12 week PCR - seeking advice

Hi folks,

Got my 12 week PCR. My starting VL was 9.3M. My 4 week PCR was 1.0M (which was a .92 log drop.) Today I got results of 12 week PCR and I am at 53,000. (Which translates to a 2.2 log drop).
The tx has not been a piece of cake for me and some sides such as fatigue, itching, eye pain, hair loss and site rashes have been almost unbearable at times.  My fatigue however is not severe enough to warrant the rescue drugs and the doc has only prescribed a cortizone cream for injection site rashes, which only delays the rash for a few more days.

So my question (and my confusion is), with the 2.2 log drop at 12 weeks with SOC, what are my probabilites of getting an SVR with 48 weeks of treatment ( Genotype 1A)? And with 72 weeks of tx? I think that since I am not UND at 12 that the protocol is now to treat for 72 weeks? I am a stage 2, grade 3. My thoughts are why should I continue to tx until summer of 2010 with a low probability of SVR and all the harsh affects on my body if in 2011 the new PIs will be available with a shorter tx time (24 wks) and a higher probablility of SVR? 80 -90%? Do I have those stats right on the PIs?

I can always count on this forum to help guide my thoughts to wellness so your input is much appreciated.  I am really needing to be convinced to continue sx at this stage of the game.

[nygirl7]

So my question (and my confusion is), with the 2.2 log drop at 12 weeks with SOC, what are my probabilites of getting an SVR with 48 weeks of treatment

Sadly, not really very good at all.  You need to see now if you do succeed and get to UND at wek 24, if you do not you should probably not continue. If you do, you will need 72 weeks to have any real good chance at success here.

The starting VL really doesn't matter except to figure out how your decline is. For example mine was only 568,000k and still at week 12 I only had 419 but that was NOT undetectible and I had to do 72 to have any real chance.  I have been cured for over two years though.

It's not just getting to UND it's WHEN.

I don't know why some people have it tougher than others, it isn't fair to me a bit.  Are you being medicated enough? For week 4 it seems to me that 1m is rather a high number to still be holding on to, almot log drop or not.  Being UND at week 4 gives you excellent rate of success - being UND at 12 is about 50% but you aren't there yet.....

[HCA]

Your etimates for success with protease inhibitors and a 24 week treatment are a bit high-basically 66% of all patients and 51% of prior treatment faiures and 82% of relapsers is nearer the mark.
You would certainly have to treat for 72 weeks on your current program-it's a tough call and only you can decide

[annieCinMD]

I'm sorry to hear your in this predicament.  I don't know if I'd want to continue for 72 weeks. I may be in your situation. My 12 week is not this week but next week. I had written before that my 4 week had jumped back up from 97,000 to 324,000. My 8 week came back down to 112,000. So it's still up in the air if I make UND at 12. I do have the option of adding in a PI if I'm not UND at 12 because I'm in a study. I will almost certainly take that choice if given it. I think I would strongly consider waiting on the PIs if I were you. I think Teleprevir is due to hit the market in 2011. Best to you, and good luck with the decision.

[Virusbuster]

I'm about to face the same situation, and frankly, a 2.2 log drop at 12 weeks would not do it for me. Then I will prefer to wait two year and try again. Esp. protease inhibitor BI 201335 sound quite promising to me.

[copyman]

Like some of the others suggested I would wait for the new drugs. The 2 log drop at 12 weeks is old protocol. The latest protocol by any "up to date" doctor are using the 4 week test as the predictor of SVR. Best of luck whatever you decide.

[AnotherJourney]

Copyman,
Can you refer me to any links to the 4 week PCR being an indicator?

NY (or anyone) know the probability of SVR if not UND at 12 but UND at 24 weeks under SOC of 72 weeks? 48 weeks?  

Also what is the protocol for the new PIs. Is treatment for 24 weeks? or is it still 48?  

[Tippyclubb]

I am so sorry to hear this.  Please keep of posted as to your decision.

Hopefully, some more people will chime in with advice.

[portann]

I also am very sorry to hear this and hope you'll keep posting about what you decide.

[nygirl7]

NY (or anyone) know the probability of SVR if not UND at 12 but UND at 24 weeks under SOC of 72 weeks? 48 weeks?  

You need to read the Berg Study and the Sanchez Tapias spanish study but here is an excerpt from Berg (sorry I don't have the whole things any longer but you can google it all up or hopefully someone else will come in and post their notes) This is part of what I used in my own personal decision to extend to 72 - but Dr. Ira Jacobson who is one of the preeminent (spelling?) HCV doctors in the entire world (and has been lead investigator of most of the big studies that have been done recently to further HCV advances) told us about the Tapias study which backed this up further. I went to him for a second opinion when my own doc hadn't even yet heard of the Berg study.......I figured his info was pretty darn old since I knew about it myself.  You'll notice that it says 46/82% relapse rate for 48 weeks versus 29%/44 for 72.  If you ask me changing it down that much was worth the risk for sure.

"However, a significant difference in relapse rates was found in patients with a late virological response, defined as HCV RNA greater than 1000 U/L at week 4 or 12, and negative at week 24. In the group that was treated for 48 weeks with a late virological response the relapse rate was 46% or 82% compared to 29% or 44% in patients who were treated for 72 weeks.

The authors concluded that a small but significant number of genotype 1 patients with detectable HCV RNA at week 4 or 12, but who became HCV RNA negative by week 24, would benefit from a longer duration of therapy. There is a larger prospective study underway to confirm these findings"
------------------------
Tapias

[zazza]

I posted this a couple of days ago:

"Informative video 'Hepatitis C Update' from University of California Television, first aired 4/1/2009. 'Dr. Lorenzo Rossaro, UC Davis Chief of Gastroenterology and Hepatology presents an update on the treatment of Hepatitis C.'

http://www.uctv.tv/search-details.aspx?showID=16056&subject=health

Dr Rossaro states that triple therapy will be available in 2012-2014. He talks about SVR as CURE which is so nice to hear. He also talks about the importance of extended tx for slow responders, among other things."

If Dr Rossaro is correct in saying that triple therapy will not be available until 2012-2014, would that affect your decision? In this video he also talks about SVR percentage for slow responders with 72 weeks, so you might want to watch it.

Take care,
Za

[AnotherJourney]

Za,
YEs if not available until then that definetly affects my decision.  GOing to watch video now.

NY, Doing some research and thanks for the feedback

[AnotherJourney]

That video was very informative. A lot of the info was basic and can be garnered from this or other sites. But you are right that his calling SVR a cure adds such more optimism to treatment. I would really recommend those new to this journey.

As you and I discussed after my 4 week. I think my doc could have perhaps dosed me at a higher riba dosage. I asked her about that at week 4 and she insisted that 1400 mg was the max. But here again, Dr Rossaro talked about the importance of 15g/kg.  Another lesson learned about this treatment process.

Also, Dr ROssaro does mention the success rates of the Sanchez and Berg studies.

[Isobella]

You have gotten some great advice....I just wanted to come by and give you a great big (((((HHHHUUUUUGGGGG)))))

Wish you the best in making your decision.

Isobella

[frijole]

I don't think your chances are good, even if you do extend to 72 weeks.  The Berg study found it beneficial for those with viral loads under 6000 to do 72 weeks.  I am afraid that your VL is too high for just extended time.  I think you would have to change other protocol for success.  There have been a couple of members her (fishdoc and bill1954) who have been riba-resistant.  That is, the normal weight-based dose of ribavirin was not adequate to get their blood level to the point to do any good.  The indicator (besides the fact that they didn't clear at 12 weeks) was that they did not become anemic.  You said you were fatigued but not enough for rescue drugs.  While that sounds good, it may, in fact, indicate that you are underdosed with riba. The anemia is actually a good sign that the ribavirin is doing its job.

Fishdoc went to a specialist for a consult at week 12 - her VL was, I think, similar to yours at 12.  She increased riba to 1800 (I think) and succeeded in clearing with about 52 weeks (again, I say I think because this was all about 2005-2006, the time frame I treated (nygirl, too)).  Bill1954 was dosing at about 2200 -- maybe more -- and he is clear too, although he did about 90 weeks the second time around (after 72 or so the first time).  

There have  been other members who have doulble up on the interferon, an idea that interests me.  However, all of this would take a good hepatologist to work with.  Do you have one, or do you have an SOC GI?

I wish you luck with your journey but, unless you can make some changes in your treatment plan now, it might be advisable to hold until the PI's hit the market.

frijole
There

[zazza]

Frijole makes a good point here. (Hi, Frijole!) I remember reading an article by Berg where he suggests 30,000 IU/ml at week 12 as an upper limit to do 72 weeks. It makes me frustrated, since with a higher riba dose you would probably have been beneath 30,000. Arggh...

[jmjm530]

Given your stage (no significant liver damage), slow viral response and side effects -- I think stopping and cutting your losses is very reasonable. The alternative is 72 weeks which could potentially present a whole host of other problems post treatment, not to mention the remaining 60 weeks themselves. If you do stop, just make sure you monitor your liver on a regular basis under the care of a good liver specialist (hepatologist). 2011 is the year I hear most for the PIs but if you're still stage 2 in 2011, I don't see the rush as even better treatments are in the works.

-- Jim

[AnotherJourney]

Za, Frijole ..."Berg where he suggests 30,000 IU/ml at week 12 as an upper limit to do 72 weeks. " ...this is info I have never seen and gives me some relief that I am making the right decision to discontinue treatment. I will have to see if I can find a link to this suggestion of Bergs.

I went to my family dr yesterday. And we went over results. He is by no means a Hep but he is a good listener and will try to get one all the help they need. Dont see my Hep until this next Friday. I told him of some of my issues with her & her staff & my treatment in general. Frijole, I think you are right in that I am going to need a good Hep to work WITH me. So fam dr is refering me over to UofM to see if perhaps something more can't be done.  Will see if CT is an option if not, I have halted SOC drugs and will wait for 2011, 12 ...as long as my liver can remain somewhat healthy. I am also hoping these 12 weeks have done some liver repair. .

Thanks all for your support and your advice. This is such a hard decision and one that carries a lot of quilt/frustration/saddness. As always, your imput makes me feel informed to do the right thing for me. Hugs & Best wishes to each and every one of you. Believe me I am going to still be hitting this sight so I am lookind forward to hearing more good news stories.

[jmjm530]

Make no mistake, the choice is either stop now or 72 weeks. The 48 week option will give you a very poor chance of success. If you are told otherwise, seek the counsel of a good hepatologist as gastro's and family docs simply aren't up on the subject.

[frijole]

I agree with Jim -- it is either 72 weeks or cut it off now.  But what has your hemoglobin been all during treatment?  Even if you decide to continue, you may still want to increase the riba.    I only did 36 weeks clear, after my first UND by sensitive test at week 20.  You have no idea how much I wish I had gone the 72. I based my decision on the "Drusano" model -- another after the fact, mathematical assumption (that is flawed) and the fact that I had a mere 40 IU/mL at week 12.  

Hey Zazza - it is good to talk to you.  Long time.  I really do not remember the 30,000  IU/mL as the upper limit for continuing on for 72 weeks.  As I recall, the Berg study was more of a compilation of the facts of past studies than an actual study. It was more mathematical than anything else.  I do remember that the viral load testing was sensitive only to 50 IU/mL - a test that most of us considered inadequate.  It seems that maybe you had some info on the life cycle of the heptocyte - the liver cell - that seemed to indicate the benefit of staying on treatment for the longest possible life of the liver cell which was like 500 days (coincidentally, about 72 weeks).

frijole

[zazza]

Hi Frijole,
I am 1 year post now, do you believe it? Time does fly!

You are correct that in the Berg study, Berg talks about the benefit of 72 weeks tx for those below 6000 IU/ml at week 12. What I am referring to is an article by Berg which he wrote in December 2006 in the German magazine Hepatitis&More. Look at the chart on the last page, that is where he says equal to or less than 30,000 IU/ml at week 12. The chart also suggests to up the riba if detected, both at week 4 and at week 12.

http://www.hepatitisandmore.de/archiv/2006-2/HEPandMORE_2006_2_S12_S13_S14_S15_S16.pdf

I understand it to be that AnotherJourney discontinued tx last weekend. She is going to go to a research university to find out more about her options. She was dosed low on the riba, something like 12.7 mg/kg, so I think she probably made a wise decision. I would hate to go 72 weeks being underdosed on riba. If you look at Berg's chart, he suggests 15 mg/kg for geno 1s.

Have a nice day!
Za

[zazza]

I just checked the new guidelines for hepatitis C treatment for Germany from 2009. They use 30,000 IU/ml as the cut-off line at week 12 for geno 1. 150 hepatitis C experts and several hepatitis C organizations have participated in writing these guidelines.

[zazza]

To clarify, according to the German guidelines if you have at least a 2 log drop and less than 30,000 IU/ml at week 12 and are UND with a viral load test with the sensitivity of  12-15 IU/ml at week 24, you go 72 weeks.

http://www.hepatitisandmore.de/archiv/2008-2/Hep2_08_FoBiLeitlinie.shtml

[AnotherJourney]

Za,
My HGB started pre tx at 14.5 At 4 weeks it was 12.5 (I think) and then at 6 weeks it hit 11 where it hovered around through the remaining treatment.

The sensitivity of my PCR was < 43. But with a VL still in 50K, the sensitivity really isn't a factor is it?

Frijole,

Did you relapse? Is that why you wish you did the 72 weeks?

Interesting stuff that life of the liver cell which was like 500 days (coincidentally, about 72 weeks)

[zazza]

Your hgb during tx shows that you most likely would have tolerated an additional 200 mg of riba. What a shame you did not get that. Doctors have to stop thinking about the total dose of riba, and start thinking milligram per kilo. My hgb hovered around 10 during most of my tx. While I was down and out spending most of my tx horizontally, I was happy about my hgb considering it to be an expression of good absorption of riba, and I did eventually reach SVR!

[frijole]

aj - Yes, I did relapse.  Since my liver damage is relatively low - grade 1, stage 1-2 - I have just been on hold.  I would like to treat again and rid myself of this virus but there is no sense in giving up another 72 weeks of my life. I can wait until 2011.

Zazza - I had not read that additional information by Berg. THanks.  Also thanks for explaining the low dose of riba that aj is on.  One year post.  Wow - how is that possible.  Has life gotten back to normal for you?

frijole