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: Kimberly Y Smith, Fernando Garcia, Princy Kumar, Judith S Currier, Robert Ryan, Ron Falcon, Joseph Mrus, Kathleen Squires
• Journal: Journal of the National Medical Association (J Natl Med Assoc) 2012 Jul-Aug Vol. 104 Issue 7-8 Pg. 366-76 ISSN: 0027-9684 [Print] United States
• PMID: 23092052 (Publication Type: Clinical Trial, Phase III, Journal Article, Meta-Analysis, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• HIV Protease Inhibitors
• Sulfonamides
• Ritonavir
• Darunavir

Topics

• Adult
• Canada
• Darunavir
• Female
• HIV Infections (drug therapy, ethnology)
• HIV Protease Inhibitors (therapeutic use)
• HIV-1
• Humans
• Male
• Middle Aged
• Multivariate Analysis
• Puerto Rico
• Ritonavir (therapeutic use)
• Sulfonamides (therapeutic use)
• Treatment Outcome
• United States