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Abstract
TMC114 provides durable viral load suppression in treatment-experienced patients: POWER 1 and 2 combined week 48 analysis
A. Lazzarin1, F. Queiroz-Telles2, I. Frank3, J. Rockstroh4, S. Walmsley5, E. De Paepe6, T. Vangeneugden6, S. Spinosa-Guzman6, E. Lefebvre7
Background: In the POWER 1 (TMC114-C213) and 2 (TMC114-C202) 24-week primary analysis, TMC114 (darunavir) with low-dose ritonavir (TMC114/r) demonstrated better antiviral activity than control PIs (CPIs) in treatment-experienced patients. The highest dose (600/100mg bid) provided the greatest virologic response. The combined 48-week analysis of these trials assesses long-term efficacy and safety of TMC114/r 600/100mg bid versus CPIs.
Methods: In both trials, PI-, NRTI- and NNRTI-experienced patients with ³1 baseline primary PI mutation were randomized to receive an optimized background regimen plus one of four TMC114/r doses or boosted CPI. Virologic response and adverse events (AEs) in patients initially randomized to TMC114/r 600/100mg bid and CPIs were compared at Week 48 (ITT-TLOVR). The primary efficacy parameter was the proportion of patients with ³1 log10 viral load reduction.
Results: At the recommended dose for treatment-experienced patients, TMC114/r achieved significantly higher virologic response rates than CPIs at Week 48, similar to those observed at Week 24 (table).
| Pooled POWER 1 and 2 virologic response rates | | | Week 24 | Week 48 | | Efficacy parameter | TMC114/r 600/100mg bid (n=131) | CPI
(n=124)
| P-value | TMC114/r 600/100mg bid (n=110) | CPI
(n=120)
| P-value | | Patients with HIV RNA >=1.0 log10 reduction (%) | 70 | 21 | <0.001 | 61 | 15 | <0.001 | | Patients with HIV RNA <50 copies/mL (%) | 45 | 12 | <0.001 | 46 | 10 | <=0.003 | | Mean HIV RNA log10 reduction (copies/mL) | –1.89 | –0.48 | <0.001 | –1.63 | –0.35 | <0.001 | | Mean CD4 increase (cells/mm3) | 92 | 17 | <0.001 | 102 | 19 | <=0.005 |
The most commonly reported AEs during TMC114/r 600/100mg bid treatment were diarrhea (20%), nausea (18%), headache (15%), nasopharyngitis (14%) and fatigue (12%), reported in 28%, 13%, 20%, 11% and 17% of CPI patients, respectively. The majority of AEs were grade 1–2 in severity.
Conclusions: TMC114/r has demonstrated sustained efficacy in this treatment-experienced population. Its tolerability profile is similar to that of CPIs, with a lower incidence of diarrhea.
AIDS 2006 - XVI International AIDS Conference
Abstract no.
TUAB0104
Suggested Citation
"A.Lazzarin, et al.
TMC114 provides durable viral load suppression in treatment-experienced patients: POWER 1 and 2 combined week 48 analysis.
Oral abstract session:
AIDS 2006 - XVI International AIDS Conference:
Abstract no.
TUAB0104"
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