Wonder what my chances are for SVR

Question

I am on triple therapy with Incivek, just did shot #10.  Genotype 1, prior 3x non responder.  I have looked for some stats on my chance for SVR and haven't really found anything...Pegasys and Riba have both been reduced because platelets dropped to 19.  As of last week, platelets are up to 31, Pegasys was increased from 90 to 135, however, I remain on 800 Riba.

Beginning PCR  1.9 million
2 week PCR       444
4 week PCR       179
8 week PCR         77

Although I continue to go down, not being undetectable by week 8 is of some concern to me.  PCR will be done again at 12 weeks.  Doc said she will not stop treatment unless I am not undetectable by week 24.  Curious what my shot at SVR is at this point.  Ready to fight this til I can't fight any longer......it is tough!

HectorSF · Accepted Answer

Hi. Welcome.

You said your platelets count went down to 19,000.
What was your platelet count just before you started treatment? Under 125,000? Do you have cirrhosis?

"Considered increasing the Riba dose myself just didn't want the platelets to drop even more and doc wonder what was going on." 
By the way...Riba does NOT cause lower platelet counts. Interferon does. In fact the combinations of interferon and ribavrin raises platelet counts higher then interferon alone.
http://www.clinicaloptions.com/Hepatitis/Annual%20Updates/2003%20Annual%20Update/Modules/ccohep2003_sulkowski/Pages/Page%209.aspx

Reference source:
"A Practical Guide for the Use of Boceprevir and Telaprevir for the Treatment of Hepatitis C"

• All previous partial or null responders and cirrhotic patients treated with telaprevir should receive a fixed-duration 48-week course of therapy (12 weeks of triple therapy followed by 36 weeks of pegIFN/RBV alone). Tolerability should be followed closely in patients with cirrhosis. 

SRV rates depend on the stage of your liver disease.
For previous "partial responders" (at least a 2-log decrease in hepatitis C viral load during HCV treatment).

Stage 0-2 = 72% SVR
Stage 3 Bridging fibrosis = 56% SVR
Stage 4 cirrhosis = 34% SVR

"Infergen/Riba and never came close to a 2 log drop at 12 weeks."
These numbers would apply to you.
For previous "null responders" (A person who does not see his or her HCV viral load decrease by at least 2 log (at least 99 percent) by week 12  of peg-INF & Riba treatment).

Stage 0-2 = 42% SVR
Stage 3 Bridging fibrosis = 39% SVR
Stage 4 cirrhosis = 14%

As far as stopping your doctor is correct.

For all patients treated with telaprevir, the following futility rules should be employed:
•	If HCV RNA is > 1000 IU/mL at treatment Week 4 or 12, all 3 medications should be discontinued. 
•	If HCV RNA is detectable at Week 24, pegIFN/RBV should be discontinued. 

Best of luck with your treatment!
Hector

spectda · Answer

If your blood levels weren't where they are I would think extra riba and interferon for 2-3 weeks might very well get you there. I wouldn't do anything without the docs help personally at those low levels. Maybe you could take promacta or nuemega for the platelets for a short time and increase your interferon along with riba since those remaining viron are likely to be Incivek resistant and need the soc to quash them. 

I took neumega injections about once every other week to raise low platelets during tx and it kept me in a low but safe zone and kept me treating. 

Good luck,
Dave

ASmile4U · Answer

Thanks so much for the detailed reply!   I started with a platelet count of 61, I've been below 100 for approximately a year prior.  Unsure if I have cirrhosis.  Because my doctor and I were certain it was a recent infection when diagnosed, he chose not to do a biopsy.  I was referred to a transplant institute for this treatment and am now under the care of the assistant director and her team.  A much better approach for me and I am in a good place in the event my platelets crash.  Except for platelets, labs have remained stable, without much concern since being diagnosed in '05.  MELD score is 9.  I increased my riba this morning!  I have got to give it everything I can....I am so close to UND. Thanks again for taking the time to reply...things are a bit clearer this morning.

ASmile4U · Answer

Hemoglobin and all other labs look great...I think it dropped from 14 to 12.X in 10 weeks.  Considered increasing the Riba dose myself just didn't want the platelets to drop even more and doc wonder what was going on.  The platelets need to stabilize...we'll see what this weeks CBC shows since increasing the Pegasys.  Thank you!

paen53 · Answer

I can understand the Interferon reduction with the low platelets, but not the decrease in the Riba. Has your hemoglobin taken a hit as well? If not, any chance of upping the Riba? It might give you the added oomph to reach UND at 12 weeks..........Just a thought.

Pam

ASmile4U · Answer

These numbers are considerably better than my last 3 treatments. I treated with Pegintron/Riba, Infergen, 3x weekly/Riba and Daily Infergen/Riba and never came close to a 2 log drop at 12 weeks. Needless to say I was thrilled with these 2 week results, but the 4 to 8 week result is a bit discouraging. Hoped those last few would finally be gone and I could for the first time say I was UND!!!!!

JasmineT · Answer

I know i found some info on this once upon a time but of course did not bookmark it.  I do remember the fda site had some stats though that might help.  The FDA site seems to indicate you would have to be over 1000 to stop treatment (section 2.3).  I think Table 11 also shows some stats on success based on whether you were or were not under the 1000 rule for stopping and prior treatment outcomes.

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdf

I know yesterday I saw an article that mentioned there was essentially no difference on RIBA 800 vs 1200 for people over 65 (both dosages were resulting over 83% or so from what I remember).  I don't have that link so there may have been more to it but thought it worth mentioning.

ASmile4U · Answer

Thanks for the info on SVR.  I wasn't sure the 32% included me since I wasn't UND at 4 or 8 weeks.  Trying to be optimistic for the 12 week PCR but with lower dose pegasys and riba I wonder if those last 77 will be found and gotten rid of!  I'm fortunate my doc didn't stop treatment when my platelets dropped to 19....time to suck it up and give it my best!  Thanks again.

frijole · Answer

smile
Well, you will be able to continue to 24 as long as your VL is under 1000 at week 12, but I am sorry that you have had these results.  How much better are they then your other 3 trys?
frijole

hrsepwrguy · Answer

That is with 48 wks tx and you don't have to be UND at 12 wks only under a 1000 but must be UND at 24 wks or will stop tx

hrsepwrguy · Answer

32% chance of SVR for prior null responders, section 14.3 on provided link

http://pi.vrtx.com/files/uspi_telaprevir.pdf

Diane12855 · Answer

I only did the interferon and Riba and was told that if I wan't UND by my 12th week that I would have to stop and try again later. Since the third drug has come along, I think the response should be faster. I was 1a and started at 6 million, and they didn't do an 8 week PCR but by 12 weeks I was UND.

A friend of mine stopped when she hadn't reached UND by the 12th week and waited to try again later.

That's my opinion anyway,

Diane