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New Drugs. New Treatment Decisions.

Recently, someone at another discussion group asked me how I thought the newer protease inhibitors like Vertex should affect our current treatment decisions. Here’s an edited version of my answer.
-----------------------------

That's an excellent topic for discussion!

"To treat or not to treat" has always been a controversial issue.

Nowhere is it more controversial than genotype 1's with no or minimal liver damage, i.e. stage 0 or 1.

In this group, doctors are split. Some advocate treatment, the idea being you have a better chance for SVR if you hit the virus early in the cycle, when you're younger, healthier, and when the liver has little or no scarring.

Others advocate a "watchful waiting" approach with regular lipid monitoring and follow-up biopsy in 3-5 years. The idea here being why expose yourself to the side effects of these powerful drugs when your liver is still in decent shape.

In this debate, I tend to favor watchful waiting, although I respect anyone who decides to treat as long as they're making an informed decsion, weighing the pro's and con's. The only right answer is the one that's right for you.

That said, the new protease inhibitors in trials -- like Vertex --  seem to be shifting the "treat or not to treat" paradigm in this select population toward "not to treat".  Because even if we're off with the project 3-5 year release date,  this group still has time to wait.

PART II WILL SHORTLY FOLLOW...

53 Responses
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Avatar universal
The release for the VX-950 will be out sooner that you think, the clinicals will be completely done and results sent in just after the first of the yr. I know it works and is worth the wait. and it a 24 wk treatment...
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971268 tn?1253200799
That was interesting, thanks for posting it.
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446474 tn?1446347682
For those wanting the details of the new treatments and known results I would suggest viewing video link below by my hepatologist, Norah Terrault at U.C.S.F. Dated 3/12/2009.

It looks like Telaprevir will come to market 1st, in 2011 followed by Boceprevir then many others.

The bottom line is that SVR rates are increased dramatically. There will be many new challenges also. Adverse effects, treatment duration, resistance, etc. etc. But adding a third drug will be a new huge step especially for us Genome type 1s.

Dr. Norah Terrault of UCSF presents an update on treatment of Hepatitis C including use of triple therapy and other novel anti-viral agents. At UCTV.
http://www.uctv.tv/search-details.aspx?showID=15736

Enjoy!
Hector
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971268 tn?1253200799
Hi Karen,

You might want to have a look at the thread I started when my husband was deciding whether to not to participate in the trial.  It's a tough thing to decide, I know!

http://www.medhelp.org/posts/Hepatitis-C/Your-opinions-on-new-Hep-C-trial-of-TMC435/show/1001531
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179856 tn?1333547362
Kconn just so you realize this thread is almost five years old now and Jmjm hasn't bee posting in quite a while over here.  Ditto most of the rest of the names on the thread sadly - they treated and were cured and are long gone...sad for us great for them!

I just didn't want you to think that Jm is ignoring you. We wish he (and the others my old friends) were still here! I have SVR but am still here but usually people move on in time......I'm just slow!

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Avatar universal
HCA
Karen,
You have dropped in on a four year old discussion and none of the participants are around this forum any more.
Things have changed since then and the first of the protease inhibitor drugs telaprevir should be availible in 2011.
With regard to the trial for TMC435 you can learn more by applying.They may accept you or they may not-they are very picky.
In any event prospects for geno 1 patients are better than ever,so you have every chance of a succesful outcome.
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Avatar universal
I'm wondering if any of you have any input on TMC435? It's being developed by Tibotec and from the results of studies, do far, looks pretty good. But I've read this thread and am impressed with the amount of knowledge shown here. I'm geno 1 stage 3/4 and only found out about it 4 months ago. So, I'm told, I have to make a decision pretty quickly. Someone on another thread mentioned this drug and in investigating I find there's a new trial about to begin where I live.
Should I or shouldn't I? That is the question since I don't like the odds much from standard tx but have pretty much been told I don't have much choice. Oh, and I'm 64 but in good general health. My VL is 3.5 mil and ALT/AST are slightly elevated but the rest of my stats are within normal ranges.
Any info would be greatly appreciated.
Thanks,

Karen
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Avatar universal
these bottom threads are forgotten after a while, try the upper ones. Hep c is a very frustrating disease indeed!
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Avatar universal
I am genotype 1 with a low viral load and stage 0-stage 1. What frustrates me most in deciding whether or not to treat is that neither the liver function tests nor the viral load tests are clear indicators of the state of your liver. You can have a
high AST/ALT and a low viral load. You can have a high viral load and normal liver function tests. You can have a low viral load and a scarred liver. You can have a high viral load and little or no liver damage. Additionally, some of us can only guess at when we were infected and so how quickly or slowly the disease is progressing.
I had a biopsy 8 months ago. If I were sure that my liver is still at 0-1, I might wait for more clarity on protease or NM283 or other treatments in clinical trials. I wish there were non-invasive procedures( the biopsy is expensive and can add to scarring) that could tell you every few months about the state of your liver. I saw at http://janis7.hepc.com/labs3.htm#blood%20tests that new tests are being developed but are still fairly experimental. If only we could have a monthly look at the liver and monitor closely the progression of the diseaes it would be easier to make a decision.
Does anyone know about new tests ot have more info about the tests mentioned on the janis site or any other thought or comments?
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Avatar universal
Greetings from the deep south.  I am a 48 year old female, and I found out in 93 or 94 about my Hep C. I have had two biopsies, and don't plan on having another. I have only had a couple of elevated enzymes results, by only a few points.  I have had this most likely 28 to 30 years.  I have decided I am going to try the treatment, I have "waited and watched" and it seems to me a 50/50 shot is finally worth the effort.  Plus, even though I have normal enzymes, minimal biopsy results, 600,000 viral load (the only time I had that done), type 1a, I have intermittent bouts of illness that I am fairly certain are related to the virus.  One question I have is related to insurance.  I have the opportunity in October of switching to another carrier, the current one I would have had to spring for a $2500 deductible, but the blue cross blue shield i am looking at has a "$35 dollar copay for mail in non generic prescriptions", with care mark as their pharmacy.  I am troubled by the fact that pegasys/copegasys is on the list of "requires approval".  I don't want to switch and then suddenly be told no.  Does anyone have any experience with that?  Second question, in looking at research, it seems like the best clinical results are the pegasys/copegasys brand.  Is this still true?
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Avatar universal
What would I do without you guys. Thank you so much for responding. Jim, you put into words what I was trying to formulate with the shorter treatment plan. Sounds like a "very" intresting option you are talking about....... by the way, the doctor has not mentioned the European directive that allows 24 week treatment. I feel like I have to prepare my presentation of this plan.(and yes, you are assuming right, stage 0)

Like we know, this is a funky virus that behaves somehow differently in each individual, and so little is really known about it. Cutus, I totally forgot to ask for tests for the cryoglobulin. Im pretty convinced I have some sort of that going, and I have read that goes away with tx? (I have one old test with gamma-globulin over limit. does that have anything to do with cryo? Mike, it very scary thinking about this longer treatment. How is it, Im very thin, only 68 kg (I think 150 pounds?) I don
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Avatar universal
and others with extra hepatic symptoms, you might want to add to your list of tests the cryoglobulin assay. If they are present, it can lead to vascular and kidney problems. Remember, HCV is not a liver disease only. If the test is negative and you can manage the aches with OTC, wait a year or so, to see where these trials are going. As you age, your svr chances decrease along with it. The effects of the tx are temporary in the majority of cases, as long as the anemia is controlled. Those temporary sides should not keep anyone from treating, unless they are ready to live in peace with the virus.
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Avatar universal
Jah. The Albuferon is <i>still</i> interferon, but maintaining theraputic levels once speculated to be about a month.
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Avatar universal
Miked,

Sorry you didn't clear the first time. I agree with some of your thoughts regarding extended treatments for "partial" responders but I don't find the relevancy in Ice's case.

Ice has no liver damage, can legitimately decide not to treat, so I don't think exposure to these toxid drugs and side effects for even longer than the normal course makes sense. To me, it's a matter or risk/reward.

If you have severe liver damage, then it makes sense to risk the effects of the drugs in order to get cured. If you have no or little liver damage, then it makes a lot less sense. The approach I suggested for Ice was either to wait. or to expose himself as little as possible(4 or 24 weeks) to those drugs.

If getting rid of the virus at all costs is the issue, I would agree with your advice, but I think we all have to factor in the costs to make the right decision.

I wish you well in your future treatment decisions.

-- Jim



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Avatar universal
That is a tough question mike, I could argue both sides of the fence on whether it is still a good buy, at least in the short term. On the one hand, they are losing money, and have doubled in price since April on a drug that is 3 years away, and it has a market cap of about 1.7 bil.
On the other hand, they have 9 drugs in the pipeline, 2 HIV drugs approved, a third that has been fast-tracked (they collaberate with GSK so they get royalites on those), MRK is funding 3 different phase IB studies on a promising cancer compound, they have an RA drug that looks good, and a number of these will have data  out over the next 3-9 months, including the other HCV drug MMPD. And, it could be argued that 950 could bring in more revenue than their current market cap, but not for a few years.
Each time I felt it would pullback, it wouldn't drop that far, and then go up again. This is a stock that could be a mover on news, which cannot be timed.
For me, I am holding what I have, but haven't decided to move some stuff around to buy more. If I didn't own any, it might be a different story.
I do think that further positive 950 data will help the stock.
If you did buy it, only buy what you are comfortable with, and keep a floor as to how much you are willing to take as far as a decline.
On the chart side, the breakout in May was real, and strong. The long term trend is now up for the first time in about 5 years.
I would feel badly if I said that it is good to own and then you lost money on it, so I wouldn't do that-but good luck with whatever you decide.
I'll go back to your bottom line-the return would be gravy, but the bottom line is even more important to all of us.
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80575 tn?1207132364
"Couldn't think of a nickname" - Thanks for all of the info.  Is VRTX still a good buy in your estimation?  It's at $18 something right now; up 15%.

"Lauren" - Good to see your doing well too.  I've been feeling great and have been lurking periodically.

"Iceboy" - I started tx last year as a 1b; 3 million copies; age 46; caucasian; male; minimal scarring and in great health.  My VL dropped from 3 million to 15,000 at week 12; then to 9,000 at 18 weeks; then 5,000 at 24 weeks.  Then my VL climbed while on tx to 12,000 and they stopped me at 36 weeks.  There was no reduction in PEG-Intron or Riba throughout tx.  Right now I'm seeing Dr. Paul Kwo @ IU Med. Center who categorizes me as a "partial responder".  If I was to treat again using the conventional drugs, I would only do so by increasing the amount of PEG (off-label) and/or increasing the frequency of PEG injections to something like every 4-5 days versus weekly.  Dr. Cecil Bennett in Louisville uses this off-label approach with 1b's because the increase in volume and/or frequency of PEG better decays the virus.  With that said, how does one stand up to a shot of increased PEG every four days???  At week 36 of conventional tx I wasn't about to give up but it really took a toll on my body....weight went from 205 to 170 and generally felt like shxx most of the time.  You have age and low VL in your favor.  If I were you I'd tx but talk to your doc in advance about treating past 48 weeks (72 for 1b's) and also will he give Procrit if blood platelets go down.  Good luck and let us know what your decision is.
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Avatar universal
Assuming "no scarring" means stage 0, if it were me I wouldn't treat now. I'd wait for those newer drugs that should be around within 5 years. And even if they're a little late, as long as you monitor your liver on a regular basis with another biopsy in 3-5 years you should be fine.

What I think your doctor is saying is that if you were a genotype 2, then they'd recommend to treat. But you're not a genotype 2, you're a genotype 1. Here's the difference. Geontotype 1's have about a 50% of being cured with 48 weeks of treatment. Geno 2's have about a 80% cured of being cured with 24 weeks of treatment. Very big difference. Much less drug exposure for geno 2's with much better results.

When you doctor says you could clear in 24 weeks, they're referring to the new European directive that allows 24 week treatment for SELECTED geno 1's. In order to qualify you first have to have a pre-tx viral load under 600,000 IU/ml which do. You also have to be non-detectible at week 4 in treatment. Just remember, only 40% people clear the virus at week 4. That means if you went this route, you would have a 60% chance of not clearing.

So, I'll offer you an alternative to not treating now. You could treat and then have a very sensitive PCR test (50 IU/ml or under) at week 4. If you're non-detectible, then treat for another 20 weeks and be done. If you're detectible at week 4, stop treatment and wait to treat another days with the newer drugs. The concept behind this approach is to expose yourself as little as possible to the toxicity and side effects of interferon and ribavirn while still offering yourself a a very good chance at cure.

All said, this is what I'd do, but I'm not you, don't have an intimate knowledge of your complete medical history or personal issues. You could very legitimatley decide to treat for 48 weeks now.

Whatever you decide, don't feel rushed or pressured, you have time to make the decision. See what your liver specialist says, I'm sure they'll talk about the newer drugs. And run the 24 week approach by them if it appeals to you. Let us know how things pan out.

-- Jim
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Avatar universal
"This decison is a very individual thing, and there is no right answer."

I shouldn't type when I first wake up. I meant to say there is no WRONG answer. I got up at 7, but I won't be awake until 9.
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Avatar universal
Ice, it sounds like you are in pretty good shape, considering. I am 1b, have had it for 21 years from a blood transfusion (21 units actually), but the last couple of years my enzymes have been elevated, and I do have a pretty good dose of muscle aches/pains. I had an ultrasound of the whole region 5 years ago and nothing of interest was mentioned to me, so apparently, things were fine. I also had an endoscopy to remove a gallstone stuck in a duct, and again, the GI didn't mention anything of note to me. That is my profile, and I am choosing to wait. It won't be 5 years, more likely 3 for a better option (might be just under 3 now). The sides from current treatment combined with the time, and the 50/50 chance is what has kept me from treating. My PCP tells me he thinks it's ok to wait as long as my platelets are good. He says that is more important than VL or enzymes, and that when liver disease advances, platlets drop slowly over time. My platelets have fluctuated a bit, but last Feb., they were 224,000, which is higher than last year even though my enzymes were up.
Whatever you decide, good luck. This decison is a very individual thing, and there is no right answer.

John
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Avatar universal
I was just @ "Hepatitis Central" there are some good articles on the left hand side,scroll down to almost the bottom there is an enrollment taking place to do with Shcering Plough Canada for a new drug to take with interferon, interesting articles to check out.
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Avatar universal
It doesn't happen to everyone, but just be prepared. Anemia, within the first four weeks or so, is the number one reason people either have to stop treatment or have their ribavirin dosages reduced. Either one can dramatically affect your chance of SVR. And even if they don't stop your treatment, you will not have a lot of fun huffing and puffing around the house.:)

It's good your doctor's office is taking weekly blood counts. The results are usually in within 1-2 days. Ask that they call/mail/fax you the results as soon as they're in. In my case, I have it noted on my requistion form and the blood results are faxed to me directly by the lab.

Fatigue on tx is not only caused by anemia. The interferon can also wear you down.

-- Jim
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Avatar universal
I am not very good at explaining technical stuff, but hemoglobin is how the cells transport the life giving oxygen to all the organs. Less red cells=less hgb= oxygen deprivation, which can't be a good thing, right? Riba destroys red cells at a rapid rate.
check this article on the importance of treating anemia, sponsored by the makers of Procrit of course, but interesting to know;
http://www.mydna.com/resources/news/200407/news_20040715_bbanemia.html
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Avatar universal
Thank you I get it. I am printing this out so that WHEN my doctor thinks I am being egotistical and know more than HE he will have reasons to LISTEN to me.

I do not believe doctors are NOT fallible...and I want to be armed and prepared.  I want to get better...much more than he wants me to get better if you know what I mean.

Thanks for the link.
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Avatar universal
I have a feeling Cuteus' is out binging on Champagne celebrating her SVR so I'll jump in. :)

One of her points has to do with agressively treating anemia on treatment.

To oversimply, anemia is when your hemoglobin drops to ten or below, or when you have more than a two-point drop from your pre-tx level in less than a couple of weeks.

So, let's say your hemoglobin now is 13. If it drops to 11 after two weeks or so on treatment, you may start feeling very fatigued, dizzy when you stand up, even out of breath. It's anemia caused by the ribavirin.

What you want to do is first make sure your doctor does a hemoglobin test at least every other week during the first 12 weeks of treatment. I had mine done weekly. That way you will know what is going on.

If you do develop anemia, the solution is to treat it with weekly injections of a drug called Procrit. It's really a miracle worker and in most cases will get your hemoglobin up to par within 2-4 weeks. Unfortunately, many docs are too slow on the draw and people suffer the symptons of anemia needlessly, or worse -- they have to reduce their ribavirin dose or even go off treatmen.

Vigilant monitoring of your hemoglobin level and early intervention with Procrit is what you want. This is something I recommend to everyone to discuss with their doctors prior to being treated.

-- Jim

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