title: Impact of low-level viremia on clinical and virological outcomes in treated HIV-1-infected patients.
abstract: BACKGROUND
  The goal of antiretroviral therapy (ART) is to reduce HIV-related morbidity and mortality by suppressing HIV replication. The prognostic value of persistent low-level viremia (LLV), particularly for clinical outcomes, is unknown.
  
  
  OBJECTIVE
  Assess the association of different levels of LLV with virological failure, AIDS event, and death among HIV-infected patients receiving combination ART.
  
  
  METHODS
  We analyzed data from 18 cohorts in Europe and North America, contributing to the ART Cohort Collaboration. Eligible patients achieved viral load below 50  copies/ml within 3-9 months after ART initiation. LLV50-199 was defined as two consecutive viral loads between 50 and 199  copies/ml and LLV200-499 as two consecutive viral loads between 50 and 499  copies/ml, with at least one between 200 and 499  copies/ml. We used Cox models to estimate the association of LLV with virological failure (two consecutive viral loads at least 500  copies/ml or one viral load at least 500 copies/ml, followed by a modification of ART) and AIDS event/death.
  
  
  RESULTS
  Among 17 902 patients, 624 (3.5%) experienced LLV50-199 and 482 (2.7%) LLV200-499. Median follow-up was 2.3 and 3.1 years for virological and clinical outcomes, respectively. There were 1903 virological failure, 532 AIDS events and 480 deaths. LLV200-499 was strongly associated with virological failure [adjusted hazard ratio (aHR) 3.97, 95% confidence interval (CI) 3.05-5.17]. LLV50-199 was weakly associated with virological failure (aHR 1.38, 95% CI 0.96-2.00). LLV50-199 and LLV200-499 were not associated with AIDS event/death (aHR 1.13, 95% CI 0.81-1.68; and aHR 0.95, 95% CI 0.62-1.48, [corrected] respectively).
  
  
  CONCLUSIONS
  LLV200-499 was strongly associated with virological failure, but not with AIDS event/death. Our results support the US guidelines, which define virological failure as a confirmed viral load above 200  copies/ml.
authors: Marie-Anne
authors: MA
authors: Vandenhende
authors: Suzanne
authors: S
authors: Ingle
authors: Margaret
authors: M
authors: May
authors: Geneviève
authors: G
authors: Chene
authors: Robert
authors: R
authors: Zangerle
authors: Ard
authors: A
authors: Van Sighem
authors: M John
authors: MJ
authors: Gill
authors: Carolynne
authors: C
authors: Schwarze-Zander
authors: Beatriz
authors: B
authors: Hernandez-Novoa
authors: Niels
authors: N
authors: Obel
authors: Ole
authors: O
authors: Kirk
authors: Sophie
authors: S
authors: Abgrall
authors: Jodie
authors: J
authors: Guest
authors: Hasina
authors: H
authors: Samji
authors: Antonella
authors: A
authors: D'Arminio Monforte
authors: Josep M
authors: JM
authors: Llibre
authors: Colette
authors: C
authors: Smith
authors: Matthias
authors: M
authors: Cavassini
authors: Greer A
authors: GA
authors: Burkholder
authors: Bryan
authors: B
authors: Shepherd
authors: Heidi M
authors: HM
authors: Crane
authors: Jonathan
authors: J
authors: Sterne
authors: Philippe
authors: P
authors: Morlat
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods; D005060:Europe; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000821:virology*; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009656:North America; D011379:Prognosis; D016019:Survival Analysis; D016896:Treatment Outcome; D019562:Viral Load; D014766:Viremia
chemical_list: D044966:Anti-Retroviral Agents