Abstract
Aims: The impact of baseline characteristics on response to the non-nucleoside reverse transcriptase inhibitor etravirine was investigated at 48 weeks in the Phase III DUET trials. Methods: Logistic regression was used to examine the effect of baseline demographics, disease characteristics and characteristics of antiretroviral therapy on virologic response (viral load <50 HIV-1 RNA copies/ml) to etravirine in pre-specified pooled subgroup analyses. Results: Several nondemographic characteristics were significant predictors of response in univariate analyses. Baseline viral load, adherence to study medication and use of enfuvirtide were predictive of response in the multivariate analysis. Patients treated with etravirine consistently achieved higher response rates than placebo-treated patients. Conclusions: The clinical benefits of etravirine in the DUET trials were observed irrespective of baseline characteristics.
Acknowledgements
The authors thank the patients and their families, the study coordinators and the investigators who participated in the DUET clinical trials.
Financial & competing interests disclosure
All study investigators received research funding from Tibotec to support their patients’ participation in the DUET trials.
Pedro Cahn has received honoraria as an investigator for Abbott, Avexa, Boehringer Ingelheim, Bristol Myers Squibb, GlaxoSmithKline, Myriad, Merck, Pfizer, Pharmasset, Schering-Plough and Tibotec; as a speaker for Abbott, Bristol Myers Squibb, Gilead, Merck, Pfizer and Tibotec; and as a scientific advisor for Avexa, GlaxoSmithKline, Myriad, Merck, Pfizer, Schering–Plough and Tibotec.
On behalf of Richard Haubrich, the University of California San Diego has received research grants from Tibotec, GlaxoSmithKline and Abbott; Richard Haubrich has received honoraria for consulting/lectures from Abbott, Bristol Myers Squibb, Gilead, GlaxoSmithKline, Merck, Pfizer, Progenics, Schering, Tibotec and Virco.
Christine Katlama has served on advisory boards for Abbott, Boehringer Ingelheim, GlaxoSmithKline, Janssen-Cilag, Merck Sharp & Dohme, Pfizer, Roche and Tibotec.
Fredy Suter has served as a consultant on advisory boards for Bristol Myers Squibb and Roche; he has also served as a speaker for GlaxoSmithKline and Boehringer Ingelheim, and has received research and educational grants from Bristol Myers Squibb, Gilead, Boehringer Ingelheim, GlaxoSmithKline, Jansen–Cilag and Roche.
Monika Peeters, Johan Vingerhoets, Rekha Sinha and James Witek are full-time employees of Tibotec.
These data have been presented in part at the XVII International AIDS Conference Citation[7].
The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Writing assistance was utilized in the production of this manuscript. The authors acknowledge Emily de Looze (medical writer), Gardiner–Caldwell Communications, Macclesfield, UK for providing medical writing support and collating author contributions. This support was funded by the sponsor of the trials, Tibotec Pharmaceuticals Ltd.