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[dlr2007]

Well, I got my 4 wk labs back yesterday. The only exact # I have so far is my viral load, but I guess everything else is OK.
Here's my 2 week labs- I'll just post the ones that are out of range, except RBC and HGB- no viral load or LFT's.

WBC- 3.0 - LOW
RBC- 4.76
HGB- 12.8
MCV- 78.6- LOW
MCH- 26.9- LOW
RDW- 15.2- HIGH
Platelet Ct- 134- LOW
Neuts- 42.8- LOW
Lymphs- 47.4- HIGH
Abs Neuts- 1.3- LOW

I will get the 4 wk labs in the mail, but the most important one my viral load is:
Starting Viral Load- ^5,000,000
4 Wk Viral Load- 666,000 (good thing I'm not superstitious!)

It's not a 2 log drop, but it's good enough to warrant going ahead with the tx, according to my Dr. I thought they said that if I responded adequately by Week 4, my chances of SVR would be about 75%. I'm not sure if  I understood that correctly. Anyway, it looks to me like my response was OK- not great, but hopeful. I'm starting Victrelis on Monday- I'm kinda worried about the sx, but I'll just hafta wait and see how it goes. At this point, I'm feeling OK most days- some bad headaches and some loss of appetitite, but not nearly what I feared. I can't get enough ice cream- my 14 yr old daughter had the nerve to finish my cookies'n'cream the other day, and I made her walk right down to the store and get me some more- and walking anywhere with friends is torturous for most teen girls. That'll teach her- lol.

[nygirl7]

Lord God. Please Bocep let us know when this person achieves SVR. Und is only UND and getting to UND so late in treamtent is usually a precursor to relapse eventually.

Do you even understand what Berg et al were going for when they did all their original studies? What they were trying to say?

[BoceprevirGal]

And here is a follow up post, same Forum member, but more recent:

  "By FaLaLa137 | Apr 26, 2012
11 Comments Report
Just thought I would share my status update with the rest of the group.  For those of you that recall, I am a treatment naive Genotype 1A patient doing Victrelis with a 4 week lead in and had less than a 1 log drop (not good news) in viral count.

I was also detected at week 8 at 102 viral count (which meant I do 48 weeks of treatment if my numbers are good at week 12).  Well I just got my 12 week viral count back and I am "<43 Not Detected" according to the Quest Diagnostic PCR test.  This is good news in the fact that I can continue with my treatment even though it is for another 36 weeks. :(

I just thought other people might be interested in my stats and know that all hope is not lost if you are still detected at week 8 or if you have less than a 1 log drop at 4 weeks. :)  Now if I can just not have a viral breakthrough......I would be very happy"

  I thought I'd be more thorough with my imfo~  Katy

[BoceprevirGal]

It's okay, Idyllic had shown me this handy-dandy calculator for the logs, in an earlier post on this thread. I'm not the greatest with all the #'s, on my own, to err is to be human

[hrsepwrguy]

My bad a miscalulation on my part it was a .6 drop

[hrsepwrguy]

That patient had a 1.6 log drop in the lead in, much different than a .87

Please do your research before posting

Have agreat day

[BoceprevirGal]

  I found this post, from another member here, posted a couple months ago, and her viral load #'s were very similar to yours.
   Look at how much lower her viral load got, after 2 weeks on the Victrelis, and she's still going strong~  hopefully she may see this post, and respond to it~  
   "Mar 15, 2012
To: everyone
Greetings!

So I just got back my 6 week VL and it is 941.  This is good, right?  This looks like almost a 1 log drop from my 4 week.  Does anyone know if there are any statistics for VL drop at 6 weeks and the likely hood of SVR on VIctrelis with the numbers below?

Starting Viral Load: 3,348,215
(lead in to Victrelis) 4 week VL: 882,335
(on Victrelis for 2 weeks) 6 Week VL: 941

Thank you! :)
Reply"

Happy Mothers' Day : )

[pooh55811]

This article supports the assertion that a <1 log drop at week 4 (of Inf., Riba., Bocep.) is a strong predictor of SVR. Those not attaining a 1 log drop at week 4 had SVR rates between 28 -38 percent. I have included part of the article but I also provided the link to the article so anyone who wishes can read the data.

http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%203.aspx

Role of Lead-in Response

"Despite the existence of pretreatment factors that help to predict how patients will respond to therapy, it was clear that early viral kinetics are the strongest predictors of SVR even before the advent of DAAs. Achieving RVR on pegIFN/RBV is indeed associated with a high likelihood of SVR, even in the presence of adverse baseline factors.[48]

The use of a 4-week pegIFN/RBV lead-in period before commencing triple therapy has been studied with both boceprevir  .....Although there is a lack of data from phase III trials indicating that the use of lead-in per se improves the outcomes of therapy, the virologic response to the lead-in allows an assessment of the patient’s intrinsic responsiveness to interferon-based therapy before commencing the boceprevir ... containing phase of triple therapy and is a strong predictor of the final outcome of triple combination therapy.

In the subanalysis of predictors of response in the SPRINT-2 trial of boceprevir in treatment-naive patients, response to the 4-week lead-in phase with pegIFN/RBV (Figure 7) was found by multivariate analysis to be the strongest predictor of SVR (odds ratio [OR]: 9.0; P < .001).[42] .....

Figure 7. SVR according to Week 4 response to lead-in phase in treatment-naive patients.[42] ....."

in the  "Boceprevir  Sprint" trial" those that had  <1 log drop  had success rates of 28 -38%,

"The highest SVR rates were found in patients treated with a boceprevir-based regimen who experienced a ≥ 1 log10 decline in HCV RNA after the lead-in phase, regardless of IL28B genotype (Figure 8)."

[Claire_MHModerator]

Hi, folks,

I had to remove a few posts because they were taking the discussion off course instead of focusing on dir2007's labs.  If you see a post that you feel violates our Terms of Use, please use the "Report" link to let us know.  Thanks!

Claire

[Bovary73]

Hi,
I haven't read through all of the answers here, but just would like to join in to encourage you. I'm also on Victrelis (week 19). I was still detectable week 4 (no viral load test was taken, only Hcv pcr rna positive). I don't know what my log drop was, but I surely got scared there for some weeks - till I got my 8 weeks results and was UND! So; I wish you the same and it seems like you're managing the sx's well. Adding the Victrelis may cause some extra stuff, but overall you'll be ok, I hope. You hgb is still strong.
I pray for your UND very soon ond hopefully a successfull treatment with SVR at the end. Think positive, feel the meds doing it's job :)

[Idyllic]

http://hcvsupport.org/log-drop_calculator.html

[BoceprevirGal]

I did a bit of research into the meaning of "2 log drop" and it looks like you just take two zero's of the end of your vl #.
   Good luck, and many blessings for us all <3

[1swimmer]

Glad this conversation is going on as I've been trying to interpret my 4 week labs; just got them today. My starting VL was 8.47 M and now I am at 9020 IU/ml.  Hoping for the best w/ the Vic.

dlr2007, seems like lots of good info here. I'm wishing you the best.
I see my dr. on tues. so I have a chance to talk w/ him about all my bloodwork.

[BoceprevirGal]

Here's some imfo, from the Boceprevir guide-lines:

   Boceprevir must be used in combination with peginterferon alfa and ribavirin. If peginterferon alfa or ribavirin is discontinued for any reason, boceprevir must also be discontinued.
Assessment of boceprevir treatment futility:
If the patient has HCV-RNA results greater than or equal to 100 IU/mL at treatment week 12, then discontinue three-medicine regimen.
If the patient has confirmed, detectable HCV-RNA at treatment week 24, then discontinue three-medicine regimen.
Additional Information regarding boceprevir:
Boceprevir is contraindicated when coadministered with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. Boceprevir is contraindicated when coadministered with potent CYP3A4/5 inducers, where significantly reduced boceprevir plasma concentrations may be associated with reduced efficacy.
Approvals/Renewals (refer to Table 1 for response-guided therapy rules):
Treatment naïve patients:
Initial 24 week approval
HCV RNA report required at treatment weeks 8† and 24†
If HCV-RNA is detectable at treatment week 8† and undetectable‡ at week 24†, renewal will be given for an additional 8 weeks for a total boceprevir treatment duration of 32 weeks.

  I hope this helps, but I cant say where it says for a person to discontinue, at 4 weeks~

[willbb]

sorry dir7000:  that this important post of your got sidetracked somewhat....

Hopefully you will be discussing with your doctor the options that you have and please let us know how you are doing.

All the best..
Will

[can-do-man]

Poorly interferon responsive patients who were treated with boceprevir in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.

Poor interferon response at treatment week 4
< 1-log10 decline in HCV-RNA at treatment week 4 (i.e., at the end of the 4-week lead-in treatment with peginterferon and ribavirin)
https://www.oxhp.com/secure/policy/boceprevir_telaprevir_1211.html

[willbb]

I would add also that this certainly was not to discourage you ,however it is suggested in the article I copied in my above post  from CCO that if one  has <1 log drop at the 4 week lead in ... suggestion from many Hepatologists is to have frank conversations with their patients about their options before embarking on the third drug..not only because of the lowered odss but the increased chances of resistance issues....

Again..good luck...
Will

[willbb]

Actually you have had  only a .87 log drop from baseline  and in the  "Boceprevir  Sprint" trial" of those that had  1 log drop ,so possibly you misunderstood .
------------
Sorry ..should have read..

.Actually you have had  only a .87 log drop from baseline  and in the  "Boceprevir  Sprint" trial" of those that had  <1 log drop  had success rates of 28 -38%,so possibly you misunderstood your doctor..

Best..
Will .

[willbb]

I never enjoy telling anyone what might seem like discouraging news,however when treating with these very powerful drugs one should always be aware of the facts when treating  their HCV  and these facts should have been relayed to you by your doctor.

Actually you have had  only a .87 log drop from baseline  and in the  "Boceprevir  Sprint" trial" of those that had  1 log drop ,so possibly you misunderstood .

Success depends on many factors,one of which and a very important one is early viral clearance.

Unfortunately you have not had a very good  early response(most likely from poor Interferon sensitivity) and therefore a  less than stellar early overall response.

At present the amount of liver damage(fibrosis) you have would be very important information,being that if it is mild you would  have the option of stopping treatment now  because of the lowered odds and not exposing yourself to the meds(especially the third drug) if you and your doctor feel these odds are not worth the benefit vs. the risk at this time and possibly waiting for an " Interferon free" regime,however this may be another 3 to 5 years away.

Having said all that these are just statistics from trials and many people often go on to defy statistics.

If you continue on with this therapy you will need to be UND. at week 8 to do 28 weeks of total treatment ,and if not UND. at week 8 but still <100 at week 12 and ultimately UND. at week 24 the total time of treatment recommended is 48 weeks.

Hopfully you are being treated by a knowlegable doctor who is very familiar with these new treatment paradims who can give you the proper direction...

Wishing you the best...
Will

[Idyllic]

Seems like your HGB is OK walking into the Victrellis leg. From what I've picked up it's the anaemia and/or the rash that could be problematic.  Oh, and potential lost of taste so be sure to enjoy all the good stuff now!!

But most of all I really like your optimism and spirit. I bet you see more profound results once you start the Victrellis. Wishing you a smooth and easy journey!