Pharmacokinetics and Pharmacodynamics of Darunavir and Etravirine in HIV-1–Infected, Treatment-Experienced Patients in the Gender, Race, and Clinical Experience (GRACE) Trial
Table 1
Baseline demographics and disease characteristics for the pharmacokinetic population (overall and etravirine populations).
Parameter
Overall
Etravirine subgroup
Sex, n (%)
Male
128 (34.0)
82 (43.2)
Female
248 (66.0)
108 (56.8)
Race, n (%)
Black
226 (60.1)
122 (64.2)
Hispanic
84 (22.3)
33 (17.4)
White
62 (16.5)
31 (16.3)
Asian/other
4 (1.1)
4 (2.1)
Median (range) age, years
43.0 (19.0, 78.0)
45.0 (19.0, 78.0)
Mean (SE) weight, kg
76.7 (1.03)
76.8 (1.50)
Mean (SE) BMI, kg/m2
27.0 (0.50)
Mean (SE) duration of HIV infection, years
12.5
Mean (SE) HIV-1 RNA, log10 copies/mL
4.64 (0.044)
4.60 (0.067)
Median (range) count, cells/mm3
203 (2, 1125)
186 (1, 1125)
CDC Class C, n (%)
148 (39.4)
87 (45.8)
Median (range) darunavir, fold chang
0.6 (0.3, 607.9)
Median (range) etravirine, fold chang
1.4 (0.3, 93.8)
Prior use of ≥2 PIs, n (%)
228 (60.6)
135 (71.1)
. cvirco®TYPE HIV-1 resistance analysis; patients were considered susceptible to darunavir if the fold change was <3.4 and to etravirine if the fold change was <3.2. ; 2 patients, one Hispanic and one white (both women), did not have resistance testing at baseline. SE: standard error; BMI: body mass index; CDC: United States Center for Disease Control and Prevention; PI: protease inhibitor.