title: Effects of active treatment discontinuation in patients with a CD4+ T-cell nadir greater than 350 cells/mm3: 48-week Treatment Interruption in Early Starters Netherlands Study (TRIESTAN).
abstract: OBJECTIVE
  To evaluate the safety and efficacy of discontinuing highly active antiretroviral therapy (HAART) in HIV-1-positive patients who initiated HAART at a CD4+ T-cell count >350 cells/mm.
  
  
  METHODS
  Eligible patients were identified from the Dutch AIDS Therapy Evaluation, The Netherlands (ATHENA) national observational cohort. Interruption or continuation of HAART was offered to all.
  
  
  RESULTS
  Of 71 patients enrolled, 46 (64%) interrupted HAART (STOP group) and 25 (36%) continued HAART (control group). The median CD4+ T-cell nadirs at the start of HAART were 469 (interquartile range [IQR]: 430-720) cells/mm3 and 510 (IQR: 440-637) cells/mm3, respectively. At week 48, the median plasma HIV RNA level in the STOP group had stabilized at approximately pre-HAART values (4.55 log10, IQR: 4.2-4.9 copies/mL), but the CD4+ T-cell count still exceeded the pre-HAART count (563 cells/mm3, IQR: 450-710 cells/mm3). Only 5 patients (11%) had reinitiated HAART after 48 weeks, all for personal reasons. No Centers for Disease Control and Prevention category events or death occurred after interruption. In 6 (13%) of 46 patients, mild symptoms of acute retroviral rebound syndrome (ARVS) were identified. No improvement was observed in mental or physical health scores. In 37% of patients, nonnucleoside reverse transcriptase inhibitor drug concentrations were still detectable 1 week after stopping.
  
  
  CONCLUSIONS
  Although HAART can safely be interrupted in patients with a high CD4 T-cell nadir, no improvement in quality of life was established. Patients can experience ARVS, the risk for development of resistance after treatment interruption is realistic, and there is a potential hazard of HIV transmission to sexual partners. We would not actively advise stopping treatment in patients who started treatment too early according to current guidelines.
authors.affiliation: Department of Internal Medicine, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Katalin
authors.initials: K
authors.lastname: Pogány
authors.forename: Irene G M
authors.initials: IG
authors.lastname: van Valkengoed
authors.forename: Irene G
authors.initials: IG
authors.lastname: Vanvalkengoed
authors.forename: Jan M
authors.initials: JM
authors.lastname: Prins
authors.forename: Pythia T
authors.initials: PT
authors.lastname: Nieuwkerk
authors.forename: Ineke
authors.initials: I
authors.lastname: van der Ende
authors.forename: Robbert H
authors.initials: RH
authors.lastname: Kauffmann
authors.forename: Frank P
authors.initials: FP
authors.lastname: Kroon
authors.forename: Annelies
authors.initials: A
authors.lastname: Verbon
authors.forename: Marianne F
authors.initials: MF
authors.lastname: Nievaard
authors.forename: Joep M A
authors.initials: JM
authors.lastname: Lange
authors.forename: Kees
authors.initials: K
authors.lastname: Brinkman
mesh_terms: D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D015496:CD4-Positive T-Lymphocytes / Q000187:drug effects* / Q000276:immunology / Q000821:virology; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D015497:HIV-1 / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load; D028761:Withholding Treatment