Aa
Does Ribavirin cause anemia when used with Sovaldi??
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
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
Best Answer
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
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
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.
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
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
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
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
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
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."
---------------------------------------------------------------------------------------------
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
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?
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Anemia
The primary toxicity of Ribavirin is hemolytic anemia, which was observed in approximately 13% of all Ribavirin/peginterferon alfa-2a- treated subjects in clinical trials. Anemia associated with Ribavirin occurs within 1 to 2 weeks of initiation of therapy. Because the initial drop in hemoglobin may be significant, it is advised that hemoglobin or hematocrit be obtained pretreatment and at week 2 and week 4 of therapy or more frequently if clinically indicated. Patients should then be followed as clinically appropriate. Caution should be exercised in initiating treatment in any patient with baseline risk of severe anemia (e.g., spherocytosis, history of gastrointestinal bleeding)
http://www.drugs.com/pro/ribavirin.html