The future
Boehringer-Ingelheim announced that it is beginning recruitment to an international study of an extended-release, once-daily formulation of its antiretroviral drug NVP.
The VERXVE study will compare twice daily dosing with once-daily dosing of a new, extended release formulation comprising one NVP tablet. All participants will receive TDF/FTC alongside NVP.
VERXVE is a 48-week study that will recruit around 1000 treatment-naive patients in North and South America, Europe, Australia and South Africa, and results are expected in 2010.
The study will also need to put to rest concerns regarding the efficacy of combinations which combine NVP and TDF. The DAUFIN study (Podzamczer, D, et al. 15th Conference on Retroviruses and Opportunistic Infections. 2008. Boston, USA. Abs 960) found a high risk of failure using the combination of tenofovir, 3TC and nevirapine, while an Italian study (Lapadula G et al, 11 European AIDS Conference, Madrid, abstract P7.3/10, 2007) found a high failure rate in recipients of Truvada (TDF/FTC) plus twice daily NVP who had high viral load.
The potential licensing of a new once-daily formulation will have an additional commercial advantage for Boehringer-Ingelheim: its patent exclusivity on the current formulation of NVP expires in Europe in 2010 and the United States in 2011, at which point generic manufacturers could begin to sell cheaper versions of the drug. A new extended release formulation of the drug would be patented as a new product, and so would be protected from generic competition.
From AIDSmap News, February 13, 2008
Parts of this CME:
start of the CME
Clinical pharmacology of NVP
Pharmacokinetics
2NN: efficacy
Other clinical sudies on NVP QD efficacy
Transition from BID to QD: clinical data
Conclusions