Clinical Study

Pharmacokinetics and Pharmacodynamics of Darunavir and Etravirine in HIV-1–Infected, Treatment-Experienced Patients in the Gender, Race, and Clinical Experience (GRACE) Trial

Table 2

Population pharmacokinetics at Week 48 (univariate analysis).

Darunavir Etravirine

Median (range)
Ng·h/mL

Median (range)
ng/mL

Median (range)
ng·h/mL

Median (range)
ng/mL

Overall population37660,642 (26,117–128,790)3624 (931–9570)1904183 (212–27,960)280 (4–2211)
Age, years
 ≤303958,309 (33,050–128,790)3317 (1145–9570)173476 (568–5261)212 (5–331)
 >30 to ≤5026059,955 (26,117–105,130)3584 (931–6841)1284348 (212–27,960)286 (4–2211)
 >50 to ≤656864,337 (40,299–120,880)3957 (2215–8906)384366 (295–11,684)291 (11–890)
 >65963,978 (38,171–84,295)3916 (1879–5869)77484 (2213–17,921)541 (126–1392)
Weight at baseline, kg
 ≤62.339461,005 (32,271–128,790)3665 (1169–9570)463675 (295–17,921)226 (11–1392)
 >62.33 to ≤73.949658,367 (29,888–93,408)3489 (931–6081)483824 (1004–20,495)250 (42–1605)
 >73.94 to ≤87.099263,942 (34,692–105,130)3903 (1568–6502)524960 (212–27,960)332 (4–2211)
 >87.099461,090 (26,117–100,710)3561 (1258–6943)444638 (1319–18,977)314 (60–1487)
Hepatitis B co-infection status
 No36260,831 (26,117–128,790)3618 (931–9570)1844141 (212–27,960)278 (4–2211)
 Yes1457,936 (37,506–97,125)3718 (1640–6784)65504 (3751–11,684)382 (241–890)
Use of TDF
 No5861,443 (38,104–109,410)3489 (1169–7473)455051 (295–17,921)329 (11–1392)
 Yes31860,601 (26,117–128,790)3627 (931–9570)1453998 (212–27,960)258 (4–2211)
Use of etravirine
 No18758,933 (26,117–128,790)3489 (1036–9570)NANANA
 Yes18962,626 (30,960–109,410)3806 (931–7473)NANANA

: area under the plasma concentration–time curve over 12 hours; : trough concentration; TDF: tenofovir disoproxil fumarate; NA: not applicable.