Hep C Discussion Forum

marktrux · Senior Member

RE: trying to decide if I should take the new triple therapy with Incivek

Scout · Senior Member

I'm new to this forum. I'm in week 4 of Incevik, Peg & Riba. I was UND at 2 weeks (ALT 58 AST 51) and do my week 4 labs on thursday. Platlets are sliding a bit (85 down from 116) but nothing to be to concerned just yet. My sides are fatigue, rectal burn, mostly just tired, foggy.

My VL was 7ML before I began treatment and I was stage 2/3.

My 2 cents is that I tried Peg and Riba but didn't tolerate them well at that time(6 years ago). However I'm a lot better physically and mentally prepared this time. I'm going to go the distance if my body allows me to. I want my life back.

Isiscat2011 · Guru

kannon wrote:
Enough about Jack.
______________________
Jack Who?
______________________

How do they determine the length of treatment with Incivek?
_______________________
People can discontinue therapy after 24 weeks, provided that their HCV viral load is undetectable after four weeks of therapy and that the virus remains undetectable for the remaining 20 weeks.
Usually forty-eight weeks of treatment for all others. 48 weeks is also recommended for people who have cirrhosis, and for certain repeat treatment-takers (called null responders).
This tx is still evolving and I have also read about people whose tx has been extended due to dosage reductions.
__________________________

And, what are the new drugs that are in development or testing phase?
___________________________
There are a number of them. I would begin by looking in the new members area. I'll bet there are even web links!

kannon · Member

Isiscat2011 wrote:
Isiscat2011 wrote:
With all due respect, Kerouac died in 1969 which was decades before Hep C could be diagnosed.
Alan Ginsberg had Hep C, but he died at age 70. -__________________________________________
kannon wrote:
"Any idea that helps us to deal, whether practically or intellectually, with either the reality or its belongings, that doesnt entangle our progress in frustrations, that FITS, in fact, and adapts our life to the realitys whole setting, will agree sufficiently to meet the requirement. It will be true of that reality." William James
_______________________________________________
Well, alrightee then, if the belief that Hep C was responsible for Jack Kerouac's death at age 47 will help one to deal, despite the fact that it isn't true, then by all means believe it. But, many people who are reading this are trying to make reality based decisions.

My point is this - Hep C is a SERIOUS disease. I brought up Jack because it is highly suspected that he had hep C (he shared needles with other beatnik poets, like Gingsburg and Burrows) and the combination of drinking and Hep C caused his early death. DISCLAIMER: this is my own opinion along with other followers of Jack. I doubt that this information, whether accurate or not, will have a significant impact on anyone else. For me, and I can only speak for myself, this motivates me to 1) not drink, and 2) take this disease seriously. Taking it seriously means, living a healthy lifestyle (working out, drinking lots of water, eating a healthy diet) regular check-ups, and conducting my own research. I don't take anything at face value. If you make a statement, I do my own research and examine the information myself.

So, by the standards that James discussed, value information based on its usefulness, then the information is very useful to me.

Good luck.

kannon · Member

Enough about Jack.

How do they determine the length of treatment with Incivek?

The results from the studies I've read were all 48 week treatment. I haven't seen any results from 24 week tx.

And, what are the new drugs that are in development or testing phase?

-- Edited by kannon on Monday 12th of March 2012 02:01:54 AM

Isiscat2011 · Guru

Isiscat2011 wrote:
With all due respect, Kerouac died in 1969 which was decades before Hep C could be diagnosed.
Alan Ginsberg had Hep C, but he died at age 70. -__________________________________________
kannon wrote:
"Any idea that helps us to deal, whether practically or intellectually, with either the reality or its belongings, that doesnt entangle our progress in frustrations, that FITS, in fact, and adapts our life to the realitys whole setting, will agree sufficiently to meet the requirement. It will be true of that reality." William James
_______________________________________________
Well, alrightee then, if the belief that Hep C was responsible for Jack Kerouac's death at age 47 will help one to deal, despite the fact that it isn't true, then by all means believe it. But, many people who are reading this are trying to make reality based decisions.

Isiscat2011 · Guru

krowdog wrote:
The protease inhibitor Victrellis or Incivek is used at or near the beginning of TX.

This is terribly misleading. Incivek is used for 12 weeks, which cannot honestly be described as merely "at or near the beginning of tx." 12 weeks represents 50% of the treatment duration for most patients.

I have never used Victrelis, but my understanding is that the length of time one must take it depends on the patient's response, and for many people it will be necessary to take it throughout the treatment, following a 4 week lead in.

We are all on the same side here, which as I see it is providing authentic factual information as well as opinions about options, and supporting those who have made their choice in whatever choice that is.

krowdog · Senior Member

Yes, early UND, called eVR (Early viral response) is associated with much better SVR rates.

As for the lead in, SOC (standard of care) for Incivek, is no lead in, all 3 drugs are started together.

For Victrellis, SOC is 4 week lead in with Peg & riba only, then all 3.

That is way EVR is tested at 4 weeks for Incivek, and 8 weeks for Vic.

I have heard of someone who did a 4 week lead in with Incivek...I guess that is up to your health care provider. But if my doc was not following SOC, I'd be REALLY curious why not!

Brad

kannon · Member

krowdog wrote:
The protease inhibitor Victrellis or Incivek is used at or near the beginning of TX. For most people, there will be a big reduction in the viral load (If not, treatment is ended). Some small amount of virus may remain, and develope immunity to the protease inhibitor.
But, because the viral levels are now low (if you are a responder), the other 2 drugs are continued. They each work differently.
The interferon stimulates your own immune system to fight the virus. (There is a cool animated video on line that shows how that works, but you have to hunt that down yourself ;)
The Ribavirin is picked up by the virus, as it is similar to a material the virus uses to create new virus. That causes non-viable, mutated virus to be produced. Quoted:
Ribavirin's carboxamide group can make the native nucleoside drug resemble adenosine or guanosine, depending on its rotation. For this reason, when ribavirin is incorporated into RNA, as a base analog of either adenine or guanine, it pairs equally well with either uracil or cytosine, inducing mutations in RNA-dependent replication in RNA viruses. Such hypermutation can be lethal to RNA viruses.
(From:^ Crotty S, Cameron C, Andino R (February 2002). "Ribavirin's antiviral mechanism of action: lethal mutagenesis?". J. Mol. Med. 80 (2): 8695.
Brad
This is some helpful information. So, VL is tested before tx is started then a few weeks after the protease inhibitor/peg/riba is started to see how the patient is responding.
The earlier the virsus is undetectable the better. So having an undetectable VL at 4 weeks is better than undetectable at 8 weeks.
Has anyone heard about having a 6 week lead in with peg/riba before starting incivek?

krowdog · Senior Member

Hi Col135

There just isn't much info on the side effects of the newer drugs. All I could find was from

http://i-base.info/htb/13592

"Side effects reported in trials of nucleoside/tide and non-nucleoside polymerase inhibitors include nausea, vomiting, diarrhea, fever, weakness, flatulence, chills, headache, fatigue, and rash."

Sounds familiar, huh?

You know, I think they just don't know that much until they "guinea pig" us in trials.

That above site has TONS of info on the newest drugs of all kinds, but doesn't make for the most fun reading.

Well. it's an absolutely beautiful day here in Las Vegas. I think I'll take off my thinking cap, and go try to enjoy it.

Brad

(Geno 1a, Incivek triple TX, Und @ wks 4,8,12, & 16. In wk 21 of 24)

col135 · Member

Interesting reading there seems a lot of people on this forum that have a great knowledge of hep c and its associated problems.Does any body know if the most recent newer type drugs lower your platelets/white cell count whilst having treatment.Ive already had the standard tx in 2010 and was a non-responder to the peg/rib and sx of the above,therefore tx was stopped after 12wks.Now have been told that need to be treated at a viral hep c centre for my hcv geno 1 this would be for clinical trials but ive not been told exactly what this involves.Had the first liver biopsy in 1986 so then it was called non a non b hepatitis so the virus has had a good few years to imbed itself according to my consultant ive got cirrhsosis and some scar tissue.Any info or help please.Thanks col.

krowdog · Senior Member

The protease inhibitor Victrellis or Incivek is used at or near the beginning of TX. For most people, there will be a big reduction in the viral load (If not, treatment is ended). Some small amount of virus may remain, and develope immunity to the protease inhibitor.

But, because the viral levels are now low (if you are a responder), the other 2 drugs are continued. They each work differently.

The interferon stimulates your own immune system to fight the virus. (There is a cool animated video on line that shows how that works, but you have to hunt that down yourself ;)

The Ribavirin is picked up by the virus, as it is similar to a material the virus uses to create new virus. That causes non-viable, mutated virus to be produced. Quoted:

Ribavirin's carboxamide group can make the native nucleoside drug resemble adenosine or guanosine, depending on its rotation. For this reason, when ribavirin is incorporated into RNA, as a base analog of either adenine or guanine, it pairs equally well with either uracil or cytosine, inducing mutations in RNA-dependent replication in RNA viruses. Such hypermutation can be lethal to RNA viruses.

(From:^ Crotty S, Cameron C, Andino R (February 2002). "Ribavirin's antiviral mechanism of action: lethal mutagenesis?". J. Mol. Med. 80 (2): 8695.

Brad

Isiscat2011 · Guru

kannon wrote:
That's what happened to Jack Kerouac, one of my favorite writers. He had Hep C and continued to drink - a lot. The hep C and the drinking caused so much liver damage that his blood lost it's clotting ability and he bleed to death at 47.

With all due respect, Kerouac died in 1969 which was decades before Hep C could be diagnosed.

Alan Ginsberg had Hep C, but he died at age 70.

kannon · Member

Yes, that would be another thing to consider before starting tx.

kannon · Member

Yeah, that's the effect it had on me. Scared the crap out of me. That's what happened to Jack Kerouac, one of my favorite writers. He had Hep C and continued to drink - a lot. The hep C and the drinking caused so much liver damage that his blood lost it's clotting ability and he bleed to death at 47.

I'm sure my doctor was grossly exaggerating the progression of the disease to give me the "worst" possible case senario. The reality usually falls somewhere in the middle.

Isiscat2011 · Guru

kannon wrote:
If it gets too rough then I can always stop.

Well, this isn't quite true either. Stopping can cause resistance and limit options for future treatments. So, it is not that simple.

Isiscat2011 · Guru

kannon wrote:
I don't have any detectable liver damage, but my doctor said that it's very difficult to predict how this disease will progress. He said it could rapidly worsen and the liver damage could prevent my blood from clotting and I could bleed to death.
I hate to disagree with your doctor but this is simply wrong and might scare people silly. Nobody goes from no liver damage to rapidly bleeding to death as a result of this virus.
And, while it is true that the disease progression is certainly not an exact science, there are some fairly reliable predictors. In general, this is considered a slow progressing disease; not something that will cause one to quickly bleed to death.

krowdog · Senior Member

Hi Kannon, I'll throw my 2 cents worth in.

I am almost finished with the incivek triple therapy ( in week 21 of 24.)

The points Isis makes are good. I however, opted for treatment. I am early 50, and had a liver biopsy of grade 2 inflammation, stage 2 scarring. (Mild to moderate scarring) I am in good shape, and have worked a busy, full time job through-out TX.

I went undetectable at weeks 4, and have stayed that way so far. Because of this, I qualified for the shorter 6 month TX.

For me, the side effects were quite uncomfortable at times, but that's about it. My worst side now, is the itchiness (from the ribavirin) that makes it hard to get to sleep sometimes.

I chose to treat for 2 reasons. First I was double covered insurance wise, so the financing was easy. Secondly, I just wanted this GONE. My thought was "If it gets too hairy to handle, I'll just quit. But I've got to give it a try." It looks like I got lucky.

My odds are now exceptionally good to achieve SVR. The idea of never having to worry about this is wonderful.

So my suggestion is this...don't decide yet! Study this forum, read EVERYTHING you can, everywhere. As was mentioned, the drugs, and standards of care can only get better. I believe the answers will come when your time is right.

So, whatever you do, my best wishes for you.

Brad

(Geno 1a, Incivek tripleTX. Und @ wks 4,8,12,16. Currently in wk 21 of 24)

Isiscat2011 · Guru

Hi Kannon: For some people tx will be worth the risks (as well as the time, difficulties, and costs) but assuming little or no liver damage I would recommend waiting, and here is why:

The triple therapies have been well marketed by the pharmaceutical companies, but I would encourage you to take a closer look. High SVR rates assume quite a lot. Specifically, SVR assumes that the patient will adhere to and complete treatment. Completion of tx assumes that the tx will not be discontinued due to an inadequate response or tx intolerance.

Moreover, SVR rates do not take into account tx caused or exacerbated health problems that may continue post treatment.

Discontinuation because of inadequate viral response is between 10-20%. Regarding tx side effects, clinical trials showed that many, if not most, people will experience what are considered serious side effects: 56% skin rashes and 36% anemia. In the clinical trials 14% were discontinued due to severe side effects. That number may well increase in the general population.

Dealing with tx caused anemia is proving a challenge. Doctors are opting for reducing dosages and/or prescribing drugs such as Procrit (which is not FDA approved for this tx and carries its own serious side effects including cardiac problems such as strokes). The effects of reducing dosages on SVR are not clearly established.

Additionally, 40% will still have to tx for 48 weeks. (These stats are from the FDA and Incivek data bases).

Also consider that medical support during and after tx will be inadequate for many people.

IMHO, the FDA approval of the protease inhibitors created a rush to treatment which will subside as the drugs are tested on the general public and the risks/benefits are reevaluated. The marketing of these drugs also created unrealistic expectations and a heightened sense of need for tx. The promising SVR rates give a misleading picture when the triple therapy is viewed as a whole.

I would expect to see doctors recommending triple therapy with less frequency and primarily to people who already have substantial liver disease that is expected to progress to an unacceptable point within the next few years (before better tx arrives). Is the triple therapy actually superior to the double therapy? Nobody really knows. It will be many years before the actual costs/benefits of the triple therapies are known.

kannon · Member

Isiscat2011 wrote:
kannon wrote:
I don't have any detectable liver damage, but my doctor said that it's very difficult to predict how this disease will progress. He said it could rapidly worsen and the liver damage could prevent my blood from clotting and I could bleed to death.
I hate to disagree with your doctor but this is simply wrong and might scare people silly. Nobody goes from no liver damage to rapidly bleeding to death as a result of this virus.
And, while it is true that the disease progression is certainly not an exact science, there are some fairly reliable predictors. In general, this is considered a slow progressing disease; not something that will cause one to quickly bleed to death.

Is it stopping or taking it that causes the resistance? And, if the virus is buiding a resistance against the protease inhibitor wouldn't that mean its not working anyway? Might as well stop and try or hope for something different.

-- Edited by kannon on Saturday 10th of March 2012 06:44:49 AM

kannon · Member

Isiscat2011 wrote:
kannon wrote:
That's what happened to Jack Kerouac, one of my favorite writers. He had Hep C and continued to drink - a lot. The hep C and the drinking caused so much liver damage that his blood lost it's clotting ability and he bleed to death at 47.
With all due respect, Kerouac died in 1969 which was decades before Hep C could be diagnosed.
Alan Ginsberg had Hep C, but he died at age 70.

"Any idea that helps us to deal, whether practically or intellectually, with either the reality or its belongings, that doesnt entangle our progress in frustrations, that FITS, in fact, and adapts our life to the realitys whole setting, will agree sufficiently to meet the requirement. It will be true of that reality." William James

-- Edited by kannon on Saturday 10th of March 2012 06:35:11 AM

krowdog · Senior Member

Another good point by Isis.

If you do quit with the protease inhibitors, you cannot re-treat with a protease inhibitor again. (Untested so far, so no FDA approval. It has been proven that the virus can develop immunity. But it is being hotly contested by some researchers who believe the immunity is lost by the virus in a couple years...who knows?)

But, many of the newer drugs appear to be heading in the nucleotide-polymerase inhibitor direction, which should not contraindicate treatment due to an earlier protease inhibitor failure. (Meaning you could treat with these after failing Incivek or Victrellis)

Among companies with these in the works (and there are others), all in phase 2 testing:

Gilead - GS 9190 NN Polymerase Inhibitor w&wo Ribavirin and peginterferon

Bristol-Myers Squibb / Pharmasset - BMS-790052 NS5A inhibitor plus PSI-7792 Nucleotide Polymerase inhib. w&wo Ribavirin

Pharmasset - PSI-7977 a pyrimidine and PSI-938 a purine nucleotide analog polymerase inhibitors

Hoffmman La Roche -
R7128 (RO5024048) Nucleoside Polymerase Inhibitor

So, although this probably doesn't help you much, all I can suggest is get all the info you can, then...

Follow your Heart.

Brad

-- Edited by krowdog on Saturday 10th of March 2012 05:57:13 AM

wilsondog · Senior Member

If I were you, I'd wait. That's only because I'm on Incivek, Riba, Interfuron, and if there are better, less harsh drugs coming down the line, why not wait? I sometimes question the absolute need to do this therapy if we have little or no liver damage. My liver is healthy and I am treating because my Dr. said I was a good candidate, I'm getting older, new miricle drugs, etc. But I could have waited.

This is no picnic. I still function and get to work, but barely-- and I have a very flexible relatively light job. I'm a strong, healthy, 47 year old who is pretty tough when it comes to pain and illness. This is a serious committment and may be much more manageable once I'm done with the Incivek at 12 weeks. I am also at week 7, the stage where it seems things really head south with anemia, so I'm in an ugly position at the moment, which is worth taking into account. I do still wish I had done more research.

It's all up to you and I know there are others who would argue in the other direction. My feelings are based on the condition of the liver! Best of luck in your choices!

kannon · Member

Thanks for the feedback. I don't have any detectable liver damage, but my doctor said that it's very difficult to predict how this disease will progress. He said it could rapidly worsen and the liver damage could prevent my blood from clotting and I could bleed to death.

There are no guarantees with this disease. Best case scenario, at this time, would be to take the meds, clear the virus, with the least number of adverse side effects. The only way to find out is to try it.

Thanks Brad. What you suggested is I'm thinking. I can start the meds and see if I can tolerate them. If it gets too rough then I can always stop.

-- Edited by kannon on Saturday 10th of March 2012 04:31:52 AM

kannon · Member

I've done a little bit of research and the results for triple therapy look very promising.

I took the peg/inter about 8 years ago. I cleared the virus at 6 months. That was the first time during the treatment that my viral loads were tested. The side effects were not too bad. I didn't have an appetite so I lost a lot of weight and lost some hair. I was able to tolerate it.The loss of hair only lasted a few months.

The research I've done shows that triple therapy with incivek achieves SVR in like 85 to 90% of relapers with geno type 1. I have geno type 1 and I'm considered a relapser. I can't remember if it's a or b.

I've had liver test and there doesn't seem to be any liver damage at this point. My doctor said there are some new promising, effective drugs that are not as hard on the body in phase 1 testing and should be approved in the next 2 or 3 years.

So, I'm having trouble trying to decide on whether or not to start the new triple therapy or wait.

I'm looking for some feedback from some people who have or are going through treatment right now. I work full-time and my job is fairly physical. How are you guys dealing with side effects? Are the side effects managable?Are you able to work?

One thing I am going to do if I start therapy is drink a high calorie shake to keep from losing so much weight.

I appreciate any feedback.

THanks so much!

Good luck

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