Week 12: <43 ~ Week 17: UND

Good news -- I am back to being undetected :-)

Other news -- I may have to continue treatment for 30 more weeks, instead of just 10; my doc just informed me that she is leaving but.....I will be assigned to the head of the department, who has already been consulting on my case; the (possible) extension of treatment has to do with the 12 week <43 and the African American factor.  My hemo is currently stabilized (with the help of Procrit), my platelets are fine.  My neutrophils, however, are fluctuating so we are keeping a close eye on that.

Question......for those of you with neutrophil issues.....what did your doc do/recommend?  How long before a difference was noticed and was it lasting?

[orphanedhawk]

I am so happy for you!!

About low neutrophils, when my anc gets below 500 I take neupogen.
My hepatologist said to take it before my interferon.
I take it the day before, about 24 hours.
It raises our wbc and neutrophils, but not for long, only a few days.

I'm a lightweight and my first neupogen shot wiped me out, so my doctor agreed to lower the neupogen dosage.
I haven't heard of others doing this, but thought I'd mention it.

Good luck on getting to the finish line!
I'm rooting for you.
OH

[oceanblue701]

beeblessed, I am so glad to hear you are undetected again and still continuing with treatment! Keep on keeping on. Good Luck with neutrophils. I have no advice with that, but will see here what others say and learn the answer too.

[pooh55811]

I am happy that you are back to UND status. I wish you the very best. I also know nothing about the neutrophil issue.

[JasmineT]

So glad you are UND!!  Wonderful new.

[zako7]

congratulations on your return to been undetected. I am also African and I am also concerned about the African America factor. I am on the same path of victrelis with you (but I am G4) and have done only 2 weeks.
But for you I am almost sure you will be SVR. Just take it one day at a time. You are in my prayers.

[suezeeque]

I don't know the answer to your question but I just wanted to say how happy I am for you on the UND.  Not so much on the additional weeks but hey, you're UND!  :D

<3

[hrsepwrguy]

Just wanted to say congrats, wishing you all the best moving foward.

Keith

[indy531]

Congrats on UND again-hang in there!

[willbb]

Good stuff Bee.. what is the neutrophils  level? It may be referred to as the ANC (absolute neutrophils count.) The part of the white cell that is an important infection fighter.
Many doctors will start a patient on the rescue drug Neupogen if it gets too low usually <500 or possibly 600.
It is fairly fast acting and may need to be taken regularly for awhile and with some until the end of treatment.
Best to you..
Will

[aj7538]

sooooo happy about the.und. I knew it. I felt it. My friend I am celebrating with u.

[can-do-man]

Depends on what your doctors comfort level is. Some RX neupogen and others dose reduce the interferon. My doctor wasn't to concerned if mine got to 0.3 while others would be at 0.5.

Mine seemed to bounce around alot so i was lucky i didn't have to do either.

BTW, congrats! I kinda figured you would be und...:) Best to you.

[Advocate1955]

Congrats on UND! My husband was prescribed Neupogen when he became neutropenic during treatment #2.
Advocate1955

[can-do-man]

"I will be assigned to the head of the department, who has already been consulting on my case; the (possible) extension of treatment has to do with the 12 week <43 and the African American factor."

Sounds like a wise move on your doctors part, i'm sure not news you wanted to hear though............ Give it your best shot and be done with HCV.

Best;
cando

[orphanedhawk]

I am so happy for you!!

About low neutrophils, when my anc gets below 500 I take neupogen.
My hepatologist said to take it before my interferon.
I take it the day before, about 24 hours.
It raises our wbc and neutrophils, but not for long, only a few days.

I'm a lightweight and my first neupogen shot wiped me out, so my doctor agreed to lower the neupogen dosage.
I haven't heard of others doing this, but thought I'd mention it.

Good luck on getting to the finish line!
I'm rooting for you.
OH

[working dog]

great news bee !! hang in there...good luck...billy

[babs824]

glad to hear of your status bee. as for the potential longer tx this is disappointing but if it buys you svr  it will be worth the extra weeks. hang in there and wishing u all the best. babs

[eureka254]

Well, there's 'good' news, and then there's GREAT news... congratulations!
Don't have any input on the neup question, as my husband never went below his doc's <500 red flag... but just wanted to say: YAY for you!

[Mary4now]

congrats on the UND, but yuck on another 30 weeks, but whatever it takes right?   good luck
mary

[beeblessed]

Wow.  THANK YOU EVERYONE!!   The doc did mention the possibility of further Peg reduction first, then Neupogen IF needed.  No Procrit for tomorrow, will see if my HGB continues to rebound on its own over the next week.  She also mentioned that 500 red flag for the Neutrophils.  The labs I did this morning say: 0.8 (x10E3/ul).  The preferred ratio is: 1.3-7.0.  

CanDoMan -- Not too upset about the doc change, as I will still have the same team (and my tx nurse) looking out for me.  Plus, this isn't a doc I expected to keep forever, as once I am SVR......I never wanna see that place again!!

As for the possibility of longer tx time......I want to reach SVR.  I only want to do this once, so I'm in it to win it.  My New Year's attitude will be to move forward and do more to get my life back, instead of letting this continue to be the focus.  The support, education and encouragement in this forum is a much needed blessing and makes this easier to process.  THANK YOU THANK YOU THANK YOU ALL.

[screaming48]

Great news Bee! So very glad for you.

[Dee1956]

Hi I am so very happy for you, great that you are UND, during a trial I had the same issue, at the time no rescue drugs were available so they dose reduced me, mine went under the 500 about 4 times during tx, I was not aware until the day they called and told me to stop all tx.  Mine had goten to low and a paper cut could have been serious.  I really did not want to stop however it was not my call, that was Nov 2008, I relapsed New Year's eve 2009
I wish you all the best.  I know how hard it is to have to change doctors, I had a pretty good guy, the someone related to the trial came in and said he was not doing it properly so he left and I had 3 more clinical coordinators the last few months.  Having the Head of the Dept is wonderful and I wish you nothing but good wishes into the New Year.
Dee

[frijole]

Bee, I am in it for the long haul too.  Just glad you got that UND back.

As for the low ANC, my doctor rxed Neupogen at one every 4 days when my ANC dropped to 600.  I balked at that and did one shot and waited until my next CBC.  The neupogen brought ANC up so hgih -- like 4.3(300) that I have not done another one yet and I think that was a month ago.  Wednesday my ANC was 1.0 (1000).  I don't like that stuff either -- it makes me really achey (achy) all over and I have never been able to see that I really needed it in the first place.

I hope the head of the departments takes good care of you and is not too busy.  They do seem to be keeping pretty close tabs on you and that is great.

[hcvJames]

Just realized your avatar is Calvin & Hobbes! I love reading them in the original ancient Sumerian cuneiform format, don't you?

“Who was the first guy that looked at a cow and said," I think that I'll drink whatever comes out of those things when I squeeze them?”

I mean that's priceless in Sumerian. It gives a contextual vibrancy that awakens the whole Sumerian civilization. Sure by todays standards clay tablets are a bit cumbersome but the pictographs are still crisp after nearly 6000 years. Who knew Sumerians were so funny? and invented the forerunner to todays tablet PC? A people misplaced in time. ... Anyway! Pip Pip Cheerio!

[beeblessed]

Whaaa? Hunh?  I looked that up but.....never heard of Sumerian cuniform.  I do, however, remember that quote from Calvin & Hobbes.  Priceless!!  LOL.

[eureka254]

Wow James, thanks for reminding me of that old format, yes, they were great... it was so long ago, I'd almost forgotten it started my son's fanaticism for C&H.  He used to have those comic page clippings all over his room... as a mother, I was sort of relieved when the books came about... easier to pick up books than newspaper strips all over the floor! :)

Though I loved C&H as much as my son did, being that he was reading them  by the time he was 5, you can imagine how interesting my early years of motherhood were :). ~eureka

[streamline569]

Great attitude. Glad you're doing so well. I"m a platelet person. So happy to hear your platelets are good. I think that's very important. That is the one signs of how the liver is functioning. Keep it going....:)

[HectorSF]

Glad to hear the good news and you're still in the fight! Yeah!

You want to give yourself the best odds possible so treating longer sounds like a good idea. I am hoping your blood levels stay good throughout treatment and you don't have too many debilitating side effects. Try to be as compliant as possible as far as taking your meds. I am guessing you will have viral load tests at week 24 and periodically thereafter to assure no viral breakthroughs?

Best of luck to you, Bee. Hang in there. I am routing for you to beat this virus this time. You are well into treatment. Just take it day by day and week by week. It will amaze you how quickly time goes by.

Cheers!
Hector

[HectorSF]

VICTRELIS - HIGHLIGHTS OF PRESCRIBING INFORMATION
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202258lbl.pdf
-------------------------------------------------------------------------------------------------------
5.3 Neutropenia (Use with Ribavirin and Peginterferon Alfa)
In Phase 2 and 3 clinical trials, seven percent of subjects receiving the combination of VICTRELIS with PegIntron/REBETOL had neutrophil counts of less than 0.5 x 109/L compared to 4% of subjects receiving PegIntron/REBETOL alone (see Table 4). Three subjects experienced severe or life-threatening infections associated with neutropenia, and two subjects experienced life-threatening neutropenia while receiving the combination of VICTRELIS with PegIntron/REBETOL. Complete blood count (with white blood cell differential counts) must be conducted in all patients prior to initiating VICTRELIS combination therapy. Complete blood counts should be obtained at Treatment Weeks 4, 8, and 12, and should be monitored closely at other time points, as clinically appropriate. Decreases in neutrophil counts may require dose reduction or discontinuation of peginterferon alfa and ribavirin.
Refer to Package Inserts for peginterferon alfa and ribavirin for additional information regarding dose reduction or discontinuation for peginterferon alfa and ribavirin.
-------------------------------------------------------------------------------------------------------
14 CLINICAL STUDIES

The efficacy of VICTRELIS as a treatment for chronic hepatitis C (genotype 1) infection was assessed in approximately 1500 adult subjects who were previously untreated (SPRINT-2) ...

Previously Untreated Subjects:

SPRINT-2 was a randomized, double-blind, placebo-controlled study comparing two therapeutic regimens of VICTRELIS 800 mg orally three times daily in combination with PR [PegIntron 1.5 μg/kg/week subcutaneously and weight-based dosing with REBETOL (600-1400 mg/day orally divided twice daily)] to PR alone in adult subjects who had chronic hepatitis C (HCV genotype 1) infection with detectable levels of HCV-RNA and were not previously treated with interferon alfa therapy.

Subjects were randomized in a 1:1:1 ratio within two separate cohorts (Cohort 1/non-Black and Cohort 2/Black) and were stratified by HCV genotype (1a or 1b) and by HCV-RNA viral load (≤400,000 IU/mL vs. >400,000 IU/mL) to one of the following three treatment arms:
•
PegIntron + REBETOL for 48 weeks (PR48).
•
PegIntron + REBETOL for four weeks followed by VICTRELIS 800 mg three times daily + PegIntron + REBETOL for 24 weeks. The subjects were then continued on different regimens based on Treatment Week (TW) 8 through TW24 response-guided therapy (VICTRELIS-RGT). All subjects in this treatment arm were limited to 24 weeks of therapy with VICTRELIS.
*
Subjects with undetectable HCV-RNA at TW8 (early responders) and who were also negative through TW24 discontinued therapy and entered follow-up at the TW28 visit.
*
Subjects with detectable HCV-RNA at TW8 or any subsequent treatment week but subsequently negative at TW24 (late responders) were changed in a blinded fashion to placebo at the TW28 visit and continued therapy with PegIntron + REBETOL for an additional 20 weeks, for a total treatment duration of 48 weeks.
•
PegIntron + REBETOL for four weeks followed by VICTRELIS 800 mg three times daily + PegIntron + REBETOL for 44 weeks (VICTRELIS-PR48).

All subjects with detectable HCV-RNA in plasma at TW24 were discontinued from treatment. Sustained Virologic Response (SVR) was defined as plasma HCV-RNA undetectable at Follow-up Week 24. Plasma HCV-RNA results at Follow-up Week 12 were used if plasma HCV-RNA results at Follow-up Week 24 were missing.

Mean age of subjects randomized was 49 years. The racial distribution of subjects was as follows: 82% White, 14% Black, and 4% others. The distribution of subjects by gender was 60% men and 40% women.

The addition of VICTRELIS to PegIntron and REBETOL significantly increased the SVR rates compared to PegIntron and REBETOL alone in the combined cohort (63% to 66% VICTRELIS-containing arms vs. 38% PR48 control) for randomized subjects who received at least one dose of any study medication (Full-Analysis-Set population).

SVR rates for Blacks in a predefined analysis who received the combination of VICTRELIS with PegIntron and REBETOL were 42% (Response Guided Treatment ) to 53% for  48 weeks of treatment (see Table 10).

Table 10
Sustained Virologic Response (SVR)*, † and Relapse Rates‡ for Previously Untreated Subjects

********NOTE: 13% HIGHER RATE OF SVR WHEN TREATED FOR 48 WEEKS VS 24 WEEKS.************************************************************

Cohort 2 (Black)  n=55 (out of 366 patients)
VICTRELIS-PR48 treatment
SVR† % = 53%
Relapse‡ % = 17%

VICTRELIS-RGT
SVR† % = 42%
Relapse‡ % = 12%

†Sustained Virologic Response (SVR): reported as plasma HCV-RNA < 25 IU/mL at follow-up week (FW) 24. The last available HCV-RNA value in the period at or after FW24 was used. If HCV-RNA value at FW24 was missing, the FW12 value was carried forward.

‡Relapse rate was the proportion of subjects with undetectable HCV-RNA at End of Treatment (EOT) and detectable HCV-RNA (≥ 25 IU/mL) at End of Follow-up (EOF) among subjects who were undetectable at EOT and not missing End of Follow-up (EOF) data.
--------------------------------------------------------------------------------------------------
Hector

[beeblessed]

Hi Hector.  Thanks!  Of course now -- my brain is full. (LOL)  I think this doesn't address what happens if a patient was an early responder (week 8) and then had a setback (week 12) before week 24.  BUT, the last part looks as if the recommendations for Blacks to reach SVR, is 48 weeks anyway.

Cohort 2 (Black)  n=55 (out of 366 patients)
VICTRELIS-PR48 treatment
SVR† % = 53%
Relapse‡ % = 17%

VICTRELIS-RGT
SVR† % = 42%
Relapse‡ % = 12%

Is that what this means??  I confuse easy these days.  Additionally (if I may sound schoolteacher-ish), these figures seem to indicate that while SVR rates were slightly higher with 48 weeks, the percentage of relapse with response guided therapy was less.  I can see my medical team has their work cut out for them!  The percentages here are also maddening, in that -- they made it sound like the new drugs raised the SVR rates to 70-80 percent, across the board.  I forget what I was initially told but whatever the number, it was greater than just the SOCs, enough so that it was worth it to treat at this time.

[fretboard]

Happy to hear you've gotten your UND.  Bummer that you have to tx for 48 but unfortunately that's how it works sometimes.  Seems like you have a good enough attitude going into this so that should help you moving forward as well.  Hope the rest of your journey is smooth as can be!  good luck!!