title: Efficacy and safety of once-daily maraviroc plus ritonavir-boosted darunavir in pretreated HIV-infected patients in a real-life setting.
abstract: OBJECTIVE
  Nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens may be needed in patients with NRTI toxicity. Maraviroc (MVC) plus ritonavir-boosted darunavir (DRV-r) or atazanavir is associated with slightly lower response rates than triple therapy in drug-naïve patients. No information is available on these combinations in pretreated patients. The aim of this study was to assess the efficacy and safety of MVC plus DRV/r once-daily (qd) in HIV-infected pretreated patients.
  
  
  METHODS
  A retrospective cohort study including patients starting MVC 150 mg plus DRV/r 800/100 mg qd, with CCR5 tropism and no resistance mutations for DRV/r, was performed. The primary efficacy endpoint was the achievement of plasma HIV RNA < 50 HIV-1 RNA copies/mL after 48 weeks. The frequency of serious adverse effects was investigated.
  
  
  RESULTS
  Sixty patients were recruited to the study, of whom 48 (80%) had HIV RNA < 50 copies/mL at baseline. Reasons for starting MVC plus DRV/r were: adverse effects in 38 individuals (63%), simplification in 15 (25%) and virological failure in seven (12%). The main analysis (intention to treat, noncompleter = failure) showed that 47 patients (78%) achieved HIV RNA < 50 copies/mL at 48 weeks (paired comparison with baseline, P = 1.0). On-treatment analysis showed that 42 (86%) of 49 patients presented HIV RNA < 50 copies/mL at 48 weeks (paired comparison with baseline, P = 1.0). Median (interquartile range) CD4 cell counts increased from 491 (301-729) to 561 (367-793) cells/μL at 48 weeks (P = 0.013). Only one patient discontinued therapy because of adverse effects.
  
  
  CONCLUSIONS
  Most individuals starting MVC plus DRV/r qd because of simplification or adverse effects maintained HIV suppression after 48 weeks of follow-up.
authors.affiliation: Unit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Seville, Spain; Instituto de Biomedicina de Sevilla (IBiS), Seville, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Macías
authors.forename: E
authors.initials: E
authors.lastname: Recio
authors.forename: M
authors.initials: M
authors.lastname: Márquez
authors.forename: C
authors.initials: C
authors.lastname: García
authors.forename: P
authors.initials: P
authors.lastname: Jiménez
authors.forename: D
authors.initials: D
authors.lastname: Merino
authors.forename: L
authors.initials: L
authors.lastname: Muñoz
authors.forename: J
authors.initials: J
authors.lastname: Pasquau
authors.forename: G
authors.initials: G
authors.lastname: Ojeda
authors.forename: P
authors.initials: P
authors.lastname: Bancalero
authors.forename: N
authors.initials: N
authors.lastname: Chueca
authors.forename: J A
authors.initials: JA
authors.lastname: Pineda
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D065100:CCR5 Receptor Antagonists / Q000008:administration & dosage*; D003510:Cyclohexanes / Q000008:administration & dosage*; D000069454:Darunavir; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D023581:HIV Fusion Inhibitors / Q000008:administration & dosage*; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D017320:HIV Protease Inhibitors / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D000077592:Maraviroc; D008875:Middle Aged; D012367:RNA, Viral / Q000032:analysis; D012189:Retrospective Studies; D019438:Ritonavir / Q000008:administration & dosage; D013449:Sulfonamides / Q000008:administration & dosage; D014230:Triazoles / Q000008:administration & dosage*
chemical_list: D019380:Anti-HIV Agents; D065100:CCR5 Receptor Antagonists; D003510:Cyclohexanes; D023581:HIV Fusion Inhibitors; D017320:HIV Protease Inhibitors; D012367:RNA, Viral; D013449:Sulfonamides; D014230:Triazoles; D000077592:Maraviroc; D019438:Ritonavir; D000069454:Darunavir
keywords: CCR5 tropism; HIV; darunavir; maraviroc