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NEwArT Study
Jun 19, 2008

Dr. DeJesus,

I've heard that the NEwArT study, of which you are the lead investigator, has been halted or soon will be halted because of concerns about the Viramune arm. (The study compares Viramune-Truvada with boosted Reyataz-Truvada.) The concerns, specifically, being: (a) higher rates of early virological failure; (b) higher mutation rates (conferring cross-class resistance or intra-class only?); and (c) evidential support from small studies such as DAUFIN and Lapadula et al.

Is this true? If so, can you explain, elaborate -- especially since nevirapine is the NNRTI most widely used in less-developed countries (and used, also, by those wishing to avoid the potential psychiatric side-effects of efavirenz)?

Thanks!

Response from Dr. DeJesus

Thanks for you question, and a very good one! The short answer is "No". There is no validity to any rumors suggesting that the sponsor of this trial is planning--at least at the time of this response-- to stop this study. For this to occur, the DSMB (Data and Safety Monitoring Board) will have to meet and find evidence that this regimen is associated with less efficacy and safety. The DSMB for this study will be conveying soon to make that determination, on a protocol defined time-point (after certain amount of pts have achieved Week 12 data--which by the way will be occurring very soon!).

The reason why the board did not conveyed earlier to make this determination for this study after the recent reports you mentioned is because on a similar study been conducted in other countries, the ARTHEN study, the DSMB did not find any unknown safety or efficacy concerns on patients using this regimen.

Regarding the reports by Daufin and Lapadula, raising concerns on the efficacy and safety of nevirapine, FTC and TDF combination, there are a few things we need to keep on mind. For example, in those studies nevirapine was given once daily (instead of twice a day), which may have accounted for a higher rate of adverse events; also at least on one of those studies, 3TC was used instead of FTC, which is known to have a shorter half-life.

Today, there is no reports from any large, randomized study that could definitively confirm the findings and concerns raised by those smaller studies; reason why the conduction of the NEwArT trial is critical to understand any potential unfavorable interactions. I will assure you, that if any significant safety or efficacy concerns is identified during the conduction of this study, we will immediately notify the investigators to prevent placing any future patients at risk.

Thanks again for sharing your questions and concerns.



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