AEGiS-Glasgow [PL2.2] Susceptibility of a protease inhibitor (PI) treatment-experienced UK clinical cohort to TMC-114

Eighth International Congress on Drug Therapy in HIV Infection

Glasgow, UK - 12-16 November 2006

[PL2.2] Susceptibility of a protease inhibitor (PI) treatment-experienced UK clinical cohort to TMC-114

Int Cong Drug Therapy HIV 2006 Nov 12-16;8:Abstract No. PL2.2

C Loveday, E MacRae, on behalf of the ICVC Clinical Collaborative Research Group
ICVC Charitable Trust, Buckinghamshire, UK

PURPOSE OF THE STUDY: The new PI TMC-114 has approval for use in the USA and is likely in the EU later this year. TMC-114 is expected to be effective for many patients with extensive PI-treatment experience. The aim of this study was to determine the susceptibility of a UK PI treatment-experienced clinical cohort to TMC-114.

METHODS: PI-experienced patients who had genotypic resistance tests performed at failure of their current regimen as part of their clinical care were included (1996-2006). Mutations were derived from the Power 1, 2 and 3 trials including PR: V11I, V32I, L33F, I47V, I50V, I54L, I54M, G73S, L76V, I84V, L89V (bold=high impact mutations (HI) developed in ≥10% virologic failures). Statistical analyses were performed using SPSS (v14).

SUMMARY OF RESULTS: 885 patients were included: 532 (60.2%) currently failing with PI containing regimens; 188 (21.2%) on non-PI treatment but with PI experience; 165 (18.6%) off treatment, but with PI experience.

104 (19.5%) patients currently on PI treatment presented with TMC-114 related mutations including: V32I=15, L33F=23, I47V=13, I50V=6, I54L=10, I54M=1, G73S=23, I84V=49. 83 patients had one related mutation (of which, 22 were HI), 11 had two (13 HI), 6 had three (12 HI), 2 had four (32+47+54L+84) and 2 had five (32+33+47+54L+84).

8 patients on non-PI treatment had L33F=1, I54L=1, G73S=1, I84V=5 (no patient had >1 mutation); 14 patients off treatment had: V32I=3, L33F=7, I54L=1, G73S=4, I84V=9 (7 with one mutation (3 HI), 4 with two (3 HI), 3 with three (5 HI)).

CONCLUSIONS: In this PI treatment-experienced clinical cohort, the majority had very low frequency of TMC-114 related mutations. Only 10 patients had ≥10 PR mutations with 2 patients including 4 HI mutations. Based on these data TMC-114 should be of benefit to PI treatment-experienced patients in a UK clinical cohort.

Plenary Session: Open Papers

2006-11-12
PL2.2

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