Just found out I relapsed,, soooo upset,, help!!

[fashion345]

Help,,, just found out I relapsed at 1300 pcr,,,sooooooooooo upset,,, since I have only been off drugs 1 month,, they want to start me on interfergen,,, what should I expect,, shots daily,, worse sx???

[fashion345]

Thank you all again for your wonderful advice and feedback.  I will be seeing my dr. on Tuesday and will know more.  I believe he stated that he would do a liver biopsy if I did not treat now.  I am going to try the infergen and if I clear at 4 wks, will decide if I can tolerate going forward.
I am sure anyone that relapsed, questions,,"What did I do to cause the relapse" which is what I am doing.  Obviously a silly point as the virus is so strong, that it can reoccur with anyone.  Can't help but wonder.

[Trish77]

Good luck with this.  Always a tough decision, situations like this.  Wondering what your decision is on whether you will get a biopsy or not?

Trish

[pcds]

I would get a second opinion about what to do from here.  I sent you a message with the name of the mayo doc that did the trials in Scottsdale, who I will be seeing in March and some other resources.  I was upset when I stopped tx after 13 weeks still detected. Wasted abuse to my body, I can't imagine how difficult this is.  Reading the posts, it sounds like your plan is good, get the meds.  Part of me thinks, you've come this far  why not give it a go?  Part of me hates this treatment that soon will be out of date so why trust in the poor results so many can have with it.  It's a tough decision you have to make.  Remember in the end you will get rid of this virus.  And so will I.  I must tell you I am currently enjoying feeling normal.  It's nice to have a "breather" before dropping into tx again this summer.
Judy

[Mary4now]

Wishing you good luck and a strong body to get through this.

[paen53]

I applaud your call on this. By week 4, you will know whether or not it is working and can stop and gather your strength for the upcoming wedding if it isn't. If you're UND, you'll know that the likelihood of SVR is so much greater. I can't imagine it otherwise -  you did respond to SOC and have a very low VL to start and now the big gun should blow them to smithereens.

Did your Dr. say how long you'd be on the Infergen? Is there a chance you can run another PCR just to be sure you've relapsed before you jump into it again?

Hang in there, Fashion!

[fashion345]

Thank you for caring and feedback.  Right now, I most likely will begin the grueling shots every day of infergen.  Had a great day today celebrating a girlfriends bday.  So nice to have some relief.  I have decided if the sx are too difficult on the infergen,, or more difficult then the interferon/riba 48 wk tx I just completed,,, I will stop.
At that point I will wait until either new drugs are out or atleast until the Fall to start again. Need to be at my best for the wedding.

[Trish77]

"for relapsers with stage 1-3 disease and good interferon sensitivity (12 week svr)  the svr rate is much higher than reported above for nonresponders (10 -15%)  as high as 35 - 40 % for infergen retreatment "

Some of the docs I looked at mentioned the stats you're quoting but I didn't find any studies in co-relation to that?  Best I found is the one I posted where it was as high as 31% for F0-F3 and demonstrated response to SOC in first 12 weeks.  Do you have any links to supporting data?  I'd really appreciate that.

[Bill1954]

Here’s a link to Labcorp’s IL28B test if you’re interested:

http://people.genome.duke.edu/~dg48/L8464-0710-Service-Announcement-FINAL.pdf

[bostoncream]

the cc type clears about 80% of the time on soc (peg / riba)  this is better than triple therapy offers also as i understand it there will be very close monitoring of patients on triple therapy and if things start to go bad they will stop treatment to reasses the case also genotype 3 is an unlikely candidate

[paen53]

Do know of any of the eligibility requirements that they've established? And how exclusive is the il28B test? Only CC's? This is all news to me.......Did you get this news from your Dr.?

[bostoncream]

for relapsers with stage 1-3 disease and good interferon sensitivity (12 week svr)  the svr rate is much higher than reported above for nonresponders (10 -15%)  as high as 35 - 40 % for infergen retreatment  also the new therapy wont be available for everybody they have already established some eligibilty requirements and exclusion tests like il28b test and are working on othersive done peg intron and pegasys now im on infergen  i cant really tell any difference in the sides -and all have been minor for me

[willing]

sorry to hear the grim news. I expect some time to adapt and adjust is probably the best strategy. While making plans for going forward, gathering more information seems crucial. (1) Figure out how much liver time you have left. Diagnosing staging by photograph seems very suspect. I got some great photos of my liver from my last laparoscopic bx. The surgeon was quite proud of his shots but the hepas were not remotely interested. Short of gross anatomical distortion on the surface there's not much information. A bx will collect a cell by cell snapshot of inflammation and fibrosis,  A Fibroscan will assess the overall stiffness of a  much larger area. A bx is not usually recommended for g2s because of the high success rate but for you it seems a key item of information as it determines how long you can wait. (2) Investigate likely causes of failure. Three of the usual suspects are inadequate rbv, ferritin and IR. If you have enough VL data from early tx you should be able to track how ifn responsive you were. Often, fixing one the logjams above can yield dramatic improvement for the easier genotypes. (3) check out new tx options - eg bms790052 is about to recruit for a g2/g3 trial. There are some much better options than infergen on the horizon - but first you'll need to know how much liver time is left.
All the best.

[mikesimon]

I think willy and ball are right - it should be in its own thread because it says nothing about G2s and what it does say isn't too clear to me anyway. It is a rather brief discussion and hopefully when we see it fleshed out we will know more.

Mike

[spectda]

"Keep in mind, this is not the high dosing, double dosing, extended dosing."

I agree, I would however tend to believe that it is about response based dosing. That is why I mentioned it in the first place.


At the same time the information Mike posted certainly doesn't make a strong argument for increased riba in G2 tx.

"Factors Affecting Efficacy in Patients with Genotype 2 Chronic Hepatitis C Treated by Pegylated Interferon Alpha-2b and Ribavirin: Reducing Drug Doses has No Impact on Rapid and Sustained Virological Responses"

[Bali05]

thanks for that link Willy.
I agree it really deserves its own thread.
the data almost exactly reflects my personal experience.

[desrt]

"... Those ten Swedes must have been feeling poorly for a year, huh?"

With no follow up except the 24 week post-tx PCR we don't know how many of those patients actually survived the tx or were left with permanent health problems. "The operation was a success, but......"
Not everyone has your incredible tolerance to riba.

[Willy50]

This is somewhat in response to Bills post that was in response to spectda's.....

Some recent findings about predosing RBV

http://www.hivandhepatitis.com/2010_conference/aasld/docs/1214_2010_a.html

Keep in mind, this is not the high dosing, double dosing, extended dosing.

I hadn't seen people post this or talk about it and thought that this might be as good a place as any to add it in, although it may also deserve it's own thread.

Willy

[mikesimon]

I neglected to cite the source for the previous quote.

http://www.medscape.com/viewarticle/724836

Mike

[mikesimon]

Factors Affecting Efficacy in Patients with Genotype 2 Chronic Hepatitis C Treated by Pegylated Interferon Alpha-2b and Ribavirin: Reducing Drug Doses has No Impact on Rapid and Sustained Virological Responses

Posted: 07/19/2010; J Viral Hepat. 2010

"....Multivariate logistic-regression analysis showed that only platelet counts [odds ratio (OR), 1.68; confidence interval (CI), 1.002–1.139] and RVR (OR, 11.251; CI, 5.184–24.419) were independently associated with SVR, with no correlation being found for the mean dose of Peg-IFN and ribavirin for RVR and SVR. Furthermore, in the stratification analysis of the timing of viral clearance, neither mean dose of Peg-IFN (P = 0.795) nor ribavirin (P = 0.649) affected SVR in each group. Among the patients with RVR, the lowest dose group of Peg-IFN (0.77 ± 0.10 μg/kg/week) and ribavirin (6.9 ± 0.90 mg/kg/day) showed 100% and 94% of SVR. Hence, RVR served as an important treatment predictor, and drug exposure had no impact on both SVR and RVR in combination therapy for genotype 2 patients....."

[Trish77]

I would agree that it would be worthwhile looking at the ribavirin dosage in conjunction with infergen if you go this route.  Your hgb never seemed to get overly low and indeed went up at one point, correct?  Certainly worth discussing with your doctor, I think.

[jusjames]

i too am very sorry to read this terrible news ...

[Bill1954]

Spectda likely was referring to the high ribavirin study by Lindahl, ’05; I’ll caption and link the abstract here for reference, although I believe it was specific to GT-1. Those ten Swedes must have been feeling poorly for a year, huh?

I completely agree that properly dosed ribavirin is associated with SVR; it wouldn’t take much to review your lab history and see if you’d tolerate higher mg/kg/day ratio in the future:

http://www.ncbi.nlm.nih.gov/pubmed/15660393

“Improved treatment regimens for patients with chronic hepatitis C, genotype 1 and high viral load are needed. Increasing the dose of ribavirin has increased the response rate, but experience with doses of more than 1,200 mg/day is limited. The aim of this study was to investigate the safety and tolerance to treatment with a high and individualized dose of ribavirin in combination with peginterferon. Ten patients with chronic hepatitis C, genotype 1 and high viral load were treated with peginterferon alfa-2a and ribavirin for 48 weeks in a prospective trial. The initial ribavirin dose was individualized and calculated from a pharmacokinetic formula based mainly on renal function. Ribavirin plasma concentrations were monitored, and the dose was adjusted to reach the target concentration. Hemoglobin was monitored, and patients were treated with erythropoietin and blood transfusions when indicated. After dose adjustments, the mean dose of ribavirin was 2,540 mg/day (range, 1,600-3,600) at week 24. The main side effect was anemia, which was controlled with erythropoietin. Two patients required blood transfusions. One patient was withdrawn at week 24 because of a lack of viral response, and one patient at week 39 because of side effects, primarily interferon associated. At follow-up (>or=24 weeks posttreatment), nine of ten patients had undetectable HCV RNA and thus were cured by standard definitions. In conclusion, a high dose of ribavirin according to an individualized schedule is feasible but associated with more frequent and serious side effects such as anemia. The viral response merits further evaluation.”

Good luck, Fashion—

--Bill

[spectda]

I've been thinking of you and what you must be going through to adjust to this new challenge and having to make new decisions about treatment after all the time you put into it already.

Although i have limited experience regarding treatment, I have been wondering if your relapse might have more to do with your ribavirin dose then your interferon choice. You didn't seem to have that tough a time getting to und, although a week four und with g2 would have been better, week 7 is still a good response.

I am not saying you shouldn't try the infergen, just thinking that also hitting it hard with riba might increase your chance of svr. I don't know how it effects svr late in treatment, or soon after treatment. I just thought it was worth mentioning.  

Perhaps I am incorrect, but I always had the impression that riba plays a huge role in preventing relapse. If anemia is truly and indication of good riba absorption and potential for svr, then it seems that you had a slow response to the riba. At 4 weeks tx you reported hgb of 13.7, and at 29 weeks 11 hgb. What was your starting hgb?

Where you prescribed weight based riba, or was it 800 mg which I think they often use for treating g2 regardless of weight?

There are people on this forum that relapsed and used much higher dosages of riba during their next tx and were successful. Bill posted a small study where they had very high success rates with very high dose riba.

Anyway, i just thought I would mention this if it hasn't already crossed your mind and you haven't already discussed it with your doctor

Take care and you know we are all thinking of you,
- Dave

[Trish77]

Here is some information on response rates to treatment with infergen, some actual data.  

It seems the best responses are for those who have responded to INF/Riba treatment previously - which you did in going UND at 7 weeks in - and for those with lower fibrosis - F0-F3.  That last one may or may not apply to you. Depends...you've been on 48 weeks of treatment and there is some degree of reversal of fibrosis for many people after treatment.  Might be worth doing that biopsy just to get an accurate picture of where you are now.  Raises chances of success to between 10 and 31% at the highest end.

Patients demonstrating partial response (>2-log drop) with previous treatment and low fibrosis scores F0-F3 had SVRs of 10.7% and 31.6% for the 9 mcg and 15 mcg arms

http://www.allofdrugtest.com/infergen-with-ribavirin-in-hepatitis-c-treatment-failures.html

The best SVR rates were seen in:
Patients achieving the greatest reduction in baseline viral load with peg-IFN/RBV therapy, especially in patients demonstrating > 1-log drop with initial therapy
Patients with fibrosis scores of F0 to F3 at baseline demonstrated SVRs of 7.8% in the 9 mcg arm and 13.1% in the 15 mcg arm
Patients maintaining full dose of INFERGEN/RBV therapy had SVRs of 7% and 17% for the 9 mcg and 15 mcg arms respectively
Patients demonstrating partial response (>2-log drop) with previous treatment and low fibrosis scores F0-F3 had SVRs of 10.7% and 31.6% for the 9 mcg and 15 mcg arms

Infergen treatment is apparently best for those with less fibrosis or non-cirrhosis and those who responded to previous treatment within certain parameters and you did.

http://www.ncbi.nlm.nih.gov/pubmed/19291790?dopt=Abstract

Because you'll be treating with ribavirin again with the infergen, that is still in your system and perhaps that's what your doctor was referring to - not the interferon.

The other factors that stand out to me is that you did 48 weeks of treatment, went UND at 7 weeks and yet relapsed.  So...just maybe...infergen is the way to go for you.  And if infergen does not work, then you DO have the PI's still in the arsenal.  

A tough decision regardless.  Good luck with this.

Trish