1280753 tn?1367757932

End Treatment Early

I am on my second round of treatment, first was INF/RIBA for 48 weeks. I relapsed 1 month after finishing tx. I am currently on triple tx, with Incivek/INF/RIBA. I was clear at 4 weeks. Geno 1A, IL28B CC, early stage 4.

I am struggling to get to week 36 which is my goal. I'm coming up on week 34. The sides have been debilitating; can't work, difficulty breathing (asthma/allergies on shots and advair/ventolin, zertec), getting bruising on arms and legs from low platelet count (59k), on Procrit HGB is 8.7, WBC is 1, constant infections (ears, throat, intestinal, chest), a severe cough that usually ends with the dry heaves, extreme fatigue, vertigo....and blah blah and so on.

I know that the protocol for stage 4 is to do 48 weeks. But there probably is very little clinical data that substantiates that for patients that treated with Incivek and cleared. Before I started this round they were recruiting patients for a 24 week triple trial for stage 4's. I didn't make it in.....

My thinking is that if I can do (which I doubt) 12 more weeks of this torture and if I relapse I have to wait for new meds in a couple of years. If I stop now and take my chances, I end this living he11 and i get my life back NOW. I'm sure my chances of reaching SVR may be reduced if I stop now, but I am willing to roll the dice. this gotta end.

I am I wrong in my thinking?  
15 Responses
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Avatar universal
I sure can't say whether your right or wrong. But I hope you fully understand the risk your taking. First being a 1a has been more of a problem then a 1b, your cirrhotic, a relapser. I also have to wonder how much of the hype of new drugs is playing a part into this. If that is the case then I would think long and hard before stopping, all this hype was here for the PI's as they were going to be a cure all, even for us cirrhotics and that has not been the case.

I hope you understand if you don't clear now what might be next, and what if these new drugs fail you then what? You have a very good chance now at gaining SVR as you did have a eRVR. Why would one want to risk that being cirrhotic? A lot of people that have cirrhosis feel good and maybe don't think of what could be next... all one has to do is read Hectors thread on where he is now, for me that would be enough to man up and do everything possible to beat this with every chance I have......

Good luck to you, hope you have the correct outcome and gain SVR.
Helpful - 0
2059648 tn?1439766665
Hey Guy!!! Your incredible to have made it this far.  I can't even imagine
how strong you must be.  WOW!   Before you think about throwing in the towel... go read the following  thread in the cirrhosis of the Liver" forum.
"Does This Make Sense" I believe was the post.  You are so close and un
at 4 weeks!!!! You can do it!! You can!!
Helpful - 0
446474 tn?1446347682
I can't agree more with what can-do says.

To  come all this way and not give yourself the best chance of curing the virus when you have cirrhosis, and your odds of SVR are already lower, is a huge risk. You may have to do 48 weeks all over again or you won't be able to do any treatment and will then need a liver transplant. Read about the reality of liver transplant if you want a reality check. People like myself that need transplants to continue living would trade anything to be able to be in your position. Ask mikesimon who has been through the whole process.

There is no guarantee that new treatment will cure your hepatitis C. It may depend on how advanced your cirrhosis is when it becomes available and that is not anything anyone can predict. The more advanced your cirrhosis the less odds of cure and the more side effects you will have.

Serious side effects in cirrhotics are to be expected with triple therapy.
"Incivek, Victrelis Associated With Serious Side Effects in Cirrhotic Patients"

Many people living with hepatitis C virus (HCV) can’t wait until all-oral, potentially less toxic regimens become available. In these patients, notably those with cirrhosis of the liver and who didn’t respond favorably to prior treatment with pegylated interferon and ribavirin, regimens containing Incivek (telaprevir) or Victrelis (boceprevir) may boost the likelihood of curing HCV, but with the risk of serious side effects.

Unfortunately, rates of serious side effects were high. Among those receiving Incivek plus peg-IFN/RBV, nearly 49 percent experienced at least one serious adverse event. Among those receiving Victrelis plus peg-IFN/RBV, 38 percent experienced at least one major side effect. Roughly one of every seven people in the Incivek group had to discontinue treatment prematurely because of serious side effects, compared with one of every 14 people in the Victrelis group.

Severe anemia occurred in 10 percent of patients in both treatment groups, and erythropoietin therapy to boost hemoglobin levels was required for more than half of patients receiving either Incivek or Victrelis. Moreover, 20 percent of Incivek recipients and 10 percent of Victrelis recipients required blood transfusions because of severe anemia-related fatigue.

Serious decreases in neutrophils—the most common type of white blood cell and primarily responsible for engulfing bacteria—occurred in 5 percent of patients receiving either Incivek or Victrelis. Serious decreases in platelets (thrombocytopenia) occurred in more than one in five CUPIC participants receiving Incivek and in 7 percent of those receiving Victrelis.

“The safety profile of [Incivek] or [Victrelis] with peg-IFN/RBV in cirrhotic patients was poor and associated with increased rates (30 to 51 percent) [of serious adverse events] compared to those reported in phase III trials (9 to 14 percent),” Hézode and his colleagues concluded. “These data strongly suggest that triple therapy must be administered cautiously with intensive safety monitoring in these patients.”
According to clinical trials there is no guarantees that Incivek is a cure-all for hepatitis C in previously treated cirrhotics.

The SVR stats from the REALIZE trial for cirrhotics depend upon prior response to treatment.

Twenty-three percent of INCIVEK-treated subjects had cirrhosis at baseline.

SVR rates among cirrhotic subjects who received INCIVEK combination treatment compared to Pbo/PR48 were: 87% (48/55) compared to 13% (2/15) for prior RELAPSERS,

34% (11/32) compared to 20% (1/5) for prior PARTIAL RESPONDERS

14% (7/50) compared to 10% (1/10) for prior NULL RESPONDERS.

Of course it is your life and your decision. Just make sure you are educated enough to realize the risk you are taking. One way or another you will have to cure your hep C. Either before transplant or after transplant.

Good luck with your treatment.
Helpful - 0
1815939 tn?1377991799
I agree with everything Can-do and Hector said.

You sure do not want to risk failing this treatment by stopping early. I hope you try your very hardest to complete the 48 weeks so that you have the very best chance of SVR.

Best of luck.
Helpful - 0
1494170 tn?1361750860
I'm just gonna parrot the above comments and add that you and I are about the same stage. I have treated two full 48wk tx's and relapsed then attempted a third triple tx with incivek and made it to 38wks and had a breakthrough. I was having a hard time too and wondered if I could make it to 48wks but since I had the breakthrough at 38wks I was pulled off tx.
I know that starting wk 34 and all the sx you are having and the thought about ending tx and taking a chance that it worked may sound good but since you have already invested so much into this if there is any way possible you think you can keep going for a full 48wks then I would sure try and stick it out.
You still have a good chance right now to kill this virus, a chance many of us only wish we had...
Hang in there and Best of luck either way...
Helpful - 0
230202 tn?1370793579
I know what it's like to have your hb at 8.5.  It's really hard and difficult to do anything.  You really do feel like a bus has hit you.  You are on Procrit so that should help your HB.  On saying all of this, I have to agree with everyone here.  The bottom line is.......do you really want to have to re-treat later down the track?.  Could you forgive yourself if you stopped earlier and then relapsed....?.  I feel the only time to stop treatment is when your medical team tells you to.  They are keeping an eye on you and there is something for every side.  Ask them if you need extra help.  

I wish you all the best.......hopefully tomorrow it will be easier for you.  I found that each day bought different sides some days were easier and some were harder...............

Take care
Helpful - 0
Avatar universal
  Hi Uncle, and big hugs for you.  I also had an HGB of 8.8 and platelets count of 66 when I ended my Tx. I was afraid to cross a busy street, for fear my legs would buckle from weakness.
  I think your chances of clearing, with this Incivek Tx, are very good.  I had 3 ladies in my support group here in town, they all had to do 48 wks with Incivek (prior relapsers, although they were all Stage 3) and they all cleared!  One had an hgb below 8, and had to have several blood transfusions. She got very thin also, and sometimes I feared for her life. Also, she didn't clear until weak 12, even with the Incivek, put she wnet on to do the 48 wks, with every symptom in the book, and did obtain SVR.  Now, 8 months post Tx, sghe is already feeling great again.
   I think instead of taking it by "the weak" that you try to get thru each day. Maybe you could have a minor nervous break-down on here like I did, it helped pass the days, but drove many old-timers on here crazy!  
  But in all seriousness, this website helped me to get thru my Tx, and that is because of you and all the others onhere.
   I am going to be hanging around here, waiting for your UncleDude is SVR post~
Helpful - 0
1669790 tn?1333662595
Hey Unc, so sorry to hear this round has been such a struggle for you.  I know the first one wasn't easy for you either.  You've gotten some good advice and encouragement from the long term members and I support what they say.  I think gene and Hector really help to put things in the proper context.  The more advanced your cirrhosis, the less odds of cure.  Do your best to increase your odds by continuing as long as you can hold out.  Only you know how much you can endure, so wish you the very best.  We all want to see you SVR.  
Helpful - 0
1118724 tn?1357010591
"SVR rates among cirrhotic subjects who received INCIVEK combination treatment compared to Pbo/PR48 were: 87% (48/55) compared to 13% (2/15) for prior RELAPSERS.."

I'm easily confused .. this is saying those cirrhotics whose first treatment is with Incivek have an SVR rate of 87% compared to those whose first treatment is a Placebo / Peg & Riba? While cirrhotic Prior Relapsers have a 13% chance of SVR?

Sorry, I've asked on this once b4, maybe twice, and musta been pretendin to understand, cuz I pop a fuse every time I read it, especially the 13% part.
Helpful - 0
1118724 tn?1357010591
You are one tough puppy to have come this far. If there is any way to continue for one more week, just one more day.. we're all hoping the best for you.
Helpful - 0
1815939 tn?1377991799
James, I think this copy and paste from Clinical Care Options may answer your questions:

"Protease Inhibitors in Cirrhotic Patients"

"Response to interferon is a critical determinant of response to protease inhibitors. As a result, the presence of cirrhosis, which significantly affects interferon responsiveness, also affects response to PIs.

In the SPRINT-2 study, treatment-naive patients with advanced fibrosis had lower rates of response than those with early-stage disease (Capsule Summary).[Poordad 2011] Based on the improved SVR rates seen in this population with 48-week boceprevir therapy rather than with response-guided therapy, a fixed duration of 48 weeks of treatment may be superior to a response-guided approach in cirrhotics. In the treatment-experienced population studied in RESPOND-2, cirrhosis was also a negative predictor for response overall, and higher SVR rates were seen with 48-week boceprevir therapy compared with the response-guided strategy in patients with cirrhosis (77% vs 35%, respectively) (Capsule Summary).[Bacon 2011a] On the basis of these data, the US Food and Drug Administration has approved the 48-week boceprevir regimen in patients with compensated cirrhosis.[Boceprevir PI]

In the ADVANCE study, treatment-naive patients with bridging fibrosis or cirrhosis who received telaprevir achieved SVR rates of 62%, compared with 75% in comparable patients with portal fibrosis and 81% in those with no or minimal fibrosis (Capsule Summary).[Jacobson 2011a] Similarly, in the ILLUMINATE trial, which included more patients with bridging fibrosis or cirrhosis (n = 149), SVR rates were 63% for patients with advanced fibrosis compared with 75% for those with early disease (P < .01) (Capsule Summary).[Sherman 2011a] The effect of cirrhosis on response to telaprevir appears to be most striking in treatment-experienced patients. In the REALIZE trial, 22% to 28% of previous null responders with bridging fibrosis or cirrhosis, who received telaprevir, achieved an SVR (Capsule Summary)[Zeuzem 2011] : When considering cirrhotics only with previous null response, the SVR rate is much lower at 14%.[Forestier 2012] Notably, however, previous relapsers with bridging fibrosis or cirrhosis still did very well if they received telaprevir, with SVR rates of 84% to 85%. Therefore, cirrhotic relapsers are good candidates for first-generation protease inhibitor therapy.

Relatively limited numbers of patients with cirrhosis were enrolled in the registration trials with either approved protease inhibitor. A French early access program, the Compassionate Use of Protease Inhibitors in Viral C Cirrhosis (CUPIC), was initiated to gain real-world experience treating cirrhotic patients with boceprevir and telaprevir. The program enrolled previous relapsers and partial responders to peginterferon/ribavirin with compensated Child-Pugh A cirrhosis and genotype 1 HCV infection. Patients were treated with peginterferon, ribavirin, and either telaprevir or boceprevir, at the discretion of the treating physician. As part of an interim 16-week analysis, safety and efficacy data were presented for 292 patients treated with telaprevir-combination therapy and 205 treated with boceprevir-combination therapy.[Hezode 2012] All patients had well-compensated cirrhosis with a mean platelet count of approximately 150,000 cells/mm3 and a 33% to 40% prevalence of esophageal varices. However, 33% to 46% of telaprevir-treated patients and 29% to 40% of boceprevir-treated patients would not have been eligible for the phase III registration trials (depending on which trial criteria were used).

In this interim analysis, serious adverse event rates requiring admission to the hospital were high at 45% among telaprevir-treated patients and 33% in boceprevir-treated patients. The incidence of grade 3/4 anemia was 11.4% with telaprevir and 4.4% with boceprevir at interim analysis, and grade 3/4 thrombocytopenia occurred in 12.7% of telaprevir-treated patients and 6.3% of boceprevir-treatment patients. Infectious complications were also common, with grade 3/4 infection reported in 6.5% and 2.4% with telaprevir and boceprevir, respectively. In addition, 4.8% of patients treated with telaprevir reported grade 3 rash or severe cutaneous adverse reaction, and 2.0% to 2.9% of patients treated with either protease inhibitor experienced hepatic decompensation. Despite a high rate of erythropoietin use (46.3% to 53.8%), blood transfusions were required in 16.1% of telaprevir-treated patients and 6.3% of patients treated with boceprevir. There were 5 deaths in the telaprevir group (2.6%) and 1 death in patients treated with boceprevir (0.5%). Deaths were primarily from infectious complications and/or hepatic decompensation. Despite the high rates of adverse events, early antiviral efficacy was good with undetectable HCV RNA achieved by Week 16 in 58% of patients treated with boceprevir and 67% of patients treated with telaprevir.

Multivariate analyses identified 2 predictors of severe complications: baseline platelet counts of ≤ 100,000/mm3 and baseline serum albumin level of < 35 g/L. Baseline predictors of developing anemia reaching < 8 g/dL of hemoglobin or requiring transfusion included female sex, the lack of a lead-in phase, patient age of 65 years or older, and a hemoglobin level of ≤ 12 g/dL in females and ≤ 13 g/dL in males.

In summary, the CUPIC data show that adverse events are more frequent in patients with cirrhosis with both agents than was reported in the registration trials. However, on-treatment efficacy appears to be similar to clinical trial data."

Helpful - 0
1280753 tn?1367757932
thank you all for your support and advice. I guess I have a really big decision to make soon.
Helpful - 0
223152 tn?1346978371
Oh boy, I hear your pain.  This has got to be the anemia talking.  Plus it is spring and the asthma and allergies are probably really kicking in to make this more difficult. Are you getting any procrit or epogen to help with that anemia?  It is just so hard to see the end of the tunnel when you are this far in but 3 months is a pretty short time and if you could just hang in there.  None of us wanted to do this for 48 weeks but then again, none of us want to do this again.

Look at Gene53 - his profile looks pretty similar to yours and he had a breakthrough at week 39.  You are not safe yet, uncle!   I was clear at week 6 (week 2 of Victrelis) and was too scared to quit at 36 even though my doctor said, with early cirrhosis I probably would be safe to do it.  Yes there may be new drugs coming but I was hoping to never treat again ever.  

You have not said whether your doctors think you are in danger.  I know there are lung issues with the treatment drugs.  Have you been checked out thoroughly?   Are you doing too much?  With HGB in the 8's, I think  not, but try to scale back if you can.  Please try to make it and don't keep trying to "play the odds."

Helpful - 0
1494170 tn?1361750860
Bean is right on, our profiles are pretty close except you have a much nicer bike.  I was UND all the freaking way through until the 36wk lab test. Just getting ready to start wk39 and they pulled me off tx.
Your sx sound much worse then mine and mine were terrible. The depression and fatigue were kicking my a$$ but after 2 previous full 48wk tx's I knew I had to keep going and I did until I was forced to quit.
Now all I can do is hope the new meds will be released before I go decompensated and then I have to try round 4 and hope it works and as you know there are no guarantees with any of these drugs.
As long as you are still UND and have a pulse I highly recommend you tighten your spurs, hold on tight, and kick some a$$.
Seriously wishing you the Best with this battle!!!
Helpful - 0
Avatar universal
Sending positive thoughts your way and hope you don't pick up the dice and decide to roll them.  I know it's difficult.  Do the best you can.

Helpful - 0
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