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time frame for new meds?
Jul 1, 2001

I just read that trimeris expects approval of t-20 by the end of 2002. I know tenofovir should be approved this year. Are there any other new drugs expected this year-or early next year-for us hiv'ers failing meds?

Response from Dr. Cohen

Well - there are a few meds in the research pipeline. None are expected to be approved this year except tenofovir. But there should be a few others either next year or more likely the one after.

You have mentioned already T-20 - the first in what may be a series of new meds in the new class of entry inhibitors. There is already a second one in development by Trimeris called T-1249 - and it is further behind in development but suggests that this approach may yield more than one fruit. There are other pathways that are undergoing testing with inhibitors - but so far no agents in these other approaches are entering Phase III testing - which is the phase done prior to approval if successful - and suggests that if all goes well, a medication could be available in the next 2-3 years.

So what else? Well there are a few new nucleosides. Furthest along in DXG/DAPD being developed by Triangle. Still not in Phase III yet but early data suggest that it has important potential for use. Other companies also have developed other nucleosides but it'll be awhile before we know their trajectory.

There are a few new nonnukes in development - we have seen information about a few of them in recent meetings - from duPont and a new company called Tibotec for example. But again these are still early on.

In the PI world - there is one from BMS still called 232 - and another called tipranavir. Both of these appear to be pretty important for use in this circumstance - since both have resistance profiles suggesting they'll work even after others no longer do. And these are in or nearly in phase III development - so could be available in these next few years if all goes well.

Those are the ones closest to being useful in the next few years. But since their widespread approval is still generally years away - there are a few issues to consider.

One is considering being a part of research studies - those who do often have earliest access to promising meds - even in randomized controlled studies, those who participate can have access to the new medication before others outside of trials do. And it is only through the enrollment in these trials that new meds get developed to see if they warrant approval. Trials are not for everyone - but it is an option for those in need.

Second is to look at new strategies using current meds - specifically there is promise in using "boosted" doses of the protease inhibitors, either alone or in combination with more than one boosted PI. And for some, there have been some impressive results, beyond what was expected.

Third is to see which combo can even partially control HIV -since when HIV is just slowed down but not stopped, our immune system appears to do better for a fair bit of time. Keeping you well for these next many months to years while the newer meds get here...

And of course - doing what can be done to stay well while the pipeline does what it can. And while not trying to be trite - perhaps it is helpful to think of it as the meds that are failing you, not the other way around...



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