When to extend tx for Genotype 1's. Recent Study.

[DoubleDose]

Here is a link to a study regarding the use of 48 weeks of tx versus 72 weeks of tx for Type 1's.  Again, the results indicate that 'slow responders', or those who are still positive for the virus after 12 weeks, but undetected by week 24, are the group that really benefits from extended therapy.  The study found almost double the SVR rate for the slow responders by extending to 72 weeks.  If you get undetected before 12 weeks (by highly sensitive PCR of course) then your odds are pretty much the same with 48 weeks of tx.

All you 'slow responders' might want to keep this article for your doctors, if they are not up to date on extended therapy, and related research.

http://www.hivandhepatitis.com/hep_c/news/2006/051606_b.htm

Have a great week!

DoubleDose

[NYgirl]

Maybe I better call today and make an appt. with Dr. Jacobsen.  I don't know why my doc can't just do it himself but he said no no no so now I think I better talk to someone about this study and the results and find out.

I was a superresponder at 4 weeks (3log) then cleared only somewhere between 12 and 24.  As a GENO 1A and a GENO 1B I would think maybe I should.

BUT I do not WANT TO.  I WANT to be over on August 18th.

[FlGuy]

I think it's interesting that riba was only 800mg/day.  I would have expected a higher dosage for G1's.

[FlGuy]

I think this study has your name one it.

[DoubleDose]

FlGuy:   I agree, they should have been closer to 1200 mg, but at least they used the same dosing for both groups.  I think the 1200 mg. would have pushed up the SVR rates similarly for both study groups.  This extended benefit for slow responders is being reinforced now by several studies.  Also, from anecdotal experience, I have seen many cases of SVR being achieved by extension of tx (including myself) after initial tx failures or relapses.



NyGirl:   If you were told your chances of succeeding would be DOUBLED, by doing the extension, I think I can guess what you would choose to do.  I know it is really a pain to have to reconsider the duration of your therapy (I hated the thought of extending as well), but the prospect of being back at square one, and having to do tx all over again, is not a scenario that I think you will want to entertain.  If you have to re-treat, due to relapse, it will most likely be an extended tx as well.
Best wishes to you.

DoubleDose

[NYgirl]

I honestly don't know if I can physically do this for another 48 weeks.  I just don't. Well it would be another 40 (39) right now.  I am falling apart and it would be one thing if I wasn't working...but I just can't barely handle it anymore you know? August is one thing but like next August is too far ;)

I haven't decided.  I might do a PCR at 40 and see where that stands. I'm just not sure I can physically handle another 40 weeks of this stuff.

It's almost like I Just don't care anymore  at that point and could monitor and wait for the new drugs someday. I am not sure.

[doglover28]

I saw the specialist today.  He did blood work, and I am scheduled for an ultrasound next week.  Then when I go back in June, they will schedule the biopsy.  Duke is getting ready to begin a Study on a new med that is used with Interferon.  He said I could possibly get in on the Study.

NY girl...I got hime to prescrive a AD.  He gave me Celexa. I am tired of hiding and crying.  I hope it works.

[NYgirl]

Thanks guys!

My spirits aren't really that low - just when I think about doing 39 MORE weeks yuck... I mean I can do the 15 I have left standing on my head...it's the concept of another 39 weeks from now sounds too GROSS.  I just can't imagine being this tired for THAT long you know what i Mean?

I just talked to my shrink about it at lunchtime and he said good advice - get the second opinion and stop projecting he might not want you to it because of all the physical problems you already have from treatment and you wont OR he will think it will help you tremendously and then you will be happy to!

He's right.  I think it's this limbo not knowing what is going to happen or what I will do that is making me NUTS

But...I went down and got a giant bowl of frozen yogurt and sprinkles at lunchtime (yup I eat healthy here at work) so I am feeling better already!  :)

[Mister beagle bailey]

Deb, sorry your feeling the way you are.  Maybe it would be a good idea to have a PCR test done at week 40, to put your mind at ease.  Like you said your a super responder and I think you'll be one of the lucky ones and clear this bug once and for all.

BEAGLE

[dyce]

I feel for ya , It's a son of a b!tch workin on the meds . Just try to go 1 day at a time , thats what keeps me goin . We're close to easier tx and I'm like you , I don't know if I could do much more than 48 weeks. My hats off to those who do .

[DoubleDose]

Try not to think at all about the prospect of 72 weeks total.  Set doable targets ahead of you, reach them, then go for the next set of targets.  That might be 5 week targets, 10 week targets, or something else.  Try to get one week down at a time, and then deal with the next.  If you don't dwell on the bigger numbers, but dwell on getting each week under your belt, you will get there before you know it.  Once you have gone as far as you already have, the rest is nothing much worse.  You almost get used to it.  Just keep telling yourself that you will beat this thing, and try to find some enjoyment in your life each week.  You really CAN do this.  Just take it a bit at a time.

You also really want to do everything in your power to avoid the 'relapse situation'.  Nothing feels worse.  If you are going to suffer, do it for a great outcome.  Of course there are no guarantees, but the odds are much better by extending.

DoubleDose

[jmjm530]

From study abstract: ..."patients shown to be still HCV-RNA positive at week 12 achieved significantly higher SVR rates when treated for 72 instead of 48 weeks (29% vs 17%, P = .040)...."
===================
As usual they're several ways to interpret this study in terms of treatment strategies -- with extending to 72 weeks for slow responders being just one.

Even with 72 week treatment duration, those detectible at week 12 only show a 30% chance of SVR -- assuming they're non-detectible at week 24.

This then begs the question whether or not treatment is worth continuing if detectible at week 12, and if the benefits of extending treatment to 72 weeks outweigh the statistical rewards. I would think this becomes a very individual decision with the amount liver damage, as well as other issues playing an important part in the ultimate treatment decision.

Another thought, as mentioned, is how does the 800mg dosing affect the study data? Does it lower SVR rates for 48 weeks in the slower responders equally, not equally, or not at all?

A recent and similar discussion here:
http://www.medhelp.org/forums/Hepatitis/messages/40813.html

-- Jim

[doglover28]

Please try to hang in there.  I will found out the name of the study that the doctor might get me in to.  
I wish there was something I could do to lift your spirts.  YOu have always helped me.

[jmjm530]

Chevy,

That's a really great link and probably deserves it's own thread if any are open. DD and others have been talking about this for some time and hopefully many of us will participate in the survey.

NY,

Sorry treatment is crashing in on you. Just remember that how you feel today is not how you will feel tomorrow. I hit a low around week 40 but did bounce back a little afterwards. The decision to extend -- and how long -- doesn't have to be made until the last minute. In the meantime, seeing another doc for more input is a good idea and if nothing else probably will keep the anxiety level down as is so often the case when you take action.

== Jim

[willing]

DD - thanks for posting. The TERAVIC study, which should be in the same issue of Gastroenterelogy but is still marked "in press" should follow shortly.

It's discouraging that current tx decisions cannot benefit from more recent data (the basic Berg data was available in '03 and the riba dosage is an indication of its age). However this is still very valuable data, both because of the longer tx time and the higher sensitivity VL tests (many older studies did not look below 600).

I believe Jim has summarized it very well. The gains over 48 weeks for 'slow' responders are impressive, but 30% still looks like a long run. There is good reason to believe that both the 17% and 30% would both be boosted by modern riba dosing, but of course it's hard to guess by how much. If you're feeling lucky or if you are at stage 3 or above this is  very encouraging news. For others however, I don't believe it provides clear guidance.I was at 2 when I started tx and have relapsed after 48 but would be reluctant to go longer. Clearing the effects of tx took me well over a year and, as I've mentioned before, the sense of having aged five years in one remains.  Given the age of this data it's likely that more recent extented tx data will be released at one of the forthcoming liver meetings, hopefully in time for those currently on tx.

[FlGuy]

How much riba do you take on a daily basis?  You mentioned recently that you might pop and extra now and then.  Have you considered getting to the 1000-1200 range?  Your gonna be at this a while longer, maybe trying to 'settle in' without the concern of overdoing the riba?

[jmjm530]

If you plan on seeing Dr. J -- in addition to bringing all your bloodwork, scans, etc, with you -- also bring your original set of biopsy slides, not just the report. Actually, much better to send them to him in advance so his pathologist can review prior to your visit. You might also want to get your VL test done in advance of your visit as well. Don't be put off if they tell you he's booked for several months. Ask to speak to him directly -- or his nurse -- and explain that you're currently in treatment and need to see him ASAP in order to make an important treatment decision. This has worked for me a couple of times with mid-treatment consults. All the best luck!

-- Jim

[friole]

FL - Regarding the use of only 800mg riba - the study said "we chose this dose for our study because dose-finding studies allowed an estimate of the optimal ribavirin dosage still were lacking when we initiated the study."  They further go on to say that 40% of patients w/ dose of 1000-1200 end up with dose reductions.  They also say that 800mg/day for 72 weeks is comparable with 1200mg/day for 48 weeks and that they had concerns about the safety due to the lenght of the study.

NY - I understand fully girl,  I don't want to extend either.  The problem with the study (for me) is that the sensitivity used for the study was <50IU/mL.  With my 40 IU/mL at 12 weeks, I was already under the radar for this study.  Not too many doctors would give me much sympathy about extending, I think.  You need to weight all the negative factors for extending, but flatlining like you did for 8 weeks is a pretty negative thing.  I did send you the study.

[willing]

I came across a paper by <a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16108760&query_hl=1&itool=pubmed_docsum">Terrault et al '04</a> that sheds some light on a question that fishdoc and miss moneypenny raised about interpreting log drops close to the cutoff. Table 4 of that study tracks the % who failed tx and did not meet a particular log drop and also calculates drop cutoffs for other, higher, percentage values. Among those who did not make a 2 log drop at 12 weeks 89.5% did not SVR (were NSVRs in their terms). By estimate, for 1.94 it was 90% and for 1.10, 95% NSRVs. They don't give full details of their logistic regression model, but the overall quality of the fit had P>0.05.

Does this help? Maybe a little bit. It confirms the common sense observation that lowering the bar just a bit, from 2 to 1.94, and thus allowing more to make the cut, didn't produce a huge increase in the number of NSVRs among those who didn't make the cut. Thus it supports taking these cutoffs with a bit of salt, all  based on 239 geno 1s who did intf/riba (not peg).

The other point they make is that the negative predictive value, NPV,of not getting either a 2 log drop or VL < 1000 at week 8 is very close to that at week 12 (97.1 vs 97.2). The flip side of the extended tx studies are those that allows patients to reliably determine early on when tx isn't working. The above study is sketchy because it relied on ifn, but, for those starting out, it would be worth looking at  week 8 NPVs estimates of peg-based data.

[strator]

DD-Thanks for posting this. I only allow myself brief moments of question and projection on this. I'm a 1a w/start of 18.7mil, 12wk 291,000, 24wk 3140. I also noticed there is an article on that same site under adverse events that says long hard alcohol use does seem to be a factor in slower reponse. Well that was me. I'm on 180peg, 1000 riba, down to 134 from 158lbs. I'm not making a decision on whether to extend until, first, getting clear, and then finishing or being close to finishing 48 which I think my doc would have me finish no matter what It is dragging but sometimes, but lately I've been pretty fortunate with sx, haven't needed procrit or ADs yet. As a grade 2, stage 1-2, I may have some options time wise but I'm looking at these questions...
1. I may just commit into extension a month at a time.
2. By the end of these 48 weeks I may actually be better at managing tx. (Of course my family might not be)
3. I want my energy back but wonder how upset I'd be if I stopped at 48, and the sx effects took another 24 to 48wks to wear off, and I might as well have been on the meds.
4. If I'm not clear at 36 wks it may be another ballgame.
5. Dream scenario...I'd like to take a break after 48, work more  and get a little $$ stability, so I don't have to push through constant work and would have the option of upping dosage and maybe missing some work.
6. If I stop too soon to wait for another time or med I may risk losing the insurance I have or not being able to afford it.
7. All the increased percentages in the world are still not a guarantee.
8. Can I get a other bx towards the end of 48 to see if anyhings changed.
9. I'm a different person than I was 3years ago, and a different person than I was 8mos ago. Might have to let whoever I am 8mos from now decide.

Thanks for posting, Any thoughts on this situation always welcome.
My heart goes out to all who don't have the options I do, and to all who face finding their way through all the gray areas to make their own decisions.
Don

[can-do-man]

Keep in mind theres usually clinical trials going on for slow or non responders. That cover the cost. Best to you my friend on whatever you do.

[NYgirl]

I am already on 1,000 a day.  :)  Minimum.

LOL popping a few extra for my weight is probably what lead to the anemia hahahahaha

[FlGuy]

No one hates the buggers like you.  Whatever the length you decide on you just need to make sure your body is up to the committment your brain makes.  That was my concern about the added riba. Keep killin' em.

[merlino]

Hi, I just read you worked during your treatment. I am considering treatment and am a single mom who has to work. I have been talking to flguy. It is my first time on a site like this. I have Genatype 1-inflammation no fybrosis but I only had the fibrosure test. I also have been doing some alternative treatment(glutathyione treatments. had blood work done 2 weeks ago. Alt and Ast both in low 70- vl 8 mil. This is the highest levels have ever been. Scared me.

[cuteus]

very good suggestion on looking at tx extension in manageable blocks of time. The huge down I felt when I "won" the argument for extension, meaning I now had 24 more wks to go, after the 48, it felt like someone had signed me up for an around the world running marathon. It was an overwhelming state, to learn I have to feel like **** longer than I wanted to.  I then decided I would do chunks of time, and see how I felt after each one, with the thought that I would stop should an adverse event occur. It is the only way to finish the goal. Don't look at the total number to do, dissect it into pieces, much like cutting the steak into smaller pieces so that you can chew it better.
merlino, I too am a single mom, and had a desk job for the duration of tx. My supervisor knew I was treating, she was the only supervisor who knew. I did not miss many full days of work, maybe one or two. I found that staying home made me feel worse.
You can play it by ear.

[merlino]

I too have a desk job with going on road on occasion. Cannot tell anyone at work. I would hope with enough makeup one could get by however I heard drastic weight loss aslways an issue. Is weight loss aslways a side effect.

[cuteus]

no, I did not have a drastic wt loss, I ate anything I wanted, whole cakes and ice cream pints and gained no wt, and if lost anything, maybe a couple of pounds at most. It was a blessing to eat and not worry of wt gain....those were the days.
Just today I thought I should go back on the meds, just so I can loose a couple of pounds while eating like a pig.
a fleeting thought.

[merlino]

That gives me hope. Especially the fact I love to eat.What were the worst sides for you? Most of the time I go to work sick but I know this will be totally different. Flguy said he worked through.

[merlino]

How does treatment usually go over with health insurance? My co has Aetna. Just want to start planning. If I do decide its going to be at the end of the summer, so I want to be ready.

[FlGuy]

I have Aetna too. Insurance is sometimes tricky and you may need help from your doc. With my employers' policy the Interferon was covered by the medical portion of coverage and Aetna required that the interferon (prefilled special syringes knows a Redipens by Shearing) be filled by the Aetna Specialty Pharmacy.  They mailed them (cooler with icepaks) in pack of 4 each month. The riba (pills) were filled by a local pharmacy.  I had no decuctible to pay on the interferon, and only $10 for a 30 day supply of the riba.  Also, I got almost weekly cbc's at a nearby oncologist/hemotologist.  Those were 100% covered as were the shots of Neupogen (boost white blood cells).  Neupogen is expensive stuff too.  Once the doc, aetna, pharmacies were on board all went smooth. But there were some early speed bumps to get over.  For other blood work doc sent me to Quest and they direct billed insurnace with no deductable to me.

[merlino]

Thanks again-starting to feel a little overwhelmed. What is Procrit? I though that was for the white cells? I also just read some people get anxiety with tx. How much meds do you actually end up on by the time you finish tx? I know about the Gold Bond for the rash. I don't sleep all that well now. What about the reactions to the shot area's. I read they are also pretty bad.

[merlino]

I am so sorry for throwing all these questions at you. As I said before, I have really never discussed this with anyone other than Doctors. I get about half of what they say. I really appreciate your replies.

[FlGuy]

No problem with the questions - it's all good information. Procrit aka EPO is an injection to boost the body's production of oxygen-giving red blood cells and measured on blood test as hemoglobin or hgb. Low hemoglobin is anemia. A lot of times the fatigue and flattened feeling you read about is a result of low, or decreasing hgb.  Meds can also cause a decrease in white blood cells, specifically ANCs (absloulte neutrphil count) these are your body's infection fighters.  For both, docs have minumum levels in mind at which point they want to reduce med doses (not a good idea) or give 'rescue' drugs Procrit for hgb, Neupogen (aka filgastim) also injections for low ANC's.  On tx people have frequent cbc's (complete blood counts) to watch all these blood components to make sure they don't get too whacked out.

[FlGuy]

I injected ifn into my thighs, alternating legs each week. Within a couple of days I had a bruise that looked like i was hit with a baseball, red spot, didn't hurt and went away in 2 weeks when I was ready to hit that leg again.  Both the ifn and riba come with psychiatric warnings about depression. Part of this is assouiated with the riba rage that you read about. Some people start ad's (antidepressents) before they start tx and others get them during tx. Some people get very dry skin, it's important to drink lot of water.  If skin gets too dry and itchy or if riba rash visits that when folks turn to stuff like gold bond.
Ready to think of reasons NOT to tx yet?

[FlGuy]

In the interest of full disclosure I want to let you know that the comments I made today may not be in total acccord with the opinions of other folks here.  In addition, we (the folks in the forum) don't necessarily agree with the medical establishment either in all situations either.  So as you continue your quest for knowledge you need to gather data from lots of sources and arrive at what's right for you.  After all, this is the internet.  As you engage people here just keep in mind that there is no question too trivial and no opinion that can't be questioned.  We all started where your are so don't hesitate to inquire. You are doing the right thing - keep it up.

[merlino]

Hi, Was on road yesterday-feel totally wiped today-have a contact in the medical field. They are looking into the Clinical Trials for me. I am starting second round of Gluthione treaments today. When levels are like mine is there usually a lot of damage? As of last July-when I did the Fibrosure, my Gastro said I was very inflammed but no Fibrosis. How quickly may this have changed since? Today is one of those days I am really down. So tired of waking up thinking of this every day. I try not to complain, know there are others worse off than I am but sometimes I do get frustrated.

[FlGuy]

Biz travel is always tiresome. Thinking about this junk everyday heaps on the brain drain aspect of it.  Here are some articles about fibrosis and progression.  http://janis7hepc.com/learning_about_liver_fibrosis2.htm#Fibrosis%20and%20Cirrhosis
One item that is discussed here every once in a while is how hcv affects the way we feel from day to day, if we blame normal day- to-day woes and ills to hcv.  Early on, I decided that for me HCV is not always the answer to my question why do I feel lousy? But, hcv gets a bunch of the blame.

[merlino]

Just got back from Gluthione treament. Alertnative treatment Dr. wants me to cut out carbs. and take a supplement called IP6 this time around. Told me wouldn't hurt but might help. I have read most of the comments on line and  couldn't find any  one else who has tried Gluthione treatments.

[FlGuy]

I haven't heard of that either.  Others here may have. It may be a good idea to throw it out as a question in a current-day thread.  Not a lot of people troll down here in the older threads.  Don't worry about breaking into a thread of another topic - it happens all the time.  Supplements and alternative therapies are discussed often and you'll get varied opinions.  We have some folks here who are very astute about vitamins, beneficial foods and supplements.  There are actually some foods/supplemnts that should be avoided too. I don't have strong opinions either way since I don't see evidence of results in me. But just in case, I take a few like milk thistle, a multi, alpha lipoic.  Not sure if you realized it but IF you decide to treat it's going to be difficult to keep it unnoticeable by those closest to you.

[merlino]

Is that because of how I will look? Really don't want anyone home or work to know. Or will it be because of the wonderful personality I will end up having?

[merlino]

I do not want anyone to treat me different. That would make everything unbearable. I want to try and just live each day as normal as possible. Sometimes I hear poeople talk about this disease and some of the comments bring me very close to tears and I usually able keep my emotions in check.

[FlGuy]

Both.  Tx is an emotional and physical drain and even in the best of circumstances I don't think that it would be easily hidden especially if you live with a family.  Teenagers, despite outward appearances and actions are pretty perceptive people especially when it comes to moms. Even Millie Vanilli couldn't pull that off. I think, and this is just me, if you decide to tx you are going to have to widen your circle of knowledgeable people a wee bit. All the shots, all the pills, tiredness crankiness, possible weight loss. You might be able to disguise the fact that you have hcv by saying that you have a form of cancer.  Nah, need to be a straight-shooter about this when the time comes.  Give the people who love you a little credit.  Your health belongs to them too.

[merlino]

I just read on one of the threads that blindness is a sx fm tx ( I'm learning the lingo) please tell me this isn't true.

[FlGuy]

There are lots of possible sx's but you need to look at % of incidences.  I haven't heard of people going blind but something called 'cotton wool spots' is a little more common - little floaty things in your vision.  Some people have also mentioned degredation of sight but you also need to consider that a lot of folks here are in age range 50 - 60 where you'd expect things to get a little more dysfunctional.  That's what I meant by not ascribing everything to hcv.

[merlino]

You have me just a little nervous. Will I be able to get by at work? I know I don't have to tell them anything. Has anyone including you been able to work and not have anyone notice too much that your not well.

[FlGuy]

I worked throughout tx, as have many others.  Others have a tougher time.  I work in an office where there are a lot of people but I don't work with them. I told my boss that I was going to be on a form of 'chemo therapy for a blood disorder' and left it at that. My boss is in another state and we didn't even see each other during those months.  I was able to carve my travel and avoided most trips.  You might put a thread out there something like 'I'm thinking about tx what can I expect - can I work'.  Include something about yourself single, teens, workm 'the' secret.  You'll get comments.

[merlino]

I can probably put off a lot of travel, and will probably say pretty much the same as you and let it drop.What were your levels when you first treated? I have read of people with really high VL, ALT & AST clearing, and others with lower non-responding. Also, is it true the higher evrything is the more difficult tx is?

[merlino]

Do you every have pain on your side? It happens sometimes and makes me worry. My Gastro told me its not pain from my liver but the inflammation of the surrounding tissue.