Sorting through treatment options

[BeatTheBeast]

A woman in her early 30s I'm close to was diagnosed recently with Hep C (acquired as a child).  She's not symptomatic, and liver function test results are within normal ranges.  Results of liver biopsy and gene test will be available soon.  No HCV treatment to date.  Depending on the results of the liver biopsy, treatment could be called for soon with telaprevir or boceprevir, or if disease is early stage there would be the option of waiting for better drugs now in the pipeline to be approved within a few years.

Even if the liver disease proves to be early stage, it might make sense to get rid of the virus ASAP for a variety of reasons -- lessen the chance of liver disease or cancer later, increase the chance of treatment success, tee up the timing for getting pregnant with no risk of passing this on to the baby.  Or, especially if the genes turn out "bad" for response to telaprevir/boceprevir, it might make sense to wait and treat later.  Does anyone have thoughts?

If the decision is made to proceed, the choices would seem to be telaprevrir or boceprevir or another drug combo using a clinical trial.  Does anyone have thoughts about the pros and cons of each of these?  

1.  Shorter treatment time.  About 65% of patients getting telalprevir in a clinical trial stopped all treatment after 24 weeks.  24 rather than 48 weeks of treatment seems like a huge advantage given the side effects of IFN and ribavirin.  I gather that the boceprevir protocol is always at least 48 weeks.  Do people think that telaprevir is preferable to boceprevir for that or other reasons?  The RVR for some other treatment drugs seems better than that of telaprevir (84% of patients in a TMC435 trial stopped treatment after 24 weeks, and almost 100% of geno 1 naive patients apparently did in a PSI-7977 trial)  -- would that be a good reason to check out trials using those drugs?

2.  Trial drug vs placebo.  Most trials are double blind with a placebo component so one couldnt' be assured of getting the treatment drug.  Some upcoming trials may have telaprevir or boceprevir as the comparative.  If one could get in a trial of PSI-7977 or TMC435 with telaprevir as the comparative, would that be a better way to go than one of the approved drug cocktails (assuming good insurance so treatment cost is not a factor)?   Side effect management apparently is limited in trials.  Are there other reasons that a trial might be a bad (or good) way to go after telaprevir/boceprevir have been approved and are options?

There are so many variables to consider, especially the "unintended consequences" of treatment that get referenced here so often and that seem like complete "wild cards."   With the new drugs about to be approved and so many more in the pipeline and also with the IL28B gene tests now available, there is more ability to customize or otherwise "pick and choose" treatment -- but what does that mean as a practical matter?

Thanks for any thoughts and help.

BeatTheBeast

[BeatTheBeast]

Thanks for this additional information.  It's very helpful to hear how different people view their treatment.  It is terrific that this worked out well for you!

BTB

[sunshines76]

My treatment took 18+48 weeks, 66 weeks total. Did not respond to pegasys, so had to switch to daily infergen. It wasn't easy, but it wasn't too bad either. I remember how scared I was to start tx, and then how I was scared to start infergen, which is supposed to be a harsher type of interferon as far as sx concerned. I am sure my sx were nearly as bad as most folks report. I believe I actually got it easy, even with infergen. But I do remember my fear to start SOC and then how I was surprised that it wasn't "so bad". I finished my tx in August 2010. This week got results confirming my SVR.
I didn't do biopsy neither prior, no post-treatment. I had it scheduled prior to starting tx, but when they called me 2 days prior and started asking some formal pre-registration questions for the procedure, I freaked out when they asked me if I got my will signed. I was not ready for that at all, so I called my doc and said I really-really didn't want to do biopsy. I laugh at it now, but at the time I was under a lot of stress, and I guess I kind of overreacted when heard that "will" question. My doc was nice enough to calm me down, he also said that if I feel so scared of the biopsy, then I didn't have to go through it. So, I still have no idea as far as my stage of liver damage was/is.  

I understand your interest in newer drugs, and perhaps it's a good choice in your situation. As for me, i was kind of limited in time. I wanted to get rid of the virus as soon as I could, due to 2 reasons. First, I was told that the older you are, the harder it is to treat and achive SVR. Secon reason was my career. I am about to jump into a very busy project at work which will require a lot of time and energy, and I wanted to make sure that by the start of this project I could get rid of that annoying fatigue that HCV gave me.

At the end of the day, I think there is no wrong or right decision whatever you chose to do. Just make sure to prepare yourself socially, emotionally, and physically for tx and start when you are ready.

[HectorSF]

rambleon, I have to take issue with some of the things you state as fact to Beat the Beast...and others.

First let me say I am sorry that you are suffering in any way. I hope you find help with managing your problems. I know that psoriatic arthritis is a difficult disease to manage and I don't mean to discount the suffering you are experiencing. What I find troubling is the amount of misinformation that you are putting out that doesn't help others but only confuses them if they don't have much knowledge or experience with HCV treatment. I worry that it could lead them to be afraid to treat and then one day they end up with cirrhosis or have let things go so far that treatment is no longer a possibility.

To blame your doctor for your treatment is disingenuous. You choose your doctor. I'm sure there are many other docs in your area that you could have have chosen to manage your treatment also. Besides no doctor can make anyone undergo any treatment, even if that treatment might save your life. You can refuse it. People do every day. In the same vein it is the patients responsibility to understand the risk involved in any medical treatment, test, or procedure. With the availability of the Internet there is an array of resources for people who are interested. Also, did you read the package insert warnings that come with the meds? (See below for a partial view of insert) Is it the doctors fault if you didn't read it or ignored it? You are not a passive victim. Treatment is a partnership. You have responsibilities too. And one of them is to indicate to your doctor that you are having problems with the meds. Please take some responsibility for your own choices and stop blaming others and especially please refrain for multiple postings of dooms day scenarios about HCV treatment when the vast majority of persons that undergo treatment do not suffer from these side effects that you attribute to HCV treatment. For the 5% of us, as you like to say, with cirrhosis is it no picnic either I can tell you. Cirrhosis destroys the body and mind bit by bit over sometimes years and if a liver transplant is not an available option, it will eventually kill you. Psoriasis is not lethal as least.

Worsening or development of Psoriasis is well known possible side effect of treatment. It is part of the inset in every box of the meds you took. Just because you didn't know about it doesn't mean that experienced medical professionals who treat HCV don't. If your doctor shrugged it off, why did you continue to have them manage your treatment? Who's fault is that?
I had psoriasis before treatment. I saw a dermatologist before treatment and was warning by my GI, dermatologist that treatment could effect my psoriasis. My doctors told me they would stop treatment if it got too far out of hand. Psoriasis is mentioned under warnings.
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The package insert:

PEGASYS®
(peginterferon alfa-2a)
Rx only
Alpha interferons, including PEGASYS (peginterferon alfa-2a), may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping PEGASYS therapy (see WARNINGS and ADVERSE REACTIONS).
Use with Ribavirin. Ribavirin, including COPEGUS®, may cause birth defects and/or death of the fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen (see COPEGUS Package Insert for additional information and other WARNINGS).

403
Endocrine Disorders
PEGASYS causes or aggravates hypothyroidism and hyperthyroidism. Hyperglycemia, hypoglycemia, and diabetes mellitus have been observed to develop in patients treated with PEGASYS. Patients with these conditions at baseline who cannot be effectively treated by medication should not begin PEGASYS therapy. Patients who develop these conditions during treatment and cannot be controlled with medication may require discontinuation of PEGASYS therapy.
410
Autoimmune Disorders
Development or exacerbation of autoimmune disorders including myositis, hepatitis, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis, interstitial nephritis, thyroiditis, and systemic lupus erythematosus have been reported in patients receiving alpha interferon. PEGASYS should be used with caution in patients with autoimmune disorders.

1291
What are the possible side effects of PEGASYS, and PEGASYS taken with COPEGUS?
Also see “What is the most important information I should know about PEGASYS therapy?” in this Medication Guide.
PEGASYS and PEGASYS/COPEGUS combination therapy can cause serious side effects including:
• See “What is the most important information I should know about PEGASYS therapy?”.
• Blood problems including anemia: Anemia is a reduction in the number of red blood cells you have, which can be dangerous, especially if you have heart or breathing problems. Tell your healthcare provider right away if you feel tired, have chest pain or shortness of breath. These may be signs of low red blood cell counts.
• Serious infections.
• Stroke: Some patients may experience weakness, loss of coordination, and numbness due to stroke.
• Autoimmune problems: Some patients may develop a disease where the body’s own immune system begins to attack itself (autoimmune disease) while on PEGASYS therapy. These diseases can include rheumatoid arthritis, systemic lupus erythematosus, psoriasis or thyroid problems. In some patients who already have an autoimmune disease, the disease may worsen while on PEGASYS therapy.
• Heart problems: PEGASYS may cause some patients to experience chest pain, and very rarely a heart attack. Patients who already have heart disease could be at greatest risk. Tell your healthcare provider if you have or have had a heart problem in the past.
• Liver problems: Some patients may develop worsening of liver function. Some of the symptoms may include stomach bloating, confusion, brown urine, and yellow eyes. Tell your healthcare provider immediately if any of these symptoms occur.
• Nerve problems: People who take PEGASYS or other alpha interferon products with telbivudine (Tyzeka) can have nerve problems such as continuing numbness, tingling, or burning sensation in the arms or legs (peripheral neuropathy). Call your healthcare provider if you have any of these symptoms.
• Harm to unborn children: PEGASYS and PEGASYS/COPEGUS may cause birth defects or death of an unborn child. For more details, see “What is the most important information I should know about PEGASYS therapy?” in this Medication Guide.

Hectorsf

[BeatTheBeast]

I should have said in my post that the reason to consider trials would be if a new trial drug would have 100% or close to it SVR rate for "like kind" (naive geno 1 with same IL28B alleles) and 24 weeks or less of treatment.  Even with telaprevir, there's the possibility of 48 weeks of treatment and nonresponse or breakthrough.  There's no question of SOC only given that the approval of telaprevir and boceprevir is imminent.  Vertex reps say telaprevir will be in the pharmacies within days after approval.

BTB

[BeatTheBeast]

Yes indeed, your story is "like kind."  Did you have a liver biopsy and if so what was the stage?  When were you treated?  

It sounds like treatment options with better odds of SVR, shorter treatment time, possibly less INF and/or ribaviron, better dosing schedule (once daily or less), and fewer side effects of treatment may be available within a few years.  Knowing all that, if your liver disease were early stage, would you get treatment now or wait and what would you base that on?  (I'm very concerned about the side effects, both during treatment and long-term, and also am concerned about treatment now because the SVR rate even for telap and bocep is maybe 75%, not 100%.)

Many thanks.

BTB

[sunshines76]

My question is - are you considering clinical trials with new drugs only or is regular, now available to all of us, tx (interferon+riba) considered too? My personal opinion would be to avoid clinical trials and go ahead with the tx that your insurance covers and that doesn't limit you in any way as far as knowing your vl and dosages, etc.

Your story sounds just like mine. I was in my early 30s when diagnosed, got HCV through blood transfusion as a newborn. My LFTs were normal, didn't have any symptoms either. The decision was to treat with interferon+riba asap, not to waste time.

[willbb]

   That was certainly a rough treatment regime you went through,  After enduring all that I was wondering.. was it successful  ...I didn"t see that mentioned.

All the Best .

WILL

[BeatTheBeast]

Thank you for your post.  It is important to have input like yours in order to make informed decisions.  To that end, I've been dropping in at HCV support group meetings to hear what the experience of treatment is and was like for the patients.  That's a perspective the doctors don't necesarily have in the front of their minds when counseling patients.

BTB

[rambleon40]

I read once that 95% of people with Hep C will die with it, not of it.  That was some years ago.   Don't know if it's true.  What I am pretty sure is true is that Interferon / ribavirin do crazy bizarre things to one's immune system and body.  

If her enzymes are at normal levels and i were her, there's not a snowball's chance in hades that I would take the drugs.  

The following is what happened to me. I have posted in a few rooms.  My apologies for multiple posts.  I hope my experience helps some other person and do multiple posts hoping they will find it.



"I am happy to find this thread.  What I say below is truth.

I took interferon and ribavirin for six months from june 08 to dec 08.  I was advised of feeling flu-like symptoms.  I have had Hep C a long time.  I was feeling fine before starting treatment.  My doctor sort of pushed me into the treatment.  I was not wild about doing it.

So the treatment itself was very difficult.  Could not work.  Fuzzy vision.  Mental confusion.  Irritability.  Fatigue.  

During treatment, I developed psoriasis on me left elbow.  I did not know that's what it was.  I did not know what psoriasis was.  I knew that the warnings said "Tell you doctor if you are having skin conditions."  I did.  he shrugged and said "It'll go away."  I have since discovered on Medline that the appearance or worsening of psoriasis is for most clinicians cause to discontinue treatment.  

After treatment, psoriasis kept spreading.  in March, 09, my toes were hugely swollen and my feet were sore.

I had the most bizarre side-effect, too, in that spicy foods became intolerable in Feb - Mar 09.  that faded away.    

Long story short, I now have psoriasis on my penis, my scrotum, my legs, my arms, my back, my fingernails, my toenails.

I have psoriatic arthritis in my left ring and middle finger, my left wrist, my right wrist, my left ankle, my right knee, both hips, all my toes, going into my spine if I eat poorly.  

My thyroid went whacky, too, and it did not recover.  

I was handsome and strong before the treatment.  The interferon took much of my life away.  

I started treatment for psoriasis with "biologics" in May 09.   The "biologics" lessen your immune system. Bad side effects for liver - my liver enzymes went way up.  I have had to stop them.  Actually, they seem like interferon in reverse.  Very dangerous in their own right.

I now follow a fairly strict diet from necessity.  If I eat cheese, wheat, sugar, too much coffee, etc, i become crippled from joint pain.  My life has become dominated by fighting the side effects of interferon.  Sun lamps all the time in an effort to lessen my psoriasis.  Trying not to despair.  

It is my impression that interferon just amps up your immune system without much control.  It's like riding one of those bumper cars where the steering only kind of works.   You never know exactly what it will hit.  

It is very, very dangerous stuff.  Most doctors who prescribe it have no idea how dangerous it is, IMO.  I know mine didn't.  I believe that Roche minimizes the potential side effects.  

I am fairly certain that if the doctors had told me beforehand that I risked being crippled by joint pain and swollen stiff joints, I never would have undergone the treatment.  I was so sitting on the fence anyway.

My apologies for posting in multiple "rooms."  I just hope my problems can somehow help others.  It would bring me some comfort were it so.

[willbb]

I believe all trials have different protocols ,,in my particular trial the vl results were blinded until wk12, others here though I understand  that is not the case and hopefully they will chime in ,also whether or not I received a placebo or study drug is blinded until the end of the trial.
The blood labs are done every two weeks and were not blinded from the beginning.(other than vl)

But again all trials are conducted under different protocols and this would have to be something to inquire about up front if considering a trial..

Hope that helps

WILL

[BeatTheBeast]

Thanks for your post.

Do trials generally have blindness of viral load test results?  Other test results?

BTB

[willbb]

"There are so many variables to consider"
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This statement seems to sum up all your thoughts and yes today (thankfully) we seem to have more to think about and far greater options than in the past.

Everyone it would seem  has unique circumstances in regards to tx.and it would be hard to look at all the variables you have mentioned above and say ok...here is a definitive answer

It would seem Boce and Tela are going to be available in the near future and certainly the trial results has shown greater efficacy rates than current treatment regimes. They both seem to come with their own documented  side effects and how each individual will be affected is still an unknown.

The buzz in the medical community is that there will also be other drugs coming along ...again it seems with good trial results .

As  far as entering a trial...that seems to have it"s pros and cons also...you have the placebo aspect of most trials to take into consideration along with sometimes restrictions on rescue drugs and blindness of viral loads etc.,.however on the other hand there is no financial burden to the patient and also usually the care seems to be quite good within a trial,just to name a few.

So all and all ..yes there are a lot of variables to consider...and in the end  I guess it  is a very personal decision hopefully made with a knowledgeable doctor on how  best to  proceed..



Hope that helps some  ..and doesn"t confuse further

WILL