title: CD4 cell-monitored treatment interruption in patients with a CD4 cell count > 500 x 106 cells/l.
abstract: BACKGROUND
  Little is known about CD4 cell count changes in patients with high CD4 cell counts who interrupt antiretroviral therapy, especially in those with a nadir of 250-350 x 10 cells/l.
  
  
  METHODS
  Data derived from 139 patients from seven prospective cohorts who had > 12 months highly active antiretroviral therapy (HAART), CD4 cell count nadir of > 250 x 10 cells/l and at pre-interruption of > 500 x 10 cells/l. Endpoint was time to CD4 cell count < 350 x 10 cells/l or reinitiation of treatment.
  
  
  RESULTS
  At interruption, the median CD4 cell count was 800 x 10 cells/l, median viral load was 1.7 log10 copies/ml. At the time of analysis, 63 (45.3%) had resumed therapy or experienced < 350 x 10 cells/l CD4 cells over a median interruption of 75 weeks. Of these, 33 (52.4%) experienced a decline to < 350 x 10 cells/l and 30 (47.6%) restarted therapy before their CD4 cell count had fallen below this level. In 43 patients with CD4 cell nadir of 251-350 x 10 cells/l, median time to therapy resumption or CD4 cell count < 350 x 10 cells/l was 61 weeks. Higher CD4 cell count nadir, longer duration of viral load suppression on therapy, and higher viral load level at interruption were independently associated with longer time to restart therapy. The risk of clinical events was 5 per 1000 person-years of follow-up.
  
  
  CONCLUSIONS
  Patients who started therapy with CD4 cell count of 250-350 x 10 cells/l and who later interrupted therapy appear able to remain off therapy with a CD4 cell count > 350 x 10 cells/l for a substantial period of time.
authors.affiliation: Clinic of Infectious and Tropical Diseases, Azienda Ospedaliero-Universitaria Policlinico, University of Modena and Reggio Emilia, Via del Pozzo, 71, 41100 Modena, Italy. crimuss@uniimo.it
authors.forename: Cristina
authors.initials: C
authors.lastname: Mussini
authors.forename: Andrea
authors.initials: A
authors.lastname: Bedini
authors.forename: Vanni
authors.initials: V
authors.lastname: Borghi
authors.forename: Giovanni
authors.initials: G
authors.lastname: Guaraldi
authors.forename: Roberto
authors.initials: R
authors.lastname: Esposito
authors.forename: Enrico
authors.initials: E
authors.lastname: Barchi
authors.forename: Reggio
authors.initials: R
authors.lastname: Enilia
authors.forename: Alessandro
authors.initials: A
authors.lastname: Cozzi-Lepri
authors.forename: Andrew N
authors.initials: AN
authors.lastname: Philips
authors.forename: Patrizia
authors.initials: P
authors.lastname: Ortolani
authors.forename: Göran
authors.initials: G
authors.lastname: Bratt
authors.forename: Lars E
authors.initials: LE
authors.lastname: Eriksson
authors.forename: Laura
authors.initials: L
authors.lastname: Sighinolfi
authors.forename: Andrea
authors.initials: A
authors.lastname: Cossarizza
authors.forename: Antonella
authors.initials: A
authors.lastname: d'Arminio Monforte
authors.forename: Andrea
authors.initials: A
authors.lastname: De Luca
authors.forename: Simona
authors.initials: S
authors.lastname: Di Giambenedetto
authors.forename: Andrea
authors.initials: A
authors.lastname: Antinori
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D002784:Cholesterol / Q000097:blood; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000276:immunology*; D015497:HIV-1; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018570:Risk Assessment; D014280:Triglycerides / Q000097:blood; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D014280:Triglycerides; D002784:Cholesterol