% | $
Quotes you view appear here for quick access.

Sarepta Therapeutics, Inc. Message Board

  • billybusherman29 billybusherman29 Apr 28, 2006 10:57 AM Flag

    HCV results, EASL and ICAR

    Results of AVI's HCV trial are supposedly blinded to everyone. Trial sites are getting no RNA PCR results nor are the patients. Usually, trial results can leak out of trial sites when it is open label. It seems that while they blinded viral reduction, the ALT levels from the blood work is getting back to the trial sites and doctors.

    As others have stated, ALT levels are indicitive of antiviral activity, which would in turn improve the healthy functioning of the liver, which ALT levels help measure. They are not the key measurement for clinical evaluation, but they will often track the viral load if other factors aren't in play (in some cases, the drug itself may create an interaction in the liver that increases ALT while attempting to decrease viral count). Regardless, at some point in the treatment regiment, decreases ALT levels are one of the main goals as bringing the liver back to good health is a key part of the process. And, while there are many cases where HCV positive patients have normal ALT levels, those that have elevated ALT levels are likely to see them decrease after they have been successfully treated and achieve a sustained viral response.

    We now know some facts about one patient in the HCV trial. He started with an ALT level around 243 and saw it drop to 150 after 5 days of treatment. To confirm that this decrease wasn't just some random event based on a change in his lifestyle, etc, his 14 day number only increased slightly, to around 155, thus whatever impact was created, was continuing around the last day of dosing. Now he has posted that his latest ALT was 215, indicating that the level has bounced back a bit given a period of time without treatment with AVI-4065 (can't say for sure, but this 215 reading, based on his post, was likely taken after day 28 to 38). This increase in ALT's, approximately 2 plus weeks after dosing ended, is indicitive that the decrease in ALT's during dosing was based on AVI-4065 working as contemplated. And the fact that the ALT level remains below the start after around 30 days is also good.

    I realize there is some speculation here, but this is the only single piece of information out there on the direction of this trial. And, it is pointing positive. I would think no change in ALT's would have been viewed as a negative, although it would not have been completely predictive that they didn't get some decent drop in viral load. But, the very big drop in his ALT level during dosing and then a partial rebound is very consistent with the expectations of an effective 14 day antiviral dosing. And, if I had to speculate, I would say that achieving this effect would take more than a 1 Log 10 reduction and is likely to be closer to the AVI target of 2 Log 10.

    If the durability is as good as the theoretical possibility, then the 28 and 45 day numbers should also be impressive. I don't know if Wall Street will be looking at durability that closely, but you can bet your ass that big pharma will.

    I can buy that the company has gone to great lengths to make sure the trial results don't leak in advance of the preliminary release. But, do we really believe that nobody at AVI knows the data from the first group of patients? I would guess that certain people at AVI now know some of this data. If it starts to get "characterized" in some fashion, even during EASL in big pharma conversations, it will start to show up in the stock.

    I think data is now being monitored and has to be put into presetnation format for ICAR and potential partners. I don't think anyone will get the numbers, but there will definately be a "characterization" of the data before it makes it to release. We may already be seeing that show up in the stock.
    We also might note that as of the start of EASL, the characterization of AVI-4065 may be made to big pharma partners and that info will eventually reach certain investors.

    SortNewest  |  Oldest  |  Most Replied Expand all replies
46.33-0.59(-1.26%)Oct 25 4:00 PMEDT