title: Can we stop CD4+ testing in patients with HIV-1 RNA suppression on antiretroviral treatment?
abstract: BACKGROUND
  It is unclear whether regular CD4 testing is necessary for all patients during long-term antiretroviral treatment, after patients achieve full HIV-1 RNA suppression.
  
  
  METHODS
  In the AntiRetroviral Therapy with TMC114 Examined in Naïve Subjects (ARTEMIS) trial, 689 treatment-naïve patients were randomized to tenofovir/emtricitabine and either darunavir/ritonavir or lopinavir/ritonavir. The number of patients with CD4 cell counts equal or above 200 copies/ml and HIV-1 RNA below 50 copies/ml at week 48 was assessed. For these patients, we assessed whether CD4 cell counts fell below 200 cells/μl from week 49 to week 192, while HIV-1 RNA suppression was maintained.
  
  
  RESULTS
  Of the 520 responders, five (1.0%) progressed to an AIDS-defining event during the first 48 weeks of the trial, whereas 19 of the 169 non-responders (11.2%) developed AIDS-defining events during this time (P = 0.001, Fisher's Exact test). Of the 449 patients with sustained HIV-1 RNA suppression below 400 copies/ml from week 49 to week 192, five patients (1.1%) had reductions in CD4 cell count below 200 cells/μl on two consecutive visits. These were all short-term reductions, with follow-up results equal or above 200 cells/μl.
  
  
  CONCLUSIONS
  There was a benefit to testing for CD4 cell count in the first 48 weeks of treatment, to identify patients who have immuno-virological discordance and therefore a higher risk of progression to AIDS. However, after 48 weeks of antiretroviral treatment, for the 'responder' patients in the ARTEMIS trial who had both HIV-1 RNA below 50 copies/ml and rises in CD4 cell count equal or above 200 cells/μl, there appears to be little clinical benefit from continued testing for CD4 cell count.
authors.affiliation: aSt Antoine Hospital, Pierre et Marie Curie University and INSERM Unit 707, Paris, France bChelsea and Westminster Hospital, London cJanssen Global Access & Partnership Program dJanssen R&D, High Wycombe, UK eJanssen EMEA, Tilburg, Netherlands fJanssen EMEA, Neuss, Germany.
authors.forename: Pierre-Marie
authors.initials: PM
authors.lastname: Girard
authors.forename: Mark
authors.initials: M
authors.lastname: Nelson
authors.forename: Perry
authors.initials: P
authors.lastname: Mohammed
authors.forename: Andrew
authors.initials: A
authors.lastname: Hill
authors.forename: Yvon
authors.initials: Y
authors.lastname: van Delft
authors.forename: Christiane
authors.initials: C
authors.lastname: Moecklinghoff
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology*; D016903:Drug Monitoring / Q000379:methods*; D005260:Female; D015658:HIV Infections / Q000175:diagnosis* / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D012367:RNA, Viral / Q000097:blood; D019562:Viral Load
chemical_list: D044966:Anti-Retroviral Agents; D012367:RNA, Viral