title: Effect of baseline characteristics on the efficacy and safety of once-daily darunavir/ ritonavir in HIV-1-infected, treatment-naïve ARTEMIS patients at week 96.
abstract: OBJECTIVE
  ARTEMIS demonstrated significantly greater efficacy of once-daily darunavir/ritonavir (DRV/r) 800/100 mg versus lopinavir/ritonavir 800/200 mg (total daily dose) in treatment-naïve, HIV-1-infected patients at week 96. The influence of baseline characteristics on efficacy and safety was analyzed in DRV/r patients.
  
  
  METHODS
  Patients received once-daily DRV/r plus fixed-dose tenofovir/emtricitabine. Week 96 efficacy and safety data were analyzed by gender (males, n=239; females, n=104), age (≤30, n=115; 31-45, n=175; >45, n=53), race (Asian, n=44; Black, n=80; Caucasian/White, n=137; Hispanic, n=77), and hepatitis B and/or C virus coinfection (n=43).
  
  
  RESULTS
  Week 96 virologic response rates (HIV-1 RNA<50 copies/mL) were as follows: gender: 79% for both males and females; age: 72% (≤30), 81% (31-45), and 89% (>45); race: 96% (Asian), 71% (Black), 77% (Caucasian/White), and 79% (Hispanic); coinfection status: 72% (coinfected) and 80% (non-coinfected). The incidence of treatment-related adverse drug reactions (ADRs) and laboratory abnormalities were comparable across gender, age, and race subgroups. Coinfected patients had a higher incidence of liver-related ADRs than non-coinfected patients.
  
  
  CONCLUSIONS
  DRV/r 800/100 mg qd is an effective, well-tolerated treatment option for treatment-naïve patients of different gender, age, race, or coinfection status.
authors.affiliation: plankies@trustnet.co.za
authors.forename: Jan
authors.initials: J
authors.lastname: Fourie
authors.forename: Jason
authors.initials: J
authors.lastname: Flamm
authors.forename: Amalia
authors.initials: A
authors.lastname: Rodriguez-French
authors.forename: Don
authors.initials: D
authors.lastname: Kilby
authors.forename: Pere
authors.initials: P
authors.lastname: Domingo
authors.forename: Adriano
authors.initials: A
authors.lastname: Lazzarin
authors.forename: Juan
authors.initials: J
authors.lastname: Ballesteros
authors.forename: Nestor
authors.initials: N
authors.lastname: Sosa
authors.forename: Tom
authors.initials: T
authors.lastname: Van De Casteele
authors.forename: Ralph
authors.initials: R
authors.lastname: DeMasi
authors.forename: Sabrina
authors.initials: S
authors.lastname: Spinosa-Guzman
authors.forename: Ludo
authors.initials: L
authors.lastname: Lavreys
mesh_terms: D000328:Adult; D000375:Aging; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069454:Darunavir; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D015497:HIV-1 / Q000187:drug effects*; D006509:Hepatitis B / Q000150:complications; D006526:Hepatitis C / Q000150:complications; D006801:Humans; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D044469:Racial Groups; D019438:Ritonavir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012727:Sex Characteristics; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D019380:Anti-HIV Agents; D012367:RNA, Viral; D013449:Sulfonamides; D019438:Ritonavir; D000069454:Darunavir