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From: JuLev@...
To: bobine@..., PoWeRTX@..., atac-drugdev@yahoogroups.com
CC: pozhealth@yahoogroups.com
Sent: 1/22/2008 7:19:37 A.M. Central Standard Time
Subj: [ATAC-DrugDev] Re: Intelence Interactions??

 

Concomitant use of INTELENCEâ„¢ with atazanavir/ritonavir may cause a significant decrease in atazanavir Cmin by about 38% and loss of therapeutic effect of atazanavir. In addition, the mean systemic exposure (AUC) of etravirine after co-administration of INTELENCEâ„¢ with atazanavir/ritonavir is anticipated to be about 100% higher than the mean systemic exposure of etravirine observed in the Phase 3 trials. INTELENCEâ„¢ and atazanavir/ritonavir should not be co-administered.

INTELENCEâ„¢ and fosamprenavir/ritonavir should not be co-administered.

INTELENCEâ„¢ and tipranavir/ritonavir should not be coadministered.

The mean systemic exposure (AUC) of etravirine after coadministration of INTELENCEâ„¢ with lopinavir/ritonavir is anticipated to be about 85% higher than the mean systemic exposure of etravirine observed in the Phase 3 trials. The amount of safety data at these increased etravirine exposures is limited, therefore, INTELENCEâ„¢ and lopinavir/ritonavir should be coadministered with caution.

The mean systemic exposure (AUC) of etravirine was reduced by about 37% when INTELENCEâ„¢ was co-administered with darunavir/ritonavir. Because all subjects in the Phase 3 trials received darunavir/ritonavir as part of the background regimen and etravirine exposures from these trials were determined to be safe and effective, INTELENCEâ„¢ and darunavir/ritonavir can be coadministered without any dose adjustments.

The mean systemic exposure (AUC) of etravirine was reduced by about 33% when INTELENCEâ„¢ was co-administered with saquinavir/ritonavir. Because the reduction in the mean systemic exposures of etravirine in the presence of saquinavir/ritonavir is similar to the reduction in mean systemic exposures of etravirine in the presence of darunavir/ritonavir, INTELENCEâ„¢ and saquinavir/ritonavir can be co administered without any dose adjustments.

HIV-Antiviral Agents: Protease Inhibitors (PIs)-Unboosted (i.e., without co-administration of low-dose  ritonavir)

Table 6: Drug Interactions: Pharmacokinetic Parameters for Etravirine in the Presence of Co-administered Drugs

Table 7: Drug Interactions: Pharmacokinetic Parameters for Co-administered Drugs in the Presence of INTELENCEâ„¢



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