When and how long to extend

Hi all, I need to understand something. How do Dr's calculate extended tx. I did not clear at my 4wk PCR so for each week I am not UND how many weeks are added on to tx and my Dr feels if you don't clear by week 12 he stops tx.

[NYgirl]

Merry...read the Sanchez Tapias and Berg Studies.  These two together point to the fact that if you aren't clear by 12 - you need to extend.

Most doctors point to week 24 - if someone is not clear by then that is it. The odds go down to like a 2% chance of SVR or something ridiculously low so it's not worth it.  It's very low chances.

I had 411 at my 4 week test.  419 at week 12. Was UND at week 24. So I am doing 72.

Google the links for those two studies. I based my decisions on them and then had a second opinion with Dr. Jacobson since he was lead investigator on most of teh studies that I used as data.

(I hope you didn't call the othernight - I got tied up here at work and got home late. Like I can handle doing that right? But it's bonus time soon so I did NOT want to take the chance and say NO! I can't afford it as you know)

[NYgirl]

Here is the TeraVic 4 study (Sanchez...) quick results
http://www.natap.org/2004/EASL/easl_06.htm


18 Months Therapy (Pegasys+Ribavirin): study found relapse rate reduced by 70%; viral response rate in genotype 1 increased by 50%

[NYgirl]

I know we are not supposed to cut and paste articles or anything but here - this will show you what it's about.

The change in odds is HUGE. That is why I did this way back when nobody else was really doing it...now a LOT of people are starting to. I should have been a doctor cause I'm seriously some kind of trendsetter hahahahahaha. You know me I'm just kidding.

Actually Cuteus extended treatment and it finally worked for her so I did use her story in my decision.  I don't want to do this again. Once you get the anemia under control it's sort of like downhill from there I think.

BRIEF SUMMARY: Patients treated for 18 months had 45% SVR vs 32% for 12 months therapy (p=0.0144). The relapse rate was reduced by prolonged duration of therapy for 18 months therapy from 48% to 13% (p=0.005). For genotype 1 patients sustained viral response rate was 28% for 12 months vs 44% for 18 months of therapy. For patients with high baseline viral load (>800,000 IU/mL) sustained viral response rate was higher for 18 months compared to 12 months of therapy (37% vs 30%). For hard to treat patients (prior nonresponders, HIV+, cirrhosis, etc) 18 months therapy is worth considering.

[merlino]

Thanks Deb. My feeling is as long as the vl is going down I would want to continue at least to 24. If anything its giving my liver time to heal. If my starting vl was 1.4Mil i/u and at 4 weeks was 45,000 i/u is this a 2 log drop? I am making myself crazy.

[FlGuy]

The real devil of hcv tx lives in your question. As you've read here there are studies, probabilities, statistics, positive and negative indicators - all of which lead to a 'guess'. Many people here (NYG, Jim, me, sfbay bay soon, many others) have gone to the mountaintop to consult with bearded gurus and have asked 'how many, o wise one'.  We have come back from the mountaintops, not with stone-etched tablets, but a number and a prayer. But you never know for sure.  There are two baslines in tx, where you start and when you get to undetectable.  With your pcr draw from yesterday (5  1/2 weeker), I hope that by this time next week you'll have achieved the second. And then, it's seeking the answer to the devil question.  The grayness of tx'ing is especially vexing for those who seek absolutes in life, trying to manage the unmanageable.  I certainly don't have an answer for you and when you read the info Deb gave you you'll might have more information but might not have any more answers.  But it's good you're asking and well-informed conversations with your doc might at least get you to a target you can both be comfortable.  But first, lets get that und.

[sindog]

If you started at 1,400,000 at two log drop would be 14,000 (drop two 0's) is the way I understand it.

[sindog]

FLguy is correct. I began with a high vl (20 mil) but responded with a 3.7 log drop at 4 weeks, und at 12 & 24. I probably should have gone to 72 weeks, but after 48 weeks, I simply could not go on any longer. Don't worry about these things at this point. Concentrate on getting through tx on a daily basis.

[merlino]

Here is another question. My Dr. feels if you fail no point in doing same tx again. FLGuy, you doing the same tx only higher doses right? Are there many here doing the same tx more than once? The reason I am asking all this is beacuse if i fail I will not give up. I want to be ready with a second plan.

[NYgirl]

FLG Said: but a number and a prayer. But you never know for sure.

You said it all.  Merry, it's REALLY all nothing but a big giant guess.  I just LOVE how FL worded everything - it is true, no matter what we do we don't come back from the guru's with any straight forward tablet of instructions.

All we CAN do is take all the available data and really use our brains to decide what we THINK Is the best thing for us. Then...we use our knowledge and go to our doctors and present a case for what we want to do. More times than not if you present a good argument they WILL give in and agree with you. So don't feel that your doctor will definitely cut you off at 12 - start writing up your points to present.

My main deciding point was I kept thinking "if I DONT do it and I relapse...will that make me crazy wondering if I had done the extra time would I be clear"?  When I went to the old wise bearded one - that is EXACTLY what he said to me..."If you want to know at the end of the day when you lay down in bed you've done everything you could...then you should treat the additional time".  And I knew I had my decision.

$600 to me is like a million at this point but - it was one of the most worthwhile things I've EVER spent money on.  PEACE OF MIND!

That is why it is SO IMPORTANT  I feel for us to EDUCATE ourselves on our disease and the most current studies and data etc. When Dr. J called to consult with my regular doctor he asked him if he's read the TeraVic study and when he told him no Dr. J. said "well she has she is quite well educated and informed on this disease, a very insightful woman" hahaha.  My own DOCTOR hadn't read it but I had. I LOVED it!!!

So as you can see - had I not learned it all MYSELF my doctor would NOT have even informed me there was an option.

That is why this forum is INVALUABLE.

Get your tools together and then talk to the doctor. Thank God you found this place too.

Generally the rule is a TWO LOG DROP is needed by week 12 and UND by week 24.  So I don't know why your doc would drop you off at 12...unless you were really far off the number.

[FlGuy]

It seems reasonable to me that, with all things equal, the same tx the a second time around should expect the same outcome as the first. My tx #2, is different in that I'm going 46 (was 24) more riba (1200 vs, 800), pre-dosed riba a week, doubled the peg first 4 weeks.  I understand your concern and some of the implied risks if not clear at 12, but if you move your feet too quickly you might leave your shoes behind and you'll need to have shoes on to walk the rocky path of tx. This day, this week first. Then, think about the next week.

[Cindy10]

I agree with FL Guy. I did the same thing, worry. I thought about everything you are so I know how you feel. I still think about it. But at this point if you are clear at 12 weeks that will be great and you will be on track. In fact my doc says that is considered the norm. Yes clear at 4 weeks is good, but remember you probably had this for a while so it make take a little time to clear. I think you are doing great and there is no reason to believe you wont be clear at 12 weeks, we both will!!!

[merlino]

Thank you, I will get past this, I know. I still have time to get to UND. I filled out the form for Quest to send all my results directly to me. Don't see liver Dr till 1/10.

[Cindy10]

Also my doc says if I clear at 12 weeks, I'm still on track for 24 weeks, so I will go with what he says!

[merlino]

Thanks Cindy - I cannot believe how this is getting to me. I didn;t sleep all night. I am on the verge of tears and I have to stop. I am feeling better with the anemia so I am going to do some x-mas shopping this weekend and try to get into the holiday cheer. I will pray for both of us.

[merlino]

Deb, will talk to you tomorrow.

[FlGuy]

One of the dangers of recovering from anemia is that you now have a little more brain oxygen that you can allocate to worry :).  This time of year is taxing enough.  Throw tx and low hgb into the mix and you have the receipe for minced-meat brain pie. Save you energy for that Charlie Brown Christmas tree and the nerves it will take to enter a shopping mall.

[Cindy10]

I do understand, give it time to sink in (tool me about ten days at least) and you will see things are still good. Its hard not to think about it, this is ours lives for right now.
Things will work out, good luck with shopping. ;-)

[merlino]

Thank you my friend for always making me smile even when I am feeling this low. You are right, when I was to weak to think nothing really mattered except how I was going to get up to go to the bathroom!!!! Don't know how long i will last at the mall but will give it my best shot. Still get winded rather quickly.Procrit shot today - have to do a travel day tomorrow ( Oh Joy)

[sfbaygirl]

I'm going through the to extend or not worries right now. Time does go by quickly so I am trying to get my ducks in a row. I have 15 shots left. A few days ago Jim and a few others were having this conversation. He posted some other studies to read. You may already be UND, so see what your PCR says.

Shopping...Hmmmmbug, that's what I feel like. LOL I was thinking about how I could order a tree pre decorated, catering, present buyer and wrapper.....it is stressful. Just the noise in the mall bothers me now. John sent me three emails of gifts he wants, some with pictures! If I can order it all online, I am going to be doing well. Hope you have a successful shopping day. I know I am going to have to soon. Usually I shop all year for the holidays, this year I didn't buy one thing. This could be a good thing...

[merlino]

Hi, so funny you said that. Told my kids thats what we are doing this year.Pre-decorated tree. ha ha! Normally we go pick a tree-have them cut it and then Mom spends 2 days decorating. Want to hear something pitiful-my halloween decorations are still around my house! I just wish I could wait till after x-mas to deal with all the pcr-vl-und stuff. Jist bad timing.

[NYgirl]

ps since i've already done the extended - if this doesn't work I'd take some time off to get strength back and do a different treatment (probably infergen) I can't imagine why doing it another time would have different results.

OR I'd add the vertex on top to get to UND faster IF I read data that proved that it did matter in the long run. But that will depend on the SVR data that is not available yet. It could just manipulate the virus to appear it's gone but then it could come back or something.  At least Consensus Interferon can be used for relapsers with good results.

However MErlino you are NOWHERE near needing to think of any of this yet at your point in treatment.  You still have 20 weeks of PCRs to see what is going to be.

I know it's hard not to worry but........you have to just let what will be...be.

At least you can get to the bathroom right?  Nobody understands how truly important and hard to do that can be until it's too late do they?

;)

I can RELATE.

[sfbaygirl]

We used to go to this charity thing where you could buy pre decorated trees...Woke up thinking about it this morning. What are minds do. Thought about asking John if we were going. He is really big on the big tree all decorated nicely. Of course you know who does it. After Thanksgiving I told him we were using paper plates on Christmas, cuz' none of my china was going through that assault on tx again. Now he is trying to find somewhere to order dinner...still so much to do. Worry doesn't help either.

[Valtod]

I agree with FLGuy and NYGirl.

And here's my personal approach:
1) Try to reach week 48 alive and UND.
2) If my body allows it, stay 12 more weeks on Tx.
3) Once again, if humanly possible, stay 12 more weeks on Tx.
4) If alive at week 72, stop Tx. Pray for SVR.

BTW, I'm a "difficult-to-cure" patient (G1, VL >1 mil, BMI >30) with DVR (Delayed Viral Response) - 2 log drop at 12 wk and UND at 24 wk. Which is a double whammy.

If I stop at week 48, my chance for relapse may be as high as 69%.  
If I'm able to survive 72 weeks of Tx, the chance of relapse may be cut in half.

[sfbaygirl]

This is how I am looking at 72 weeks too. What week are you on?

[FlGuy]

That seems like a reasonable scheme. But a suggestions.  Since you and the doc are modifying what might be considered as standard by your insurance co, make sure you build in lead time for those milestones and extensions to account for any insurnace speed bumps that may magically appear.

[Valtod]

SFBayGirl, I'm on week 34. Between weeks 28 and 32 I had 4 quite bearable weeks. So I thought my body is finally getting used to the  poison. But this Tx can always surprise you. My last 2 weeks were VERY rough.

FLGuy, totally agree about insurance considerations. I skipped them just to make the game plan simpler. Obviously, if you (and your Doc) decide to extend Tx, you don't do that in the week of your last injection. I'm very aware of the possibility of gaps in Tx supply (I remember NYGirl's horrible experience).

[sfbaygirl]

You are a week away on tx than I am. I am at 33 weeks. I didn't understand your ins. co. Did you say you aren't going through them, or you have it figured out? I saw all the scans etc. you have had. What stage did you say you are?

[Valtod]

Scott, thanks for the encouragement!

These people who "extended to 72 and made it"

[sfbaygirl]

There are quite a few people who extended and had SVR. I know Cuteus went 72 weeks and had SVR. Jim, Friole a few others have gone several weeks longer. One I know went 60 weeks has SVR. So they are out there, not many though. I guess we have to be the lab rats.

My sx go up and down so often I feel like roller coaster. The past two weeks haven't been bad, as long as I can sleep a lot and do nothing. I've had worse. The weeks that are bad are kinda like child birth, usually you don't remember the pain that well. That's fine with me.

[cuteus]

not really, same old, except you grow more mentally exhausted of the whole thing.

[merlino]

Thanks for the chuckle. I need to lighten up. Don't you just HATE those little pink pills???

[FlGuy]

How are the clouds above your head right now? Think it will happen?

[merlino]

You have courage! Some days its not so bad now that my anemia is better but other days it takes so much just to talk. I am sure you all ready know this! I hope you clear this $$$$ virus!I will be cheering you on. How many are you doing?

[FlGuy]

Friday is already out, if no go tonight. Need to start driving in couple of hours.  What the heck, no work tomorrow anyway. As to Merlino's question, how long are you going this time?

[sfbaygirl]

I think they do that at Andronico's here. Some of the menu's look great!

Just thinking about the buying, wrapping, decorating, cooking, cleaning...too much. Plus we leave to Tahoe the day after Christmas for a week with the whole family.

I just got off the phone with GI's office. They say I don't need a referral since it is my choice to go to another doc. I am fuming.

[Valtod]

SFBayGirl, it seems we're both in the middle of the road but going the long distance :-) I hope we can both make it to the finish line.

I haven't figured out yet how and if my insurance company FL BlueCross BlueShield would pay for the extended Tx. For now (the first 48 weeks) I'm covered by PegAssist. They won't cover longer than that. But I hope my insurance will pay for 24 weeks of Tx if they haven't paid a cent for my current and previous Tx. Also, my Doc acts and talks as if getting the extended Tx will be a self-fulfilling event :-). We'll see how all this will play out.

I'm Genotype 1b, stage F2 (according to FibroSure test from last year), VL: 2.5 million at baseline; 55,143 at 6 week; 647 at 12 week, UND at 18 week. (VL drop: week 6 - 1.65 log; week 6-12 - 1.93 log; week 12-18 - 2.21 log).

About people on extended Tx: Cuteus is 1a and went 72 weeks but I don't remember if she was RVR, EVR or DVR (delayed responder). Jim went 54 weeks but only because he wanted to (and he could :-). He was RVR, so he could stay only 24 weeks on Tx and still get SVR with very high probability. I don't think my case is at all comparable to his.

I'd really like to find someone with stats similar to mine (quite negative predictive factors all of them), who ultimately achieved SVR. Just knowing about the existence of such a person would definitely boost my morale :-)

[Valtod]

Are you talking about http://us.share.geocities.com/auggieaz/board.html

[sfbaygirl]

Yep, if we extend we are almost half way there...uggh. Hopefully SVR by Christmas next year. I'm a 1a VL about 10 million copies beginning. 10 week VL was <75-200. NOT QUANT. 24 weeks UND. Wish I knew when I was UND, but I don't. I'm waiting for a new PCR now.

I am a bit worried about extending and ins. paying for it. my current dr. says NO WAY I am extending. I'm gathering my studies, seeing someone else and hope to get my extention this way. NYgirl got C to Care to pay for her extention meds. Maybe you can look into that. I may as well. I think she still gets her rescue drugs from her ins. co. Well partner, at least we have company in our tx journey.

[cuteus]

yes, two yrs SVR as of PCR (50 IU) last wk.  Did every drop of Pegasys also, and the riba 1,000 as long as I remembered it, I forgot quite a few pills in the begining but because I got anemic at month 3, I guess i was getting enough.  My VL when dx was 376,000 (I think IU)  a month later it was a million something, and at 4 wks into tx 125,000. 12 wk PCR it was 5600.  and next text was 24 wk (undetec).  Riba was lowered to 800 for almost 4 months (PA forgot to increase).  My wt was 139 pre tx, and stayed bt 130 to 139 while on tx. Damage was stage one. age 51 at start of tx.
You were very low at wk 12, so that is a good sign. I did 72 wks full dose and 2 wks at half peg, no riba (just my own thing, dr does not know). I can't think of anyone else that was detectable at wk 12, went 72 and is SVR. I do know of some still detectable that only did 48 and SVR, but maybe they had other positive factors in their favor.  Our friend Sandi did two yrs, because she was over wt, had a pos PCR (poss breakthrough, though not confirmed with another PCR), and possible steatosis.  She is negative as of 4 mo PCR.
hopefully, other slow responders will chime in with their stats.
not everyone hangs around here post tx, unfortunately sometimes.

SO, after you do 72,  you might want to keep extending that finsih line a bit at a time, if you are still alive by confirmed vital stats.
I wish you the best outcome, you have a good outlook on things

[sfbaygirl]

How were your sx while extending? Were they worse than before?

[FlGuy]

That's as good a number as any. A few extra early is why it's 46 and not 48 this time.  Relatively speaking, the end is almost near for you.

[Pdilly]

Im not really cooking at Christmas either.  I am going to one of the places that you can pick a menu and put everything in a bag(s).  Take it home and put it in the freezer.  When we decide we are going to eat, I am taking it out of the freezer and cooking it.  WEverything is measured, diced and chopped.  Real easy and all the meals are really good.