difference in time to confirmed CD4 <200 between biannual and annual CD4 measurement (P = 0.336).
  
  
  CONCLUSIONS
  Annual CD4 monitoring in virally suppressed HIV patients with a baseline CD4 ≥250 cells per microliter may be sufficient for clinical management.
authors: *Department of Internal Medicine and AIDS Research Institute, Yonsei University College of Medicine, Seoul, South Korea; †The Kirby Institute, UNSW Australia, Sydney, Australia; ‡Chennai Antiviral Research and Treatment Clinical Research Site (CART CRS), YRGCARE Medical Centre, VHS, Chennai, India; §Working Group on AIDS Faculty of Medicine, University of Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia; ‖Research Institute for Health Sciences, Chiang Mai, Thailand; ¶Queen Elizabeth Hospital, Hong Kong, China; #Hospital Sungai Buloh, Sungai Buloh, Malaysia; **National Center for Global Health and Medicine, Tokyo, Japan; ††Taipei Veterans General Hospital, Taipei, Taiwan; ‡‡University Malaya Medical Centre, Kuala Lumpur, Malaysia; §§Chiangrai Prachanukroh Hospital, Chiang Rai, Thailand; ‖‖HIV-NAT/Thai Red Cross AIDS Research Centre, Bangkok, Thailand; ¶¶Tan Tock Seng Hospital, Singapore; ##Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; ***Beijing Ditan Hospital, Capital Medical University, Beijing, China; †††Institute of Infectious Diseases, Pune, India; ‡‡‡Research Institute for Tropical Medicine, Manila, Philippines; §§§Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand; ‖‖‖Faculty of Medicine, Udayana University and Sanglah Hospital, Bali, Indonesia; ¶¶¶National Center for HIV/AIDS, Dermatology and STDs, and University of Health Sciences, Phnom Penh, Cambodia; and ###TREAT Asia, amfAR-The Foundation for AIDS Research, Bangkok, Thailand.
authors: Jin Young
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mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000494:pharmacology / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000187:drug effects* / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged
chemical_list: D019380:Anti-HIV Agents