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The Plan for Me??????
My Hep C DR. was happy to see me this morning.First thing he said to me was "They're here!!"My reply was "I KNOW !!!!.He was figuring that I would be his first patient to treat with the new drug (until I showed him the paperwork from a torn rotator cuff) Gotta get this fixed first!!!I kinda knew that...
His plan for me sounds good.
1.Start triple therapy with incivek for the first 12 weeks,at 4 weeks if my vl is below 1000 I continue on for 8 more weeks then 12 weeks of regular soc-6 months of tx
2.If not below 1000 at week 4,continue on 8 more weeks of triple therapy then 36 weeks of regular soc.
We talked about alot of scenarios and thought that since I have the CC alleye this would work best.I definatly got my 20.00 copayment out of him this morning-we talked for 1 1/2 hours!!!!When I asked about the rash he said they have hired on a dermatologist just for these drugs and if I was to get the rash it would be taken care of PRONTO...He said he would much rather me have the rash than the serious anemia that is coming with the Victrellis.
Any thoughts???????????????????????? cindy
He has just finished writing a book on Hepatitis.
His plan for me sounds good.
1.Start triple therapy with incivek for the first 12 weeks,at 4 weeks if my vl is below 1000 I continue on for 8 more weeks then 12 weeks of regular soc-6 months of tx
2.If not below 1000 at week 4,continue on 8 more weeks of triple therapy then 36 weeks of regular soc.
We talked about alot of scenarios and thought that since I have the CC alleye this would work best.I definatly got my 20.00 copayment out of him this morning-we talked for 1 1/2 hours!!!!When I asked about the rash he said they have hired on a dermatologist just for these drugs and if I was to get the rash it would be taken care of PRONTO...He said he would much rather me have the rash than the serious anemia that is coming with the Victrellis.
Any thoughts???????????????????????? cindy
He has just finished writing a book on Hepatitis.
Hi Cindy, I see on your profile that you are in GA. I am in Winder, GA that is about 20 from Athens, GA, my doctor is a gastrologist in Athens by the name of Dr. Quadri. it seems like your doctor is very good, where is he located at in GA....I am a stage 1 grade 2 and they are wanting me to start treatment but i am not sure if i want to right now. however, i am 46 and someone told me that when you are older it is harder on you so i am confused about what to do. i would like a second opinion thats why i am asking about your doc since you are in GA.
thanks, becki
thanks, becki
Thanks, I know the doctors are doing all they can to figure out the best approach to this new tx so thanks for backing this up. It still makes sense to me also but I have been reading so much on here that people are starting all 3 together so I am going to give it a few months and see how this starts to pan out.
the approach suggested by brianmo's Dr. seems a wise one. Do your 4w and see if you RVR. If you do, no need to add a PI. If not, you'll have a good sense of how strong your ifn response is and thus whether triple tx is going to work for you. The approach can be used regardless of whether one chooses vic/inci.
The trouble with the vertex no lead-in approach is you're driving blind and have no idea whether ifn will work well enough for you to clear INCI-resistant strains. How do you decide it's not working and stop? During trials they could obtain sequence data - but this is no longer an option. The cutoff of 1000IU seems to have been picked when the FDA wrote the label - it was not applied in any of the Vertex phase III trials so there's no data on its predictive value. Say you start all 3 at the same time and measure 800IU at w4 and 100 at w12, what are your odds now ? No one's going to know, but not very good.
The trouble with the vertex no lead-in approach is you're driving blind and have no idea whether ifn will work well enough for you to clear INCI-resistant strains. How do you decide it's not working and stop? During trials they could obtain sequence data - but this is no longer an option. The cutoff of 1000IU seems to have been picked when the FDA wrote the label - it was not applied in any of the Vertex phase III trials so there's no data on its predictive value. Say you start all 3 at the same time and measure 800IU at w4 and 100 at w12, what are your odds now ? No one's going to know, but not very good.
I talked with my doctor yesterday, phone call from her so I would not have to do the 2 hour drive and I really appriciated this, and it sounds like the doctors are trying to figure out whats best in how to tx us with the new drugs available. My doctor is leaving it up to me as to choose Telaprevir or Boceprevir if I decide to go that route, she also made it very clear that they do come with side effects also. Tel, a terrible rash, boc, anemia. But, my case being different in that she wants to start me SOC, at four weeks, if neg, I decide if I want to add the 3rd drug, which ever one I choose. I am CC, GT 1a high VL. This is all getting very confusing, again. Anyway, I am not going to Start until end of Aug so I have a few months to do the research.
"correction, continue SOC 36 weeks for those <1000 at week 4 and week 12 but not UND. "
You are correct to some extent and I misread this portion. The treatment duration section which confirms what you stated refers you to the discontinuation section which says to stop tx if not und at week 24.
I am surprised that treatment is recommended past week 12
http://pi.vrtx.com/files/uspi_telaprevir.pdf
2.3 Discontinuation of Dosing
Patients with inadequate viral response are unlikely to achieve SVR, and may develop treatment-emergent resistance substitutions [see Microbiology (12.4)].
Discontinuation of therapy is recommended in all patients with (1) HCV-RNA levels of greater than or equal to 1000 IU/mL at Treatment Week 4 or 12; or
(2) confirmed detectable HCV-RNA levels at Treatment Week 24 (see Table 2).
Table 2:
You are correct to some extent and I misread this portion. The treatment duration section which confirms what you stated refers you to the discontinuation section which says to stop tx if not und at week 24.
I am surprised that treatment is recommended past week 12
http://pi.vrtx.com/files/uspi_telaprevir.pdf
2.3 Discontinuation of Dosing
Patients with inadequate viral response are unlikely to achieve SVR, and may develop treatment-emergent resistance substitutions [see Microbiology (12.4)].
Discontinuation of therapy is recommended in all patients with (1) HCV-RNA levels of greater than or equal to 1000 IU/mL at Treatment Week 4 or 12; or
(2) confirmed detectable HCV-RNA levels at Treatment Week 24 (see Table 2).
Table 2:
correction, continue SOC 36 weeks for those <1000 at week 4 and week 12 but not UND.
For Incivic, if VL <1000 at week 4 AND <1000 at week 12 then continue with SOC. SOC would continue 12 weeks for those UND at weeks 4 and 12, continue SOC for 36 weeks for those 1000 at week 4 and/or week 12 then stop tx.
I was told this yesterday by both Vertex rep and a hepatitis researcher MD.
I was told this yesterday by both Vertex rep and a hepatitis researcher MD.
Just wondering why you dont slam the rotator cuff, then tx till summer vacation ends and then go into FMLA??? Just curious as to why you are waiting? Do you have to work before you take advantage of the FMLA to kick in? So what was the name of the book? Never mind I doubt I could read it , Just kidding.. Oh and Specta brings up a good point about the tx? Good luck Cindy
Why would the doctor make you wait just because of a torn rotator cuff I mean I know there is no rush to get going but I would think you could do them both at the same time?
I am optimistic that you will do well, especially with your cc status. After reading the Incivek prescribing information I had some questions about your post.
Perhaps your doctor does not plan to follow the the recommendation precisely, or perhaps I am misreading the guide or your post. In any case I didn't see in your post when you have to become und and what your docs guideline for stopping tx was.
Best of luck to you, knock those virons outta here!
-Dave
prescribing info:
http://pi.vrtx.com/files/uspi_telaprevir.pdf
"1.Start triple therapy with incivek for the first 12 weeks,at 4 weeks if my vl is below 1000 I continue on for 8 more weeks then 12 weeks of regular soc-6 months of tx"
I believe the prescribing info says that you need to be und at week 4 (and then again at week 12) to treat for 24 weeks total (12 weeks triple therapy, 12 more SOC)
"2.If not below 1000 at week 4,continue on 8 more weeks of triple therapy then 36 weeks of regular soc."
I believe the prescribing information states that you would stop tx if not under 1000 at week 4. If you are under 1000 at week four but not und you would treat until week 12. If you und at week 12 you would continue with SOC for 36 weeks (as long as still und at week 24)
If not und at week 12 all patients will stop tx
Perhaps your doctor does not plan to follow the the recommendation precisely, or perhaps I am misreading the guide or your post. In any case I didn't see in your post when you have to become und and what your docs guideline for stopping tx was.
Best of luck to you, knock those virons outta here!
-Dave
prescribing info:
http://pi.vrtx.com/files/uspi_telaprevir.pdf
"1.Start triple therapy with incivek for the first 12 weeks,at 4 weeks if my vl is below 1000 I continue on for 8 more weeks then 12 weeks of regular soc-6 months of tx"
I believe the prescribing info says that you need to be und at week 4 (and then again at week 12) to treat for 24 weeks total (12 weeks triple therapy, 12 more SOC)
"2.If not below 1000 at week 4,continue on 8 more weeks of triple therapy then 36 weeks of regular soc."
I believe the prescribing information states that you would stop tx if not under 1000 at week 4. If you are under 1000 at week four but not und you would treat until week 12. If you und at week 12 you would continue with SOC for 36 weeks (as long as still und at week 24)
If not und at week 12 all patients will stop tx
Looks like you got a doc you can work with, that is so rare, bring him some cookies.
I hope it all goes well for you and you beat the buggers early on.
Mary
I hope it all goes well for you and you beat the buggers early on.
Mary
I'd be curious to know more about your doc's reasoning for choosing Incivek over Victrelis. My hepatologist took the opposite viewpoint, that the anemia is much easier to treat than the rash, and therefore Victrelis would offer me a higher chance of completing treatment.
Did he elaborate on his reasoning at all?
Did he elaborate on his reasoning at all?
Bummer about the torn rotator cuff. On the other hand, sounds like you have a great doc! Best of luck when you get to start the treatment. Hey, maybe your doc could bring on a nice masseuse to help w/ body aches ;).
Gosh I wish I only had a viral load of 1900!!!You will have this whipped I am sure!!!Hoping you dont get the rash but if you do it will go away after you stop the meds. Do you have to be below 1000 at the 4 week mark?I think if I were you Id have my regular dr order a viral load test to see where I was at. keep in touch cindy
I'm in the Telap trial...started 3 weeks ago...only problem with doing the trial is if im not below 1000 they stop us and we dont know anything until 12 weeks...no rash so far..im a CC too and started TX with a 1900 VL so i guess if im not below 1000 it wasn't working anyway...i feel pretty good so far but can start to feel the meds dragging my wagon...you got all the right stuff to be successful in this...good luck and God bless...keep us posted after you start
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