Deciding whether to continue tx or not

[GingerB]

I have been giving much thought as to whether or not I feel it is in my best interests to continue tx at this time.
I am GT 1a , biopsy grade 2, stage 2,  and I started tx on Jan 8.  Pre-tx VL = 2.84 mil,  12 wk VL = 20 IU.
I had a consult with a liver doctor and according to him,  with 72 weeks of tx I have a possible SVR rate of 45% to 50% max, provided I clear the virus by week 16.
I have an appointment next with my tx doctor which will correspond to my 16th week VL.  At that time, I  will  consult with my tx doctor and plan to make a decision then.
Based on my stats and my VL response, and what I think are my SVR odds, I am leaning towards stopping tx and taking a wait and watch approach, and perhaps see what future meds may have to offer.
In the meantime I am still taking my meds until I see my tx doctor next week.
I want to thank everyone for their feedback to my posts - thanks for sharing your knowledge with me, and for your opinions and support.  You have all been a very big help.  I admire all of you who have treated and are treating.  And I do believe in tx as many have achieved SVR.   In my case, I am basing my decision on my particular situation and doing what I think is hopefully the right thing for me.   GingerB.

[jmjm530]

I'm glad to see you've discarded the 48-week option and narrowed the choice down to treating 72 weeks versus stopping at week 16. It's a signficant difference in exposure to the treatment drugs and a decision that reasonably could go either way.

Don't have the studies in front of me, but your doctor seems in the ball park regarding your odds of SVR with 72-weeks of treatment. So, it's either play those odds and treat, or cut your losses and go into "watch n' wait" mode.

Personally, given you don't have significant liver damage, I'd cut losses, but then again my bias is not to treat with less than signficant liver damage, esp for geno 1's. Further, if treatment is undertaken, only continue when the odds are heavily in your favor -- such as RVR -- which unfortunatly you don't have.

All said, if you do end up making your decision to stop, I see no reason to wait until week 16. Waiting until week 16 only seems to make sense if you're planning on continuing treatment should you be UND. I know you previously posted that you wanted to continue on until UND just for informational purposes for future treatments. As I stated then, I don't see this as a legitimate reason to continue on, as you've already established yourself as a responder, albeit not a rapid one. The only reason to continue on IMO is either to give yourself more time to weigh the two options, or to get a "green light" for 72 if UND at 16.

All the best with your decision,

-- Jim

[willing]

before quitting I would (a) ask your Dr. what he bases the 45/50 % outlook on (b) carefully go over all the available extended-tx studies. This includes the older Berg/Sanchez-Tapia data at 800mg riba  and the newer studies Pearlman/Sanchez-Tapia/Berg/Ide data at full riba (note that the low outcome in Pearlman was affected by patient selection, as discussed in the accompanying editorial in the same hepatology issue).

Overall, there's not yet a lot of extended tx data, but from my reading  that 45/50 looks low. From Ide, for example (aasld abstract 1321)  SVR odds were 79% for 44weeks past UND - in your case 60 weeks if your vl drops as you expect.  Also, for future treatment reasons, I think there will be some benefit to knowing exactly when you became UND. If you stop before then you would not be able to establish "responder" status for a clinical trial for example.

All the best - it's a tough decision.

[TnHepGuy_]

If you do decide to continue you may want to press your doc to add Alinia to the mix. If you make the commitment to go 36 or more weeks beyond undetectable, make sure that your doc is fully on-board with you and your ultimate goals. Explain that given just how long and tough tx'ing is, you only plan on doing it once and you want to give it all that you can during that time frame - and that includes adding Alinia. It's an FDA approved drug (though not specifically for Hep C) with a minimal sx profile.


TnHepGuy

[jmjm530]

Willing: If you stop before then you would not be able to establish "responder" status for a clinical trial for example.
-----------------------
You may be more up on this than me, but my understanding is that a two-log drop at week 12 does constitute "responder" status, in fact it's one commonly used definition of EVR (early viral response). My follow-up point being if you're going to cut losses, then cut your losses as much as you can -- unless, of course you haven't made up your mind.

-- Jim

[HectorSF]

Hi Ginger.

It's definitely an individual decision that only each person can make themselves.
I'll just give you my point of view for what it is worth...

You are very close to UND. Your viral load has dropped more than 2 log. This is all good news!

If you reach UND between week 12 and 24 that means you are a "slow responder".  The 72 weeks is the standard protocol for slow responders because the virus needs to be suppressed (UND) for a certain period of time otherwise you will relapse. That is way persons who become UND by week 4 have such a high chance of achieving SRV. They have 44 weeks of time that the virus is suppressed.

In my opinion the important thing is for you to know is if you are a "slow responder" or a "non responder". A "non responder" drops the VL by at least 2 log but NEVER reaches UND. If you don't achieve UND you will NEVER achieve SVR. This is a very important point!!! A "slow responder" can be retreated in the future (for 72 weeks). A 'non responder" is refractory to the effects of interferon and has a very small chance (3%-15%) of achieving SRV using current meds.

Therefore in my opinion you should try to go to at least UND (weeks12-24) So you can find out what future chances you will have of ever clearing the virus with current PEG-INFN - Ribiviron therapy.

Your liver is at stage 2, which is not so bad. Maybe you can wait a number of years for new therapies? I don't know your current and future life plans. But I think it would be nice to know if you have the possibly of clearing the virus in 72 weeks. Even if you don't take that route. Otherwise if you stop tx either before UND or week 24 than you will never know what your chances are of clearing the virus with current meds. You would have to go through week 12 or 24 just to know.

Personally after coming this far (for me week 12) I will go to week 24 to know if I have any possibility of clearing the virus. As I probably don't have the time to wait for future meds without PEG-INFN. As I have cirrhosis at this time I need to do whatever I can to stop the virus causing any more damage to my liver. Otherwise I may be looking at a liver transplant in my future.

This article will tell you what your odds are based on your viral response: You need to sign up with this site to view this article any slides and audio.

Understanding HCV Nonresponse and Identifying Candidates for Retreatment
Source: New Management Strategies for HCV Nonresponders and Relapsers
By: Mitchell L. Shiffman, MD

http://clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20Nonresponders/Module/Shiffman.aspx

"It is critically important to recognize the point at which a patient achieves undetectable HCV RNA during treatment as this is directly related to the likelihood of achieving a SVR (Figure 5).[7] In other words, the later a patient achieves undetectable HCV RNA during treatment, the higher the likelihood that the patient will relapse after treatment is discontinued following the standard duration of therapy (24 weeks for genotypes 2/3 and 48 weeks for genotype 1).[7] Three recent studies have now demonstrated that relapse can be significantly reduced in slow-to-respond genotype 1 patients—those who achieve undetectable HCV RNA after Week 12—by extending the duration of treatment from 48 to 72 weeks.[8-10,20] In each of these studies, the relapse rate was reduced from more than 50% to less than 20%. "

I wish you all the best whatever you decide.
Let us know how you are doing.

Hector

[merryBe]

note the last sentence of Hectors clip...

).[7] Three recent studies have now demonstrated that relapse can be significantly reduced in slow-to-respond genotype 1 patients—those who achieve undetectable HCV RNA after Week 12—by extending the duration of treatment from 48 to 72 weeks.[8-10,20] In each of these studies, the relapse rate was reduced from more than 50% to less than 20%. "

than means even slow responders relaspe rate is not as bad as they used to think.
less than 20 percent.

it's hard I know (same situation as you) to think of treating for another year plus...especially if the side effects are harsh.
I just keep telling myself I'm almost half way home, even though I'm 2 months from that.

it's a hard call, but I've added Alinia and plan to taper off Interferon as per HR's suggestions, which may mean an even greater chance of SVR than current SOC reflects.
Obviously at stage 2 it is a tough call....everyone wants better less painful tx drugs.
However biopsy can be off by a stage or more, and, things insurance wise change for people in the USA...so you have to weigh in a lot of stuff like that also.

Are you  trying t decide based on bad side effects or something personal? You know you can write me privately if that would help you.
maryB

[GingerB]

Thanks all for your valuable information.   I will let you know how things turn out for me.  Again thanks so much...GingerB.

[CockSparrow]

Google "Interferon Lactoferrin" its worth thinking about adding.
It seems to do something and adding it when und or close to it could well make the difference. I agree that your svr odds would be closer to 80% than 50%. 72 weeks has a high dropout rate, adding lactoferrin could increase those odds further.

CS

[CockSparrow]

This Article from Journal of Hepatology may help.
Which patients with genotype 1 chronic hepatitis C can benefit from prolonged treatment with the ‘accordion’ regimen?
http://www.jhep-elsevier.com/article/S0168-8278(07)00411-4/fulltext.

CS

[dranurag]

Do you mean that remaining undetected on treatment for as many weeks as possible will reduce chances of relapse (read lead to possible SVR) ? I was UND for 30 weeks when I stopped peg after a total of 72 plus weeks yet relapsed after 4 weeeks of stopping tx

[CockSparrow]

30 weeks UND in 72 weeks is nowhere near enough.
From memory much of that was without riba.
The link above gives good info, even though you are a G3.

CS

[zazza]

I just completed 72 weeks of treatment. Of that at least 57 weeks, maybe as much as 59 weeks, was UND. We will see if that was enough to reach SVR.

[HectorSF]

Hi.

"Do you mean that remaining undetected on treatment for as many weeks as possible will reduce chances of relapse (read lead to possible SVR) ? I was UND for 30 weeks when I stopped peg after a total of 72 plus weeks yet relapsed after 4 weeeks of stopping tx"

The (DUD) “Duration of UnDetectability” varies depending on the rapidity of the patient's virologic response. So I wouldn't say "as many weeks as possible". But as many weeks as is necessary, to have the best chance of achieving SVR based on current scientific data. That is why there is the standard durations 24, of 48, 72 weeks. Which is based on your viral response during the first 24 weeks. When you drop 2log. When you become UND.

Because you were treated for 72 weeks this must mean you were a “slow responder” (greater than 2 log drop by week 12, UND between weeks 12-24. Correct.? "Those patients who were treated for 72 weeks had a SVR rate of 45% as compared to 32% SVR rate in those treated for 48 weeks".

The important thing for you now that you are thinking about retreatment, is to determine WHY you relapsed? If you know why you relapsed you can try to correct it if you choose to retreat.

I would suggest reading the following articles, as they will explain your chances of achieving SVR during retreatment.
http://clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20Nonresponders/Module/Shiffman.aspx

Understanding HCV Nonresponse and Identifying Candidates for Retreatment: Mitchell L. Shiffman, MD. (You have to sign up to see the full presentation of this doc)

"In addition to MISSED DOSES and PREMATURE DISCONTINUATION OF RIBAVIRON, the other main reasons for relapse include treatment initiation with INSUFFICENT RIBAVIRON DOSAGE, and FAILURE TO CONTINUE TREAMENT LONG ENOUGH in patients with a slow virologic response. Three randomized trials have demonstrated that patients who initiate treatment with a higher dose of ribavirin have a lower relapse rate. In one of these studies, the routine use of epoetin alfa did not affect virologic response, relapse, or SVR rates, even though the frequency of ribavirin dose reduction was reduced. As discussed earlier, 3 studies have demonstrated that relapse can be significantly reduced in genotype 1 patients with slow virologic response by prolonging the duration of treatment from 48 to 72 weeks."

"Strategies for Optimizing Current Treatment and the Potential Impact of Emerging Therapies"
http://www.medicalcrossfire.com/onlineLearning/cme/2006/06-LC-27-M-100.pdf

Hope this helps!
Best of luck.

Hector

[HectorSF]

Oops. Sorry I missed this...brain fog...

I don't understand the 30 weeks out of 72??? As Cocksparrow mentioned.
Can you explain please?


thx

Hector