title: Assessing darunavir/ritonavir-based therapy in a racially diverse population: 48-week outcomes from GRACE.
abstract: The Gender, Race, and Clinical Experience (GRACE) study was designed to assess sex-based differences in darunavir/ ritonavir-based therapy and to enroll a female population representative of the racial demographics of women with human immunodeficiency virus (HIV)/AIDS in the United States. Here, we report week 48 results, stratified by race. GRACE was a multicenter, open-label, phase 3b study. Patients received 600 mg of darunavir and 100 mg of ritonavir twice daily plus an investigator-selected optimized background regimen. Virologic response (HIV-1 RNA < 50 copies/ mL) and safety were assessed over 48 weeks. Post hoc multivariate analyses were performed to investigate factors associated with response. Of 429 patients enrolled, 61.5% were black, 22.4% were Hispanic, and 15.2% were white. Black patients had more advanced disease at baseline, and more black patients discontinued (32.6%) than Hispanic (24%) or white (26.2%) patients. In the intent-to-treat population, similar response rates were seen in Hispanic (61.5%) and white patients (60.0%); lower response rates were observed in black patients (48.5%). Similar trends were observed in the nonvirologic failure censored population. The multivariate analysis revealed that being of a nonblack race was significantly associated with improved response (P = .009). Overall, darunavir/ritonavir-based therapy was well tolerated, regardless of race. Diarrhea, nausea, and rash were the most commonly reported grade 2 to 4 adverse events (at least possibly related to darunavir/ritonavir). Darunavir/ritonavir treatment is safe and effective in treatment-experienced patients, irrespective of sex or race. Despite the controlled trial environment, more black patients discontinued and experienced virologic failure than Hispanic or white patients.
authors.affiliation: Rush University Medical Center, Department of Medicine, Section of Infectious Diseases, 600 S. Pauline, Suite 143 acfac, Chicago, IL 60612, USA. kimberly_y_smith@rush.edu
authors.forename: Kimberly Y
authors.initials: KY
authors.lastname: Smith
authors.forename: Fernando
authors.initials: F
authors.lastname: Garcia
authors.forename: Princy
authors.initials: P
authors.lastname: Kumar
authors.forename: Judith S
authors.initials: JS
authors.lastname: Currier
authors.forename: Robert
authors.initials: R
authors.lastname: Ryan
authors.forename: Ron
authors.initials: R
authors.lastname: Falcon
authors.forename: Joseph
authors.initials: J
authors.lastname: Mrus
authors.forename: Kathleen
authors.initials: K
authors.lastname: Squires
mesh_terms: D000328:Adult; D002170:Canada; D000069454:Darunavir; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000208:ethnology*; D017320:HIV Protease Inhibitors / Q000627:therapeutic use*; D015497:HIV-1; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011647:Puerto Rico; D019438:Ritonavir / Q000627:therapeutic use*; D013449:Sulfonamides / Q000627:therapeutic use*; D016896:Treatment Outcome; D014481:United States
chemical_list: D017320:HIV Protease Inhibitors; D013449:Sulfonamides; D019438:Ritonavir; D000069454:Darunavir