Does Ribavirin cause anemia when used with Sovaldi??

[nan535]

My husband just got approved for Sovaldi + Ribavirin for 24 weeks. We are very excited but he needs to get his hemoglobin up before starting his treatment. We already have the  meds in the house but can not start using them. He had a shot of procrit yesterday - labwork in a week to see if his hemoglobin is up from 8.9 (normal range starts at 13.9). His red blood cell count is 2.94 (normal range starts at  4.5).

I am confused. I had been told that when my husband was on triple treatment and had to stop because of severe anemia that ribavirin was the drug that caused the anemia but I just read in some old literature its the interferon shots that cause the anemia.  So which is it? Or, is it both?

Is anyone who is using Ribavirin now with Sovaldi experiencing anemia?  Just want to know what to look out for.

Thanks
Nan

[klonny55]

According to the prescribing info document for Sovaldi the incidence of anemia in all trial groups receiving Soavldi/Ribavirin therapy was 6%-10%

Take a look at page 6 here:

http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf

[nan535]

Thanks for your responses. Both were helpful

I continued reading Page 7 of the prescribing info for Sovaldi and if I am interpreting the info correctly, Ribavirin in combination with interferon has a much higher incidence of anemia.

As I mentioned in my original post my husband had to stop triple treatment after 5 weeks because of severe anemia. It was really awful so no wonder I am apprehensive about the Ribavirin piece of this new treatment. But I think  these statistics make me feel better since interferon is not part of this treatment.  I think his doctor is on top of it because she plans to start him on a lower dosage of Ribavirin and increase it in increments.

He has been through hell these three years and I am praying that he will see SVR with this treatment  and be able to address his other complications without Hep C taunting him/us any more.

Your prayers and good thoughts on his behalf (and everyone in similar circumstance)  for a successful treatment will mean so much everyone.

Thank you.
Nan

Y

[klonny55]

Hi Nan, This subject is of interest to me as well since I am now on day 4 of Sovaldi/Ribavirin therapy. Keep in mind the statistics cited in the prescribing info is from trials. There is a relatively small amount of data used to compile these results, just a few hundred patients total. Some patients groups are quite small. There are multiple variables, such as co-morbidities, etc that may not have been represented in the trial group. Many trials explicitly exclude certain conditions. Since we are now in the "real world" of this therapy being prescribed more information will become available as time passes. I have been asked to report any side effects or anything at all that might be relevant to Gilead through supportpath.com  so they may expand their database. So far I have nothing to report thankfully. I will await the results of my 2 week blood draw with great interest.....

[hrsepwrguy]

Anemia observed with SOF+RBV and SOF+PEG/RBV treatment

Hemoglobin reductions with SOF+RBV similar to historical data with RBV monotherapy 1,2

RBV monotherapy results in ~2 g/dL reduction

Interferon contributes to anemia through bone marrow suppression

PEG/RBV results in ~3.5 g/dL reduction

.http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/antiviraldrugsadvisorycommittee/ucm375286.pdf

[nan535]

Having gone through the triple treatment (with Incivik) experience, I know exactly what you mean. The thinking was that that would be the end of the virus also. How disappointing it was when he had to stop treatment.  The real world results are what counts.

Please let us know how your treatment progresses (any signs of anemia, side effects, etc.)  I am praying that you will soon see/hear the word "undetected".

Nan

[hrsepwrguy]

That link takes you to the FDA advisory PDF, this link will take you to the page where you can also click on the text version, it is the complete application presented to the FDA for SOF

http://google2.fda.gov/search?q=Sofosbuvir&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&requiredfields=-archive%3AYes&output=xml_no_dtd&getfields=*

Have a great day

[klonny55]

Thanks! I will post my progress once in a while. I am very fortunate in that I am very healthy other than having the virus and have never had any issues or symptoms. The virus was discovered in a routine physical. I have F2-F3 fibrosis on biopsy from June 2013. I sincerely hope this time will be the charm for your husband! I am being treated at the Dartmouth Hitchcock Medical Center in Hanover, NH. This is a large teaching hospital with a large hepatology/transplant facility. Some transplant patients here were granted an early "compassion" approval of Sovaldi/Ribavirin several months ago. I was told by my doc that they are "sailing through" the treatment beautifully. This not only makes me very happy for them, I am taking this as a very good sign for us all.

[nan535]

Thanks so much  for that pdf link. It has lots of good information and easier to read than the small print product info.

What I am taking away from this is the Ribavirin definitely poses a risk of anemia for him but it would have been worse with the interferon. That is probably why he is considered interferon ineligible.

I think his doctor is handling his particular situation well.

Thanks again for your input.
Nan

[nan535]

I hate to use the word "lucky" when talking about HCV so I will say you have been blessed to find out you have this virus before significant damage was done to your liver.  

My husband is Genotype 1a. The preferred treatment is Sovaldi/Rib/Intf
for this group but as he is ineligible for interferon he will be on Sovaldi/Rib for 24 weeks.  Would you mind sharing your genotype?  We are in NYC and he too is being treated at a major teaching hospital with large transplant center.
That is definitely the way to go for anyone who is fighting this virus, especially if he/she has advanced liver disease.
Nan

[HectorSF]

HI.

For someone with anemia before starting treatment will have issues with anemia during treatment as anyone would with other conditions will have as well.Depending on the cause of the anemia treatment may or may not increase his anemia. As someone in a post above pointed out the treatment will normally drop hemoglobin is patients without initial anemia a few points but won't drop their hemoglobin enough to cause anemia (< 10.0). So the treating doctor must be aware of this and has plans for managing your husband's anemia during treatment.

The following comments are based on folks WITHOUT initial anemia as the people that participated in the clinical trials and my comments about my own experience treating for 48 weeks with the Sovaldi treatment. People with initial anemia were excluded from trials to the best of my knowledge.I know that people with Hemoglobinopathy, a hereditary hemoglobin disorder were excluded from the FISSION trial for example. And the NEUTRINO and FUSSION trials excluded those with "History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol."
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As others have said the incidence of anemia when treating with Sovaldi is very low as seen in the data sets from the clinical trials.

There were in five Phase 3 trials with Sovaldi with a total of 1724 HCV mono-infected subjects with genotypes 1 to 6 chronic hepatitis C. This do not include the many people who were in the phase 2 trials.
Of course everyone responds to treatment differently. As we know there are people the treat with peg-INF treatments and have none to little side effects. Trial data sets only indicate what happened to most people not what will happen to any individual.

Triple treatment (Incivik and Victrelis) although having higher success rates than peg-INF and RIbavirin alone, is notorious for anemia and is especially difficult for folks with cirrhosis to complete due to side effects including anemia. Many cirrhotics need procrit or transfusions to complete the treatment.

As I have post for over a year it is the combination of peg-INF AND ribavirin that causes anemia NOT ribavirin alone in THE MAJORITY of patients as has been shown is numerous studies.  

As you may remember while awaiting liver transplant for HCC (liver cancer) I  was one of the first 61 cirrhotics to be treated for 48 weeks with Solvaldi and ribavirin. I never became anemic (< 10 HGB) during the entire treatment. As treatment progressed I did experience increased fatigue from the ribavirin but then I treated for 2x the duration as your husband will and I had advanced cirrhosis with ascites and HE. One side effect of ribavirin I would point out is insomnia. I took my meds at 12 hour intervals and took my night dose late in the evening. For many months I could only sleep 3-4 hours a day. I am sure my cirrhosis also contributed to the sleep problems but it is something to be aware of should sleep issues arise during treatment. All in all it is a was easy treatment to do. By weeks 4 at the latest he will be undetectable and through treatment will not have the virus doing further damage to his liver. The only other side effect I had was headaches (which is one of the common side effects of treatment) for a few weeks around weeks 5-10 and then they went away. All this information is available in the Sovaldi label including the early results of the trial I was in for us with HCC awaiting liver transplant. That is the reason that Sovaldi is approved for patients with hepatitis C and HCC (liver cancer).

All of what I am saying can be found on the Sovaldi label.

http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf

I wish the best to your husband with his treatment!
Hector

[klonny55]

Hi Nan, I'll use the word lucky, yes I am lucky on many levels. The experience has been a wake up call. I stopped drinking, lost 35 lbs and rode my bike 6000 miles in 2013 all in preparation for treatment. I am lucky to not be sick. I am lucky to be a genotype 2. I am lucky to have found this group for support. I want to give back and am thinking about how best to do this...any ideas?

[nan535]

You already are by being a participating member of this forum. You are getting help and you are also giving help by sharing your knowledge, experience, and encouragement.

Once you have reached SVR, I am sure other ways of giving back will come easily to you. You will have much to celebrate having dodged a big bullet!

I wish you the very best in your quest for SVR!

Nan

[nan535]

Thank you, Howie. As usual you always provide valuable information based on knowledge and experience.

Yes, I believe his doctor is preparing to treat his anemia throughout this treatment. She already ordered 5 vials of Procrit for him (40,000   which he will inject once a week (or at least that's the initial plan anyway).

Since going through the prior terrible experience of anemia on triple treatment, I think it is normal to be really nervous about this. Its what caused him to having to stop treatment and just the thought of that happening again is
just too hard to think about. Hence, the post.

My gut tells me he will probably have some issues with the anemia but he will make it through treatment this time - successfully.

Thank you for your encouraging post as usual.

Hope you are continuing to do well post-transplant, Howie.

Nan

[nan535]

Just an update -
My husband's ;atest labwork shows some improvement in hemoglobin and hemocrit one week after his first shot of Procrit.  Hemoglobin is at 9.1
and Hemocrit is at 28.0.  Dr prefers to start treatment after Hemoglobin is above 10 and Hematocrit above 30. He had his 2nd shot of Procrit today.
Hopefully he'll be ready for treatment soon.

Nan

[JimmyMose]

I hoping to start Sovildi & Ribavirin in about a month Genotype 2a,2c

My readings last week
HEMATOCRIT 47.3 % 38-50
HEMOGLOBIN 17.1 High g/dl 13.5-17

My doctor wasn't too concerned because my reading were near or a tad over the high end and have been like that for quite awhile although my PLATELETS ave 90 to a 100.   Once I start treatment I will provide regular updates.  In my journal I posted some blood test and biopsy history.  

[nan535]

Hoping you start your treatment very soon and that you will soon hear the words UNDETECTED and SVR!

Nan

[Sassydmeaner]

I am posting this to nan, just because that is the predominant poster here, although this actually reaching out to the group. I am a newbie-starting treatment tomorrow with Sovaldi and Ribapak. I am a genotype 2 having been exposed in the early 70's. I decided that I will share info as I go through this treatment. I am nervous about what to expect, but I am sooo grateful for the new meds. Interferon scared me. I don't really see where anyone has had very serious side effects. That to me, is good news. Anything I should be aware of?

[Livelife777]

So many posts and not sure which one to address.      Week 5. Solv/ribv.         12 weeks.      Geno 2.      Undetectable virus after 2 weeks.     Side effects are minimum to none so far.    No anemia.    Labs all good.    Get more results on Friday so will post when I know.     Please don't be nervous about taking these meds.    I've had antibiotics that made me feel worse than this combo.    Honestly if I had to stay on them forever I would do it to keep this virus at bay.   Never took interferon but the Ribavarin seems to get a bad rap as well.    So far I don't see any bad reactions from it.    To nan not sure about the anemia with your husband but sure he will be watched so carefully that if a problem arises you will know what to do.    Perhaps they may start with a lower dose to see how he does.     I go to Mayo Clinic and the only thing they told me was if my temp exceeds 101.3 to go to the. ER.    I have cirrhosis as well.      Wish you all so well on this journey and will give you further updates.   My only wish is that this drug will be available soon to everyone as no one deserves to have this virus.        Kim

[nan535]

Great news!  My husband's hemoglobin is now up to 10.1 and he will be starting Sovaldi plus Ribavirin tomorrow!  Livelife777 you are right - they are starting him with only 400 mg. of Riba  and will increase as they see what happens with it.

What a great birthday present for him! It's his birthday tomorrow too. I can't help but think its a great omen after everything he's been through. He's geno 1a so we know its not the best possible option but God willing he'll be undetected soon and it will give his new liver a much needed break. He will continue to take Procrit once a week and have labs done once a week to see how things are going.

Thanks everyone for your continued support and prayers.

Nan

[flyinlynn]

Fantastic news Nan good luck and wishing your husband a rapid SVR for his birthday

[Faithdove]

Hi Nan, I am so happy for you and your husband!!!! I am still trying to help my husband get on treatment. We got soooooo far and now all of a sudden his gastro wants him to come in next week to discuss the plan. You see, he wrote a script for Olysio and Sovaldi. We have the bottle of Sovaldi sitting here on the table. The Olysio is at his insurance company just waiting we us to call to have it shipped!!!!!!! The plan was to have him checked for Q80K and then decide. So after waiting for 4 weeks for results (and of course me calling them every few days to see if results came in) GUESS WHAT? He is negative. So what could be the problem? He is genotype 1a, has a major accident last year, over 8 surgeries and still has issues. He is in early stages of cirrhosis. Do you think he is considering going to Sovaldi, RBV and Interferon. I am so upset. I need advice and support. My husband can't understand all this science and gets very confused when I try to explain. His accident also caused two bleeds on his brain, so he has some cognitive issues. I want to cry....I can't see him going through the interferon with all he had already gone through. We have a prescription for Zoloft that he was going to fill if he was to go on the interferon and that was before we got the doc to write a script for the off label combo. However, have you ever gone on an antidepressant and then come off? The withdrawal from that stuff is horrific. Nan, I feel like we share somewhat similar situations, I again, know what you are going through. I am praying for you and your husband.  

[nan535]

Wow, just when you think you are alone with all the madness, you hear someone else's story and realize no, you are not alone -there are others out there who are dealing with as much or even more than you are. Your husband is lucky to have you as his advocate and supporter - that is a huge part of his being able to get through this terrible ordeal.
So sorry to hear about your husband's accident and surgeries. Head injuries are really tough and then throw in the possibility of hepatic encephalopathy starting as a result of beginning cirrhosis, it makes it very, very difficult to deal and live with.  
You mention that he is being treated by a gastroenterologist. Has he been evaluated by a hepatologist, preferably at a major transplant center? They work in teams and would be the best qualified to make these decisions.
I know your husband is still at early stages of cirrhosis and God willing won't need a transplant but I think you would want the very best overseeing his case given his other complications. He may have a very good doctor already.
The important thing is that you have confidence in his decisions.  I'm not sure that's what's happening right now. That's why I would suggest another consultation with a hepatologist.

Hang in there, Faithdove! I truly know how difficult life is right now for you and your husband. The hope these new meds provide is priceless.  Be patient and know that things will be better with time.

All the best,
Nan
    

[nan535]

Thanks so much.  I was so happy filling his medicine tray last night. Don't know what to expect but it does provide new hope for FINALLY get rid of this insidious beast that has caused us so much trouble these last three years!

Here's to slaying that "blankety" dragon at last! I know many of you know exactly how we feel!!!

Here's to SVR in the near future for all  of you.
Nan