title: High rate of virologic suppression with darunavir/ritonavir plus optimized background therapy among highly antiretroviral-experienced HIV-infected patients: results of a prospective cohort study in São Paulo, Brazil.
abstract: OBJECTIVE
  To assess the virologic and immunological response of darunavir/ritonavir plus optimized background therapy in highly antiretroviral-experienced HIV-infected patients in Brazil.
  
  
  METHODS
  Prospective cohort study carried out in a tertiary center in Sao Paulo, Brazil. Three-class antiretroviral-experienced patients with confirmed virologic failure began darunavir/ritonavir plus optimized background therapy (nucleoside/tide reverse transcriptase inhibitors ± raltegravir ± enfuvirtide ± maraviroc) after performing a genotypic resistance assay. Clinical evaluation and laboratory tests were collected at baseline and at weeks 12, 24, and 48. Multivariate analysis was performed to identify predictors of virologic response at 48 weeks.
  
  
  RESULTS
  Ninety-two patients were included. The median of darunavir resistant mutation was 1 (range 0-6). The median genotypic sensitivity score in the optimized background therapy was 2 (interquartile range 1-2). At week 48, 83% (95% CI: 75-90%) had an HIV RNA level <50 copies/mL and the median CD4 cell count was 301 (interquartile range 224-445) cells/mm(3). Baseline HIV RNA >100000 copies/mL was inversely associated with virologic success at week 48 (HR: 0.22, 95% CI: 0.06-0.85, p=0.028).
  
  
  CONCLUSIONS
  Darunavir/ritonavir plus optimized background therapy was a highly effective salvage regimen under clinical routine conditions in a referral center in Brazil, which is similar to the reported in high-income countries.
authors.affiliation: Department of Infectious Diseases, Medical School, Universidade de São Paulo, São Paulo, SP, Brazil. josevibe@gmail.com
authors.forename: José Ernesto
authors.initials: JE
authors.lastname: Vidal
authors.forename: Alice Tung Wan
authors.initials: AT
authors.lastname: Song
authors.forename: Maria Laura
authors.initials: ML
authors.lastname: Matos
authors.forename: Daniel
authors.initials: D
authors.lastname: Bartmann
authors.forename: Guilherme Dos
authors.initials: GD
authors.lastname: Anjos
authors.forename: Érique José Peixoto de
authors.initials: ÉJ
authors.lastname: Miranda
authors.forename: Ângela Carvalho
authors.initials: ÂC
authors.lastname: Freitas
authors.forename: Mirian de Freitas
authors.initials: Mde F
authors.lastname: Dalben
authors.forename: Claudinei
authors.initials: C
authors.lastname: Santana
authors.forename: Aluísio Cotrim
authors.initials: AC
authors.lastname: Segurado
authors.forename: Cláudia Cortese
authors.initials: CC
authors.lastname: Barreto
authors.forename: Adrián Vladimir
authors.initials: AV
authors.lastname: Hernández
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D001938:Brazil; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D000069454:Darunavir; D024882:Drug Resistance, Viral / Q000235:genetics*; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D005838:Genotype; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000187:drug effects / Q000235:genetics*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009154:Mutation / Q000235:genetics*; D011446:Prospective Studies; D019438:Ritonavir / Q000627:therapeutic use*; D013449:Sulfonamides / Q000627:therapeutic use*; D013997:Time Factors; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D013449:Sulfonamides; D019438:Ritonavir; D000069454:Darunavir