Continue TX for 36 wks or 44 wks from UND

I will be starting TX soon.  There is so much to think about and I was wondering if you could help with this question.  I have heard that some believe in deciding how long to treat based on when they reach undetected status.  Are you familiar with continuing TX for 36 weeks from the time of being UND?  Or 44 weeks from the time of being UND?
Thank you.  And Happy Holidays to all.  Ginger B.

[jmjm530]

Standard treatment (SOC) for geno 1's is 48 weeks. Newer studies suggest benefits of extending treatment to 72 weeks if you achieve a two-log drop at week 12 (EVR) but are still detectible and then go on to become UND by week 24. Some also suggest a better chance of extending if still detectible at week 4. And others suggest if UND at week 4, a reasonable option is to shorten tx to 24 weeks, with either no effect on SVR, or about an 8% effect, depending on which study you read. And then there are the add-on 'rules' like "Drusano -- add 36 weeks to UND, or variations like add 48 weeks, etc

Since you haven't starting treatment yet, plenty of time to work this out with your medical team, and hopefully you have a good one -- a hepatologist (liver specialist) as opposed to a Gastro.

All the best,

-- Jim

[cottoncandy99]

So are you saying that if we drop just the 2 logs?? whatever they are in 12 wks then what another 2 logs or according to what my viral load is that I will have a better chance that this won't come back, as now a lot are talking 72 wks and don't think I could go a extra 24 wks.

My was UND by the 2nd time which would be the 36 wks as I am remaining very positive at this time and hope this will do the what it should have the 1st time if treated properly.  Really at the first I never understood these logs but the first time dropped 2 1/2 and was told that  I had to UND by the 2nd draw in order to continue on which in fact I did.

I have the geno type 1a according to the blood tests, but all this gets confusing after a while, because the first time was done incorrect but then it come back in 3mos went back on tx and stayed on the full 48 wks, and was in remission for 7 mos before it come back again  as I am taking this a 3rd time but they said the last until something new is approved.  I will finish this time on the 29th of Jan.

Hope you have a Merry Christmas!
cottoncandy

[jmjm530]

Hi Cotton,

I'm unclear from your post at what week you had a two-log drop and at what week you became UND. If you have your tests handy, maybe you could post what were your viral loads and when the tests were taken including your your pre-treament viral load. Also, what was the sensitivity of the tests, if you have that handy. Also, not sure how you're using the word "remission"? And lastly, what exactly happened the first two treatments in terms of your viral response. In any event, it's Christmas, and you have probably better things to do than go through records, so I'll give you a general answer and try and break it down a little differently than before.

As a genotype 1, treating for the first time, if you were still detectible at week 12, but had a two log drop, then you will benefit from extending to 72 weeks. If you didn't have a two-log drop by week 12, then even if you extend to 72 weeks, your chances of SVR are very low. And, in any case, if you're not UND by week 24, your chances of SVR are very low and most doctors would have you stop treatment.

But in your case, you apparently have already treated twice. So even if you were UND by week 12, you still might benefit by extending to 72 weeks, depending on what happened the first two rounds of treatment. Still, you have to meet the viral response criteria (see previous paragraph) to continue on with a decent chance of SVR.

Again, this is general stuff and I don't know your individual stats or circumstances. Also, and especfially since this is your third time around -- unless you're already seeing a hepatologist (liver specialist) and have extreme confidence in their abilities -- now might be an excellent time to arrange for an outside consult with a liver specialist who can thoroughly review al your records, and help you come up with a plan moving forward.

Happy Holidays,

-- Jim

[GingerB]

I am genotype 1a with a 2.8 million VL.    Is there a way to estimate how much you increase your chances of SVR if treating for 72 wks instead of 48 wks?  This will be my first time treating and my tx plan medication is for 1000 mg Ribarivin daily and 180 mcg Pegasys weekly.  Thanks for your help.  Ginger B.

[cottoncandy99]

Jim,
Well this is a short the very first dr put me on the tx and then when it showed negative he took me off and then in that 3 mos time that it had returned I had went back on the tx for the full 48 wks but not weight based. He left this country and went back to Iran as I was not the only patient that he did this to,I really didn't know that it had returned until my epilepsy was checking medication levels that he discovered again that my ALT and AST were very high plus through that period of time I was sick and not being able to keep much on my stomach and was tired otherwise I thought I was O.K.  (Here I weighed 329lbs and was given 80 upg 2Rebetol in am and 3 in pm)

Well I go to another Gastro dr and he tells me lets just watch it and I'm thinking what for as it wasn't this high the first time around as he also was out of that same building so I decided to get another dx eslewhere and then make the decision whether or not to just wait.

Well the Gastro that I went to see said that #1 I was not treated according to weight base or else this would not have happen at all but since going through it this time I dropped 2 logs the first 12 wks and 3 logs at 24 wks which put me at a negative as they checked again here 36 wks as it is still UND and she explained that if this was done the first time that all this didn't have to happen all these other others times. (Now I am at 121lbs and taking 96upg but it's that Redipen and 2 Ribavirin am & 2 pm) I will have the last blood work done in 3 wks. as then she will follo-up every other month for the first year due to the reasons above. But they really think this time should control VL but still have to have a bx in 1 yr from now due  to the liver damage that was done.

My VL load according to the this lab work that I have here in front of me it 11300000 which was done at Quest Dig.that''s the Heptimax HCV RNA my AST was 129 and ALT was 190 & Alkaline Phosphastase was 171 GGT 820 this is all post tx this treatment as now they are all in range.  The only  things that are low are my white and red blood counts which comes along with tx though.

Taking shot today and thought that I would give you this as I don't feel good afterwards.  I will not be leaving my house as my family is celebrating without me this year but you have a MERRY CHRISTMAS!

God Blessing's
Pam

[jmjm530]

If I'm understanding you correctly, it sounds like your treatment was botched by your medical team the first two times, so based on that alone, you don't necessarily have to extend the third time.

However, if you had a two-log drop at week 12, but were still detectible -- then extending to 72-weeks will give you a better chance of SVR.

Assuming detectible virus at week 12, if your doctor did not discuss the 72-week extension option with you -- what I personally would do is ask for copies of all blood tests and procedure reports such as biopsy. and bring them to another liver specialist for a consult. Important that the consult be with hepatologist (liver specialist) as opposed to a gastro. Hepatologists are generally found at your larger, teaching hopsitals, and any travel involved most probably would be worth it.

A Merry Christmas to you as well,

-- Jim

[zazza]

Looking at the different studies I have read, a rough estimate would be that among those detectible week 12 but UND by week 24 and still UND at EOT (end of tx), the relapse rate gets cut in half by extending to 72 weeks. The benefit of 72 weeks tx is still under research, so this is no definite figure. But it seems clear that for the majority of the geno 1's who become UND by week 12 there is no benefit in extending.

[zazza]

As a geno 1, there is about a 20% risk/chance of you being a slow responder, ie dropping at least 2 logs by week 12 and UND by week 24. 20% of geno 1's become UND by week 4, another 40% by week 12, 20% are non-responders. Rough numbers, of course.

[cottoncandy99]

Jim
Talked to my liver specialist (which I'm already going to because I don't have much trust in Gastro dr. for the Hep-C at this point) this a.m. and she said those were my begining stats but now everything has been with in range for a long time and didn't see that there was a reason for me to go any longer that the 48 wk tx as that is approved through the insurance co. as she said that wouldn't pay nothing further and the rest would have to come from me.  She said the first doctor (Gastro) should have treated me correctly  in the first place as I wouldn't be going through this now.  She explained the cirrhoris is due to the Hep-C as she wants to monitor me closely as they don't like to do bx to close to together as they are necessary but once a year because of the grade 3-4 liver damage that I have as they  had consulted with St Lukes Hosptial Liver Foundation Medical Center here in Houston where they are affilated with before they started my tx this time.  I have Fibrosis on many of the bridge areas (whatever that means) So I have this cirrhoris and fibrosis which they have it at a 3-4 stage and I do drink or smoke and never have so that I don't understand either.  If it comes down to it all and because of rx for seizures then Neurologist will have to come up with something else, well that won't hurt my liver. ***Since blood work at 24 wks I was UND and all levels were within normal range with my ALT, ALT, GGT was 44 but normal now and this Alkaline Phosphatase also was  normal the only things that were low she said was white and red blood cts. but she said that is normal for anyone being on this tx.

But I was also told that this Dilatin that I am taking for my seizures will cause these levels to unexplainable to go up at times and then return to normal again, especially my GGT but not as high as they were though.

She had also said that after I am off the tx that my liver should start to heal as it is a fast regeniating organ that we have in our body ......as I am not so sure about that but she is the Liver specialist so I am listing to her.

She told me that she wanted to know why I am asking all these questions now as I said someone had asked and I was not 100% sure and so I had to wait till you were in the office for me to ask, as I thought that you had Hep-C yourself.

She said that she will have to send me to a good Gastro to deal with my Gerd,IBS,as well as my gallbladder if that continues otherwise, she said that she still wants to follow-up monthly and monitor everything.

She was also stating that watching the fat intakes will help me a lot and to continue to eat the fruits and vegtables like I have all along.   I had also asked her about the this Milk Thistle that so many had told me that was good to take and she said that there was no scientific proof that helps at all and for me to save my money to buy some clothes.

I really hope that I asked her all the questions that I needed to as I can get another copy of bx when they do one as the one is the old one that went before I started the tx this time, as well as blood work.

Hope you have a blessed New Year!

cottoncandy

[jmjm530]

Cotton,

Still unclear on your viral response this time around, as your previous posts have mixed previous treatments up somewhat, but if you had a two-log drop at week 12, but still detectible virus, then you might present the following study to your doctor for review and highlight the exerpt below. (Note that I believe there is a typo and that "350" really is ">50" which you can see by looking at the headline of the study".)
Conversly, you did not have a two-log drop at week 12, then extending to 72 weeks might not make any difference. Same if you were still detectible at week 24. And lastly, never take the final word on what is covered by your insurance company from a doctor's office. Always indpendently verify with the insurance company itself. Many here have been approved for 72 weeks of treatment, but it most probably would requrire some effort -- or at least a letter from your doctor.

Here's the study:

"In contrast, in a subgroup of patients who had an EVR but who had incomplete viral suppression (HCV RNA 350* IU/mL) at week 12, a longer treatment duration of 72 weeks was significantly (p50 IU/ml)

[jmjm530]

Here's a link to the study cited above:

http://www.natap.org/2006/AASLD/AASLD_34.htm

[cottoncandy99]

thanks so much as I have been looking for something terminalogy that states this.  I appreciate it. then I'll get all update reports in 2 wks when I go to dr.

When Medicare is involved they don't want to pay anymore than they have to as I might have to call them and find out like you said though.

God be with you,

cottoncandy

[jmjm530]

Don't know much about Medicare, but you may find out that they will approve extended treatment if demonstrated by your doctor to be a "medical necessity" or something like that.

This then requires your doctor's office to fill out some forms or maybe submit a letter stating why they think it's a necessity. Sometimes, doctors don't want to do this because of the xtra work involved or other reasons that are not to your benefit. If this becomes the case, getting another liver specialist (hepatologist) involved is a reasonable strategy, and I wouldn't wait too long.

As I mentioned before, I'm still unclear from your previous posts if extending treatment is to your benefit or not, but if it is, then you do want a doctor who will work with you and the insurance company. I'm a strong believer in second opinions at important treatment junctures, if for nothing else, peace of mind.

I truly hope everything works out best for you.

-- Jim