Clinical Study

Pharmacokinetics of Etravirine Combined with Atazanavir/Ritonavir and a Nucleoside Reverse Transcriptase Inhibitor in Antiretroviral Treatment-Experienced, HIV-1-Infected Patients

Table 3

Pharmacokinetic parameters and statistical analysis of etravirine after administration of etravirine 200 mg bid for two weeks in combination with atazanavir/ritonavir 300/100 mg qd or 400/100 mg qd and one NRTI and from the pooled DUET pharmacokinetic substudies at Week 4 [21].

Pharmacokinetics of ETR mean ± SD; : median (range)Pooled DUET [21]: ETR 200 mg bid + DRV/r 600/100 mg bid, Week 4
(reference)
()
ATV/r 300/100 mg qd
+ one NRTI + ETR 200 mg bid, Week 2 (Test 1)
(*)
ATV/r 400/100 mg qd
+ one NRTI + ETR 200 mg bid, Week 2 (Test 2)
()

, ng/mL545.0 ± 818.6422.2 ± 327.9316.6 ± 215.4
, ng/mL452.6 ± 806.0425.1 ± 328.1286.5 ± 198.0
, ng/mL879.6 ± 1030773.0 ± 360.5 628.7 ± 294.0
, h3.95 (0.08–6.08) 4.00 (3.00–9.00) 4.00 (2.00–6.07)
, ng⋅h/mL7964 ± 111807629 ± 4213 5171 ± 2695

LSM ratio (90% CI) of test versus reference

Test 1 versus referenceTest 2 versus reference

1.07 (0.60–1.90)0.83 (0.54–1.29)
1.06 (0.78–1.46)0.87 (0.65–1.18)
1.24 (0.88–1.76)0.84 (0.60–1.18)

ATV/r: atazanavir/ritonavir; : area under the plasma concentration-time curve from time 0 to 12 hours; bid: twice daily; CI: confidence interval; : maximum plasma concentration; : minimum plasma concentration; : predose plasma concentration; ETR: etravirine; LSM: least square mean; NRTI: nucleoside reverse transcriptase inhibitor; qd: once daily; SD: standard deviation; : time to maximum plasma concentration.
* for , for , for , for , and for and ; calculated based on log-transformed pharmacokinetic parameters.