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No Darunavir & Kaletra Major PI Mutations in ARTEMIS 96 Weeks
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Reported by Jules Levin
7th European HIV Drug Resistance Workshop, Stockholm, Sweden March 25-27 2009
Two VFs in the DRV/r group developed a NRTI RAM:M184V and M184I/V (FTC RAMs). The development of M184V and M184I/V was associated with a decreased susceptibility to FTC included in the background regimen (Tables 1 and 2).
Five VFs in the LPV/r group developed a NRTI RAM: K70E (TDF RAM), M184I and M184V (n=3). Development of the FTC RAMs M184I and M184V mutation was associated with decreased susceptibility to FTC included in the background regimen (Tables 1 and 3).
No VFs developed the K65R mutation and no phenotypic resistance to TDF was noted.
Adherence to the trial medication was analysed using two methods
- according to the pharmacokinetic sampling, 20.0% of the DRV/r VFs were suboptimally adherent as compared with 3.7% in the DRV/r arm, excluding the VFs. Similarly, 32.2% of\ the LPV/r VFs were suboptimally adherent as compared with 8.6% in the LPV/r arm, excluding the VFs
- according to the M-MASRI, 23.7% of the DRV/r VFs were suboptimally adherent as compared with 17.1% in the DRV/r arm, excluding the VFs. However, 39.7% of the LPV/r VFs were suboptimally adherent as compared with 20.5% in the LPV/r arm, excluding the VFs.
Transmitted drug resistance was rarely observed. At baseline and/or screening, only one DRV/r VF harboured PI-resistant mutations (I84V and L90M), and one DRV/r VFs and one LPV/r VF harboured NRTI-resistant mutations (M41L, L210W, and T215D/S/Y and T69D, respectively) according to the list of transmitted drug-resistant mutations proposed by Shafer, et al.13 In the
DRV/r treatment arm, excluding VFs, eight patients harboured PI-resistant mutations (D30N, M46I, I54V/L, V82A, I84V, N88D, L90M) and 14 harboured NRTI-resistant mutations (M41L, D67G, T69D, L74V, Y115F, Q151M, M184V, L210W, T215C/D/E/S/V, K219E/Q). In the LPV/r treatment arm, excluding VFs, two patients harboured PI-resistant mutations (D30N, M46I, N88D) and nine harboured NRTI-resistant mutations (M41L, L210W, T215C/D/S), according to
the list of transmitted drug-resistant mutations proposed by Shafer, et al.13
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