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Avatar universal

polymerase vs protease inhibitors

Hi Folks,   Sorry I haven't been posting.  Been gone and off on other tangents a lot recently.
I am starting to get some buzz from my connections for clinical trials. They haven't yet told me what's up, but I can tell that they are gearing up for something that I would qualify for as a non responder.   They know I will only do protease inhibitors because of 2 failed attempts with combo.  The only protease inhibitor trials I know of in my area are sch503034 and vx950.  Sch503034 will not go into phase 3 until much later this year and vx950 is only doing tx naive.  So, as best I can tell that leaves only the polymerase inhibitor nm283.  I haven't been following this drug.  The best info I can find on it was just released from a phase 2b showing good results, but nothing like the early reports on vx950 and sch503034.  
Since it seems I will likely be invited to a trial of nm283, does anyone have some advice on choosing this route instead of waiting a year for one of the protease inhibitors.  I would jump on the chance for a trial with one of the protease inhibitors, but I don't know much about nm283, so I'm not sure.
I have a 0-1 biopsy, but am quite sick with the HCV.  I cannot do another failed attempt for several reasons.  I do appreciate any and all feedback on choosing nm283 soon, instead of waiting for the others.

Thanks much,

Rossman
36 Responses
Avatar universal
there are a couple of members here who are on NM and are reporting excellent response with it. At least one of them is very happy to have finally achieve a negative PCR.  Maybe he/she will check in this wk.
perhaps you can add a comment with a title NM283 to call the  attention of these members. I can't remember their monickers. It did sound like a good drug for non responders.
Avatar universal
Here's some info:

- data from week #12

<a href="http://www.natap.org/2005/AASLD/aasld_42.htm">NM283 +Pegasys for Nonresponders: phase II 12 weeks</a>


- data from week #24

<a href="http://biz.yahoo.com/prnews/051214/new020.html?.v=33">Partial 24-Week Data Demonstrate Valopicitabine (NM283) Combined with Pegylated Interferon Continues to Produce Greater Viral Suppression in Hepatitis C Treatment-Refractory Patients Compared to Retreatment with Ribavirin Plus Pegylated Interferon
</a>

(from the study):

"<i>At Week 24, mean HCV RNA reductions in the two high-dose arms of valopicitabine plus pegylated interferon were 3.01 log10 and 3.32 log10, with 11 percent and 25 percent of patients achieving undetectable levels of virus. In comparison, patients in the pegylated interferon plus ribavirin retreatment control arm showed a mean HCV RNA reduction of 2.31 log10, with 19 percent of patients achieving undetectable levels of virus.</i>"


Halfway through tx and there's only a 6% increase in serum clearance vs. re-tx'ing with current tx, and a 25% clearance overall. Not-so-hot odds, especially given that there's still another 24 weeks of tx'ing left - and 6 months after that to reach SVR status. Makes you wonder what that 25% figure will drop down to 50 weeks on (i.e. - when the SVR data comes in).


Your tx or wait decision should include the possibility that future trials of these other drugs (assuming they would even be in your geographic region) might only want tx-naive patients, in which case NM238 may be your best/only bet for the near-term (assuming you are that much in want of re-treatment).


TnHepGuy
Avatar universal
Thanks everyone.  Yea, I'm not sure if having another failed attempt on my record could preclude me from future tx possibilities. I doubt anyone could answer that ahead of time.  But, that is one variable to consider.  I must make a better decision this time.  There are several reasons to not have another failed attempt at tx and being precluded from future tx is one I need to consider.
Thanks for the tip about another post addressing nm283 directly.  I will do that soon if not many responses.
Thanks for the link on the nm283 phase 2 trial.  I too saw those 24 week stats and thought it didn't look great.  Only a little better than ribo.  And I cannot take that chance.  I cannot take a chance on only a 6% improvement.  But, I've also read that the nm283 is showing a potentiated response with continued tx and this is the reason they extended the study up to 48 weeks.  With Ribo, the tx has done it's best by week 24.  Apparently not so with nm283. I'll check out the link.  
Thanks everyone for the input.  This is what I'm after; help making the best decision.
Avatar universal
Peg/283 is infinitely easier to tolerate than peg + riba.  It took Nuepogen and Epoetin to get me through peg/riba.  
Rudy
Avatar universal
Evening. How's treatment going? Are you able to hold your weight on your extremely healthy diet? How about your taste buds? Mine were altered (and still are) from the treatment drugs and many of the healthy foods I liked I can't eat now. Did you find a flax substitute with your riba?

-- Jim
Avatar universal
did they give you a print out of the results of the fibroscan?  intersting about your journal!
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