Ribavirin reduction

[fran4702]

My physician's assistant called yesterday and said I am anemic and to take a shot of procrit. Also to reduce to 400mg/day ribavirin instead of my  800mg. I am in week 15 and have been UND at week three on triple therapy with incivek. Genotype  1a.  Weigh 140 lbs. I was on 1000mg for 6 weeks and for the remainder of the time have been on 800mg.  Yesterday I started on 400 mg and am worried about relapse.  What is the role of ribavirin and just how important is it to SVR? I am on course for 24 wk. treatment period. I have 9 more weeks.How likely am I to relapse if I stay on this lower dosage for two weeks while my Hb rises?

[Idyllic]

I was hoping someone could translate that. Would treatment duration would be 48 weeks...even if Und at week 4?

[Idyllic]

Fran Hgb of 8 is low. It looks like even with all these dose reductions your Hgb is not really increasing that much.

If there are no health constraints then I encourage you to ask about weekly maintenance with Procrit.

[fran4702]

My Hb is 8.0. I am 3 of 6 on March biopsy. Lowest Hb was7.8 in Sept. Already had two transfusions. Started tx july15 2012. UND at three weeks and remain so.

[Claire_MHModerator]

Hi, folks,

I removed a number of posts regarding heart disease and hemolytic anemia for a few reasons:

1. The member hasn't gotten her hgb results yet.
2. The member hasn't said anything about having heart disease
3. Arguing about it obscures the OP's question, which is "how likely am I to relapse if my dosage is decreased due to low hgb?"

As such, the discussion is off-topic.  More importantly, it's likely to cause needless anxiety in an already anxiety-provoking situation.  Let's wait to hear back from the OP about her results and keep good thoughts for fran4702.  Thanks.

Claire

[can-do-man]

Hi, fran is a prior RVR that had a breakthough her first treatment due to Riba reducing, also this time had to stop Incivek at week 8.

http://www.medhelp.org/posts/Hepatitis-C/riba-reduction-to-600mg-day/show/1805636#post_8317425

[Idyllic]

•*´★¸¸.•*¨*Hang in there!  *¨*•☀¸.•

There are a lot of things going your way
☞  what with being stage 2 (I thought you more further along)  
☞  being UND at week 3.
☞  You were an early responder the 1st you treated but had to stop due to anaemia. (??)

____________________
I am gathering you are at the week 15- 16 point of treatment.

July 15 is start date
Week 3 UND
Week 4 transfusion
Week 8  Stop Incivek + dose reduce to 600
Week 15 dose reduce to 400 + Procrit

1) I can't tell when you reduced to 800 or if you started at 800.
It looks like week 15 is the first time Procrit was suggested.

2) As others have stated managing your anaemia by Riba dose reduction is usually the first intervention when Hgb drops below 10 g/dL

3) At your next appointment you might want to:

☆★ Come right and ask when (or if) you could be put on Procrit with regularity and frequency.
☆★ Ask if your doctor is concerned about Procrit and your coronary artery disease
☆★ Express your concern as (it seems to me) this was your main obstacle the first time you treated.

Weekly Procrit requires weekly CBCs to monitor your Hgb. It also shows your platelets and few other things.
_____________________________

Oh, are you treating for 48 weeks? If so your Riba dosing and anaemia is something you do not want have to worry and wonder about. Right now you sound justifiably worried and a little scared.

In addition to what the literature says many doctors taper treatment to suit the patient's individual medical condition. So far it seems like you are stage 2 with some type of cardio condition. Other than that I haven't really picked up on why you would be unable to develop a routine with Procrit given you  have dose reduced consistently from the outset.

Show your doctor this. It is not a study but it does address Procrit
(It is from the VA web site)

How will your doctor monitor you during the treatment?

Hemoglobin and hematocrit: the red blood "count" is measured by hemoglobin and hematocrit, it can be reduced by taking ribavirin. If it comes down a little bit, that is usually fine. If it comes down too much, then sometimes your doctor will either adjust the dosage of the ribavirin or add another medication (called Procrit) to boost the cell count back up.

http://www.hepatitis.va.gov/products/patient/treatment-update.asp

_____________

Quite honestly managing your side effects (however you and your doctor decide) is very important this time. Lastly (finally!) start asking for copies of your labs. The people on here can explain them and maybe help you learn to participate in managing your care.

___________________
Oh, I can't tell if you treat 24 or 48 weeks.

Does this post mean you are prior partial or relapser:

"Went on riba/interferon tx in 2005. Was an early responder and SVR for next 6 months but then developed severe anemia. Was hospitalized 5 days and doctors reduced ribavirin dosage to 2 am and 2 pm(instead of 3 in the pm). Two or three weeks after I got out of hospital the virus returned."

It is the last one on this thread:
http://www.medhelp.org/posts/Hepatitis-C/diet-on-incivek/show/1547942#post_8273344

________________
This could require tweaking and others might have better more clinically  productive ideas. I learned most of this on here from the people who responded in this thread.

[rk2761]

How are you feeling? Can you see yourself going forward on the same dose?

I was on riba and INF (not triple) and my HMG dropped below 100 in the last six weeks or so. My nurse wanted me to reduce my riba from 800 to 600. I told her no.

I was really tired but still able to work every day (well often I was at work but not functioning well enough to get much done.)

I ended up with a HMG level of 97 by the time I finished. I wanted to end knowing I did what I could.

I can understand your reluctance to reduce your dose. Talk to your nurse more to find out what could happen to you health-wise if you don't reduce.

Good luck with your decision (because it is yours to make.)

rk

[fran4702]

I do not know my Hb level but will find out tomorrow.

[pooh55811]

"When it comes to dosing for such an important malady as HCV, I would only post  known clinical data and leave opinions to others on what is best to take.

The data posted should be considered and always with the guidance of a knowledgeable doctor in HCv and it's treatment paradigms"
----------------------------------------

Agreed. However, to do that, one needs complete, reliable data based on a very large study which reflects the entire Hep C population. .

In addition, no one in this thread is/was telling the OP what she should do. Obviously, that is her decision (in conjunction with her doctor).

I base my comments on data presented at the the AASLD conference, links to which I have posted previously.

[willbb]

When it comes to dosing for such an important malady as HCV,I would only post  known clinical data and leave opinions to others on what is best to take.

The data posted should be considered and always with the guidance of a knowledgeable doctor in HCv and it's treatment paradigms

best folks...

Will

[pooh55811]

Just to be clear, Will, I was not referring to you when I said "I buck the opinion of many on the forum." I know you are knowledgeable and that you do your research.

I have read those same articles and data. It is just that I have come to a different conclusion or opinion than many have. I just don't think they have thoroughly studied a large enough group of people to be able to state with certainty that they know that Riba reduction does not affect SVR and to be able to make dose reduction recommendations based on those studies.

It seems to me that they are playing with people's lives before obtaining sufficient information to make broad recommendations.

Just my opinion.

[can-do-man]

From that study will posted.... "A total of 500 patients (about 73%) developed anemia during treatment."

Were talking about a total of 500 people in that trial that become anemic, but I didn't see the amount that were hard to treat... But would guess with only 500 people the number wouldn't be really that high.

[flcyclist]

I'd also be concerned with such a low dose of Riba since you've already relapsed.  Also, if you stopped Incivek at week 8 that bring additional concern.  As mentioned, its very difficult to predict the outcome with the combination of these dose reductions.  If they are unavoidable, then you have to just hope for the best outcome.  Not knowing your current Hgb and other health issues as your doctor does, its difficult to say what is best for you.

I struggled with a very low ANC throughout the 48 weeks and used neupogen to avoid any dose reductions while on SOC.   Hope things work out for you.

[willbb]

however as I mentioned in my post above l

If you are late stage or possiby chirrotic the reduction may have more relavance as it seems overall patients with advanced fibrosis would have somewhat less desirable results than one with no or mild fibrosis given  study data

[willbb]

I don't completly disagree with my my two good friends .however there is data on the more challenging group:


http://www.hivandhepatitis.com/hepatitis-c/hepatitis-c-topics/hcv-treatment/3583-easl-ribavirin-dose-reduction-and-epo-both-work-for-managing-anemia-in-patients-using-boceprevir

Turning to the more challenging treatment-experienced group, 39% of prior relapsers, 31% of prior partial responders, and 18% of prior null responders taking triple therapy reduced their ribavirin dose, compared with 19%, 26%, and 19%, respectively, taking pegylated interferon/ribavirin alone.
Again, ribavirin dose reduction did not have a detrimental affect on SVR rates: Prior relapsers: 82% with triple therapy and 20% with pegylated interferon/ribavirin among patients who never reduced their ribavirin dose;
84% and 29%, respectively, among those who used 800-1000 mg/day ribavirin;
90% and 33%, respectively, among those who used < 600 mg ribavirin.

Prior partial responders: 62% and 20%, respectively, among people who never reduced their ribavirin dose;
50% and 0%, respectively, among those who used 800-1000 mg/day ribavirin;
62% and 0%, respectively, among those who used < 600 mg ribavirin.

Prior null responders: 31% and 3%, respectively, among people who never reduced their ribavirin dose;
50% and 0%, respectively, among those who used 800-1000 mg/day ribavirin;
22% and 25%, respectively, among those who used < 600 mg ribavirin.

[can-do-man]

"I will probably get pelted for my opinion"

Not from me you won't..... It's quite clear Riba is important during treatment as the study that didn't include Riba was a big bust. Yes some can reduce and gain SVR, but how about hard to treat people like cirrhotics, prior breakthroughs, null responders, and people of different race?

Yes I know what the guidelines say, but what they don't do is break it down for these type of people, sorry one size shoe does not fit all...

[pooh55811]

I know this is a difficult situation and it is very understandable that you would be concerned about becoming DET again.

I looked at your previous posts. You treated in 2005, reduced Riba during that treatment, and had a viral break through. So I understand your concern. You are 1a, more difficult to treat than 1b.

Personally, I would be afraid to reduce so much.

How low is your hemoglobin? Is it extremely low? Could you do more Procrit? Could you go to 600 mg instead of 400 mg of Riba?

I buck the opinion of many on the forum. I am against reducing Riba, and I am especially against reducing Riba more than 200 mg. I just don't think a retrospective look at a small trial gives us or anyone else (docs, NPs) enough information to be running around telling people that dose reduction makes no difference in SVR. Researchers have not done a large study on 20,000 or 30,000 people to specifically see how dose reduction affects them. Until they do that, a specific study of tens of thousands of people, and produce results that dose reduction does not affect SVR rates, I am not buying it.

I do agree that some people can reduce dosages and still attain SVR.  However, some cannot. We don't know all of the factors that affect SVR . We do not know in advance into which group we fall, not until we attain SVR or have a break through or relapse.

I will probably get pelted for my opinion, but I think that sometime in the near future that oft quoted Riba reduction mantra is going to change. I think docs will be rapidly back peddling on the Riba reduction.

Here is wishing you the very best.

[can-do-man]

Being you had a viral breakthrough because of riba reduction on your prior treatment I would be kinda nervous reducing to such low levels. Is your NP aware of your prior treatment results? Also you stopped Incivek at week 8 this time. I would be asking alot of questions if it was me.... Good luck

[willbb]

fran;
I have linked some info below you may be intesested in.however as you may notice from this article there are no mention of what stage of fibrosis the patients had.
If you are late stage or possiby chirrotic the reduction may have more relavance as it seems overall patients with advanced fibrosis would have somewhat less desirable results than one with no or mild fibrosis given  study data

Good luck..
Will


http://www.hivandhepatitis.com/hepatitis-c/hepatitis-c-topics/hcv-treatment/3583-easl-ribavirin-dose-reduction-and-epo-both-work-for-managing-anemia-in-patients-


Reducing the dose of ribavirin and adding erythropoietin are both good options for managing anemia in hepatitis C patients treated with boceprevir (Victrelis) triple therapy, according to study findings presented at the 47th International Liver Congress (EASL 2012) this week in Barcelona. A related study found that ribavirin reduction also did not impair cure rates with telaprevir (Incivek).

  
Triple therapy raises the likelihood of a cure and offers the potential for shorter treatment, but it also increases side effects such as anemia (low red blood cell or hemoglobin levels). Various approaches are used to manage anemia including reducing the dose of ribavirin, adding erythropoietin (EPO; brand names Epogen and Procrit) to stimulate red blood cell production, and blood transfusion. Ribavirin dose reduction is risky for patients on interferon dual therapy since it helps lessen the likelihood of post-treatment relapse.

Participants received pegylated interferon alfa-2b (PegIntron) plus 600-1400 mg/day weight-adjusted ribavirin for a lead-in period of 4 weeks, then added 800 mg boceprevir 3-times-daily for 24 or 44 weeks, depending on HCV RNA levels at week 8.

Baseline hemoglobin levels were 12-15 g/dL for women or 13-15 g/dL for men. Participants who developed anemia -- defined as hemoglobin < 10 g/dL -- or were expected to soon reach that level were randomly assigned to reduce their ribavirin dose by 200-400 mg/day or add 40,000 units/week subcutaneous injections of EPO. If hemoglobin fell to 8.5 g/dL, secondary methods of anemia management could be added. If it dropped to 7.5 g/dL, treatment was discontinued.

The primary endpoint was sustained virological response (SVR), or continued undetectable HCV viral load after completion of treatment.

Results
A total of 500 patients (about 73%) developed anemia during treatment.
SVR rates were comparable for patients randomized to ribavirin dose reduction and those taking EPO, at 71% for both groups.
10% of patients in both groups relapsed after treatment.
In a multivariate analysis, ribavirin dose reduction vs EPO was not a significant predictor of treatment success.
Serious adverse events occurred with similar frequency in both arms, 16% with ribavirin dose reduction and 13% with EPO.
Discontinuation rates due to any adverse event were also similar, 11% and 13% respectively.
2.0% and 2.4%, respectively, stopped treatment due to anemia.

"Early ribavirin dose reduction did not negatively impact SVR compared with early EPO use," the investigators concluded. "These data support ribavirin dose reduction for primary anemia management."

Telaprevir

A related retrospective analysis by Mark Sulkowski from Johns Hopkins School of Medicine and colleagues looked at outcomes among patients who developed anemia in pivotal trials of telaprevir.

The Phase 3 ADVANCE and ILLUMINATE trials evaluated telaprevir triple therapy in treatment-naive genotype 1 chronic hepatitis C patients, while REALIZE looked at prior non-responders and relapsers. Control arms i all studies received pegylated interferon/ribavirin alone.

Telaprevir is not as likely as boceprevir to cause anemia -- its notable side effect is skin rash -- but anemia rates among people on telaprevir triple therapy were higher than those for patients taking pegylated interferon/ribavirin dual therapy.

Results
Among treatment-naive patients, half of those taking telaprevir triple therapy had a ribavirin dose reduction compared with 18% of those on pegylated interferon/ribavirin alone.
45% and 11%, respectively, received < 600 mg/day of ribavirin while on triple therapy.
Ribavirin dose reduction did not negatively affect the likelihood of treatment success, with the following SVR rates: 79% with telaprevir triple therapy and 46% with pegylated interferon/ribavirin among patients who never reduced their ribavirin dose;
75% and 54%, respectively, among those who used 800-1000 mg/day ribavirin;
74% and 42%, respectively, among those who used < 600 mg ribavirin.

[Idyllic]

What is your Hgb? That is really the important question.
What is your base line and what was it at 800 and over the past few weeks?

I'll let someone else regurgitate the studies about SVR & Riba dose reduction since I am intrinsically wary of reducing Riba. I would be freaked but I am a prior partial responder and this is my 2nd time around. That could be my negative jinx karma, glass-half-empty point of view defying logic and reason.

Not knowing more of the facts I would say that off hand 400 does seem kind of low however. I would have guessed the next step would be Riba 600 but like I said we don't know your Hgb levels.
Best of luck

[willbb]

:) Im too mean to kill off ;)
. -------------------------
I don't believe it for a second...glad you are safe  :)

[nygirl7]

Nice to be back! Was kind of harrowing but we made it :) Im too mean to kill off ;)

[willbb]

So nice to see you ...   :)

[nygirl7]

Agrees with her good friend Will.  Sounds a bit low to me I thought they usually reduced to 600...but I only did SOC a million years ago so I could be wrong.

Procrit takes a few weeks to work but can save your course of treatment - it did mine when were not allowed to reduce.