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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Impact of reverse transcriptase resistance on the efficacy of TMC125 (etravirine) with two nucleoside reverse transcriptase inhibitors in protease inhibitor-naïve, nonnucleoside reverse transcriptase inhibitor-experienced patients: Study TMC125-C227
HIV Medicine, Volume 9, No. 10, Year 2008
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Description
Objectives: TMC125-C227, an exploratory phase II, randomized, controlled, open-label trial, compared the efficacy and safety of TMC125 (etravirine) with an investigator-selected protease inhibitor (PI) in nonnucleoside reverse transcriptase inhibitor (NNRTI)-resistant, protease inhibitor-naïve, HIV-1-infected patients. Methods: Patients were randomized to TMC125 800 mg twice a day (bid) (phase II formulation; n = 59) or the control PI (n = 57), plus two nucleoside reverse transcriptase inhibitors (NRTIs). Results: In an unplanned interim analysis, patients receiving TMC125 demonstrated suboptimal virological responses relative to the control PI. Therefore, trial enrolment was stopped prematurely and TMC125 treatment discontinued after a median of 14.3 weeks. In this first-line NNRTI-failure population, baseline NRTI and NNRTI resistance was high and reduced virological responses were observed relative to the control PI. No statistically significant relationship was observed between TMC125 exposure and virological response at week 12. TMC125 was better tolerated than a boosted PI for gastrointestinal-, lipid- and liver-related events. Conclusions: In a PI-naïve population, with baseline NRTI and NNRTI resistance and NRTI recycling, TMC125 was not as effective as first use of a PI. Therefore the use of TMC125 plus NRTIs alone may not be optimal in PI-naïve patients with first-line virological failure on an NNRTI-based regimen. Baseline two-class resistance, rather than pharmacokinetics or other factors, was the most likely reason for suboptimal responses. © 2008 British HIV Association.
Authors & Co-Authors
Ruxrungtham, Kiat
Thailand, Bangkok
Chulalongkorn University
Pedro, Rogério De Jesus
Brazil, Campinas
Universidade Estadual de Campinas
Latiff, Gulam H.
South Africa, Durban
Maxwell Centre
Conradie, Francesca M.
South Africa, Johannesburg
University of the Witwatersrand
Domingo, Pere
Spain, Cerdanyola Del Valles
Universitat Autònoma de Barcelona
Lupo, Sergio Horacio
Argentina, Rosario
Caici Institute
Pumpradit, Wadchara
Thailand, Bangkok
The Hiv Netherlands Australia Thailand Research Collaboration
Vingerhoets, Johan H.
Thailand, Bangkok
The Hiv Netherlands Australia Thailand Research Collaboration
Peeters, Monika P.
Belgium, Machelen
Tibotec Bvba
Peeters, Ingeborg
Belgium, Machelen
Tibotec Bvba
Kakuda, Thomas N.
United States, Philadelphia
Tibotec Inc.
de Smedt, Goedele
Belgium, Machelen
Tibotec Bvba
Woodfall, Brian J.
Belgium, Machelen
Tibotec Bvba
Statistics
Citations: 73
Authors: 13
Affiliations: 9
Identifiers
Doi:
10.1111/j.1468-1293.2008.00644.x
ISSN:
14642662
e-ISSN:
14681293
Research Areas
Infectious Diseases
Study Design
Cross Sectional Study
Exploratory Study