Two log drop at 12

Please clarify what my doctor's nurse told me about the "two log drop at 12 weeks".  I sort of get that it means drop off two zeros from your RNA load is a good sign.  But what does that all mean in the prognosis?
Thanks, G

[DoubleDose]

Basically it means you are still in the 'hunt' for SVR.  If you are fully undetected by 12 eeeks, generally you would do a 48 week course of therapy, with good odds of SVR (type 1's chiefly).  

If you achieve the BETTER THAN 2-log drop by week 12, but still have detectable HCV on PCR (less than 4000 IU is best, but higher levels still may qualify), then you MUST become undetectable by week 24 to be considered a potential for SVR response.  The caveat is, that for these 'late responders'  (weeks 12-24 becoming fully undetected, along with a greater than 2-log drop at 12 weeks) they must do an extended course of therapy, usually 72 weeks, in order to have decent odds of SVR.  Again this applies chiefly to GT-1's.  

I hope this explains the significance of the 2-log rule, and the ramifications of 'late response'.  

Most doctors will not continue treatment if you do not get the 2+ log drop by week 12, OR if you are still detectable on PCR at week 24, even if it is 100 IU, etc.

Sometimes upping the dosages for slower responders can push them into more normal response time-frames, and provide better prognosis for SVR....but only in select cases.  For the true non-responder, and for many partial responders, increasing the dosages does not accomplish a whole lot, and generally does not produce the desired undetected result.

Let us know how your response curve turns out.  If you are 2-log drop by week 12, have them do a quick follow up at week 16, and then week 20, to see if, and when you clear.

Good Luck!!

DoubleDose

[jmjm530]

Sanchez Tapias shows a 42 versus 32 per cent SVR (not relapse) rate in the sub group of patients who are HCV positive at week 4 and treat for 72 and 48 weeks respecitvely.

The Berg figures are lower but their sub-group is also defined differently -- as those who are HCV positive at week 12 but negative at week 24.

Best for anyone making any decisions on either of these studies to invest in "Full-Text" copies of both and then discuss with their doctor.

Here is the Sanchz Tapias abstract, still haven't found Berg:

http://www.natap.org/2004/EASL/easl_06.htm

[NYgirl]

At week 4 I still had a number of 400 - I had a 3 log drop right away!

At week 12 I still had a number of 400.

At week 24 I was finally undetectible.

Result...I am doing 72 weeks of treatment.  If you are detectible at 12 weeks but UND at 24 - your chances of relapsing are about 50/50.  If you do the extra weeks...it brings it down to only like 28% or something.  That is a HUGE difference and worth the chance to me.

I am a genotype 1A and also 1B - so I have two hard ones to kill...and I'll do whatever it takes to keep it going!

Good luck. I hope that helps explain extension a little bit for you.

[jmjm530]

I believe "Berg" states that the relapse rate is 71% in the sub group of patients who are virus positive at week 12 and negative at week 24 and then treats for 72 weeks. Versus a relapse rate of 83% for that same sub group who treats for 48 weeks. I believe the "Sanchez Tapias" study shows similar results. I'll try and find the actual studies but maybe someone else has them handy to post. Keep in mind, both studies (I think) used fixed dose riba so that might skew the results downward.

-- Jim

[jmjm530]

Don't know what week of treatment you're on, but if relevant, ask your doc for a sensitive week four viral load test. Something like Quest Diagnostic's "Heptimax" which goes down to 5 IU/ml. Earlier, more frequent and more sensitive viral load testing is the trend among many hepatologists these days. Ideally, you want to take the week four test either the day before your fifth injection, or the day of your fifth shot but before the injection. This will give you a conservative "trough" reading of your viral load.

-- Jim

[sfbaygirl]

So are you saying that the revised version says that tx'ing for 72 weeks you have a 57% chance of SVR versus a 32% chance of SVR at 48 weeks? This makes extending much more attractive then a measly 12% difference.

[NYgirl]

I thought it was 48 and 28% but whatever - with the numbers changing so drastically - I sure didn't feel there was any choice.  

But I was sure it said relapse (and this is what was discussed in detail with Dr. Jacobson - relapse rate of not doing the extra) so perhaps since he was lead investigator he had some information or something that did not make the paper but they opted to use "SVR" rate terminology instead (since it's so close to being the same/opposite thing).

I don't know where it came from but I am positive that this is what he said.

Since it was the reason I spent the $600 for the appointmennt I have this scribbled all over my notebook LOL.

Now at week 63 - it's the only thing that keeps me going. Urgh.

[pln]

WOW, 63, nine to go, you are a real warrior!! when I am having a bad day and only being at week 18 I think about NYGIRL.  Still week 63 blows my mind. I hope the new year finds you UND and your liver healing day by day. You are a true inspiration. Pam

[friole]

I think the significance of the Berg study was that they broke the data down further and compared the results of treating 48 weeks versus 72 weeks for participants with viral loads under 6000 at week 12.  For those individuals, the relapse rate decreased from 57% to 32% by treating for 72 weeks instead of 48.  

[jmjm530]

Here's the Berg abstract: http://tinyurl.com/y5uqtd

[friole]

To restate that, for those whose viral loads were less than 6000 at 12 weeks (and that should include you, I think), you would have a 43% chance for SVR if you did the 48 weeks and a 68% chance at SVR if you do 72.  It is a good study and I have it on my hard drive.  If you want it, email me at my screen name ataoldotcom and I will be glad to send it to you.

For me, I am not sure if the 72 weeks would have made a difference.  I did 56 and relapsed.  I sure wish now I had done the 72.
Kathy

[OceanLiver]

hi, i am new to this forum, although I have been reading your posts for the last couple of months. Thanks for all the great information and support.  I am a 1B, with Childs Plug A cirrhosis 59 year old woman (other wise healthy) and had a 3 log drop at 12 weeks and a vl of 2700.  Do any of you have any suggestions about how to increase my chances of getting to zero ASAP.  Do you think that it is important to take the riba exactly 12 hours apart.  I take 2 in the AM and 3  PM.  What about this I read about taking it with fats.  I take it with breakfast and dinner.  Does it help to have a high concentration of fat - more than just the normal amount in a healthy low fat diet?   What about exersise?  I must admit I have become a bit lazy since treatment started.  Any other tips would be greatly appreciated. Is it always a choice of 48 or 72 weeks.  If I clear at 16 weeks could it be less than 72 weeks?  Also I am responding well to procrit for low hgb.