International AIDS Society


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 parameterTMC114/r 600/100mg bid (n=131)CPI
P-valueTMC114/r 600/100mg bid (n=110)CPI
Patients with HIV RNA >=1.0 log10 reduction (%)7021<0.0016115<0.001
Patients with HIV RNA <50 copies/mL (%)4512<0.0014610<=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
[Virological response rates]

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"