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Avatar universal

SOC progress stalling after Week 4 ?

I am in a trial (genotype 2b, SOC) which makes it a little more difficult to get questions answered; have never even met the doctor. My 8 week results were emailed to me and read as follows:

"VL is < 25 at week 8.  25 is the limit of detection.  It is still present but less than 25.  If the virus stayed persistently above 25 thru week 12 you would discontinue treatment because it wasn't working."  

(I'm not sure if the last sentence was directly in reference to my 8 week results and what they predict, or just stating the protocol for someone who stays persistently above 25 through wk 12.)

I assume going back up to above 25 would indicate a non-responder? I'm wondering what the chances are for that happening?

My 4 week log drop was 5.4 (8M to 32) and I've seen literature that gives hopeful predictions (SVR) for a 2 log drop by wk 4.

However, my log drops went as follows for weeks 1 through 4: log 2.3 (1st week) then 1.5;  1.2;  0.4;  0.1;  but by week 8 I was still DET at  <25.

Seems my tx started out with a bang, but is stalling after week 4, or does anyone know if this is this how it generally goes for genotype 2 on SOC?  It's hard to find many stats from members with genotype 2. And of course I see this incredible early UND for g-1's on other tx; any solid info for g-2 on SOC would be greatly appreciated.

24 Responses
Avatar universal
I posted a link below that shows really your right on course faith. It was a study done for genotype 2's that showed people that were und at week 4 only needs 12 weeks of treatment and those that are not should do the normal 24 weeks... You was as close as it gets to becoming und by week 4. You have the odds that they give geno type 2 which is very high. From what I understand they don't even recommend the IL28B testing for geno 2's......... Hang in there.

http://www.medscape.org/viewarticle/507068
Avatar universal
Hi, one very important thing to remember is that your in a trial so viral load testing is much more often. Under normal treatment you would have been tested at week 4 and then again at week 12, so you would not have known the weekly numbers. You would have seen under 25 at week 4 and been happy. And yes the viral load should drop fast the first couple of weeks so all is fine there, the odds of having a spike in your viral now is very low, wouldn't even worry about that.

Your right on course for being und at week 12 and that is normal for genotype 2's. What your seeing in geno 1's being und at 4 weeks is because of the PI drug added to the mix. Hang in there your doing just fine.
Avatar universal
Music to my ears, thank you! No wonder I could not find stats for week 8 in every piece of research literature I came across for SOC g-2!  All of the charts and data give only 4 and 12.
Although SVR is never a guarantee, you have definitely recharged my faith for healing. :)
148588 tn?1465778809
Being a geno 2 who was still detected at 4 weeks, this might interest you:

An IL28B Polymorphism Determines Treatment Response of Hepatitis C Virus Genotype 2 or 3 Patients Who Do Not Achieve a Rapid Virologic Response

http://www.gastrojournal.org/article/S0016-5085(10)00841-3/abstract

".......patients who failed to attain RVR ...... SVR rates: CC, 87%; CT, 67%; and TT, 29%........."

Your genes are just as important as the results of your vl tests. Since this is a high $ trial, I'm asuming they've done an IL28B test on you. See if you can get this info.

Good luck.
Avatar universal
I appreciate your response, desrt!

I can't get in to read that article, I registered, I tried. I don't know anything about the IL28B test, and my screen lab test only says, "HCV GENOTYPE, LIPA = 2b". Does it significantly change the old predictions? I guess what I'm asking is, how important would it be to have that info? Is it more definitive by 20% or 70%?  And do the old standards still hold, but this test just tweaks it more precisely?

By "old standards" I mean data I find that aligns with what can-do-man said. Generally, Wk 8 has no (or very little) published info in terms of predicting SVR for SOC?

I don't know if I am reading the chart correctly (or if the info is too old to be relevant), but it seems the best "prediction" is told in Wk 12 since only 29% attained PCR-neg at Wk 4 while 60% attained PCR-neg at Wk 12. It also includes Genotype 1 which skews things a bit?

http://hepatitiscentral.net/hcv/info/2003/sept/hepcinfo645.pdf

The EVRs were defined as PCR-neg and/or log drops of 1- 3; mine was 5 at Wk 4 which I am choosing to take as a good sign?

It seems Wk 4 data is not the best predictor on SOC, and as can-do-man said,  "Your right on course for being und at week 12 and that is normal for genotype 2's" ....so for right now I'm hanging with that, lol.

But I'd like to know more about the IL28B test, and if I should get it.

Thanks, FFH
1815939 tn?1377991799
At this point getting the IL28B test  would be of interest just to know which one you have, but I doubt it will change your course of action at this point.  

As Can-do-man said, you are already doing well.

I am Genotype 1, but the anxiety is the same for all of us on Tx no matter which Genotype we have. When I was still detectable, but <43, at week 4, I really started getting stressed out and worried. I went over the numbers and figures and percentages for SVR in every article I could find. It was definitely stressing me out. But a friend reassured me and told me not to get too hung up in the numbers (other than the important numbers like when one needs to be UND to stay on Tx). I still occasionally crunch numbers but I am not as stressed out about it as I was at first. I cannot change the outcome as long as I follow the rules. I would not stop TX even if I found out I was TT. So knowing whether I am CC, CT, or TT would be of interest and might reassure me if I was CC, but it might cause unnecessary stress if I discovered I was TT.  

Just hang in there. Less than 25 is very good.
Avatar universal
Thanks! That is my take on it....not much to really do at this point but wait for week 12. Seems most of my indicators hold promise so far, and we all know there are no guarantees so it's just wait and see. I am looking into my options should I get discontinued at wk 12 if I don't go und....best to be prepared.

I appreciate both of your reassurances, and the link, can-do-man.

Thanks again!

Avatar universal
Hang tough and good luck on the week 12  :)  That is the key.... as mentioned.

Will
2114467 tn?1358210256
Like Will says, hang tough. I think we all get a little anxious waiting on our labs. When I did that, I had to let go. The things that I could control, would be my focus. Take my meds on time, drink lots of water and now I've learned that I do need to rest.
Best of luck to you,
C
Avatar universal
I know this thread is old now, but just wanted to post that you were exactly correct in your information: "Under normal treatment you would have been tested at week 4 and then again at week 12, so you would not have known the weekly numbers. You would have seen under 25 at week 4 and been happy."
It's too bad I was ever even tested at wk 8, and as they told me today (at wk 12 testing) they never expected und at week 8 given SOC and genotype 2. I sure wish they would have told me that; fortunately, you did and I chose to go with what you said and have been stress-free, lol.
Thanks again. FFH
Avatar universal
Thanks for the kind words, wishing you the best...
163305 tn?1333668571
I'd like to add a comment for anyone looking at doing a trial in the future.
Faith's situation points out just how important it is for people to find out what kind of care they can expect. The time to ask questions is before beginning treatment.
It's important to know, beforehand, how often you'll be doing labs, what happens if you need rescue meds, how often you'll be seeing the doctor, etc.

Glad to hear things are well for you Faith~
Avatar universal
I think the most important thing to know in doing a trial is to know the history of the group doing the trial (e.g., research how long they have been involved in trials, how many they have done, the hospital and doctors' reputations, etc.). Talk to people who treated with them privately, etc.

There are a lot of appointments prior to being accepted for the trial. An 18+ page disclosure that covers a multitude of issues, including risks, lab and other test schedules, what if injury occurs and much more. It is dated, signed and witnessed. I could have asked any question I wanted, but being a newbie I was really low on the learning curve. I never had a clue to ask, "What results do you expect at wks 1, 2, 3, 4, 8, etc" or "Why are you testing me at those intervals?"  I didn't know it was unusual to be tested at wk 8 on SOC. I just knew they expected UND by week 12. I was sick, anxious, and afraid I'd waited too long to treat, didn't have the $$ to treat, but had "too many assets" for financial assistance to treat; I just wanted the friggin' meds and a chance at getting rid of the HCV, lol.

But as I said, the important thing is to research the people to whom you are entrusting your life, and that would be true in private tx as well. And on a trial there are "independent outside monitors" who watch over the pharm companies practices, decisions, doses and other protocols of their trials so they do no harm. A lot of private gastros jump into treating HCV and don't have anyone watching over them, and we've heard those stories about drs who don't seem as familiar with tx protocols as some of our own members on this site.  Buyer beware. :)

Another interesting thing I learned is that the reason we on trials don't see our labs is that they are top secret info, not even the team gets to see all of the results. Our blood work does not go to regular labs like Labcorp, they go out of state by courier to an international company that only does labs for biomedical research. These pharm companies are spending a fortune to do research (trials) and they do not want their data stolen....remember these pharm companies are competing with each other to win first place, they are not sharing their info. I now understand why the team seems so closed-mouthed; it's a serious confidentiality issue with spies lurking around.
317787 tn?1473358451
Hi, I am really happy to hear that you are UND at 12 weeks, great news

I was treated with a trial back in 2008.   I, unfortunately, trusted the doctor to do the best thing for me.  I did not realize all the questions I should have asked about the trial and had a very rough time.  That trial was the last one as the medication was too hard for the body, luckily the monitors overlooking the trial stopped it.  
My best to you
Avatar universal
Hi Dee, I wish I could say thank you, but it would be premature as I only had the 12 wk blood draw on Tues, and I do not know the results yet! I hope UND, but it's still a hope, not confirmed.

I am sorry to hear about your trial experience, but it is due to people like you, and your sacrifices, that contributed to making UND possible for thousands of people. That may not be much of a comfort to your personal search for UND, but you are owed a lot of gratitude for your part in helping to find the better tx for so many. I assume you are not genotype 2? At the time did they have any FDA approved and highly successful  tx for your genotype?

So, what did you end up doing? Did you tx with something else? Are you still working towards UND or did you find success elsewhere? I hope it is working out for you in one way or another.

I knew going in that I was going to get exactly what I would have gotten if I had txd privately (i.e., the old FDA approved SOC) so in that sense I knew I wasn't risking much other that what anyone risks when they choose to tx with SOC, and therefore I didn't have a lot of questions. The other arm of my trial is the experimental one. My decision was a no-brainer, not like yours which involved far more risk of experimentation.

My best to you, too.
179856 tn?1333547362
That was a very nice post F4H. :)
Avatar universal
sure wish they would have told me that; fortunately, you did and I chose to go with what you said and have been stress-free, lol.
Thanks again. FFH
--------------------------------------------------
Very nice to see a member recognize the help that  "can-do -man"  has provided here for years even though already long since cured..

Best to you...FFH

Will
1669790 tn?1333662595
I agree with pooh that getting the IL28B test would be of interest just to know, but wouldn't change your course of action.  If you found out that you are an unfavorable genotype, it would probably just stress you out throughout tx.

"Early viral responses are influenced by all pretreatment factors, and therefore once treatment has started, prognosis is almost entirely dictated by the rapidity of decline in HCV RNA. As an illustration of this point, the IL28B genotype loses predictive value for SVR after controlling for treatment response. A patient with the unfavorable non-CC genotype who achieves a rapid virologic response (which is less likely but still possible) has a better chance of obtaining an SVR than a patient with a favorable CC genotype who does not achieve a rapid virologic response.[Mangia 2011b; Thompson 2010] "

http://www.clinicaloptions.com/inPractice/Hepatology/Hepatology/ch8_Mgmt_of_Hep_C_Infection/Pages/Page%2010.aspx

Avatar universal
Will, you are another invaluable asset to us....you have always come through with the best answers for me. I sure hope I didn't forget to thank you, too!

I can't imagine doing this without all of the support and good info on this site! Yes, we are grateful to those who could just move on, but choose to give their valuable time and continue to enlighten us newbies. Otherwise we would be the blind leading the blind without all those voices of experience. You all help so many to sleep at night. :)
Avatar universal
How is EVR defined for genotype 2? I've read everything from UND to a 2 log drop by wk 4, but then again, my hgb keeps dropping and I'm not at my best in the reading comprehension department.
Thanks
Avatar universal
Or am I looking for RVR definition? Confused, as usual. Both would be nice to know....
Avatar universal

Thank you for that.....

Good luck the rest of the way.

Will
1669790 tn?1333662595
•Early virologic response (EVR): at least a 2 log10 reduction in HCV RNA (a partial EVR) or HCV RNA negativity (a complete EVR) by week 12 of treatment

"Once antiviral therapy for chronic hepatitis C virus (HCV) infection has been started, the likelihood that a patient will achieve a sustained virologic response (SVR) can be predicted by the virologic response at 12 weeks of therapy, and probably even earlier.)

http://www.uptodate.com/contents/response-guided-therapy-for-chronic-hepatitis-c-virus-infection
Avatar universal
Awesome link! Thank you! Why don't my hours of feeble searches find this  good updated stuff?!? ("updated" being the operative word) I was also pleased to see my doctor's work referenced in this article.
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