Case for Geno 1 Tx Extension/Kaiser

This is a call for assistance.  A friend is going to be aggressively petitioning Kaiser Permanente for tx extension this week, and we want to make sure we have collected all the essential studies.  We have the Drusano and TeraVic in hand, for starters.   The treating doc attended the last AASLD conference,  but this doesn't guarantee anything.

Her stats:   Was on reduced dosage Peg-Intron for 6 months because of severe anemia; finally, in June, started full dosage.  Experienced EVR.  However, her 6-month PCR still shows detectable RNA.  (Viral count not in yet.)   Doctor promises to review after count is back, but in the meantime has rx'd just one additional shot.  Doesn't look good.

Given this situation, and Tony's, it would also be helpful for all Kaiser patients to share as much information as possible, as this HMO's treating guidelines strike me, at least, as two years behind the beat.

[BobK]

" Her stats: Was on reduced dosage Peg-Intron for 6 months because of severe anemia; finally, in June, started full dosage. Experienced EVR. However, her 6-month PCR still shows detectable RNA. (Viral count not in yet.) Doctor promises to review after count is back, but in the meantime has rx'd just one additional shot. Doesn't look good."

What was her start date for tx?  How long was she on full dose prior to dose reduction?  Was she treated with growth hormones (procrit ect)?  Was EVR after re-starting full dose or prior?  How long has she actually been taking the drugs?

Important questions whose answers will help focus the research.

regards,
BobK

[annainitaly]

scott,

I've read about your relapse. I'm so sorry about it. not so many words to add, just hope you'll get a smooth way through your tx next time and (most of all) I hope it will be the last time.

anna

[cuteus]

I copied the results of a very small study(9 patients) done in Israel. Why?
8 out of 9 achieved svr with extended tx. heck, I pay attention to that! to hell, the small sample part. like Scott said, anemia is not caused by the ifn, I was riba reduced not peg reduced. Kayser just sounds better and better.
check the hepatitisdoctor.com site for info on customizing tx.

[Califia]

" Her stats: Was on reduced dosage Peg-Intron for 6 months because of severe anemia; finally, in June, started full dosage. Experienced EVR. However, her 6-month PCR still shows detectable RNA. (Viral count not in yet.) Doctor promises to review after count is back, but in the meantime has rx'd just one additional shot. Doesn't look good."

What was her start date for tx? How long was she on full dose prior to dose reduction? Was she treated with growth hormones (procrit ect)? Was EVR after re-starting full dose or prior? How long has she actually been taking the drugs?
And I thought I was being clear. Uh oh.  

Don't know how many weeks she had a normal dose, mabe one or two; she became anemic almost immediately so riba was reduced, and then plunging platelets forced a cutback of interferon.   So the first block of time, from January to June of this year, she was on a suboptimal dose (while taking Procrit the whole time, trying to stabilize).  As far as I'm concerned, the REAL starting date is in middle of  June when improved blood values allowed her to take full dosages of  both interferon and ribavirin.  THIS time she experienced EVR, but this week's PCR (she calls it "six months" into treatment") still reads "detected."

She's a textbook flunkee when measured by standard criteria.  It's a miracle she made it through June; it speaks well for her doctor.   The question is, will he use his head and get creative, or arbitrarily decide that her viral load is still too high, the odds are against her, and drop her from tx?   The last time she measured a month ago the viral count was extremely low--nearly undetectable.  

I hope this helps to clarify--and thanks so much, BobK, for your input.

Scott--Interesting to see which road this HMO will take.   I myself am ready to blast them with both barrels if they misstep, brain fog be damned!

[Califia]

Sorry--real trouble cutting and pasting and right-handed trackball mouse scrolling.

Above message should start at paragraph 3.

CUTEUS:   Paste the Israeli study, please!

[Tony-z]

55th Annual Meeting of the American association for the Study of Liver Diseases
October 29-November 2, 2004
Boston, MA  Back  

  
  
  
  
Prolonged Pegasys+RBV Therapy to 72 Weeks May Improve SVR in Patients Who were HCV RNA+ after 4 weeks & slow responders


  
  Reported by Jules Levin

There were two studies presented at AASLD examining the potential benefits of extending treatment from 48 to 72 weeks with Pegasys plus ribavirin. One study found that patients with detectable HCV RNA after 4 weeks of therapy could benefit from extending therapy from 48 to 72 weeks. The second study found that in patients with 'slow viral response' (positive HCV RNA at week 12 with between 50 to 5,000 IU/mL, but negative HCV RNA ayt week 24) could reduce relapse rates and improve sustained response rates. Read details of both studies below.

"Longer Treatment Duration With Peginterferon alfa-2a (40KD) PEGASYS and Ribavirin (COPEGUS) in Na

[Califia]

Thanks, guy.   Note that these are all European studies, first delivered at the European Assoc for the Study of the Liver held in Berlin last April.

I hope the obstacles roll from your path this week and that Kaiser comes through for you.   Onward!

[DoubleDose]

Check out the thread above titled sexual transmission.  Post number three, by Sally say-so, is by my HCV doctor, Mark Sulkowsky.  It addresses Type 1's, and the need for creative treatment strategies, and asks whether 48 weeks is enough.  Also some good supporting documentation.  Sulkowski is at the top of the pack as far as knowledge and treatment experience.  His scientific foundation is the best, and he is a very insightful coach throughout tx.  He has seen it all, as far as HCV cases.

[Tony-z]

Most of my research is for non-Responders but I am looking.

What else can I do???????????

                TonyZ

http://janis7hepc.com/research_articles_2003.htm#extending

[Califia]

CUTEUS:   Good driving directions...now watch me make a few one-handed left turns!   (Better yet, avert your eyes.)   Muchas gracias, chica.

TONY:   Just being here to bounce ideas around is good.  I just found out that my friend was started out at a suboptimal riba dose (800 mcg), which makes no sense for someone weighing 135 lbs.  Why??????   This is the same doc who refused me a liver biopsy when I first entered the Kaiser system.   I'm grateful I followed my gut instincts and fired him back then.

There's a bit of a lull in action until her viral count is back...but I'm networking like crazy on her behalf in the meantime.   Ironically enough, she's an RN,  but is a pretty tired cookie after 11 months of anti-virals and is glad to have the assistance.   (Prayer is also good.  She's a woman of the cloth.)

to be cont'd....

[DoubleDose]

Two suggestions for your friend:

1.  She needs to increase the Peg-Intron dose as a first strategy, while keeping the ribavirin at full tilt (I am not sure what the max. recommended Riba dose is for 135 lbs.  It MAY indeed be closer to 800 mg. or maybe 1000 mg).  I believe that the Peg dosage level is what really gets one to undetected, and it needs to be adequate in order to get the job done.  The dose needed varies quite a bit, from patient to patient, so early ,and frequent viral load PCR's are really helpful in determining what adjustments might be helpful.  Most docs do not do this, and use very safe, approved protocols, which are often sub-optimal. They also do not do enough early PCR testing, to determine effectiveness of the regime.

2.  Since she was undetected for a period of time, but is now detected, lots will depend on the quantitative count for her current situation.  If it is very low, like 2000 IU or less, she might get undetected again with the current dose, or a slight bump upward...BUT the breakthrough of the virus is NOT a very good indicator.  If the interferon is working, the virus should keep decreasing as you go....so either she is on a sub-optimal dose OR she is somewhat of a non-responder.  Only renewed attempts, with creative dosing, will determing which she is.  I think there is lots of hope, since she apparantly did go undetected for awhile.  So the other strategy would be for her to discontinue tx, take a three to six month rest and recuperation, and start therapy again at 'full tilt'...higher Peg-Intron doses, full allowable ribavirin, growth factors as needed (Procrit, etc.) and to look for a good viral response pattern.  Ideally they might check PCR levels at 1 week, 4 weeks, 12 weeks, and further as necessary.  Getting the undetected before 24 weeks is pretty important, as well as getting the minimum of a 2-log drop by week 12.  She may need a more experienced, more aggressive doctor as well.  The right doc, and the right treatment protocol can make all the difference in the world.

Best of Luck!!!!   DD

[Califia]

We're all on the same page with this -- too bad the G.I. isn't.    BTW,  when I spoke of  her EVR once on full dosage,  this meant the requisite 2-log drop.  Sadly, she's never been undetected.   At any rate, thanks much for your input.   I really appreciate.

[cuteus]

I finally found the darn study! (due to copywright stuff)and the fact that I can't link, take these directions; janis7hepc.com take a southbound turn to world news & research, click and scroll all the way to bottom to get 2003 articles, find it in May 2003. one out of nine dropped out, so 7 out of 8 achieved svr, all G1.

[Califia]

Extension!    Seems the viral load came back < 600 and > 7 virions, low enough to continue.    I am still suggesting that my friend continue tx under another doctor's care, however.  Her present situation is way too chaotic.  (Neither doctor nor patient seemed to recall that she had actually only been at full dosage for only 2 1/2 months.)

Keep excellent treatment records, everyone.  Elementary self-defense.

[DoubleDose]

Now is the time for your friend to hit it very fast, and very hard...at full dosages...both for Peg. and Riba.  A good doctor, with lots of HCV exp. can make all the difference in the world.  There are many drugs being used today, from antidepressants, to growth factors (Procrit, etc.), to sleeping aids, pain killers, anti-inflammatories, so that almost all tx patients should be able to stay at or very near full dosages THROUGHOUT tx, if not at even higher, tailored dosages, for slow responders.  

Good luck to your friend!

DD

[DoubleDose]

By the way, a PCR result of <600 would have been an 'undetected' result before the more recent, ultra-sensitive tests.  What her test results seem to show is that she is on a slightly sub-optimal tx regimen, which you already realized since dosages were reduced.

Ask the doc WHY she is not on PROCRIT, right NOW, to combat anemia, and to allow her to go fully undetected.  This is no academic game, and the doctor is doing her a grave disservice by not optomizing her therapy, and not using the tools available to get her undetected.  She is virtually RIGHT THERE, and probably just needs the bump back to full dosages, especially on the PEG, but also with the Ribavirin.  If she gets back to full dosing, and tolerates it, she should most probably go for a very extended period after the undetected result (48 weeks to 60 weeks), in order to assure full eradication.  This would of course also be at full dosages.  MAYBE very late into the final stages there may be some 'wiggle room' for dosage modifications, but now is the wrong time, and it is keeping her from being fully successful.

The opportunity is at hand, if she can get to a really good, highly experienced HCV doc, who can salvage her therapy.  She is SO close!!!!

DD

[Califia]

FYI,  she's been at full dosage for 2 1/2 months;  does take Procrit,  and has for months now.   (Still had trouble getting to acceptable Hg and hematocrit levels even with regular Procrit.)  The real problem was the neutropenia that presented way back in week two, and her allergic reaction to the prescribed Neupogen.   The doc wanted her to stop its use altogether (not an unreasonable assumption), but as my buddy is a nurse, she persisted w/  small  incremental increases on her own.  Got the white count high enough to start full dosage interferon.   (I'm sure she would want me to say don't try this at home. )

Regardless--this is a good opportunity for her to find another doc, and I'm lobbying hard for that outcome, even at the risk of being a bit obnoxious.   Hey, what are friends for?   I totally agree w/ your assessment  of her situation.  My gut feeling is that she needs to crank it up right now with an enhanced protocol and then extend to 72 weeks, with the weekly count starting in June,  which is when she started at full dose.   That's what she would like, too.