title: Association between first-year virological response to raltegravir and long-term outcomes in treatment-experienced patients with HIV-1 infection.
abstract: BACKGROUND
  We explored the relationship between virological response in the first year of treatment and long-term outcomes in the BENCHMRK studies.
  
  
  METHODS
  Patients failing antiretroviral treatment with 3-class resistant HIV-1 received double-blinded raltegravir (or placebo) with optimized background therapy (OBT) until week 156, followed by open-label raltegravir with OBT up to week 240. In this exploratory analysis of patients randomized to raltegravir, virological response over weeks 16-48 was categorized as continuous suppression (CS; viral RNA [vRNA] always <50 copies/ml), low-level viraemia (LLV; vRNA always <400 copies/ml, >50 copies/ml at least once), or not suppressed (NS; vRNA >400 copies/ml at least once). The association between these first-year vRNA response categories and baseline factors was analysed with univariate and multivariate models. Virological and immunological outcomes for years 2-5 were assessed by first-year vRNA response category (observed failure approach).
  
  
  RESULTS
  Baseline vRNA, baseline CD4(+) T-cell count and rapid viral decay (vRNA <50 copies/ml between weeks 2-12) correlated with first-year vRNA response (P<0.001); only rapid viral decay remained significant by multiple regression. Virological response rates were similar in the LLV and CS groups and lowest in the NS group. CD4(+) T-cell count increased through week 240 in the CS and LLV groups. Time to loss of virological response (confirmed vRNA ≥400 copies/ml) through week 240 did not support as strong a difference between the LLV and CS groups (log-rank P=0.11) as previously reported through weeks 156 and 192 (P<0.05).
  
  
  CONCLUSIONS
  Treatment-experienced patients on a raltegravir-based regimen with early LLV may have long-term virological and immunological benefit when their therapy is maintained.
authors.affiliation: University of North Carolina, Chapel Hill, NC, USA.
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: Eron
authors.forename: David A
authors.initials: DA
authors.lastname: Cooper
authors.forename: Roy T
authors.initials: RT
authors.lastname: Steigbigel
authors.forename: Bonaventura
authors.initials: B
authors.lastname: Clotet
authors.forename: Patrick
authors.initials: P
authors.lastname: Yeni
authors.forename: Kim M
authors.initials: KM
authors.lastname: Strohmaier
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Rodgers
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Barnard
authors.forename: Bach-Yen T
authors.initials: BY
authors.lastname: Nguyen
authors.forename: Hedy
authors.initials: H
authors.lastname: Teppler
mesh_terms: D019380:Anti-HIV Agents / Q000494:pharmacology / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D016516:CD4-CD8 Ratio; D005260:Female; D005838:Genotype; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology*; D015497:HIV-1 / Q000187:drug effects / Q000235:genetics*; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D000068898:Raltegravir Potassium / Q000494:pharmacology / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D000068898:Raltegravir Potassium