title: Effectiveness and pitfalls of initial highly active antiretroviral therapy in HIV-infected patients in routine clinical practice.
abstract: OBJECTIVE
  To assess the long-term effectiveness of and factors associated with response to protease inhibitors (PIs) in a cohort of treatment-naive HIV-infected patients.
  
  
  METHODS
  Prospective study in a tertiary care centre.
  
  
  METHODS
  A total of 207 treatment-naive patients starting PIs from March 1996 to May 1998.
  
  
  METHODS
  Clinical, virological and immunological outcomes, and adherence to therapy after 12 months.
  
  
  RESULTS
  Baseline median CD4 cell count and viral load were 160 cells/mm3 and 5 log10 copies/ml, respectively. After 48 weeks, 168 patients (81%) reached plasma HIV-RNA levels below 400 copies/ml, and the mean increase in CD4 cell count was 196 cells/mm3. Clinical events were observed in 29 patients (14%) after a median time of 100 days on therapy, yet mortality was extremely low (0.9%). By multivariate analysis, adherence over 90% [relative risk (RR), 16.66; 95% confidence interval (CI), 5.26-50; P=0.00001] and AIDS diagnosis at baseline (RR 0.35; 95% CI, 0.14-0.90; P=0.02) were the strongest predictors for virological suppression. An immunological recovery over 100 cells/mm3 was significantly associated with an initial virological response (RR 2.94; 95% CI, 1.31-6.66; P=0.009) and adherence over 90% (RR 3.44; 95% CI, 1.61-7.69; P=0.005). There were high rates of change with the first PI (40%), mostly due to adverse events (51%), but it did not compromise long-term effectiveness.
  
  
  CONCLUSIONS
  Initial PI treatment in the clinical setting is able to reach equally good outcomes as those found in controlled trials. Changes in therapy due to toxicity do not compromise a successful outcome, which clearly depends on an adequate adherence to therapy.
authors.affiliation: Infectious Diseases Service, Ramón y Cajal Hospital, Madrid, Spain. amoreno@hrc.insalud.es
authors.forename: A
authors.initials: A
authors.lastname: Moreno
authors.forename: M J
authors.initials: MJ
authors.lastname: Perez-Elías
authors.forename: J L
authors.initials: JL
authors.lastname: Casado
authors.forename: V
authors.initials: V
authors.lastname: Muñoz
authors.forename: A
authors.initials: A
authors.lastname: Antela
authors.forename: F
authors.initials: F
authors.lastname: Dronda
authors.forename: E
authors.initials: E
authors.lastname: Navas
authors.forename: J
authors.initials: J
authors.lastname: Fortún
authors.forename: C
authors.initials: C
authors.lastname: Quereda
authors.forename: S
authors.initials: S
authors.lastname: Moreno
mesh_terms: D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000502:physiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011446:Prospective Studies; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D018894:Reverse Transcriptase Inhibitors