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AIDS Research and Treatment
Volume 2015, Article ID 938628, 11 pages
http://dx.doi.org/10.1155/2015/938628
Clinical Study

Pharmacokinetics of Etravirine Combined with Atazanavir/Ritonavir and a Nucleoside Reverse Transcriptase Inhibitor in Antiretroviral Treatment-Experienced, HIV-1-Infected Patients

1Desmond Tutu HIV Foundation, UCT Medical School, P.O. Box 13801, Mowbray, Cape Town 7705, South Africa
2Private Practice, 3535 San Dimas Street, Suite 24, Bakersfield, CA 93301, USA
3Parexel International, University of the Free State, Campus Avenue South, Bloemfontein, Free State 9301, South Africa
4Janssen Research & Development LLC, 1125 Trenton-Harbourton Road, Titusville, NJ 08560-0200, USA
5Janssen Infectious Diseases BVBA, Turnhoutseweg 30, 2340 Beerse, Belgium

Received 11 September 2014; Revised 26 November 2014; Accepted 9 December 2014

Academic Editor: Andrea Mangano

Copyright © 2015 Catherine Orrell et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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 ( each group) over 48 weeks. Results. At steady-state etravirine with atazanavir/ritonavir 300/100 mg qd or 400/100 mg qd decreased atazanavir by 18% and 9%, respectively, with no change in or versus atazanavir/ritonavir 300/100 mg qd alone (Day −1). Etravirine 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.