Double Chances of SVR (cure) on SOC

That's correct. Double your chances of SVR on SOC (standard treatment) by treating with a Hepatologist (liver specialist) as opposed to treating with your Gastroenterologist or Family Doctor. At least so it appears according to this recent study, posted earlier by "Orleans" but lost in yesterday's shuffle:

http://www.hivandhepatitis.com/hep_c/news/2007/100507_b.html

The difference was absolutely astounding:

SVR (cure rate) WITHOUT Hepatologist: 66% (genotype 1 and 4)
SVR (cure rate) WITH Hepatologist: 34%  (genotype 1 and 4)

SVR without Hepatologist (signficant liver damage): 25%
SVR with Hepatologist: 69%
--------------------------------------------------------------------------------
While the incredible difference in SVR rates is more than anyone would have guessed --  from what I've seen posted here over the past two years it doesn't surprise me that treatment outcomes would be signficantly higher when treating with a hepatologist versus a GP or Gastroenterolgist.

While the study mentioned "less frequent treatment interruptions or dose reductions" as the primary reason, there's no doubt a lot more to it, including more liberal use of helper drugs like Procrit and Neupogen as opposed to pulling patients off of treatment prematurely (or as mentioned in the study, "dose interruptions"); plus the overall knowledge and experience a hepatologist imparts to the treatment process which can be manifest in other numerous ways.

For those not familiar, Hepatologists can usually be found at your larger, teaching hospitals. They are NOT the same as Gastroenterologists or Gastroenterologists that treat Hep C.

For anyone thinking of treating -- or anyone treating not happy with their doctor or in need of a second opinion -- take this study to heart and see a Hepatologist (liver specialist).

-- Jim

[jmjm530]

Here's an abstract summary:

Treatment Outcomes in HCV Patients Whose Therapy Is Supervised by Expert Hepatologists

Prior large, multicenter trials have reported sustained virological response (SVR) rates of 45%-80% in individuals with chronic hepatitis C. However, few data are available concerning whether similar SVR rates are achieved in "real world" settings (outside clinical trials), and to what extent success rates depend on supervision by expert hepatologists.

German researchers at the University of Dusseldorf conducted a retrospective study that analyzed these issues among patients at their outpatient clinics during May 1997 and March 2004 who received at least 1 dose of interferon-based treatment.

Results

    • A total of 302 treatment-naive HCV were included in the analysis.

    • 215 patients (72%) had HCV genotype 1 or 4, 78 (25%) had genotype 2 or 3, and 9 (3%) had an undetermined genotype.

    • Of these 302 patients, 196 consulted an expert hepatologist at least once every 3 months during treatment (regular visitors), whereas 106 patients had their treatment performed and supervised by a general practitioner (irregular visitors).

    • The 2 patient groups did not differ in their baseline characteristics.

    • Virological response rates at the end of treatment (ETR; 74% vs 48%; P < 0.001) and 6 months thereafter (SVR; 66% vs 34%; P < 0.001) were significantly higher in regular visitors.

    • In patients treated with pegylated interferon plus ribavirin, this difference was highly statistically significant (P < 0.001) for those with HCV genotypes 1 and 4 (SVR 61% vs 27%; P < 0.001), but not for those with genotypes 2 and 3.

    • SVR rates were also significantly higher in regular visitors with advanced liver damage (SVR 69% vs 25%; P = 0.004).

    • Among regular and irregular visitors, 7% and 15%, respectively, discontinued treatment prematurely (P = 0.015).


Conclusion

These results led the study authors to conclude, "Patients with…genotypes 1 and 4 or with advanced liver damage benefit from HCV therapy supervision by a specialist, probably because of less frequent treatment interruptions or dose reductions."

Klinik für Gastroenterologie, Hepatologie und Infektiologie, Universitätsklinik Düsseldorf, Moorenstr, Düsseldorf, Germany.

10/05/07

Reference
A Sagir, T Heintges, Z Akyazi, and others. Therapy outcome in patients with chronic hepatitis C: role of therapy supervision by expert hepatologists. Journal of Viral Hepatitis 14(9): 633-638. September 2007.

[glucklich]

Intersting article,
Guess which one I had the first round?
Sigh my early error.

[FlGuy]

Interesting to see data, although I think some is reversed. I'm glad I  consulted with a liverhead who worked with tx doc (gastro) to work me through tx 2.  Went to see the tx doc this week to map out post-tx schedule.  Most made sense; another pcr at 3 months, AFP, CT, LFT, CBC, TSH all at the same time. And, ongoing scehules for alternating CT and US, endoscope (once a year), colon (3 year increments, yeah).  Then he astounded me by suggesting maint dose of peg even if svr to aid fibrosis (am early cirrhosis).  At that point, I said hold the phone - think we should engage the liverheads again.  Expert advice, if not care, is crucial.

[susan400]

I'm not disagreeing that seeing a hepatologist is a good idea, but not all communities have easy access to a hepatologist, whereas there are plenty of gastroenterologists close by.  In all of my county there are not any hepatologists.  I drove all the way up to Jacksonville and saw the hepatologist up there as part of my study, which incidentally-I still did not clear.  They did not even see a reason for me to follow-up again with them, and were going to just have me go back to my gastroenterologist.  I, however, made an "outside of the study" appt., for 6 mon. from now, up there.  So, I am going to be seeing my gastroenterologist until that time.  Also, my gastroenterologist is very caring, he is really into researching Hep C and attends all the meetings-like the big one that's coming up in Nov., and he helps to go over my general overview of it all...whereas, the hepatologist is all business and very rushed and really doesn't have a type of personality where I can spend time discussing what to do with all of this stuff.  So, that's my experience.   Susan

[honey11]

FIGuy,,,,Lets hope that you reach SVR!!  That does surprise me about him suggeting maint dose though because once you have reached SVR, then your liver would continue to heal or is this old school and now people with fibrosis are continuing maint dose?

Jim,,,Thanks for posting that and I beleive it!!  I had to change up mid tx due to my  gastroenterologist wanting me to stop tx for a week due to hemo drop.  I then found a heptalogist quickly and he told me not to quit the meds and scheduled me in his office the next day and prescribed procrit. If it wasn't for me also coming here and talking to folks,,,,I may have stopped my tx for a week,,,,not knowing any better,,,,,

[mikesimon]

Did you consider that statistics from Germany might not be 100% applicable to the US where most of us treat? Or did I miss something - it was a German study population wasn't it? I am not trying to be argumentative - it just crossed my mind. And one other thing - I think you have the numbers reversed making it appear as though there is a greater likelihood of SVR WITHOUT a hepatologist. Mike

[jmjm530]

Sorry about the reversal of numbers. Early morning post.

Mike, I wouldn't be surprised if the numbers were more tempered in an all U.S. population, but these numbers were so dramatic, it really does give one pause. Even if the U.S. numbers weren't half as good, it would still make a very strong case to see a liver specialist if you possibly can. Don't you agree?

-- Jim

[mikesimon]

Once I back away from it and take out of the equation how knowledgeable the members here seem to be, yes I do agree. My immediate reaction is that we all know this stuff pretty well and would push against a GI who was deviating from the right course but we are probably not representative of the HCV infected population at large. Does the word "compulsive" seem appropriate or at the very least, "well informed". Mike

[nygirl7]

I went to a GI and told him what a Heptologist would do and turned him effectively into my own personal hepdoc from being in here.  I just couldn't afford a Jacobson or the like.  That's what any good compulsive obsessive HCV patient who couldn't see a heppy would do, right?

I do agree that the wiser the doctor who does NOT involve dose reductions and the like...is the better chance at success.

:)

[gauf]

I learned this the hard way too. My Infectious disease doc never even mentioned my risk of fatty liver disease, or weight based riba. I blindly followed her advice which really hurt my chance of an SVR. Wish I knew then what I know now.

[willing]

interesting study, but it would be more remarkable if it showed that visiting a hepatologist, and thus benefiting from "cutting edge", individualized, strategies actually increased your chances of SVR *beyond* the baseline set by the large scale clinical studies. (the overall 66% SVR rate, with 25% geno 2/3  is what just one would one expect  from the published odds, say .75*.60+.25*.80)

As it stands, it sounds they're saying visiting a hepatologist is a proxy for the 80/80 adherence rule, which to me sounds like  waste of a specialist's time. From their conclusion:

"Several phenomena may account for this, however, one major reason may be that therapy-associated side effects may lead, in the absence of a specialist, more frequently to premature dose reductions and/or unnecessary treatment discontinuation. In line with this, treatment interruptions/discontinuations occurred significantly more often in irregular visitors when compared with RV. Our results show that SVR rates in patients infected with HCV, which were seen regularly from a specialist were well comparable with published success rates from large multicentre studies, whereas treatment success is only half, when no specialists are involved during treatment. "

A good PA+an informed patient are sufficient to ensure adherence to protocol; hepatologists have much more significant applications for their specialized skills. I tend to agree with Mike that one of the points this study makes indirectly is that seeing a hepatologist will be of little benefit for the typical participant on this forum who is already at full adherence. Incidentally, my anecdotal observation of this forum is that the SVR rate here, particularly for those extending tx, seems *higher* than the baseline odds.

[jmjm530]

Unfortunatly, that's not what the vast majority of HCV patients do. This group probably goes to one doc, doesn't do a lot of research and probably doesn't scour the internet for information. So if their doc drops the ball, then the ball is dropped.

But even for many of us here -- how many find out just a little too late in the treatment cycle that they should have had this or shouldn't of done that.

Everything equal, always best to start with a knowledgeable doctor or switch to one if possible. Unless of course you have the time and motivation (like I did) to be totally compulsive and direct your own treatment. But even then, you need a doctor who will be compliant to your wishes. I got PCRs WEEKLY from week 1 until UND. Even if someone else wanted that, unless the doctor agrees, it would be very difficult. Same with the helper drugs. We've had more than one person here rightfully ask their doctors for some only to be turned down.

-- Jim

[jmjm530]

The numbers speak for themselves. And so do the experiences of many here who have had bad treatment guidance -- more so under the care of a GI than a Hepatologist.

If you're saying that the same can be accomplished by a "well-informed" patient and a "good" PA -- in many cases it just doesn't play out like that.

How knowledgeable were you during the critical first 4-12 weeks of treatment? Maybe you were, don't know, but I wasn't. And from what I've read here, many folks who have become knowledgeable, picked up their information somewhere mid treatment. Again, often too late. How many times have we heard, "If I only knew then..."

And patient knowledge is just half the equation. The other half is getting the "good" PA to order up the right tests, do the right PCRs and administer the right helper drugs. I daresay that unless they work with a cutting edge hepatologist, getting everything necessary may not be that easy.

And then there are other reasons to see a Hepatologist, including pre-tx evaluation, sophistication of treatment approaches, etc.



-- Jim

[jmjm530]

Just one example of the above -- of many examples.

"Gladitsnotworse" posts today from the other side:

Your comment was exactly the thing I needed to hear today. It has helped me make my decison to  find another md. I treated with my GI and he did not want to give me procrit or neupogen. He felt it best to reduce the Ribaviron. I am a 1a, biopsy stage 1, 40's female, with 8million vl. I cleared at 12 weeks, then it showed back up 3 months post treatment on pegintron. I am considering retreating and my GI says this time he will give me the extra meds I need. I wanted to wring his neck. I wasted a year of my life going thru treatment. I found a hepatologist in Charlotte just now with my insurance company. Its 100 miles away but if it even gives me a small edge in reaching permanent svr it will  be worth it.
-------------------------------------------------------

How many times here have we heard similar?

Again, most of us that become "experts" , often get that knowledge a little to late to be of maxium benefit. And many, just don't have the time, energy or 'obsession' to do the work that their doctors should have done in the first place.

-- Jim

[PSP-n-Me]

"A good PA+an informed patient are sufficient to ensure adherence to protocol; hepatologists have much more significant applications for their specialized skills."

I absolutley, totally - 100% agree with this statement - but what do I know I am a *dip* :)

[willing]

>how many find out just a little too late in the treatment cycle that they should
>have had this or shouldn't of done that.

based on observation of this forum, I'd say that was a small number indeed. For most people there it  seems to come down to
(a) stay at full dose (with procrit/neupogen if needed)
(b) know when to stop

The value of that study may be that it underscores the cries of "don't do it" every time someone posts that their GI recommended a dosage reduction.

(b) is the tricky one and that primarily depends on the availability of data; a  hepatologists' training doesn't provide them with a crystal ball. For example, my high-end-specialist gave me the same recommendation as my GI re continuing to 72 : don't bother. Back in '03 the available data  indicated:

"In an early randomized trial, patients with genotype 1 who were naïve to interferon were given 48 vs 72 weeks of combination therapy, and there was no difference in sustained virological response.[71]"  (from that Scott/Gretch JAMA review).
Frijole, I suspect, was in part bitten by the fact that Berg's second study did not specifically track patients with VL from 2-50 at 12.  

At least as far as this study is concerned, seeing a hepatologist didn't imply any  variation beyond cookie-cutter SOC in tx:

"All patients included in this study underwent combination therapy with standard IFN-α or PEG-IFN-α plus ribavirin. Depending on the HCV genotype patients were treated for 24 weeks (genotypes 2/3) or 48 weeks (genotypes 1/4) with IFNα-2a or -2b (3 μg three times weekly)– or PEG-IFN α-2a (180 μg once weekly) or -2b (1.5 μg/kg/week) plus oral ribavirin (Rebetol, Schering Plough; Copegus, Roche, Germany) at a dose of 1000 mg (weight 75 kg) daily. "

thus the significant difference in outcome pretty much has to be due to adherence.

[susan400]

Just another point I'd like to add:  My gastro doc, on my treatment-before the study where I ended up at the hepatologist office-DID give me both Procrit and Neupogen.  When I went to the Hepatologist's office at the big diagnostic center, I was in the study and was not allowed to have rescue drugs.  Hmmmm.   I think that my Hep Dr. (a gastro) is knowledgable enough to help me.  Also, the hepatologist's office is not covered under my insurance as in, on their list of preferred provider's so I have to be able to come up with the $100-$200 up front out of my own pocket and then, turn around and get reimbursed (a portion of the expense), whereas my gastro doc is on both my Medicare and my supplemental insurance.  Since I'm not employed, I think that it's obvious which doctor I'll be spending more of my time at--unless the costs are all covered by a study.  Susan

[willing]

PSP: I'm not sure what squabble led to that label, but, from my end, I much value your input here (and I like your reminders that even an allegedly sluggish/overloaded bureaucracy may be less hazardous to one's health than someone with a vested financial interest in denying coverage!).

Jim: that one's too easy.. how much value would  a hepatologist appt. bring to zazza (who was teetering on the very edge of UND at 12) or stiffneck or Susan?

[susan400]

I'm not saying that they're not valuable, but I can't afford to go to one on a regular basis--without the drug company footing the bill!

Susan

[jmjm530]

Willing,

We must have signficantly different readings of the posts here over the past two years. Almost every week, I've read cases posted where adverse action was taken (or not taken) where a good hepatologist probably would have made a difference.

And even if that were not the case (and I strongly think it is)  the study speaks for itself and not everyone (even here) has the time to invest in becoming "well-informed". And again, that "Don't Do It" post you're talking about, all too often is a "You Shouldn't Have Done It Post".

Susan,

Study protocol is study protocol and it's laid out in advance. I'm talking about private treatment.

As to the issues you bring up, I certainly understand your point. And I'm not saying that everyone should rush out to see (or switch to) a hepatogist. Logistics and economics may make that impossible. But if logistics and economics are OK, then that would be my recommendation for anyone treating.  And also, you're one of the very knowledgeable ones, who has been reading and contributing to this forum for a long time. People in the study cited -- and many here -- are relatively new to the process and more times than not, may not question their doctors. So, if they have the wrong doctor, they can end up getting the wrong treatment.

-- Jim

[willing]

I'm certainly not saying that either; just quibbling with the "halo" effect. One has to be realistic about what they can contribute, which often may not be much. Still, I plan on continuing to see mine occasionally, and given your extraordinary history I would think you would as well. BTW, R1626, as foo posted above, is recruiting for phase II. If anyone  deserves a shot at combined R1626/Vx950 therapy I think it would be you.

[PSP-n-Me]

thank you for your kind words :)

[moahunter]

I wonder if it might not have more to do with where you are treated, versus by whom. It seems to me that if you are treated by a larger hospital / university, you will probably do better with almost any disease. There is just more in-depth experience of more types of illness.

In my case I am being treated by an infectious diseases specialist (due to HIV concerns at the time of initial infection). However, she confers with Heptologists in the hospital. She told me that I will stay with her, basically so that she can learn more about this disease from them. She has made good decisions IMO (including stopping a treatment that was not working), so I trust her.