title: Pharmacokinetics of Etravirine Combined with Atazanavir/Ritonavir and a Nucleoside Reverse Transcriptase Inhibitor in Antiretroviral Treatment-Experienced, HIV-1-Infected Patients.
abstract: Objectives. TEACH (NCT00896051) was a randomized, open-label, two-arm Phase II trial to investigate the pharmacokinetic interaction between etravirine and atazanavir/ritonavir and safety and efficacy in treatment-experienced, HIV-1-infected patients. Methods. After a two-week lead-in of two nucleoside reverse transcriptase inhibitors (NRTIs) and atazanavir/ritonavir 300/100 mg, 44 patients received etravirine 200 mg bid with one NRTI, plus atazanavir/ritonavir 300/100 mg or 400/100 mg qd (n = 22 each group) over 48 weeks. Results. At steady-state etravirine with atazanavir/ritonavir 300/100 mg qd or 400/100 mg qd decreased atazanavir C min⁡ by 18% and 9%, respectively, with no change in AUC24 h or C max⁡ versus atazanavir/ritonavir 300/100 mg qd alone (Day -1). Etravirine AUC12 h was 24% higher and 16% lower with atazanavir/ritonavir 300/100 or 400/100 mg qd, respectively, versus historical controls. At Week 48, no significant differences were seen between the atazanavir/ritonavir groups in discontinuations due to adverse events (9.1% each group) and other safety parameters, the proportion of patients with viral load <50 copies/mL (intent-to-treat population, noncompleter = failure) (50.0%, atazanavir/ritonavir 300/100 mg qd versus 45.5%, 400/100 mg qd), and virologic failures (31.8% versus 27.3%, resp.). Conclusions. Etravirine 200 mg bid can be combined with atazanavir/ritonavir 300/100 mg qd and an NRTI in HIV-1-infected, treatment-experienced patients without dose adjustment.
authors: Desmond Tutu HIV Foundation, UCT Medical School, P.O. Box 13801, Mowbray, Cape Town 7705, South Africa.
authors: Catherine
authors: C
authors: Orrell
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authors: Franco
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authors: Felizarta
authors: Parexel International, University of the Free State, Campus Avenue South, Bloemfontein, Free State 9301, South Africa.
authors: André
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authors: Nell
authors: Janssen Research & Development LLC, 1125 Trenton-Harbourton Road, Titusville, NJ 08560-0200, USA.
authors: Thomas N
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authors: Kakuda
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authors: Ludo
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authors: Lavreys
authors: Janssen Infectious Diseases BVBA, Turnhoutseweg 30, 2340 Beerse, Belgium.
authors: Steven
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authors: Nijs
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authors: Rodica
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authors: Van Solingen-Ristea
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authors: Frank L
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