Need to Get Some Clarification on What a Dr Told Us.

My husband has hep c and mild to moderate cirhossis.  His dr was going to put him on the triple therapy with incivek.  That dr is no longer practicing, so found another liver specialist.  We were told my husband is not a good candidate for the therapy, and due to certain criteria feels he's at a 30% or less success rate, if he takes the therapy.  And also said if he decided to take the risk and go on this medication, he would never again be eligible for any future treatment.  We went to get another opinion, and this dr never heard about this happening, and felt it would be worth trying this therapy.  I then called the mfr of the medication incivek, to see what I could find out.  And they did say something about a possible intolerance for future therapies if on this triple therapy for too long.  But also said there is no defined data, that proves this is 100% the case.  So I'm confused as to what to do.  Does anyone know anything about this...or can offer us some advice. I'm trying to be there for him emotionally, the best way possible.  It's hard, though, not knowing what the right thing to do is, and wanting so much to give him positive reinforcement and hope.  Thanks.

[curiouslady1]

They are beginning to schedule trials for people who fail the triple with newer drugs from another class.  The trials haven't started yet and they are not for cirrhotic patients.  Doesn't mean they won't eventually be applied to cirrhotic patients; probably they will be.  But probably they will be applied to cirrhotic patients even without having failed the triple and perhaps with better odds.  Anyway, the efficacy is somewhat up in the air right now for all.    

Still, based on what you are writing here,  neither doc seems to be up on the latest developments and understanding of HepC and the treatment mechanisms.  Perhaps they are strong in the liver department but not so strong in the infectious disease area.  The second doc who "never" heard of such a thing doesn't seem up on drug resistance and the first doc does not seem up on the newer drugs.  

Nevertheless, the research is very new and trials are only gradually bringing in cirrhotic patients.  I would ask the first doc what he would then suggest your husband do?  Is he concerned about side effects?   In addition, you will want to do your own research by using this site, searching the archives, looking for new drug news, reading what others have to say, etc.  

[willbb]

Hi there...If your husband  has cirrhosis ,and still compensated then he is a candidate for the triple therapy. Many people with cirrhosis currently here and some in the past in trials  for both the new approved drugs (Victrelis and Incivek) have  successfully treated with either one of these.

What the manufacturer was most likely referring to ...if he is not having a good enough response ..then there are time frames where he would stop the drug so as not to develop resistance ,however this is certainly not a reason to try therapy.

The doctor you went to and told you he should consider trreatment is correct. Is he a hepatologist,as  this is who should be overseeing his treatment,seeing as he has chirrosis (cirrhosis)

Welcome to the group and keep asking any questions you may have..
Will

[eureka254]

You will find many differing opinions from both doctors and regular folk about whether someone should or should not do treatment, and which treatment is the right approach.  There's no one right answer, but understanding the risks and benefits of all the options will help you and your husband make an informed decision.

Early cirrhosis is an indication that your husband should get rid of his virus sooner rather than later.  If doctors are discussing Triple therapy, I'm presuming your husband has genotype 1 hcv.  Although it is a challenging genotype and even more so to rid in someone with cirrhosis, it can be done.  There are a number of folks here who have cleared with triple therapy and cirrhosis.  

Perhaps that one doctor doesn't feel 30% is worth his investment, but my view is 30% is better than a sure 0% if your husband doesn't treat.  The question of whether or not to do triple, which triple, and for how long is very much an individual decision and guided by response.  

Because the triple therapy is fairly new there is no long-term data yet, so the full understanding of hcv mutation and resistance is still being explored and worked out -- and there is a small possibility of not being able to treat again right away if he is not successful with current triple -- not forever, but possibly not for a while. All the more reason why it's important to have someone who is very knowledgeable about these new treatments so as to minimize these possible pitfalls.

If your husband has never done treatment before, it's also possible to consider doing SOC and see how he responds at different points; many options to consider, but most important that your husband consider these, as being diagnosed with cirrhosis makes it that time and hcv is not on his side.  Hope that helps, keep asking questions, and welcome to the forum. ~eureka

[write2unique]

Thank you all for taking the time to respond to my posting.  I'm so grateful for the information you've all provided.  Every bit of knowledge we gain helps in gaining some confidence in the decision we make.  It's a good point to look at 30% still being hopeful, rather than looking at it, as not worth trying.  My biggest concern was certainly his resistance to future medication for treating hep c.  But being that he does have cirhossis it's important to stop the virus as soon as possible, to lessen the inflamation (inflammation) on his liver and to stop the progression of the disease.  I'm so thankful to all of you for sharing the information you have.  It does seem that each dr we go to, we learn a little bit from each one but not any one has all the answers.  I've definitely found that doing my own research is critical in this process.  I saw that other drug name (Victrelis) thru some reading...but didn't know if it was a different therapy all together or if it's the same type of triple therapy as with incivek, just a diff manufacturer.  Is it different altogether?  Never heard of SOC before.  But eureka you mentioned it is used for those never having been on any therapy prior.  My husband was a partial responder to an initial interferon and ribovarin therapy.  So I guess that means it wouldn't be an option for him.  The dr that told us he's at 30% or less, said there are other therapies being tested and to wait for something to come out, where he's more of a candidate for.  Since he already has cirhossis, it's not as if we have a lot of time to wait.  The current dr that wants to put him on the triple therapy did say he just treated a woman with very mild cirhossis and she was cured from the virus.  But he did also said it was within 12 weeks.  And I thought that the viral load being reduced in the first 12 weeks is positive, but does not mean a permanent cure.  Does anyone how that works?  My husband is further along with his cirhossis but the dr feels that people can beat the odds, and defy many times what medical science may not have proven to work.  That does give us a reason to try anything that may even have a remote chance of working.  We do know about the side effects, and they are pretty scarey, but he's willing to do whatever it takes and deal with them, with the help of his doc as they happen.  Is there a difference with Victrelis to Incivek?  And does anyone know if 12 weeks can be a point where the virus can be dormant and stay there without further therapy?  

[curiouslady1]

It is not clear what is meant by "cure within 12 weeks".  Does this mean she had an SVR 12 (meaning she has been UND for at least 12 weeks after dosing stopped)?  Does it mean she achieved an UND status by 12 weeks?  Not sure what this means.  This is not like HIV.  This virus doesn't stay dormant as far as I have ever heard.  It is either there and detectable or not detectable or it is not there.  If it is undetectable then it should stay that way for 24 weeks beyond the time all treatment is stopped before a cure (eradication of the virus) is announced.  

It is my understanding that if he tries the current therapy and fails, he will be able to try the newer drugs later because they belong to a different class and drug resistance will be less of an issue but they are at pretty early stages of working with cirrhotic patients with many of these newer drugs.  

[willbb]

My biggest concern was certainly his resistance to future medication for treating hep c.  But being that he does have cirrhosis it's important to stop the virus as soon as possible, to lessen the inflammation on his liver and to stop the progression of the disease.
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This seems to be an important part of your post. There are many new drugs for HCV in the pipeline,however they very well  be still 3  to 5 years away and the fact as you mentioned ..the benefit of trying therapy  "now "  with cirrhosis far outweighs the risk of worrying about treatment failure and possible resistance down the road,IMO

I wouldn't put not too much stock in the  "only30%" chance of success with the new drugs. Yes as a previous "partial" and the cirrhosis ,the chances are usually lessened somewhat ,however ,there are also many other factors considered.
Actually in the "Respond 2 .trial " (Victrelis) for partials with cirrhosis the success was much higher than that.

The two new drugs (Victrelis  & Incivek) are from the same class  called Protease Inhibitors,however they are made by two different drug companies and have somewhat different dosing regimes and side effect events,however in terms of success ,relatively the same rates.

As far as the 12 week mark and the drug  being "dormant " as you say.

As a previous  "partial"  and chirrotic   the recommended time to treat . with either of these drugs(Incivek or Victrelis) is 48 weeks  combined with Interferon and Ribiviran..
SOC is the term used for the combination treatment(just INF. /Riba) that he did before,however the chances of that being successful again would be almost nill.

I would agree with the current doctor  who wants to get him started with one of these new drugs..sooner rather than later because of the cirrhosis  as he still has a good chance of success.

Keep asking questions..there are many  knowledgeable people here ..who have treated with cirrhosis..

Best

Will

[spectda]

As you understand your husband having cirhosis somewhat reduces his chance of success with the currently approve triple treatment of either interferon/riba and victrelis or interferon/riba and incivek.

His previous response to interferon and ribavirin (SOC) is the biggest factor in predicting his chance of success with either of those combos of drugs because they still rely heavily on interferon and ribavirin.

What exactly do you mean by his previous partial response? What was his starting viral load last time? Do you know what his viral load was at 4 weeks of treatment? Did he ever become undetectable? How long did he treat for?

Victrelis and Incivek are both protease inhibitors that work in a similar manner and have somewhat similar resistance profiles. Incivek seems to be slightly more effective the Victrelis, has more side effects and shorter time (about 2 years) before resistance virus from unsuccessful treatment returns to the "normal" wild type virus.

No one yet knows how newer classes of medications will work for people who have previously treated and developed resistance because they were unsuccesful with one of the approved new protease inhibitors or some of those still in trials. Some are starting to retreat and some seem to be having success.
-Dave

[Advocate1955]

My husband is Hep C, genotype 1, with beginning Cirrhoiss.  He is a previous partial responder to two treatments 1) SOC Standard of Care:  Interferon and Ribavirin) and 2) daily infergen injections (another variety of interferon) + an increased dose of Ribavirin.  He is now on triple therapy with Incivek, and so far so good.  His viral load was 78 at week 4.  We don't have week 8 results back yet.  His doctor has said if Incivek doesn't work, he won't be able to try Victrelis, because they are similar and if one doesn't work, the other won't work.  However, his doctor has also said that if Incivek doesn't work, he will be a candidate for new medications currently being developed and expected to be available in a year or two.
Advocate1955

[eureka254]

So your husband has already done previous Standard Of Care, Interferon and Ribavirin, so it would not be worthwhile to pursue that again; since he has already experienced treatment once, perhaps a second round with one additive may not be much worse, hopefully. As spectda says, the fact that he did have some response last try makes him a good candidate for triple therapy.

As you and your husband consult with different physicians, doing research and educating yourselves will help a great deal in helping you find the right doctor.  Because your husband has cirrhosis, a hepatologist with ties to a Transplantation center or someone with extensive experience in treating viral hepatitis is the best option if possible.  

Because your husband has cirrhosis, it is important for him to be proactive, not only in seeking to rid himself of the virus, but also to do his best to preserve his liver function.  NO alcohol, low fat, high protein, low salt are all important considerations in his diet, as well as adequate hydration (especially if he goes on treatment).  It's important that he be screened every 3 to 6 months with a blood test called AFP and have imaging (via ultrasound, CT-Scan or MRI) at similar intervals.  He should also have an endoscopy to check and make sure he has no complications due to his cirrhosis.

As you navigate your way around, you might find this list of abbreviations and explanations helpful:  

http://www.medhelp.org/health_pages/Hepatitis/Hepatitis-C-Acronyms-Abbreviations/show/3?cid=64