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Skip Navigation LinksHome > February 19, 2007 - Volume 21 - Issue 4 > Efficacy and safety of TMC114/ritonavir in treatment-experie...
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AIDS:
doi: 10.1097/QAD.0b013e328013d9d7
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Efficacy and safety of TMC114/ritonavir in treatment-experienced HIV patients: 24-week results of POWER 1

Katlama, Christinea; Esposito, Robertob; Gatell, Jose Mc; Goffard, Jean-Christophed; Grinsztejn, Beatrize; Pozniak, Antonf; Rockstroh, Jurgeng; Stoehr, Albrechth; Vetter, Norberti; Yeni, Patrickj; Parys, Wimk; Vangeneugden, Tonyk; on behalf of the POWER 1 study group

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Abstract

Background: The ongoing phase IIb POWER 1 (TMC114-C213) trial is designed to assess efficacy and safety of the protease inhibitor (PI) TMC114 (darunavir) in treatment-experienced HIV-1-infected patients.

Design: This randomized, partially blinded, 24-week dose-finding study compared efficacy and safety of four doses of TMC114 plus low-dose ritonavir (TMC114/r) with investigator-selected control PI(s) (CPI[s]).

Methods: Patients with one or more primary PI mutation and HIV RNA > 1000 copies/ml received optimized background therapy, plus TMC114/r 400/100 mg once daily, 800/100 mg once daily, 400/100 mg twice daily or 600/100 mg twice daily, or CPI(s). The primary endpoint (intent-to-treat) compared proportions of patients achieving viral load reduction ≥ 1.0 log10 copies/ml from baseline.

Results: In total, 318 patients were treated. Baseline mean viral load was 4.48 log10 copies/ml; median CD4 cell count was 179 cells/μl. In the CPI arm 62% of patients discontinued (virological failure: 54%); 10% of TMC114/r patients discontinued. More TMC114/r (69–77%) than CPI patients (25%) reached the primary endpoint (P < 0.001); 43–53% of TMC114/r patients and 18% of the CPI arm achieved viral load < 50 copies/ml (P < 0.001). TMC114/r demonstrated greater mean CD4 cell count increases versus CPI(s) (68–124 versus 20 cells/μl; P < 0.05). TMC114/r 600/100 mg twice daily demonstrated the highest virological and immunological responses. Adverse event incidence was similar between treatments; headache and diarrhoea were more common with CPI(s).

Conclusions: TMC114/r demonstrated statistically higher 24-week virological response rates and CD4 cell count increases than CPI(s). TMC114/r 600/100 mg twice daily has received regulatory approval in treatment-experienced patients.

© 2007 Lippincott Williams & Wilkins, Inc.

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