riba reduction to 600mg/day

[fran4702]

Incivek stopped end of week 8.  Riba reduced from 800 to 600 that day also. Rash and anemia. Has anyone out there been able to sustain a viral load of undetectable in my same situation?  What are the statistics on this? I have come so far. I want to beat the dragon!  A few bits of information will be helpful- Genotype 1a, diagnosed 2004 and treated but viral breakthrough in month 6 due to riba reduction to 600 after anemia development. Was early responder both treatment times.  Und at week 3.  Viral load 11.8 stage 2(3 of 6) in March biopsy. Weight is 140 so the 800 mg/day did not worry me as much as this 600 does. Anyone out there have any information that would be helpful.  My Hb is 8.6 and I would rather live in the 8's for 6 more months so this will work this time. I am 56 and don't know if I can go through this torture again.  

[PJ1966]

This is what my doc said yesterday.  I posted that he reduced my riba due to my RBC, hub results.  I was a little upset but starting to feel better.  I'm not sure if I should have argued with him or not about reducing my riba.  But I felt he knows what he's doing.  He said that the reduction should have no effect on SVR.   I just want to finish the incivek completely without reduction or having to quit early.
Thanks for your information.  I posted my blood in another separate post if you have a chance, maybe you can review it and give me your advice.
thank you!

[Idyllic]

"A medrol dose 18 day pak presribed to take at home. Which I have heard interferes with the efficacy of the interferon. ."
_____________-

Interferon = peginterferon alfa 2a  
Medrol Dose Pack = methylprednisolone

Interactions between your selected drugs:

There were no interactions found in our database between Medrol Dosepak and peginterferon alfa-2a.

However, this does not necessarily mean no interactions exist. ALWAYS consult with your doctor or pharmacist.

Medrol Dosepak is in the drug class glucocorticoids.
Medrol Dosepak is used to treat the following conditions: Adrenogenital Syndrome, Asthma, Asthma, acute, Asthma, Maintenance, Atopic Dermatitis, Dermatologic Lesion, Gout, Acute, Hay Fever, Immunosuppression, Inflammatory Conditions, Neuralgia, Osteoarthritis, Rheumatoid Arthritis, Shock.

Peginterferon alfa-2a is a member of the drug class antiviral interferons.
Peginterferon alfa-2a is used to treat the following conditions: Hepatitis B, Hepatitis C.


http://www.drugs.com/drug-interactions/medrol-dosepak-with-peginterferon-alfa-2a-1607-3550-1806-0.html

[pooh55811]

Sorry, guess I did not answer very well. I tried copy and paste a chart but that did not work, LOL.

eRBR is Extended Rapid Virological Response

Extended Rapid Virological Response is defined as Undetectable HCV RNA at Weeks 4 and 12.

Here is a link to a PDF file which will explain all of the terms:

http://www.hcvadvocate.org/hepatitis/factsheets_pdf/treatment%20response%20terms.pdf

And here is another link:

http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%202.aspx

[fran4702]

early viral response?

[pooh55811]

Triple med treatment with Teleprevir:

eRVR is defined as Undetectable HCV RNA at Weeks 4 and 12.

eRVR is used to determine treatment duration in appropriate patients.

[fran4702]

what does eRVR mean?

[can-do-man]

Fran just so you know all is not lost with even 8 weeks of Incivek as they did do a study on this. Wishing you the best...

http://www.clinicaloptions.com/Hepatitis/Annual%20Updates/2011%20Annual%20Update/Modules/DAA%20Naive/Pages/Page%206.aspx

ADVANCE
The ADVANCE study was a randomized, double-blind, placebo-controlled phase III trial in which 1088 treatment-naive patients with genotype 1 HCV infection were randomized to one of 3 treatment arms[19]:

1. Telaprevir plus pegIFN/RBV for 8 weeks followed by pegIFN/RBV for a total duration of 24 or 48 weeks (T8/PR)
2. Telaprevir plus pegIFN/RBV for 12 weeks followed by pegIFN/RBV pegIFN/RBV for a total duration of 24 or 48 weeks (T12/PR)
3. Placebo plus pegIFN/RBV for 12 weeks followed by pegIFN/RBV for a total duration of 48 weeks (PR)

The main purpose of the study was to compare the efficacy of the regimens including 8 and 12 weeks of telaprevir vs the standard of care, with SVR as the primary study endpoint. Assessment of whether the duration of therapy could be shortened in patients who had an eRVR was a secondary goal of the study. The reason for studying a shorter duration of telaprevir exposure (8 weeks) was to determine if the incidence of adverse events, specifically rash, could be reduced while maintaining virologic response. However, there was a higher rate of virologic failure in the T8PR arm compared with the T12PR after triple therapy had been completed and pegIFN/RBV alone was ongoing, and therefore, the recommended period of triple therapy is 12 weeks.

The SVR rate was higher in both the 8- and 12-week telaprevir arms compared with the standard-of-care control arm. SVR occurred in 75% of patients in the 12-week group, 69% in the 8-week group, and 44% in the standard-of-care arm (P < .0001 for the comparison between each telaprevir arm and placebo). In addition, 58% of patients in the T12/PR arm and 57% in the T8/PR arm attained eRVR and were able to truncate the course of therapy to 24 weeks

[maybe368]

It sounds to me that everything was handled to standards, after the rash was real bad. The question is did they offer anything for the rash before it got so bad? It really compounds fast, mine was pretty severe...Mark

[fran4702]

This is franb. I have had a hard last 5 days. On friday went to UR Hep dept to see my np. she looked at rash. gasped, called dr. Maliakkal and they decided I had to stop immediately the incivek. Skin reaction appeared to be heading towards Stephens-Johnson Syndrome. Prescribed hydroxyzine, vicodin, triamcinolone tub.  Sat night about 10 could not take the severe pain any longer. went to highland hospital ER. They brought me straight back and gave me shot of benadryl and solucortef and drew 6 vials of blood. Then transferred me via ambulance to strong hospital where i was in ER until sunday evening.  I was given IV fluids,BP 87/45. Burn unit doctors looked at me.. Eosinophils were 0 so wasn't SJS. Not Dress either. Entire body covered and blood coming out the rash. Anal and vaginal eruptions and burning also.  Injection of Dilaudid and more benadryl.  A medrol dose 18 day pak presribed to take at home. Which I have heard interferes with the efficacy of the interferon.

[willbb]

canman:

when I was little and asked 'Why"

..I was told   "just beacause"    :)

[can-do-man]

LOL, a simple question but not one answer as to why...

[Asuncion]

Hi, I think that this is a great forum. You can find lots of people willing to help and share their knowledge. Can-do-man, Willbb, frijole, HectorSF, FaithForHealing, and basically everyone in the forum have given a lot of valuable information.  Some even send web pages to the information. I like reading the posts so I can ask my doctor better questions.
People in the forum will help you prepare better, they have been though all the pain and know what helped them feel better. Once you get to know them, you will feel that they care for you, you will find friends to lean on.
They will give you hope. Every time I read of someone else that has achieved SVR it gives me strength to continue fighting HCV.
This forum is not meant to replace your doctor, it is meant as a link so that we can help each other.
I don´t think that any doctor knows more of any med that the lab that created it. If both Vertex and the FDA advice not to reduce the dose of Incivek, it is because they did a lot of clinical trials to support that claim. I would definitely talk to my doctor about it. Maybe there is another option that he thinks is too risky, but I might be willing to take my chances.
Anyway, I wanted to thank every single one of you. I don´t write that much. I don´t think I know enough to help. But I read almost every day and you people have helped me a lot. I don´t feel like I am walking this road alone anymore.

Best regards,

[maybe368]

Also, my doc told me that I could stop the incivek at 11 weeks, I refused (to her face and took them all, because I didn't want this to affect my chances at svr...Mark

[maybe368]

Maybe soc says they should, if they become anemic. One of the reasons that soc is developed is to establish an acceptable standard for everyone with that disease.  On day one of paramedic training, they taught us that when all else fails, look at the patient. That is the art part of medicine...Mark

[willbb]

I personally have never thought "one size fits all" however I always, as most know try to relay accurate research data.

To somewhat play devils advocate ....the stats below show that even in tx. experinced patients the SVR rates were no diffent  as it pertained to the Riba reduction arm vs. the introduction of the growth factor "Procrit"

Especially as it pertains to the OP who was asking about this being  St2 damage.

There is no indication in the stats below about any patient treating having chirrosis so this may be still an unknown

Best...
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-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:

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.

[frijole]

fran, welcome to the board.  As you probably knew and got confirmed by this thread, we are not doctors.  We are people with Hepatitis C who are just trying to figure it all out.  We have a lot of insight just because we read about and make friends with a lot of like-afflicted people.

The questions I would ask are who is treating you?  How much experience does he have?  Has he treated you previously?  Hector is exactly right.  Your Incevik should not have been stopped so I do question your doctor's experience.  I don't much like riba reduction, but that should have been the first thing, not the incevik.

You got dangerously anemic very quickly.  I don't even know how you can think of continuting at that level for another 16 weeks.  My lowest HGB was 8.9 and the doctor said I would need to transfuse if it got any lower.  If your doctor will not use procrit or transfuse, ask for a referral to a hemotologist (blood specialist).  They are experts at blood monitoring and I am pretty sure they would transfuse first and perhaps then use procrit (epogen).

I never transfused but did have riba reductions and used procrit.  At the end of my 48 weeks I had reduced riba to 800 (from 1200) and used procrit every 5 days (40,000 IU)  and still got down to 8.9hgb.  I was under 10 for 27/48 weeks.

"Has anyone out there been able to sustain a viral load of undetectable in my same situation?" was your original question.  Yes, there are a few, working dog being one of them.  I don't kow about statistics but the radical anemia drop seems to be an indicator too that increases the chance of SVR.  I have no statistics on this.

I wish you luck.  You have some hard decisions to make.  
frijole

[pooh55811]

"Well if one shoe fits all with these PI's then one has to wonder why they don't just reduce everybody once they become und... "
------------------------------------------------------

Precisely.

[Bill200]

Hector is there any similar data for INF dose reductions (due to, say, low wbc)?

[working dog]

i had to stop my riba from 1200 to nothing at 4.5 weeks into tx because of hgb tanking....that was for 10 days....then went back on and built up too fast to 1200 and tanked again to stop riba for 5 days....then back on it and got it up to 1000....my doctor and np did what they had to to keep me on tx...i did keep up with the incivek for 11+ weeks...the combination of incivek ...interferon....riba....and zoloft....had me falling down everyday....a couple times close to getting in trouble bad...everyone seems to be different with these drugs...maybe someday they'll be able to check out our body chemistry before tx ....i would think take as much riba as you can...i took it until i could only take 5 to maybe 50 steps without stopping....i was in the 8s hgb also and post incivek the 8s were doable....there were plenty of folks on this forum pushing me to take more riba......so i took as much as i could...and i am svr...billy

[can-do-man]

Well if one shoe fits all with these PI's then one has to wonder why they don't just reduce everybody once they become und...

[maybe368]

Thank you, that is exactly what my doc told me...Mark

[HectorSF]

'Incivek stopped end of week 8.'
Incivek should NEVER be stopped early. It is the stopping Incivek that has reduced your chances of SVR, not ribavirin dose reduction.

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use INCIVEK safely and effectively.

'2.2   Dose Reduction
To prevent treatment failure, the dose of INCIVEK must not be reduced or interrupted.'

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdf

--------------------------------------------------------------------------------------------
Reducing ribavirin has NO effect on SVR rates with triple therapy.

Practical Gastroenterology • April 2012

'In clinical trials of TVR triple therapy versus a control group treated with PIFN/RBV, 32% of patients experienced anemia and 22 % of patients required RBV dose reduction due to anemia versus 15% and 9% respectively in controls. EPO use was prohibited in TVR-based studies. In patients on TVR triple therapy, 4.6% required blood transfusions and 2% discontinued therapy early due to anemia versus 1.6% and 0.5%
respectively in controls.
The likelihood of achieving SVR has been found to be independent of RBV dose reductions or EPO use during therapy. This important finding
demonstrates that SVR rates are not adversely impacted by managing side effects by decreasing RBV dose, especially once HCVRNA levels become undetectable. It should be noted that RBV dose reduction criteria differed in BOC and TVR clinical trials. In TVR -based trials RBV was dose reduced to 600 mg/day while in BOC-based trials RBV was dose reduced by 200
mg intervals. While predictors of anemia with BOC triple therapy have yet to be determined, predictors of anemia during TVR triple therapy include older age, lower BMI, lower hemoglobin, advanced liver disease
and genotype 1b. Thus, patients with these characteristics, especially those with advanced liver disease, should be monitored for anemia at more
frequent intervals. It is contraindicated to dose reduce BOC or TVR, or to use BOC or TVR as monotherapy under any circumstances. RBV dosages may be held for up to fourteen days. Permanent discontinuation of RBV requires permanent discontinuation of BOC or TVR due to the risk of developing drug resistance.

http://practicalgastro.com/pdf/April12/Palmer.pdf

Cheers!
Hector

[maybe368]

Exactly

[FaithforHealing]

"There seems to be a reluctance on this forum to even consider something that goes against the beliefs that are sometimes thrown around here. It also sounds very close to medical advice, I don't think self treating off the internet is such a good idea."

Pretty strong statements and assumptions. I don't know what they are based upon.

I've only been around this site since March, and maybe I've missed seeing posts that led you to this impression. People who come on here looking for medical advice are told right up front there are no doctors here.

I've also seen many posts in which the "advice" to find a new doctor made all the difference in the world because the doctor was a novice to treating HVC.

Anyone who would take this site as medical advice and go against their dr, or self treat would have to be a little "not right" in the head. If they did so, I would wager it wouldn't be their first really stupid mistake in life.

How would one self treat off the internet? Can we get access to these drugs without a doctor? Has anyone on here done that?

I'm sorry you have come away with such a negative impression of this site.