So confused!!

[Grace724]

Just a bit of background...my husband has HepC. Used to drink daily. Stopped in Feb. '08 after having his first bout with HepEncephalopathy. Liver biopsy done in mid July, results Stage 4, Grade 1.

We finally had a follow up appt. with the gastro doc last Friday. He decreased the amount of Lactulose from 2 T. twice a day to 2T once a day, in hopes of decreasing the # of BM's from 6-7 a day to 2-4 a day. He wants to see where hubby's ammonia level is w/ the decrease in Lactulose. So he gave us a prescription to have the following blood work done: Chem 7, CBC, PT-INR/PTT/Platelets, Alpha Feto Protein, NH3 (ammonia).

Hubby's platlets count has been very low for quite some time. Six months ago it was 58. His last blood work in July showed it had come up to 89. He said he would like to treat hubby's HepC but is concerned about beginning treatment with an already very low platelet count.

I asked him what genotype HepC my hubby has (had never been told up to this point) and he said Genotype 1a. All I know about that is that it's the hardest to treat.

I asked him how he would treat the HepC. He said with PegInterferon and Ribavarian. I asked him for how long and his answer was 24 weeks. I told him that I'd been doing quite a bit of reading up on the treatment and that I was under the impression that 48 to 72 weeks was more the norm these days. He said to me and I quote "Any one who is treating a patient for 48-72 weeks does not have a clue what they're doing." He said that he has been treating HepC patients for many years and has never treated over 24 wks. and has many patients who are SVR and remained that way. He says that he works hand and hand with the hepatologist in the practice and that they both follow the patient each step of the way during treatment. He said they do offer "rescue" drugs such a neupogen, procrit, antidepressants, etc. if necessary.

I'm totally confused. We really like our doctor. He comes highly recommended, as do all the doctors in the practice. That being said I don't feel good about the number of weeks he plans to treat my husband. Am I wrong to be leary? Or do I have the wrong information in my head?

I admit I've read so much that I don't have it all straight in my head. I really haven't taken notes or kept much of the information I've read in my bookmarks. I figured I'd get it all figured out when it came time, if it came time to go through treatment. Well that time appears to be near and I need to first get my facts straight and secondly figure out if our doctor is right or wrong about the # of weeks to treat.

I would love to hear from those of you on the board who are so well informed on the course of treatment for genotype 1. I'd also be very appreciative if you could point me in the right direction of some research that I can copy not only for myself to familiarize myself with but for our doctor if he is behind the times.

Thanks so much. I appreciate the knowledge each of you bring to the forum.

~Grace

[comeagain]

I had no steaotis biobsy done between treatments showed grade 1 inflamation stage 0 fibrosis, always been eating healthy no drugs in 21 years no alcohol no nikotin in 17 years . Moving a lot walking bycykling etc .

I dont know about any insulinresistans, thx for the info gonna check that up.

My doc said he was quite suprised i didn´t clear ar first tx , had some overweight though
bmi 28  also during bx and when started this present tx now BMI is 24.8 had been so for 4months hope that and the higher doses and extend tx will do the trick this time.

Where i live the protocol has changed in treating naive paitient geno 3, have a friend treating right now for the first time, he has weight based interferon and riba they also extended his tx because he wasn´t UND at week 5 ( he missed his week 4 apointment)

My first tx was peginterferon and it was weight based but not the same as for geno 1 which it is now.

ca

PS. Still think its amazing it took 6 years to figure that one out and change the ptotocol,
i think dr Dieterich extend his paitents tx that isn´t UND at week 4 to 24weeks after being UND.

[CoWriter]

"CoWriter I didn`t liked that you posted that link with that 2002 protocol for treating geno 2,3 because I´m a victim of it. "

Not really.  Your doctor didn't follow the NIH guidelines.  He underdosed the interferon.  So you were a victim of your doctor's lack of knowledge, to say it kindly.  


"This is so way out, when I asked my doc this about the riba why I 91 kg and she
64kg had the same doses he replied we have a studie ( and maybe a fuuucking statement from the NIH my thinking now when seeing this link) that showes that it
doesn´t make any differens in SVR rate with geno 2,3 if more riba and if extended tx. "

Actually there were multiple studies that showed that.


"When I started my second tx 10 months later I asked him again (comeagain lol)
since he was so sure  that  doses didn´t matter and neither the lengt, how come they now has changed the protocol and are giving all geno 3s weight based riba more interferon and also extended tx if not UND by 4weeks."

That's not true.  In 2006-2007 the dose of Peg didn't change.  It was 180mcg for Pegasys and weight based for PegIntron.  ALL Geno 3's don't get weight based Riba.  Some doctors are doing that for RELAPSERS for most docs still treat NAIVE patients with 800mg daily and 24 weeks (it's hard enough to get them to treat cirrhotics with 48 weeks).  


There were several things that could have been done better when treating Geno 3's.....

1.  Studies put Genotype 2/3 together so the results showed a high SVR.  But in reality, Geno 3 has a lower SVR.  Studies should look at them separately.  

2.  The tests used to check SVR were not very sensitive.  So they may have shown people were clear when they really weren't.

3.  Liver biopsies were not always done.  So they didn't know if patients had cirrhosis and needed 48 weeks of tx instead of 24.

4.  Since the steatosis in Geno 3's is caused by the virus, docs didn't think diet was as important as on Geno 1 which is associated with having insulin resistance.


Years ago, I told a hepatologist that I believed ALL Hep C patients were insulin resistant, even Geno 3......so diet (and weight loss if obese) would help decrease insulin resistance and raise SVR.....

And he laughed....said I was wrong.   But I turned out to be right.  Geno 2's and 3's are also INSULIN RESISTANT.....and insulin resistance LOWERS SVR.  And obesity also causes insulin resistance.

So you see...it may not be all about increasing the Riba dose.....but about loosing some  weight if you're obese.




J Hepatol. 2008 Jan

Insulin resistance and response to therapy in patients infected with chronic hepatitis C virus genotypes 2 and 3.

BACKGROUND/AIMS: Obesity is associated with impaired treatment responses in chronic hepatitis C. The aim of this study was to determine the relationship between the insulin resistance frequently seen in obese subjects and sustained virological response to anti-viral therapy (SVR) in patients with genotype 2 or 3 infection. METHODS: Eighty-two patients were studied; 59 received interferon/ribavirin while 23 received peg-interferon/ribavirin. RESULTS: The overall SVR was (77%). Patients with a SVR had lower mean serum insulin (10.7+/-0.8muU/ml vs. 22.2+/-4.9; P=0.03), fibrosis stage (1.9+/-0.1 vs. 2.7+/-0.3; P=0.007) and insulin resistance measured by the homeostasis model (HOMA-IR) (2.5+/-0.2 vs. 6.1+/-1.5; P=0.03). Age, gender, ethnicity, alcohol consumption, treatment regimen, viral load, portal activity and steatosis did not influence the SVR. By linear regression, body mass index (P<0.001) and fibrosis stage (P<0.001) were independently associated with HOMA-IR. After adjusting for fibrosis stage, patients with HOMA-IR of <2 were 6.5 times more likely to achieve SVR than those with HOMA-IR2. CONCLUSIONS: Even in treatment-responsive genotypes 2 and 3, high HOMA-IR is associated with a reduced response. Improving insulin sensitivity may be a useful adjunct to anti-viral therapy in these individuals.

[hepcgirlfriend]

Grace724,
my heart goes out to you...spent 10 long heartbreaking years taking care of my dad who had cirrhosis and most likely had hep c too, but docs didn't look for it back in the 80's. Oh that ammonia level....so tricky...dad hospitalized because of it many times over the years...remember the lactolose and all the blood transfusions!....it's a constant juggling act to keep their bodies balanced.  My boyfriend just completed his hep c treatment and watching what he went through....I think it would have been a huge challenge for my father to undergo such a treatment.  He should definitely be under the care of a liver specialist.
Good luck

[Trinity4]

Thanks again Jim.  Info has been extremely helpful.  Got home from work and felt like
c-r-a-p.  Head was banging, entire body aching.  Took my temp and it's 101.  Highest it's been in a long long time.  No throat, ear or stomach problems so must be tx. Thought that didn't happen when you got to week 23.  Got to go to bed and hopefully tomorrow can think straight enough to make some sound decisions.  I probably shouldn't have talked to the docs office today -  I knew I didn't feel good.  I started bawling after I hung up with them - something I rarely do.  72 wks - heaven help me!!  
Trin

[jmjm530]

For clarity, let me re-do the punctuation on that last part, plus add a little.

Given it all, I'd be very surprised if a top hepatologist would stop treatment at week 48.

Assuming you are UND by week 24,  72 weeks sounds like the magic number to me that affords you the most reasonable chances in the risk/reward equation. But even if you're detectible at 24, I'd still try for that second opinion given your stage 3 status. They may tell you to stop but I'd still want to hear it from the real deal. That means you might consider lining up that appointment ahead of time and even testing your vl prior to week 24.

[jmjm530]

Checked your profile. Stage 3 and if I remember in your late 50's? You did have at least a two-log drop by week 12 which is good or let's say a lot better than if you didn't. Given it all, I'd be very surprised if a top hepatologist would stop treatment at week 48, assuming you are UND by week 24. 72 weeks sounds like the magic number to me that affords you the most reasonable chances in the risk/reward equation.

[comeagain]

Grace your doc sound mighty dangerous to treat with, in my opinion.
Saying that he had treated patients for many years and never longer the 24w.

Yes if he has treated 2or 3 persons over 20years all geno 2 or 3 it could make a little sence but he also claims "many" have recived SVR and remained that, thats what suistained means remained.Your hubby isn´t geno 2 or 3 so he is talking ballony.

I urge you to get a second opinion.

CoWriter I didn`t liked that you posted that link with that 2002 protocol for treating geno 2,3 because I´m a victim of it.

In septemper 2006 I was on that regimen was on 800mg riba and not weigt based interferon either, I already then asked my doc how come i have the same 800mg riba
as a woman whoweigt 34kg and I´m 91kg.

CoWriter I can say that NIH was wrong.
This is so way out, when I asked my doc this about the riba why I 91 kg and she
64kg had the same doses he replied we have a studie ( and maybe a fuuucking statement from the NIH my thinking now when seeing this link) that showes that it
doesn´t make any differens in SVR rate with geno 2,3 if more riba and if extended tx.

When I started my second tx 10 months later I asked him again (comeagain lol)
since he was so sure  that  doses didn´t matter and neither the lengt, how come they now has changed the protocol and are giving all geno 3s weight based riba more interferon and also extended tx if not UND by 4weeks.

Then he said the study that had determen the protocol for geno 2 and 3 was performed in a south european contry where the people are smaller and thinner then in most other countries, he also mentioned that USA have lesser SVR rates compared with Europe because off higher weight in the population.

So first he answer the question with +, and a year later the answer to the same question is - and this is the amazing part its the same study hes backing up answer+ as in answer -

Are the docs this stupid I dont think so, its much worse then that its all albout money
I believe.

In Sweden the meds are paid by the taxes,that is money to so we have this fancy economic guys whos job is to save money, this is who i think they very well might
reason, what do we have here a diseas were a lot of the paitents are addicts or former addicts lets save there.

It seems  that in your country where I can imagen the insuranse companys play the same roll, since the protocol is the same in our countries.

It took 6 years to figure that one out how very convenigent and millions mabe billions of dollars saved = earned.

It could be an even bigger scandal that my ex bumped into when she was investigating if the alt ast nr could say something about SVR chanses.

The thing is the limit for them has been set higher a few years ago the reason for that is the that the weight among the population has increased.
But is that healthy people whos getting fatter? shouldn`t the limits be what is considerated healthy and not what is "normal" among an unhealthy population.

She also find a small study where they checked people who now with the new values
wouldent even be considered at risk but wih the old would have, and guess what 8 out of 10 had severe liverdamage they will just pull through in any regular blood check nowadays can you see the money saved =earned here.

You really got me going by posting that link CoWriter I´m all exhausted now but I tell you this if my suspisions are true the media is gonna get a hold on this when I´m of tx and have more energi.

ca

[jmjm530]

What some have done is to do a one-time consult with a out-of-town hepatologist, who then works with a local GI (or even family doctor). If your current doc has a problem with that -- seems he does -- than you could find another doc who is wlling to follow instructions from an out of town expert.

Don't know all your stats, but givenyou were detectible at week 12, I think it's pretty cut and dry they will recommend 72 weeks. In fact, it's even possible you could accomplish all this via a phone consult with all paperwork sent to the doctor in advance. Not usual, but has been done.

What you want to end up with is a recommendation from a leading/known hepatologist for extended treatment and a statement of willingness to work with a local doc or hospital. Of course, might be easier just to hop in a plane for a one-time consult.

I do feel for you and others who are geographically isolated from top care. I was fortunate due to both location and travel opportunity to have been able to see three leading hepatologists at various points during treatment. I was, however, able to consult with another three via email/phone in a more limited capacity.

-- Jim

[Trinity4]

I spoke with my NP today and could detect the disdain in her voice because I brought up the subject of extending.  I probably shouldn't have been so adamant with her that I would consult with another doctor (hepatologist) if they will not consider extending tx.  Also, made it very clear that my doc was not a liver specialist that dealt with the treatment of hepc everyday, even though he is listed under hepatology transplants.  All that means to me is he refers you to a transplant center once you become cirrhotic. I've stated all along he is behind the treatment curve but haven't really pushed any issues until now.  Of course, this is all contingent on whether I'm UND by 24 wks.  Perhaps he will be progressive enough in his thinking to consult with the specialist I end up seeing.   It is around a 400 mile round trip to the closest teaching hospital.  And then one must consider - How important is this to you?  Are you willing to make the financial sacrifice because I would be jepordizing my job by making bi-weekly trips.  Who knows -  It's unlikely he will cooperate only because most doctors respond negatively if they think you are questioning their ability - damn skippy I am!!   Might just be getting way ahead of myself here -  but I have to start thinking about this as it's going to be a difficult fusion of conflicting medical opinions.  Thanks for the info -  I remain hopeful till the end.

[jmjm530]

Not current on all the studies, but the one related study that I do remember doesn't recommend stopping tx if detectible at week, 4 but does suggest extending tx past 48 weeks if detectible at week 4. This is even a more agressive approach than extending to 72 if >two log drop at week 12 but UND at week 24. As to stopping tx if still detectible at week 24, one consensus I is that continuing is "moot" but some have brought up the notion -- and a study -- that this subgroup could find benefit extending beyond 72 weeks using a formula based on viral response.

As with so much in this field, once you start getting a little out of the box in terms of matching your stats with study stats, tx decisions start becoming more art than science. Here's where a an experienced and crackerjack medical team come into play, as their "guesses" are at least based on more anecdotals from their practice. In my case, I sat around while my eminent hepatologist and his NP disagreed significantly in how long I should treat :)

All the best with your week 24 results.

-- Jim

[Trinity4]

It's my understanding that the latest studies now indicate that RVR is when UND is achieved at 4 wks.  Even with a 2 log drop at 12 wks, people are considered slow responders and treatment duration should be extended to 72 wks.  I have been told repeatedly on this forum that I should treat for 72 wks since my vl was 793 at 12 wks which was a 3+ log drop but still considered a slow responder because I did not clear.  Of course, 24 wk PCR next week so it could be a moot point.  I have read the newer studies which indicate extending treatment to 72 wks and studies that say if you are not UND at 4 wks treatment should be stopped even with geno 1's.  This is very confusing to me as well.  

[bandman54]

just to avoid confusion..

http://consensus.nih.gov/2002/2002HepatitisC2002116html.htm


"Early viral response (EVR), defined as a minimum 2 log decrease in viral load during the first 12 weeks of treatment, is predictive of SVR and should be a routine part of monitoring patients with genotype 1. Patients who fail to achieve an EVR at week 12 of treatment have only a small chance of achieving an SVR even if therapy is continued for a full year. Treatment need not be extended beyond 12 weeks in these patients."


So, some geno 1s may not be allowed to continue for the full 48-72 weeks...This confused me at first.

bandman

[CoWriter]

Every few years, the National Institutes of Health conducts a big conference with all the top hepatologists in the nation.  They review all the latest studies and write new guidelines for treatment.

Tell your doctor that according to the National Institutes of Health Consensus Conference on the Management of Hepatitis C, treatment for Genotype 1 should be 48 weeks.

There is NO WAY he can say that the NIH is wrong.  Here's the link and the section that says treatment should be for 48 weeks.....


http://consensus.nih.gov/2002/2002HepatitisC2002116html.htm



Treatment of Naive Patients

"a 24-week course of pegylated interferon and ribavirin was found to be as effective as a 48-week course in patients with genotypes 2 and 3, but not in patients with genotype 1. Similarly, a reduced ribavirin dosage of 800 mg daily appeared to be adequate for patients with genotypes 2 and 3, but the higher, standard dosage of 1000 to 1200 mg daily yielded better response rates in patients with genotype 1. Thus, 24 weeks of treatment and an 800 mg dose of ribavirin appears to be sufficient for persons with genotypes 2 and 3, while PATIENTS WITH GENOTYPE 1 NEED 48 WEEKS OF TREATMENT and standard doses of ribavirin."



I agree with the others....find a hepatologist who's used to treating cirrhotics with low platelets and won't want to reduce doses or stop the treatment as soon as the platelets go down a little.

[jmjm530]

As stated, something is wrong. Standard treatment for geno 1's is 48 weeks. Also, given the fact that your husband is stage 4, I personally would not play around with a GI, who on the whole are less knowledgeable and experienced than Hepatologists (liver specialists). You should be able to find a hepatologst at your local teaching hospital. Better to travel a little for good advice than to get bad advice locally.

[copyman]

Something does not sound right. The standad is 48 weeks but maybe with cirrhosis your doctor only treats for 24 weeks. There is a chance that treatment can worsen cirrhosis , maybe that is behind your doctors thinking. Tell him you can provide documentation from ClincalCare.com from top hepatologist like Dr Afdhal, Shiffman,etc, etc that 48-72 weeks is standard. Of course there are drugs in trials that hope to get treatment for genotype 1a & 1b down to 24 wks. Best of luck

[Trinity4]

Your GI is wrong -  geno 1's treat a minimum of 48 wks with SOC. Given the degree of liver damage your husband has, 72 wks could also be a consideration.  Find another doctor immediately, preferably a hepatologist who can provide you the accurate information regarding your husbands treatment options and current condition of his health.  Platelets do drop during treatment and someone with cirrhosis can have an extemely difficult time with that problem.  Good Luck and please find a liver specialist as soon as possible.
Trinity