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These changes are unlikely to be clinically significant as all subjects had etravirine concentrations well above the median protein binding adjusted EC50 of 4 ng/mL (concentration to inhibit 50% of viral replication in vitro).15 Moreover, the reductions in etravirine concentration are comparable to those seen in clinical trials when etravirine was coadministered with darunavir/ritonavir.16 High rates of efficacy were described when etravirine 200 mg twice daily and darunavir/ritonavir were coadministered in patients with extensive resistance, despite a 30% decrease in etravirine pharmacokinetic parameters (compared with historical controls).17 In recent large randomized trials, twice-daily etravirine resulted in additional antiviral effect versus placebo despite the concomitant administration of a boosted protease inhibitor.18,19 Furthermore, in a pooled analysis of these trials, no association between etravirine pharmacokinetics and 48-week efficacy (viral load 90%

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86 WongM.-L.LicinioJ

GH release begins within 10 minutes of administration, peaks at 30-40 minutes, and returns to baseline by approximately 3 hours producing a single, clean GH pulse per dose

& Keung, W