How to extend my TX?

[all_is_well]

Hi guys,
I haven't been here for a long while. Glad to get support anytime.

G 1b
base line VL: 13,500,000
wk 5 - 5,400
wk 12 - <15, but still detectable
wk 16 - UND
wk 24 - UND

Currently I am in wk 28. No sx so far, except fatigue and minor problems here and there. Still working.

I've pushed my doctor to do wk16 HCV-RNA test (first they didn't want to) and the result was UND. Because of this they don't want to extend my tx from 48 to 72wk. I know how crucial this can be for the tx outcome.
I still have time, but...

Q: Any suggestions how to deal with them?

[HCA]

Not sure you need to extend-5.95 log drop at week 12 is pretty good and a positive RNA reading of <15 could well have been a negative in real terms.
Unless there is advanced liver damage or some other negative predictive factor,then 48 weeks is probably correct.

[newleaf09]

You were awfully close to UD within 12 wks.  If it were me personally, I would not feel the need to extend beyond 48.  Just my opinion.

[mikesimon]

I would probably extend another month - your undetectable date + 36 weeks = 52 weeks.
I like at least 36 weeks of treatment while undetectable.
Mike

[Marc1955]

mikesimon is a very knowledgeable guy but you need to realize that there is no evidence to support customizing the extension of treatment.  All the studies that have been done suggest there is no difference in SVR rates for people who clear by week 12 between 48 and 72 weeks of treatment.

[mikesimon]

"All the studies that have been done suggest there is no difference in SVR rates for people who clear by week 12 between 48 and 72 weeks of treatment."

[mikesimon]

Sorry I got distracted.

Mark wrote:
"All the studies that have been done suggest there is no difference in SVR rates for people who clear by week 12 between 48 and 72 weeks of treatment."

First - he/she didn't clear by week 12 so your statement isn't really on point and perhaps even misleading.

Second - I said nothing that in any way suggested that I had hard scientific evidence for extending or "customizing treatment.
I said:  "I like at least 36 weeks of treatment while undetectable' and I do.
I thought it was quite obvious that I was merely stating my opinion and, had I been relying on a study or article, I would have cited my source.

Mike

[nygirl7]

I did't get a 16 week PCR and only know I was 419 at week 12 and cleared somewhere before 24.  I went to get a second opinion with one of the top hep docs in the world and he agreed. Still the insurance company at that time was calling it experiemental and denied the meds. Because they denied me Commitment to Care gave me the meds for free delivered right to my house. The insurance still paid for the doctor they just didn't want to pay for the meds.

Wasn't there an old study that said to do 36 plus whenever you got to UND? What was it HaltC or WinR or one of them? I realize it's not Berg or Sanchez Tapias and is considered outdated at this time but for somebody in this situation it might be ideal.........a good compromise.

[RCM829]

Mike is certainly entitled to his opinion and I happen to agree with him.
I personally would extend treatment beyond 48 weeks.
Perhaps presenting your doctor with the Berg or Sanchez Tapias trial might help?
My best to you.

[all_is_well]

Great input! Thank you!

Since I do have time I'll do some research pertaining to the studies as suggested.

My point was: since I am tolerating tx quite well (well I am taking Eprex=Procrit due to low Hb), would it hurt to go the extra mile (meaning extending tx to 52 or 72wk) and to try to increase my chances of clearing the bug. Of course I have to convince my Dr. about that too.

FYI: I am stage 3, grade 3.

[IAmTheWalrus]

Most studies historically have indicated that 72 week TX helps slow responders. This means those who have a 2 Log drop but are not UND at 12 weeks.

I have heard some recent criticism of this claiming that there is not a great benefit, but all the data I have seen supports the extended TX period as long as the patient tolerates treatment well enough.

I treated for 84 weeks, but relapsed. Given the choice again, I believe I would choose the same.

Best of luck to you in this battle!

Brent

[IAmTheWalrus]

Dr. D answered a similar question -

http://www.medhelp.org/posts/Hepatitis-C/Stop-tx-or-extend-to-72-or-more-weeks/show/579284

[eureka254]

My husband has very similar stats to you, genotype 1, and has needed epo (although I'd say he's had significant side effects):
week0 17,000,000
week4         9,310
week8             71
week12         <50 but detected
week 13        < 5 undetected
He's getting ready to do shot #33, and at the last visit with his tx doc we discussed the possibility of extension as well, and if it might increase his odds of SVR.  We were told it could improve his current SVR odds of 50% by about another 10% -- maybe it's not a "significant" enough differential for some people, but for my husband who's a Stage 4, it's incentive to consider continuing as long as possible in spite of the heavy sx.   Hope that helps, and best wishes. ~eureka

[zazza]

Read this:

"Seventy-Two Weeks of Peginterferon and Ribavirin for Patients with Partial Early Virologic Response?"

http://www.liverfoundation.org/downloads/alf_download_321.pdf

My 12 week result was exactly the same as yours, detectable but not quantifiable. I did 72 weeks and SVRed. Who knows, maybe I would have SVRed with only 48 weeks, but I sure as h*** was not willing to take the risk. I have seen too many barely detectable at week 12 relapse.

If you want a copy of the Berg study, send me a PM with an email address to which I can send it.

Nothing new has come up lately as far as I have seen regarding 72 weeks. The latest study I have seen said no statistical significance, probably due to too low numbers of participants or something. The trend of higher SVR with extended tx was there, but it did not reach what is referred to as "statistical significance". So nothing proved, either way.

Doing tx is a gamble, question is how much do we want to put into it. I hate risks, so I did my best to better my odds and lower my risk of relapse.

Good luck to you! Hope you reach SVR however long you go!

[zazza]

PS I was UND by week 15.

[frijole]

I was not clear at week 12 -- with a viral load of 40 IU-mL (the test was sensitive to 2) -- and had to really twist my doctor's arm to extend.  He saw no purpose but finally let me.  I was probably clear at week 16 but definitely clear by sensitive test at week 20 and decided, using the Drusano model, to treat 36 weeks after clearing, for a total of 56 weeks.  It was not enough, my friend, and wish I had gone the 72.

You have to do a lot of soul searching, especially when so many of the GI's around are still thrilled to death with the 2-log drop at week 12.  To me that 2-log drop is only significant if you don't make it -- and then I think it means change your course of treatment or drop treatment.  However, you fit very well into the Berg study which showed a significant increase in SVR for treaters who had VL under 6,000 at week 12, treating 72 weeks instead of 48.

good luck on your research
frijole

[justme53]

I don't have any more studies to support extending, but I do have my personal input. I'm another stage 4 going 72 weeks. I did clear by week 12, but I understand that my liver damage drops my odds of clearing, hence my willingness to go the 72.

I understand the drawbacks of long term interferon, but as I see it, I'd rather give it my best shot NOW, rather than having to do this over again and subjecting myself to even more combo therapy. I am also convinced that once we're UND, we have less inflammation and our livers are getting a well needed break.
  
I echo Eureka when she says that 10 % increase in likelihood of SVR is huge when you're a Stage 4. Heck it's 10 % more than I had before....

Hopefully your  Dr. will come around and you'll both draw up a plan that will work for you. Good Luck!  Pam

[all_is_well]

This is terrific!
You guys are making my life easier even before I've started to make serious attempts to find any studies that can support the combat with my Dr's resistance. It definitely will be the best ammunition.

Brent:
Thanks for the link - I'll read it thoroughly. OMG - treating 84 wks and relapsing - this must have been a real battle. Are you going to treat again? Wish you Good Luck!

Eureka:
Thanks for your help. Your hubby and I will be going along at the same time with the tx - almost. Keep me posted.

Frijole:
I'll try to get to 72 wks. You didn't mention if you are treating again. Good Luck to you!

Pam:
I agree with you and many other that 10% higher chances of clearance mean less chances of failure. Treating a little bit longer would logically cause less damage than doing it again all over.

Zazza:
Thanks for that link. I'll take my time and read it carefully. I am very interested in this Berg study of course and will try to give you my email, even though I don't know what you mean with "send me a PM".

Thanks again,
A.