In Vitro Cross-Resistance Profile, Antiviral Activity, Safety and Pharmacokinetics in HIV-1 Infected Subjects of IDX899, a Novel HIV-1 NNRTI with High Barrier to Resistance
Reported by Jules Levin
17th Intl HIV Drug Resistance Workshop
June 12, 2008
Sitges, Spain
AUTHOR CONCLUSIONS
IDX899 was generally safe & well tolerated in HIV-1 infected subjects.
IDX899 demonstrated potent antiviral activity, 1.8 log10 using Roche COBAS Amplicor 1.5 assay, at all tested doses.
No clear PK/PD relationship was demonstrated, likely due to drug trough levels well above the EC50 of IDX899 against wild-type viruses.
The Roche Taqman HIV RNA assay frequently underestimated viral load and viral load reduction compared to the Roche Amplicor 1.5 assay.
Protocol was amended to add a 100 mg cohort which has been initiated.
