if svr not achieved at 12 week bad?

[stangshelly]

after reading through some posts i am curious if not obtaining svr at 12 weeks is a good indicator that i will not clear? i read about relapse and am worried that this will occur. all the tests etc. get confusing...doctor is positive but keeps saying chances are bad then good...he doesn't know how my body will respond to tx. we are all different. i guess i questi0on if tx is worth going through if you are going to relapse?
update on other situations all on homefront back to as normal as can be...daughter is leaving on 30 th for college stay then off to europe on the 3rd of july...gone for a month..ahhh..no teen for a whole month..i'll actually have some extra cash lol..
hope all is well today for everyone..

[jmjm530]

Thanks, Mike, and I hope your friends found something that works.

Willing, besides plaqaue psoriasis, my body was pretty much covered with guttate psoriasis and feet and hands with plantar pustular psoriasis to the point where walking was painful. Somewhat of a nightmare, but fortunately it 99% resolved by end of treatment. What persists is seb dermatitis and rosacea, which long-term may be more troublesome since they can be harder to treat and affect QOL by limiting my activities.  Hopefully, distance from the treatment drugs will make a difference. Ina (Eisbein) has similar post-tx problems. The literature suggests both can conditions can be activated by Interferon which is no surprise. Was it you who used the Mack Truck analogy when talking about Interferon? Forgot exactly how it went but you probably get the idea. It is not a very elegant drug. Thanks for your concern.

-- Jim

[stangshelly]

thanks to all first for the information. i am going on to treat for additional 12 weeks..see what happens,i am hopeful yet realistic...i have nasty rash but,withthe weather here in the northeast haven't had to worry much about swimming and sun..considering collecting 2 of each species and starting an ark lol ;)...as for the ins companies i happen to work for one so i am not able to really comment on much here, the doctors are as confused as well as us as to how to beat the virus. they just treat as can. i am geno 1a and have been tested for hiv yearly for 15 years so i think i am clear there..i did have over a 3 log drop and spirits good so keeping hopes there..physically and emotionally feeling great..can do lots more and not so exhausted. of course have to force myself..my blood work is all normal,liver function normal so far but i am still in the early stages of tx. so keeping the faith but being realistic also...thanks again to all...can't wait to drop off kid tomarrow...need to cut that cord lol...best to all shell

[willing]

Mike - glad to hear the good news; I hope this encouragement makes the ifn  a bit more tolerable.

Jim: I'm sorry the skin problems aren't resolving more quickly. Psoriasis was one of my worst enemies on tx. It did pretty much go away over time, though I was left with a couple of new patches. It's still early; this may be a good summer to stay out of the sun and rejoice in the knowledge that each day takes you further from tx.

[jmjm530]

Good news about your enzymes, whatever the reason.

I'm 16 weeks post treatment now and strength and stamina are just about back to pre-tx, as is my weight. Actually, I could probably lose a pound or two right now, but somehow it feels great to have a little extra after losing so much (30 plus pounds) during treatment. Not to mention having my strength back. Cognitive wise, Brian Fog still remains but as my doc says, "I'm two years older" so maybe that's a factor. Most of my other sides, including the GERD (reflux) have either disappeared or decreased to manageable proportions.

What does persist, and is becoming a big problem are certain skin issues, similar to what Eisbein has been experiencing, namely seb dermattis and rosacea, both of which flared because of the treatment. They may sound trivial to some, but the effects
on QOL are becoming dramatic.

My passions are outdoor sports, including the water, and now I have to avoid sun, water and too much exercise -- the three things I used to live for.  Not to mention looking into the mirror and seeing a different person because of the redness and irritations.  I will probabably require at least six-months of oral doxycyline for the acne rosacea, maybe longer. In addition, I'll probably need some sort of laser treatment as well for the redness, not covered by insurance of course.

So, yes, I'm better in some ways, worse in others. I guess that's the way it goes.

-- Jim

[mikesimon]

I got labs drawn yesterday and my enzymes decreased significantly since me last labs which were drawn 5 days ago. So I am encouraged and doing okay. I still don't know what is responsible for the decrease - the Pegasys or the increased FK or both. I am inclined to think it's the FK because Tuesday was my 4th shot and my FK dose was increased this past Friday from 2 mg. per day to 3 mg. per day and this set of labs is the first significant drop since this all started. As a matter of fact my enzymes were increased on 6/23 from 6/13 and I had taken 3 doses of Pegasys at that point. It's a puzzling situation but I can live with the unanswered questions as long as my enzymes eventually normalize. How goes it with you Jim? I would assume that you're feeling much better now that you're no longer doing that crazy TX thing. Take care. Mike

[mikesimon]

I am sorry that you're having these dematological issues. I know that rosacea can be a real drag from friends who've suffered with it. I hope that things improve dramatically and rapidly for you. Mike

[jmjm530]

That's a whole other topic and the *durablity* of any possible tx induced fibrosis regression, without SVR, is not established as far as I know, but yes, that possiblity should be factored into the risk/reward equation as an indivdual sees fit. One size does not fit all.   A related but different topic is maintenance therapy whose efficacy is being studied in I believe the Win-R trials.

But I still think it comes down to "it's your own back" so the best we can do is have the most data and information in front of us, and then come up with whatever decision makes most sense in our own minds. I can tell you what makes sense to me. You can tell me what makes sense to you. Hopefully, this type of dialogue will give others more information to make their own decisions.

Mike, I hope this finds you well in your personal battle. You are living proof that an agressive battle plan can beat the odds and win the day.
---------------

"When ten times the enemy's one, surround him...
When five times his strength, attack him...
If double his strength, divide him...
If equally matched you may engage him.
If weaker numerically, be capable of withdrawing..."

-- Sun Tzu, "The Art of War"

[cuteus]

If there is a chance that you can win the war(SVR), even when new obstacles appear(slow response), you do what you have to, as long as it's not killing the troop. Sometimes you retreat with the idea to come back stronger and with better weapons, and unforeseen obstacles prevent you. DOn't leave for tomorrow what you can achieve today.

is great to see the many approaches to war and life.

[mikesimon]

If you are of the opinion, as am I, that TX can improve histology despite not achieving SVR then treating may be advisable for those with their backs, or livers, up against the wall even though the odds of achieving SVR are not good. Mike

[jmjm530]

Willing: "...Fighting the side effects tooth and nail makes good sense to me, fighting eroding outcome odds doesn't...but I also never buy lottery/raffle tickets...
------------------------------------

I've personally likened fighting hep c to war. In war, generals are always advised to fight when the odds of victory (svr) are in their favor, and not to fight, or make strategic retreat when the odds are with the enemy (the virus). That way they can grow stronger to fight another day, hopefully with better odds and better weapons. The exception is when their back is to the wall -- in that case, diminishing odds suggest we must fight even harder. What defines when ones back is to the wall? Well, it's your own back, so everyone makes their own decision. For me, it's significant fibrosis.
------------------------------------------

"Make an estimate of the situation and fight only the battles you can win"

-- Sun Tzu "The Art of War"

[Kalio1]

Drug companies get a tax break for giving meds away, also they benefit from marketing goodwill of advertising their generosity. Not that there is anything wrong with a profit motive, they are in business to make money after all. I think the question is how much profit is acceptable when you are selling a product like drugs. The mind boggling profits can and do kill people because the drugs are out of reach for many who are un or under insured which in large part is due to escalating out of control costs of medical care, including the cost of drugs.
The ins. companies benefit from cutting off meds if you don't meet the 2 log criteria, it is somewhat arbitrary and should not be a decision they can dictate. Only the doctors should be able to dictate that.

[sfbaygirl]

Did you mean to say the insurance companies not the drug companies have an interest for people to stop if there is no 2 log drop or UND?  That makes sense, since they are the ones that look at their bottom line when approving which drugs you can or cannot use.

[Kalio1]

I agree, people do need to hear the good, the bad and the ugly so they can make an informed decision but the info should be taken with a grain of salt too. The thing about basing decisions on studies ike this example of "clear by week 12" data to me is that there IS no "cleared by week 17" or "cleared by week 23" data to compare it to. They use 4 weeks and 12 weeks because they have to pick dates to collect research data. I think they are good indicators but should not carry all too much weight. For all we know the people who clear by week 1 have an improved chance to those that cleared by week 4 for example. There is no comparision data to disprove it.
Playing the odds a gamble. Even if it all adds up, you are clear by week 4, do a your meds and have the correct dosages there is still a chance you can relapse or not respond. It's the nature of this beast. I hate for people to get discouraged based on these studies or worry throughout tx about something they have no control over.

[jmjm530]

I believe Strangeshell's original post was somewhat confusing and suggested 1.5 million, not 1,500, but I'm very happy that she is at 1,500 which is better than a 3-log drop, which means she is responding.

I definitely agree that everyone who treats needs encouragment and I've always done my best. However, when someone asks a question like "if svr is not achieved at 12 week is bad" they also deserve whatever information is out there as well. The Berg study has been posted a number of times by different members in these discussions because it adds information to the treatment decision. Like all studies, nothing is in stone but without any studies we'd be much more in the dark.

Just because a study suggests someone has decreased odds of SVR does not mean they should not treat. Quite the contrary, they might decide to treat harder and longer as I did when told in the beginning that my odds of SVR were only 40% based on genotype, age and histology. But someone else's treatment decision is not my decision or anyone else's but the person involved and their doctor. All we can do here is offer whatever information we're aware of and our non-professional opinions -- the latter of which tend to balance out in most threads.

To oversimplify, on a personal level, I believe that those with little or no liver damage should think twice before treating or continuing treatment when the odds start to decrease -- but when liver damage is significant, all that goes out the window, since they have more to lose if treatment fails. It's the old risk/reward thing. I also understand that others here have an opposite view and I respect that.  I think it's important for both viewpoints to be aired.

Shelly,

Just so there's no confusion, I wish you all the best in any treatment decision you make. With over a three-log drop, the studies suggest you have a very good shot at SVR with extended treatment. I asked you to print out the Berg study to show to your doctor if you want. I still think it's a good idea, but I can also understand you might just want to go with what he suggests. I hope in no way I discouraged you, my intent was just to add more information to the pile.

-- Jim

[FlGuy]

Fascinating story.  When my post-tx came back, my first reaction was "BS, I've got to be clear" and suspected a false positive. Soon after I accepted it and haven't been pcr'd again. I know it can happen but the concept of a false positive is a little confusing to me. What I can't figure out is if it was a false positive and the vl count was 2.5 million, then how could the test count that which isn't there?  At some point, before I re-tx,  will get another baseline pcr, but I don't quite get it.

[Kalio1]

I was told the tx is "basic training" for our immune systems and when you stop the meds and you stay SVR the training worked. If not, back to boot camp or wait and see. My guess is some people's systems maybe are like a car that is having a bit of trouble turning over when you try to start it but it eventually does and off you go.

[willing]

the support we provide one another on this board takes many forms as we variously take on the role of friends, therapists, cheerleaders, guides and skin-creme specialists (not to mention delivering that occasional well-placed kick in the behind when absolutely necessary). The role of guide is an important one though  it is often at odds with that of cheerleader. It think it would do a real disservice to this board to minimize/ignore *any* data on treatment outlook, regardless of whether it's positive or negative. I may be wrong, but my impression is that both friole's and nygirl's decision to extend is in part based on "negative" information discussed here. That's important.

The fact that the outlook for standard 48-week tx starts to look more bleak for those who are not und. by 12 dates back at least to the original pegasys clinical trial data: <em> "Those with no detectable HCV RNA by week 12 were more likely to have a sustained virologic response than those who had only a 2-log decrease in HCV RNA (221 of 293 vs. 32 of 97). In contrast, among the 63 patients who did not have an early virologic response, 61 (97 percent) did not have a sustained virologic response. " </em> from <a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=12324553&query_hl=19&itool=pubmed_docsum">Fried'02</a>.
Their results were based on the <a href="http://www.roche-diagnostics.com/ba_rmd/rmd_products_virology_10.html">Roche Cobas Ampicor v2</a> assay with a lower limit of detection of 600iu. The more recent studies by <a href=http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=16618403&query_hl=22&itool=pubmed_docsum">Berg'06</a> and <a href="http://www.hivandhepatitis.com/2006icr/ddw/docs/053006_a.html">Bergk'06</a> have only sharpened the above finding by using more sensitive tests.

Presenting information should never discourage someone from fighting as best they can, but if you're about to climb into the ring against King Kong it's good to know what you're up against. For example, the apparent spontaneous clearance Pharaoh experienced not only has been documented, (<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=15652466&query_hl=11&itool=pubmed_docsum">Potthoff'05</a>), it apparently is not even that rare ( <a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=16511757&query_hl=9&itool=pubmed_DocSum">Scott'06</a> ). However to fight the virus by simply hoping it'll go away is not a choice most of us would make.

[can-do-man]

Last Friday was my first shot of procrit. So no change yet. Hows lilmoma been?

[lilmoma]

Im doing okay, I have my moments like everybody else.
I have learned to really appreciate my "good days" and not waste time.  :)

[cuteus]

hope is good and miracles do happen as stated by this old post from pharoah, just don't rely on hope alone, help it along with whatever changes are needed to achieve the ultimate goal:

"Chevy/Cuteus - Yep. Go figure. Undetectable at week 2 and every check after that until after my last shot. I was crushed and my doctor was flabbergasted. It had to be a false positive, so we checked again just two weeks later. Not only was it positive again, but the increase was what you would expect in two weeks. I did not have a biopsy before I started tx, so I decided that since I had failed tx I would see exactly what the status of my liver was. I waited ten more weeks to do the biopsy because I was busy moving and I was so bummed out about failing tx I just didn't want to think about it anymore. When my doctor ordered the pre-biopsy bloodwork I asked him to order a PCR to see how high my VL had climbed and he thought that was a good idea. Can you imagine how I felt when that PCR came back undetectable? Well, I was happy and mad at the same time -- I was afraid to believe it. So was my doctor, so he ordered another PCR. It came back undetectable, too. My doctor had never seen anything like it, so we tested again in two months -- clear again. Then again at the one year mark -- clear -- and again at two years -- clear. Three years will be in June and I'll get tested again. I believe it now, but there is still a tiny little bit of doubt hanging on. If you could have been inside my head when I had two positives followed by two negatives in the three months AFTER my last shot, you'd understand the lingering doubt. Oh, I almost forgot, the biopsy came back Grade 1, Stage 0.

I suppose it's possible that I got two false positives back-to-back and that I was really clear all along. That would be the simplest explanation. The other explanation, which is just a theory, says that there is an optimum effecacy level for the drugs that was realized, in my case, as the drugs receded from my body, which in turn caused the desirable bio-chemical reaction that rids the body of the virus. That's an over-simplistic description of the theory, but I think you see the point. Whether I was the victim of sloppy lab work or unwittingly identified a subject for future research, I don't know. In either case I have five consecutive PCRs done over the last two and a half years that are undetectable and I like that.

GT
Began tx in September 2002, 1b, VL 750,000. Peg-Intron and Ribaviron. Double dose of Peg for first eight weeks, then standard dose. 1000 mg Ribaviron throughout tx. Tested clear at weeks 2, 4, 12, 24. Stopped tx after 42 weeks (36 weeks after testing clear). Last week of tx, VL 750. Two weeks post tx, VL 7,500. Ten weeks post tx, clear. Twelve weeks post tx, clear. Six months post tx, clear. Eight months post tx, clear. One year post tx, clear. Two years post tx, clear."

it might be rare, but it does happen, just do everything in your power to help achieve that SVR, tx extension, drug changes, etc.

[friole]

shelly, I didn't realize your 12 week came up positive.  Missed that post as well as a lot of others.  Sorry.  Still, if your VL at 12 weeks was under 6000 you are really one who would benefit from the teachings of the "Berg" study.  Basically the bottom line was that 72 weeks vs 48 weeks of treatment didn't make any significant difference to the general pool of the study.  However, when they took the data and divided it up between those with vl under 6000 at 12 weeks and those over 6000 at 12 weeks there was measurable advantage to continue treatment to 72 weeks.  You have lots of time to look at data and make decisions -- I didn't know for sure I would extend until the 47th week. -- and I chose to only extend 8 more weeks. I suppose it has been suggested on another thread, but do get another PCR as soon as you can - 16 weeks if possible - so you know exactly when you become clear.

can do man -- missed that you started with the burn on Friday.  Nasty stuff that Procrit, going in, but what a job it does.  My hemo nurse upped my rx to twice a week so I can roll out of tx in style for the last 6 weeks.  You will be bowling with the grandkids in no time!
Kathy

[cuteus]

SO berg and bergk are not the same guy, Whew!
thanks for that clarification, willing.

hum, willing and hoping... a battlecry

[Kalio1]

I think you make several very valid points and people should "consider the source" when reading studies. Even doing that can be next to impossible. Who funds what has been known to skew results.
Ins. companies have a vested interest in demanding you reach some arbitrary clearance level ( 2 logs) point showing the meds are working so they can justify not paying for further treatment. I thought that point was 24 weeks that the ins. companies stop paying for meds not 12 weeks but maybe it has been shortened up.

[Alady1620]

Welcome back, Shel.  

To answer your question, I think it is a **** shoot.  

Tell your daughter to stay safe.