title: The clinical benefits of antiretroviral therapy in severely immunocompromised HIV-1-infected patients with and without complete viral suppression.
abstract: BACKGROUND
  The aim of this study was to determine whether there is a protective effect of combination antiretroviral therapy (cART) on the development of clinical events in patients with ongoing severe immunosuppression.
  
  
  METHODS
  A total of 3,780 patients from the EuroSIDA study under follow-up after 2001 with a current CD4(+) T-cell count ≤200 cells/mm(3) were stratified into five groups: group 1, viral load (VL)<50 copies/ml on cART; group 2, VL 50-99,999 copies/ml on cART; group 3, VL 50-99,999 copies/ml off cART; group 4, VL≥100,000 copies/ml on cART; and group 5, VL≥100,000 copies/ml off cART. Poisson regression was used to identify the risk of (non-fatal or fatal) AIDS- and non-AIDS-related events considered together (AIDS/non-AIDS) or separately as AIDS or non-AIDS events within each group.
  
  
  RESULTS
  There were 428 AIDS/non-AIDS events during 3,780 person-years of follow-up. Compared with group 1, those in group 2 had a similar incidence of AIDS/non-AIDS events (incidence rate ratio [IRR] 1.04; 95% CI 0.79-1.36). Groups 3, 4 and 5 had significantly higher incidence rates of AIDS/non-AIDS events compared with group 1; incidence rates increased from group 3 (IRR 1.78; 95% CI 1.25-2.55) to group 5 (IRR 2.36; 95% CI 1.66-3.40), demonstrating the increased incidence of AIDS/non-AIDS events associated with increasing viraemia. After adjustment, the use of cART was associated with a 40% reduction in the incidence of AIDS/non-AIDS events in patients with VL 50-99,999 copies/ml (IRR 0.59; 95% CI 0.41-0.85) and in those with a VL>100,000 copies/ml (IRR 0.66; 95% CI 0.44-1.00). Similar relationships were seen for non-AIDS events and AIDS events when considered separately.
  
  
  CONCLUSIONS
  In patients with ongoing severe immunosuppression, cART was associated with significant clinical benefits in patients with suboptimal virological control or virological failure.
authors.affiliation: Research Department of Infection and Population Health, University College London, London, UK. a.mocroft@ucl.ac.uk
authors.forename: Amanda
authors.initials: A
authors.lastname: Mocroft
authors.forename: Wendy P
authors.initials: WP
authors.lastname: Bannister
authors.forename: Ole
authors.initials: O
authors.lastname: Kirk
authors.forename: Justyna D
authors.initials: JD
authors.lastname: Kowalska
authors.forename: Peter
authors.initials: P
authors.lastname: Reiss
authors.forename: Antonella
authors.initials: A
authors.lastname: D'Arminio-Monforte
authors.forename: Jose
authors.initials: J
authors.lastname: Gatell
authors.forename: Martin
authors.initials: M
authors.lastname: Fisher
authors.forename: Hanna
authors.initials: H
authors.lastname: Trocha
authors.forename: Aza
authors.initials: A
authors.lastname: Rakhmanova
authors.forename: Jens D
authors.initials: JD
authors.lastname: Lundgren
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000276:immunology; D000328:Adult; D018791:CD4 Lymphocyte Count; D004341:Drug Evaluation; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D017320:HIV Protease Inhibitors / Q000627:therapeutic use*; D015497:HIV-1 / Q000276:immunology / Q000472:pathogenicity; D006801:Humans; D016867:Immunocompromised Host; D015994:Incidence; D008297:Male; D008875:Middle Aged; D016012:Poisson Distribution; D011446:Prospective Studies; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*; D012307:Risk Factors; D019562:Viral Load; D014766:Viremia / Q000821:virology
chemical_list: D017320:HIV Protease Inhibitors; D018894:Reverse Transcriptase Inhibitors