To many geno 2 and 3 relapsing... and not enough studies done.. all 2

[Mister beagle bailey]

I have found no real studies done on geno 2 and 3 and after seeing all the forum members post yesterday that they relapsed.  I thought it would be a good idea to group us together to see just how many of us there are.  This may help us see clearer what the next step should be.

Please sign in and give your stats:

Geno 2B
VL before tx: 318,000   relaped VL:  4 million
Did peg-intron 120  Riba 800  Did not lower dose durning treatment
Procrit since week 2  Did tx 24 weeks was UND still at shot 23
4 weeks post tx: ALT 13  AST 24

Thanks

Beagle

[Kalio1]

Yes I am a 3a and I relapsed. I too dug around to find pertinent studies. I was suprised at the lack of info available and resigned myself to use geno 1 material as none seems to exist for us. I guess with "new" diseases this happens. I imagine having a rare type of cancer or something is similar in that not enough people have had it to be able to look at previous data to help your treatment. I figure I am better off than many with rarer conditions but it is frustrating when trying to plot a course of action.

[anise]

Thank you for responding to me email.  I have read so many threads and folks with different genotype, I can't remember who is what.  Are you a 3?

I do feel like a step child, as there are no studies to help us.  Your suggestion of watching the overseas studies is a great suggestion.  If I do not get an SVR in Oct.  then I have to look for another answer.  There are not many to choose from here in Seattle, (sure wish I lived in NY).  I have to think about what to do next.

[Algernon]

As a geno 3, I talked with 2 doctors--1 a hepatologist at Baylor and one a GI whose practice is almost entirely HepC.

Both of them told me from the get-go that I might be looking at 48 weeks.  The local guy (GI) "consented" to 24 weeks after I was clear at 4 weeks of TX.  By the time I hit the 4th week of TX I had decided to quit if I wasn't clear (pits of anemia at that point).

Seems like you could have even more confidence in the 24 week decision if you were clear at week 1 or 2.  Arm chair doctorin', I'm doin'.

[jmjm530]

I also want to add something that Goofy I believe also recently said, and that is that in spite of some of the unfortunate relapses of some geno 2's and 3's here -- I haven't seen anything that suggests the 80% success rate for geno 2's has changed.

Keep in mind that 80% success rate means that one out of five will not succeed, so indeed genotype is no free pass by any means. That said, in a study module at the Clinical Options web site above, one of the doctors did suggest that geno 3's fall somewhere inbetween geno 1's and 2's in terms of being hard to treat -- but closer to geno 2's if I remember correctly.

A few things I picked up from the modules -- plus my personal opinion -- is that the short course approach makes the most sense if you do not have significant liver damage and also if you don't have a very high pre-tx viral load. Also, these studies were done with weight-based ribavirin, and perhaps the results wouldn't have been as good with standard 800mg dosing.

-- Jim

[jmjm530]

Did you run the riba pre-dosing by your doc or are you just going to do it on your own? I forgot of anemia was an issue last time, but if so, you might start epo shortly after the pre-dosed peg. BTW I believe in the study someone posted a number of months ago they were pre-dosing 3 weeks prior to the first peg shot but this is just from memory. As to which Peg, maybe whichever one you did not take last time makes the most sense. All the best this round!

-- Jim

[FlGuy]

The pre-dosing is a Q I forgot to ask the liverhead. I'll be sending him an e-mail question.  I don't think my tx doc will tuned into the concept and would reject the idea out of hand. He wears a belt and suspenders. First time hgb hung around 12 and could have accomodated more riba.  Will expect weekly cbc though about week 12 so can catch any tanking quickly and am buildling in 2-3 weeks of earlyish anemia into my expectations.  Have a pre-tx appt. with the hemo to ask about pre-emptive procrit and liverhead's direction of procrit at 11, neup at 500 and platelets to 30.  Still humming the tune 'I wish I knew then what I know now'.

[jmjm530]

You have the advantage now of knowing your previous reaction to ribavirin. So, if for example, you needed Procrit last time five weeks after beginning riba dosing, a reasonable approach this time would be to take it three weeks prior, eliminating the 2 weeks or so it takes for the Procrit to kick in.

[jmjm530]

a little unclear so I'll just re-write it:
----------

You have the advantage now of knowing your previous reaction to ribavirin. So, if for example, you needed Procrit last time five weeks after beginning riba dosing, a reasonable approach this time would be to take the Procrit  three weeks after beginning the riba dosing, eliminating the 2 weeks or so it takes for the Procrit to kick in.

[jmjm530]

Just to add to my post C5, above -- I believe you would need a sensitive and negative 4-week VL test in order to do the shorter course.

[rochammer]

I am 56 male geno 2 stage 3 vl 2.500,000 iu/ml did 24 weeks of Pegasys & riba 800clear during tx and 1 month post.

Relapsed around 4 months post alt180 ast 118 on tx alt& ast were in the teens 8,14. Six-month pcr pos.12, 500,000-iu/ ml I am now on week 46 of 48of peg-intron & riba 800 undetected at week 4 & 24. I am on epo but in good shape and no other health problems. The sides are very bad. There is no information on geno 2 relapeser and very little on 3,s. Unfortunately the doc

[tulsatime]

I don't know what to say I am so sorry. I just found out about your relapse. I know you must be so depressed. This d*mn disease!! It is so flustrating!! Hope the new drugs are better at wiping it out. Beagle, with no or little damage you might be OK forever even without treatment it you have to. I know you want it gone though. I do too.I am just so sorry.
GOD BLESS, Debi

Here are my stats

geno 2
cirrhosis & enlarged spleen
Low bloodplatelets
vl 3.8 mil
24wks peg/800 riba
clear 12,24 wk
relapsed 6mo post 39mil
started again 8/25/06
48wk peg/800 riba
low dose cause of low blood platelet

[rifleman]

I didn't expect to see all the bad news here when I came online to visit.  Sorry about the relapse, BB and everyone else.  The silver lining is that you ARE proven responders, and will probably respond again.

My stats:

Geno 2b; VL 1,300,000; ALT 60; infected sometime between 1965 and 1992 (assuming thru blood products taken during that time. . .no tattoos or needle drugs, but who knows?)

TX 2005 (age 39) 12 weeks pegintron & 1200 riba

PCR UND at 4 weeks and 12 weeks (12 week ALT 39).  Stopped tx at week 12 (last shot one year ago tomorrow).

4 week post tx labs = PCR UND, ALT 34

24 week post tx labs = PCR UND, ALT 24

DJL

[Kalio1]

I am F 50, 3a. 5'11" 165 (now, was 180 first round) VL 700,000 start of tx. PegIntron 800/riba, did 24 weeks, UND from week 12 thru tx then relapsed two weeks after stopping. Restarted tx 1600/riba, double dosed Peg for 30 days, UND week 4. Still on tx.

[FlGuy]

I knew about your 12 weeks tx.  What I didn't realize was the 1200 riba.  That's very interesting.  How did you come by the 1200 and not 800?  An enlightened doc, high tx weight, other?

[rifleman]

My doc (Alan Kilby) does weight-based Riba.  I asked about 800 for geno 2 and he said he does weight based.  I was about 210 at the time, so it was probably better that way.  
DJL

[amommy]

This is a good idea.  I tend to agree with Goof and Jmjm.  I mean 80% is better than 50 but still that means 1 in 5 or so will relapse.  That is A LOT of people.  Too many as far as I am concerned.  Anyway, here are my stats.

I am a geno 2
I can't remember exact VL at start but greater than 4 mil
clear at week 4
on 800mg riba to start
1000 at week 10
completed 20 weeks of tx
clear 3 months post tx.

[Algernon]

On one of those recent clincial options modules, there are some nice graphs showing that the earlier you respond to treatment, the more likely you are to SVR.  It was true for 2s and 3s as well as 1s.  

Since most 2s and 3s clear fairly early on maybe it would make sense for us to have a PCR even earlier in Tx..

[GoofyDad]

Couldn't agree more. The majority of 2's and 3's will clear by week 4. If not, I'd take that as a warning sign. I'm surprised protocols haven't yet evolved to the point of modeling customized treatments based on weekly VL's. Current we see VL's at 4, 12, and 24 weeks. Why not weeks 2 and 3 for genos 2 & 3? Unless they start by collecting the data, they'll never be able to study the response curves. My 2 cents, FWIW.

Personally, I don't think it's a great idea to form much of a judgement by a small sampling of we folks in this forum. There simply aren't enough of us to make a statistical basis, IMHO. I think it's great to share info, but I wouldn't let it color my view of the landscape too much. Give me the peer reviewed studies, with helping of Drug Co conspiracy theories on the side.

Me:
Start
47 yo M
5-9 170 lbs
VL 1.2 mm
Grade 2, Early Cirrhosis
ALT/AST ~150/~150
Kinda dorky looking

26 wks Peg/Riba 1,200
Procrit/Neupogen

End
47 yo M
5-9 160 lbs

ALT/AST ~150

26 wks Peg/Riba 1,200
Procrit/Neupogen
ALT/AST 21/40
Kinda dorky looking

[jmjm530]

I concur with early and frequent testing. My doctor tested VL weekly until I cleared and then he suggests monthly tests. Of course, unless you have a doctor that knows what to do with the results, it's all academic.

I also agree not to weigh too heavily anecdotal relapse data you read here. On the other hand, the very same modules on Clincal Care Options did suggest that geno 3's are harder to treat than geno 2's. This point of view may be more recent than the trials the "80%" data is based on.

Also, NYGirl reports that her doctor, Dr. "J" -- suggests both geno 2's and 3's are relapsing more than originally thought. Keeping in mind this is unpublished and a second hand report, Dr. "J" is one of the leading hep C researchers in the country, so NYGirl's post did give me some pause.

If I was a geno 2 or 3 and about to treat, I'd probably bug the h*ll out of a number of leading hepatologists before making a final treatment decision.

-- Jim

[GrandOak]

Good idea,  I think because the stat's show that most HCV infections, in the US at least, are Geno 1 that the thrust of most studies has been in that arena.

The problem I've been seeing with most of these stats is that they are woefully outdated, come from studies which appear to be skewed towards geno loading based upon old stats of suspected ratios of infections per genotype, and all use extremely small sample sizes which do not come even close to representing the population at large.

I've also noticed that the rate of occurance of sx's for tx do not appear to have been studied beyond those of the initial drug trials 6 or more years ago which are documented in the Product Inserts for the meds.

All in all, it is my thinking that all these sterotypes for Hep and it's treatability are no longer valid and the stats bandied about on infection rates are woefully outdated or downright understated because of the sampling they were based upon excluded segments of the population where disease is more prevalent (i.e. incarcerated, HIV cross infected, and/or homeless populations wre not even considered).

[Tater-ToT]

Combination genotype  1a & 1b,,,
F/Age 43 when diagnosed in October 03  
Infected approx 23 years... had Little to No Liver Damage...
Treatment was "Optional" BOTH Times...
Relapsed after First Round

First Round Original VL almost 5 mill
Doc Under Prescribed Dosage (ie... only 800 per day riba)
was NOT Clear by 12 week mile marker, but undetectable by 24 week,...was not allowed to extend treatment ... stopped @ 48 weeks

Was still undetectable 10 days post tx..... 2 weeks later VL 6000....2 weeks later started round 2  vl had dropped to 1000 "on it's own"

Anyway, Round 2 I was prescribed 1200 Riba, but averaged 1400 to 1600 for the majority of TX...  Was clear at 12 weeks this time.. was SUPPOSSED To go for 72 weeks.....

Ran into a snafoo when my insurance ran out & My Dr QUACK QUACK wouldn't fill out the paperwork in time for me to get assistance from the "PEG-ASSIST" program without jeopordizing existing TX, which resulted in some exchanges that got me DISMISSED as a patient....

So I stopped in April & with "Much Appreciated Help" I managed to get in what I feel was adiquate time, (Think I got in a total of 57 weeks Maybe a few more) I Can't remember but I can easily recalculate it & I'll know for sure this Thursday!

As My Granny always said.... "Time Will Tell"

[GoofyDad]

As I see it, if you're going to treat, you're going to treat, so I wouldn't let these discussions postpone my start. I would be certain I was starting in the care of a Doc who was responsive, available, and in tune with current developments. As geno 3 I would not start on a 800 riba dose unless I was 110 lbs. And I would not be talked out of a 4 week VL.

Jim, On the weekly VL, I'm curious how it would have influenced your treatment had you cleared on say weeks 5 or 7, as opposed to clearing on week 6?

[jmjm530]

Could be, but you'd need more studies and data to corroborate -- and it wouldn't necessarily mean you'd have to be non-detectible earlier than week 4, but just have a  viral response correlating to data that probably doesn't exist :)

Like your GI, I think the  fact that you were non-detectible at 4 weeks sounds promising, and a 24 week course sounds as reasonable as anything else. All the best luck.

-- Jim

[jmjm530]

Firstly, there are several reasons my doc does weekly VL tests until non-detectible. First, he frequently double-doses peg, and I believe his protocol is to go back to single-dose after a negative VL. And second, to help determine treatment response/length.

As to your specific question, I first have to add that my numbers are a bit complex as my tx was somewhat unathodox.

The first week I did 180 Peg and 1200 riba. At that point I took my first PCR which was 16,000 IU/ml, down from 1.5 million. That's practically a 2-log drop right there in one week. Super responder by any standards I would think although there really are no standards for 1-week PCR's :) Had I known the result of that test right away, and had I known what I do now, I probably would have continued with 180 Peg and 1200 riba.

However, it took over a week to get those results back, so before that, the decision was made (this was a new doctor) to double-dose the Peg (at my prompting) and also at my prompting to  to increase the riba to 2000mg/day. My week 2 VL was non-detectible but only to <600 as I didn't know enough at that point to request a more sensitive test. My third VL (week 3) was 18 IU/ml. This is about the time I crashed and burned and ending up in the ER with anemia. I therefore went back to single-dosing and actually stopped all riba for around a week. My next PCR (week 4) jumped to 53 and went up to alittle over a huncred at week 5. By now I was getting worried that I was having a viral breakthrough. Fortunatly week six was non-detectible and remained as such until six weeks post treatment with frequent VL's along the way.

Looking back -- and this is only speculation -- I think I would have gone non-detectible as early as week 4 had I not stopped the riba, even if I did normal peg and riba dosing. I attribute the upward two-week blip in VL to stopping the riba. Of course, I could be dead wrong about this and maybe my VL curve is just a normal variance that frequently happens, but we just don't know it because VL isn't usually tested that often.

Anyway, to try and answer your specific question again, I don't think my tx decision would have been any different had I gone non-detectible at week 4, 5, or 7, as opposed to week 6. Given my VL results, I think I would have been considered an RVR in all cases. I ended up consulting 3-4 doctors on tx length, and all except my doctor recommended 48 weeks based on my genotype (1) and my RVR. My doctor suggested 54 weeks (1 year after clearing) based on my age and histology (stage 3). I decided to err on the safe side and went with my doctor and the 54 weeks.

Looking back, I sometimes think 24 weeks might have been enough but as a stage 3 that decision might have been a bit maverick.