12th Annual Conference of the British HIV Association 29 March–1 April 2006, Brighton, UK

EFFICACY OF TMC-114/R IN TREATMENT-EXPERIENCED HIV PATIENTS: FACTORS INFLUENCING OUTCOME IN THE POOLED 24-WEEK ANALYSIS OF POWER 1, 2 AND 3

HIV Med 2006; 7(Suppl. 1):11 (abstract no. P3)

Anton Pozniak¹, Michael Saag², Nick Bellos³, Philippe Chiliade⁴, Beatriz Grinsztein⁵, Jean-Michel Molina⁶, Christine Katlama⁷, Sandra De Meyer⁸, Tony Vangeneugden⁸, Eric Lefebvre⁹ and Andrew Hill^10
1 Chelsea and Westminster Hospital, London, UK, ² UAB Center for AIDS Research, Birmingham, AL, USA, ³Southwest Infectious Disease Associates, Dallas, TX, USA, ⁴ Whitman-Walker Clinic, Washington DC, USA, ⁵ Instituto de Pesquisa Clinica, Evandro Chagas-Fiocruz, Brazil, ⁶ Saint-Louis Hospital, Paris, France, ⁷ Hopital Pitie-Salpetriere, Paris, France, ⁸ Tibotec BVBA, Mechelen, Belgium, ⁹ Tibotec Inc., Yardley, PA, USA, ¹⁰ University of Liverpool, Liverpool, UK

AIMS: Data from the randomised, PI-controlled POWER 1 and 2 studies (TMC-114–C213 and C202) and the open-label roll-over study, POWER 3 (TMC-114–C215), were pooled to examine factors contributing to the efficacy of TMC-114 with low-dose ritonavir (TMC-114/r) in treatment-experienced HIV patients.

METHODS: Patients randomised to receive TMC-114/r 600/100 mg bid (n=458) or control PI(s) (CPI, n=124) were included in this analysis. Regimens were optimised using ≥2NRTIs with or without enfuvirtide (ENF). Week 24 efficacy data were analysed by baseline (BL) viral load (VL), TMC-114 EC₅₀ fold change (FC), concomitant and previous ENF use, number of IAS-USA primary PI mutations, and number of sensitive NRTIs and CPI(s).

RESULTS: Overall, BL mean VL was 4.6 log₁₀ copies/ml, median CD4 count was 128 cells/µl and 73% had ≥3 primary PI mutations. Overall BL median TMC-114 FC was 3.5, 4.9 and 3.2 for POWER 1, 2 and 3, respectively. HIV RNA <50 copies/ml was reached by 42% of TMC-114/r patients, 24% with a susceptible CPI, and 7% with a resistant CPI. Multivariate analyses showed that BL FC, number of sensitive NRTIs and concomitant use of ENF correlated with response. Subgroup analysis showed BL FC was highly predictive of virological outcome: 50, 25 and 13% of TMC-114/r patients with BL FC ≤10, 10 < FC ≤40 and FC >40 respectively reached HIV RNA <50 copies/ml. All subgroup analyses showed a higher proportion of responders in the TMC-114/r group compared to control, regardless of concomitant ENF use.

CONCLUSION: TMC-114 FC was the strongest predictor of regimen efficacy. The magnitude of the incremental benefit for all other factors was determined by BL TMC-114 susceptibility. TMC-114/r 600/100 mg bid was uniformly superior to CPI, regardless of CPI predicted activity.

2006-03-29
P3

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