| Autor: |
Smith KY; 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, Garcia F, Kumar P, Currier JS, Ryan R, Falcon R, Mrus J, Squires K |
| Jazyk: |
angličtina |
| Zdroj: |
Journal of the National Medical Association [J Natl Med Assoc] 2012 Jul-Aug; Vol. 104 (7-8), pp. 366-76. |
| DOI: |
10.1016/s0027-9684(15)30179-6 |
| Abstrakt: |
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. |
| Databáze: |
MEDLINE |
| Externí odkaz: |
|
