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FDA advisory panel for Telaprevir and Boceprevir
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Melissa Palmer, MD posted:
The FDA advisory panel voted 18 to 0 in favor of approving both protease inhibitors - Vertex's telaprevir and Merck's Boceprevir (Victrelis) for treatment of both HCV patients who are naive to therapy and experienced, but not cured from prior treatment.

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Are you going to try the new therapies?
  • No - waiting for an interferon free regimen
  • Yes - I have never been treated and have been waiting for this
  • Maybe - I have to research it more
  • No - I am too afraid of potential side effects
  • Yes, I have tried other rounds of treatment and have not yet been
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An_192623 responded:
I am willing to try this, and pray it works for me and countless others! Living with Hep C (geno type 1) is a nightmare. The quality of life I live is vital ~ not only to myself, but for others whom I adore and love. I am a fighter and will keep on, God willing!

*One obstacle I am facing, is finding a way to pay for all this medication. I was laid on in Sept. 09 and lost my medical insurance. Now I am considered pre-existing and was denied solo insurance (not that I could have afforded medical insurance, to be honest!). This road block definitely needs a miracle.


This video was so helpful, and I thank you for the clarity, now I get it! Blessings to you! DS
 
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bb2323 replied to An_192623's response:
Anon,

I am not sure what you have researched, but I am a month into a Phase 3 trial of Telaprevir plus Interferon and Ribavirin. You can find out if there are any more trials open in your area - the good news is they are free and also everyone gets the Telaprevir (no placebo group).

I hope you find an opening:
http://clinicaltrials.gov/ct2/show/study/NCT01241760?term=HCV telaprevir&rank=2&show_locs=Y#locn

Don't believe what the site says whether they are recruiting or not. Just apply anyway and if they have an opening they will contact you.

I am very grateful to have gotten into this study - this is probably some $50,000 worth of excellent treatment and care I am getting for free - plus several months before it will hit the market.

Hang in there and the best to you!
 
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goodlittlegirl replied to bb2323's response:
how are you feeling, after one month on the new treatment?
 
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bb2323 replied to goodlittlegirl's response:
Sorry I have taken awhile to respond to your question, goodlittlegirl.

I am now into my 16th week of treatment and have been told that my 4th week and 12th week blood draws showed no detectable virus, so that was very happy news to receive! This also means I only have to do Interferon and Ribavirin a total of 24 weeks rather than 48 weeks.

After the 12th week, Telaprevir is ended, so I have been off it for a month. I was getting consistently more anemic over the last 8 weeks - so I was dose-reduced to 1/2 in terms of Ribavirin after 8 weeks, and am currently off Ribavirin altogether, having dropped rapidly to 7.8 hgb.

The anemia has been difficult - getting winded just walking up the stairs, etc., but I was given Procrit to bring up my hemoglobin levels, and now I am feeling stronger. Soon I will have to start up on Ribavirin again.

All along I have been on the weekly injection of Interferon, but am now finding the side effects much more manageable because I drink almost two gallons of water each day - especially the days immediately following the injection. More than anything else I have found, hydration really helps reduce the side-effects.

In fact, had I known how much hydration helps, I would have hydated a week or two in advance of starting treatment. Dietary changes were not necessary in my case - I have been a 100% raw vegan for 3 years (including lots of fresh green smoothies daily) and found the less I shocked my body with dietary changes (e.g., cooked food, meat, etc.) the better I would handle the side-effects. The hydration is key in my experience.

Coming off Telaprevir and (currently off Ribavirin) has also greatly reduced how toxic I feel. I thought it was mainly interferon that was making me feel so bad, but now I see it was also Telaprevir because I immediately started feeling better (no more nausea, less toxicity) once I ended Telaprevir.

But also given I am off Ribavirin, I expected my rashes (which are pretty pronounced clusters on my back, legs, thighs, sides, etc.) would subside, but not so far. The good news is the rashes are not getting worse, and should start subsiding soon.

The rashes have been really itchy, especially at night, but I found I get immediate (and several hours of total relief from itching) by using a handheld shower - slowly increasing the temperature of the hot water running directly on the rashy areas. (I learned this trick a long time ago with poison oak - somehow the intense heat aggravates the area so intensely that it stops all itching in that area for hours.)

This water trick is the only way I could find these rashes tolerable, and though it will tend to dry the skin, I just use a very good hydrating lotion after every shower (about 3x per day - whenever the itching returns). So my skin is fine, not dry at all - plus it is not torn up through scratching in the middle of the night, etc.

I am on a trial - so I was dosing Telaprevir twice a day, rather than three times a day, but the same total amount of Telaprevir each day. Having to eat 20 grams of fat with each dosing was easy enough once I found out how much fat California avocados, brazil nuts, etc., contain.

I wish anyone doing this treatment the very best! The stats for Telaprevir look fantastic, especially if you are non-detectable at week 4 and 12 - something like 90% are SVR.

(I guess I got a bit long-winded here, but I hope this may help anyone going through this ordeal.)
 
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billm57 replied to bb2323's response:
sounds good bb - did they take you off the riba or are you on half dose - with combo treatment no riba is not advised - continued best wishes for a 24 week SVR
 
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bb2323 replied to billm57's response:
Thank you, billm!

Having been off Telaprevir for 4 weeks, Ribavirin for three, and starting Procrit two weeks ago - I just found out this week that my hgb shot way up - it went from 7.8 to 11.8 in two weeks, so I feel much stronger now.

With this big up-tic in hgb levels, now I am back on a full dose of Ribavirin - which has definitely jolted my body - and off Procrit now. I am feeling a bit weaker already than I was a few days ago, and will get my blood levels checked in another week or so. I seem to respond very rapidly whether coming on or going off drugs, good or bad.

Right you are about not using Ribavirin. Vertex actually had a trial with just Interferon and Telaprevir, and found statistically less SVR. So they abandoned trying to eliminate Ribavirin from the equation.

My doc said that a few weeks off of Ribavirin, especially given how long I took it for, should not change my SVR chances. Hopefully, they are right! I am actually glad to be back on a full dose again, even it is makes me feel worse.
 
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jamesraymond replied to An_192623's response:
have read that medical has been the easiest company to cover these treatments
 
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billm57 replied to bb2323's response:
y/w bb - hows it going now - i will most likely be starting triple therapy with incivek around years end - this time is probably my last shot at clearing the virus before waiting on the transplant list - i would like to wait for a quadruple or interferon free therapy but the hepatologist thinks they might be too far down the road for me - i will need to do a year on triple but would only need 6 months on quad - have you had any trouble with dosing schedule - do you take the telaprevir with fatty meal or snack
 
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billm57 replied to jamesraymond's response:
is medical for california only
 
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bb2323 replied to billm57's response:
Hi billm57. I can understand why your doctor wants you to do treatment sooner rather than later. The single therapy drugs are at least a few years off from what I hear.

I was faced with the same decision as you billm, and got into a Phase 3 trial in April - partly because I was told Telaprevir would not come to market for several more months. This turned out to not be true - it came out very quickly once FDA approved, but fortunately the trial I am in seems to be working so far, just as well as the normal recommended approach. The only difference is that I dose two times/day with Telaprevir rather than 3 times/day. It is the same amount in total each day as the normal approach, but every 12 hours rather than every 8 hours. Definitely simpler to do than 3x/day.

Yes, taking Telaprevir with fatty food (20 grams worth) is very essential - Vertex found that people who were on a low or no-fat diet did not fare nearly as well.

As mentioned earlier, I am on a raw vegan diet so had to do some research beyond their usual recommendations of chocolate cruissants, etc. The key food that helped me is California avocados - they contain almost 30 grams of fat each, and only 8 Brazil nuts contain the necessary 20 grams.

I did not see any studies whether healthy fats or junk food fats made any difference, but over time they may narrow this down.

I am surprised to hear you have to do 12 months rather than 6 months. For this trial definitely, and also normally for Telaprevir (I believe), you only have to do 6 months (24 weeks actually) if your viral loads are undetectable at BOTH 4 weeks and 12 weeks (when Telaprevir is ended).

Is the triple therapy you are referring to Standard of Care plus Telaprevir? You may want to check this with your doc and/or Incevik site.

I am down to my last injection of Interferon next week. Cannot wait to be done, and sympathize with you and others going through this.

Take care.
 
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billm57 replied to bb2323's response:
im sure the only patients lucky enough to do 6 months are first time treaters that respond early - the biggest factor in determining treatment time on triple therapy is past response to peg / riba therapy - im a 3 time peg /riba failure with borderline decomp cirrhosis - so not only will i have to do a year but also my chance for svr goes way down

yes he wants to do incivek ( telaprevir ) peg / riba
avocados n nuts are far better than junk food - that crap is absolutely a no no with advanced liver disease - just as bad or worse than drinking or smoking - i pray you remain undetectable - permanently
 
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bb2323 replied to billm57's response:
billm, you are considered a non-responder - i.e., never was undetectable when treated with SoC - or are you considered a relapser - i.e., someone who was undetectable after a short while during treatment time, but the virus became detectable again?

The latter group, relapsers, actually have been found to respond slightly better than naive patients, when both using Telaprevir.

SVR is also influenced by Il28B in terms of CC, CT, or TT.

Incivek has all the stats in a report online. Here is one:
http://investors.vrtx.com/releasedetail.cfm?releaseid=561130

Thank you for your prayers, billm. The very best to you too!
 
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2bnlitend replied to billm57's response:
Hi Bill (and all)

Some background

I am just past 4 weeks of pegytron/ribavirin, first-time treatment. Yesterday I began the Boceprivir part of treatment all the while being 25 years infected and at grade 1 stage 2, mild fibrosis.

Week for showed 3 log drop in rna, baseline 7 million down to 4950. my doctor indicated that these results indicate I am an interferon responder and based on the numbers I have a very optimistic outlook for the chance of not only reaching cure (80-90% chance was the number he gave), but also being fortunate enough to see a short treatment period.

I am very hopeful...

I have to say the first interferon injection sent me into convulsive shivers much like a heavy does of Keflex anti-body I received years ago for an infection. Since then it has mellowed to a simple irritant like a gnat you simply cannot catch sitting still. I feel more impact from the ribavirin than the pegytron.

I told my doctor yesterday the two things I have learned in the first four weeks is to keep the fluids running through the body like a broken faucet and keep the body in motion as much as possible. AND... force that food down!

Lot of truth can be found in your posts here and I were to give any myself, I would have say I hope the best for all who are infected and that yes, it may be difficult to motivate on some days.... it's a matter of forcing the move and keep it in motion.

Cheers, Dave
 
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billm57 replied to bb2323's response:
youre welcome - i have had 3 different categories of response - im not sure which one they will use - the il28 gene has some but little bearing on most categories of previous response


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