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There is promising data on this, but still early
Ocular drug delivery systems: an overview
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%
Indias regulatory framework runs through CDSCO, not the FDA
