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?

[Willy50]

Hi, I don't know the answer but I believe that the approval will bring us response guided TX, yes even for past TX failures

Here's why;
1) shortening the treatment time one one of the primary goals for a new compound.

#2 There was a level of success with Prove 3 on the shorter TX arms for RVR's;  I don't think they had a lot of difference between the 24 and 48 week TX arms in Prove 3.
==================================
http://www.hivandhepatitis.com/hep_c/news/2008/061308_c.html
"• 73% of prior relapsers achieved SVR12 with 24-week telaprevir-based treatment.

• 41% of prior non-responders achieved SVR12 with 24-week telaprevir-based regimen."
==================================

#3; Quite right about the TX times in Realize, but I'm not sure that it means that they are wed to the concept.
I think they are exploring the longer TX time for 2 reasons;
     a) They were lacking a "12 and 36" arm in Prove 3
     b)  Boceprevir had a longer TX arm that showed a very high success rate; I think Vertex decided to try it as well.  The problem....if you want to call it that, is that telaprevir worked so well that in Prove 3 if memory serves there was not a lot of difference between 24 week total and 48 week total SVR rates, at least not so much in the RVR's.  it is the slower responder that longer treatment times will probably help.

I don't claim to know the correct answer.
But a 24 week TX is one he1l of a sell for a past TX failure. I'd guess that it may be an option for RVR's.
Time will tell.

PS....I'd guess that there were exclusion factors in the trials.  Anyone who treated for ONLY 24 weeks was probably a RVR at 4 through 12 weeks.  I don't even think they are doing 12 week PCR's anymore after a RVR.  IF the didn't attain RVR they surely didn't stop at 24 weeks.

Currently there is also a mitsubishi (telaprevir) trial for past tx failures w/ a 24 week total TX time; 12 & 12.

I'm not sure you'll find it in print yet but I expect there to be 24 week potential TX  with a RVR for past TX failures.  My opinion.

I hope that this isn't too disjointed; if it is I'm posting it anyway.  : 0
Too late to be typing.

best,
Willy

[willing]

suem37: congratulations! So another case of g1  rvr-on-retx. You wouldn't know it from this thread - but these are pretty rare events! Did your husband make other changes besides ifn2a-to-ifn2b? (eg increase rbv, reduce weight or IR?). Anyway - congrats on a great outcome.

cando: I see your point about not doing the same thing over and expecting different results, but I think an rvr is VERY different from a garden variety evr. In fact I suspect that had jt57 gone through with the Dr's letter she  might  have been the 1st rvr on the planet to do 72w.

Re tx,  I'd be lying if I didn't admit it's kicking my *** pretty hard. But hopefully I've  found a steady walking pace I can keep up. Rbv is at 1500 (18mg/Kg) and the Hgb seems to be holding in the low 11s, anc   0.9. Expecting  und by start of the year (about w8). Definitely no rvr but a good improvement over last attempt. Hope to add a PI in summer to cut relapse risk but even if that doesn't pan out,  odds seem fair.

Andiamo: thanks.  I looked at their press releases but have found nothing more recent than the Sept. 7 one linked above. Wonder whether the full FDA filing will become publicly accessible at some point.

bostoncream: Please post where you read that - it would be interesting to compare. REALIZE was vertex's phase III previously-treated trial and all arms did 48w. Study design is in the press release above and at
http://www.vrtx.com/assets/pdfs/VRTXRealizeFactsheet.pdf

[bostoncream]

personally ive never heard of anyone who rvrd only to relapse later  thats not saying its not possible  but its one of the best positive predictors for treatment outcome    also i read the protocol for telaprevir with previous relapsers would most likely be 12 + 24

[Andiamo1]

I have no additional data on SVR rates for relapsers.  Did you try the Vertex website?

[suem37]

My husband repeated the same treatment for a second time. although with Pegintron instead of Pegasys. First time clear at 12 weeks, went 48, relapsed AFTER 4 weeks EOT ( 4 weeks post treatment was negative viral load ). 2nd treatment, Dr said 48 weeks was enough ( was clear at 4 weeks ), but I wanted him to do 72. My husband settled on 58 , from the beginning and stuck to it. Was SVR at 6 months post, and coming up for 12 months post. Feels great and liver function excellent.

[can-do-man]

I was responding to some posts that feel a relapser should do the same exact thing over again for the same amount of time if one is RVR the second time around even though they was evr their first failed SOC.

To me doing the same thing for the same time could bring the same results, and it looks like even with the PI's they feel a relapser should tx longer.

BTW willing how is tx going for you?