Dr. wants to extend tx!!!!! yikes!

[jt57]

2nd tx.  rvr at 4 wks this time.   Now at 41 wks.  still und.  Got a letter from my doc today that he recommends I extend tx 24 more wks past the 48!!!  Even with und at 4 wks????  he states that it is because I relapsed last time.  But last time I was und at 11 wks.  not 4.  I have had a hard time with tx, 3 blood tx.  anemia is awful.  so are the side effects from the neupogen...just to name a few.  I cannot stomach even thinking about an extra six months....what are your thoughts guys?

[willing]

not sure I understood your question. Relapsers are a pretty homogenous group. Our ifn response passes the Goldilocks test - we're neither nulls nor partials nor super-responders, just stuck in the good, but not quite good enough box. Tx naives on the other hand are all over the map. It makes sense that the  PI protocol for relapsers (with acceptable but not great ifn response) would be 12+36 whereas for naives (many of whom will be super-responders) 12+12 will work fine among those who rvr. But maybe I completely misunderstood your point ...

Sorry to hear fatigue is still an issue BTW.  It sure is one of the sides I was hoping to leave behind.

[willing]

yes - thanks! I glanced at it at the time and then lost it. Very interesting stuff - looks like the final chapter of the occult/persistent vl saga. Basically both sides were right - yes there is post tx vl and yes it eventually fades.

[can-do-man]

One thing i'm confused about here is it seems  that relapsers will extend tx to 48 weeks when the new pi's come out even with an RVR, (12+36 instead of 12+12) at least thats how they seem to being heading with the trials. So why not with just SOC.? Maybe i'm missing something here but it seems that relapse trumps RVR.

[mikesimon]

Was this it?

Sporadic Reappearance of Minute Amounts of HCV RNA after Successful Therapy Stimulates Cellular Immune Responses.


http://www.ncbi.nlm.nih.gov/pubmed/21040725

[willing]

jt57: congratulations on a very successful if difficult tx, W11 und was already respectable but pushing that back to w4 is really amazing! What strategy did you use to reduce ferritin and what was the change in your rbv mg/kg ? It never ceases to amaze me how one can make such dramatic changes in ifn-responsiveness by tweaking the right dials.

Andiamo/Trin: do you know whether vertx has released anything on REALIZE more recent than their Sept 7. press release? Agreed the numbers for relapsers look very good. Per Pockros' AASLD slides (which will likely become  defacto AASLD usage guidelines after getting cleaned up) on-label PI use will probably follow the trial protocols, so for relapsers 12+36 (and similarly for boce). An interesting detail is that the lead-in arm eked out a better (88%) response than the simultaneous start (83%).
http://investors.vrtx.com/releasedetail.cfm?releaseid=505239
I've been placing my bets on the assumption that if a 4w lead in helps, 24w can't hurt. But in any event starting a month before 1st PI seems a good idea.

all: how history repeat repeats itself!. That Shiffman'96 study was obsolete in '08 and has gotten a couple of years mustier in the interim. There may be good reasons to gradually reduce ifn dosage - but that study  does little more than confirm that in '96 they didn't yet know you can't treat G1s with 24w.  Tapering only makes sense if you believe there is a sizeable population of infected cells at eot - and whether the native immune response can control them determines whether relapse occurs. Mikesimon posted a very interesting recent paper about a month ago that provides uptodate evidence for gradual phasing out of the virus post-EOT, Unfortunately I've lost it and am too frazzled to dig it up at the moment - Anyone have the link?

[Trinity4]

In that case you might want to also monitor 3/4 of the posts on the other existing threads.

Trinity