title: CD4+ cell-count-guided treatment interruptions in chronic HIV-infected patients with good response to highly active antiretroviral therapy.
abstract: OBJECTIVE
  To evaluate the safety of treatment interruption guided by CD4+ cell count in HIV-infected patients followed up prospectively.
  
  
  METHODS
  Patients on highly active antiretroviral therapy with CD4+ cell counts > 500 x 10(6) cells/l discontinued therapy with instructions to start therapy again before their CD4+ count dropped below 200 x 10(6) cells/l. Any patients who resumed therapy would be eligible to interrupt treatment again once their CD4+ cell count increased above 500 x 10(6) cells/l.
  
  
  RESULTS
  Data on 71 HIV infected patients is reported. Their median nadir CD4+ cell count before antiretroviral treatment was 352 x 10(6) cells/l [interquartile range (IQR), 294-445 x 10(6) cells/l]. The median CD4+ cell count at the time of first interruption was 790 x 10(6) cells/l (IQR, 657-1041 x 10(6) cells/l). The median follow-up after starting the first treatment interruption was 28.3 months (IQR, 21.4-37.0 months). During the follow-up 49 patients restarted therapy and 22 patients remain off therapy; 24 patients have interrupted therapy twice, nine patients have interrupted therapy three times and six patients four times. No AIDS-defining illnesses occurred during the follow-up. The median duration of the first interruption was 15 months (IQR, 6-26 months). The overall reduction of time on therapy was 71.1%. The duration of the first interruption and the reduction of time on therapy were related to nadir CD4+ cell count. The patients who resumed HAART rapidly regained CD4+ cells and achieved viral suppression.
  
  
  CONCLUSIONS
  If carefully monitored, treatment interruptions guided by CD4+ cell count in patients with an initially high CD4+ cell counts are clinically safe, decrease exposure to the drugs and do not reduce the efficacy of therapy when this is re-started.
authors.affiliation: Division of Infectious Diseases AUSL Rimini, Via Settembrini 2, 49300 Rimini (RN), Italy. boschia@libero.it
authors.forename: Andrea
authors.initials: A
authors.lastname: Boschi
authors.forename: Carmine
authors.initials: C
authors.lastname: Tinelli
authors.forename: Patrizia
authors.initials: P
authors.lastname: Ortolani
authors.forename: Gianluigi
authors.initials: G
authors.lastname: Moscatelli
authors.forename: Giorgio
authors.initials: G
authors.lastname: Morigi
authors.forename: Massimo
authors.initials: M
authors.lastname: Arlotti
mesh_terms: D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D002908:Chronic Disease; D015331:Cohort Studies; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D008297:Male; D011446:Prospective Studies; D019562:Viral Load; D028761:Withholding Treatment