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317787 tn?1473358451

New RA Drug, Xeljanz, can reactivate HCV or HBV

Hi this is not a question as much as a warning.  There is a new drug for RA, called Xeljanz  (tofacitinib citrate) that I saw advertised in People magazine.  One of the side effects is that it can reactivate HCV or HBV.
I was horrified to read about this and wanted to share.  I know that doctors can prescribe medications without knowing the sx and I have read about many people on here having pain that could be related to RA.
I hope it is ok that I am posting this.
I am trying to help and I am wondering if this is possible? Can a drug really reactivate HCV?...HBV?
oh, I guess I did have a question.
Thank you
Dee
Best Answer
Avatar universal
Thanks!

1)   I think it is a fine thing that you posted it since many people *may* be co-infected.  

2)  I'd rather be aware of the possibility even if it only existed in the realm of possibility. If we are unaware.... we are not able to make an informed decision.

3)  We sometimes find we may be on the leading edge of information.  We can share this possibility with others...other doctors.... pharmacists and then get their informed opinion.

4)  IMHO...... this is not clear yet. It may exist as an improbable....or a theoretical, but why not side step such drugs until an answer is definitively known?  

According to what has been posted they have actively tried to NOT find out the answer.  I also think we should refrain from forming our own opinions based on the lack of evidence.

FWIW I believe that some low levels may continue to exist post SVR, the ramifications of this are not yet known....

SVR means sustained..... but..... when a new untried drug is introduced with no evidence.....since it appeared to activate/reactivate other viruses.... it would seem that this is NEW; one cannot rely on old facts to draw a new conclusion, not in the presence of a possibly stronger or more specific immune suppressing drug.

Finally..... do we all have the same immune response?
Do we all respond to interferon exactly the same?
Respond exactly the same way to immuno-suppressive drugs?

If the answer is no to the above questions.... would we be safe in relying even on a small batch of results with previously HCV infected SVR's?

Good post Dee, IMHO.

willy
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317787 tn?1473358451
Thank you all for your posts.  It said in the ad for Xeljanz

"May cause serious side effects including Hepatitis B or C activation infection in people who carry the virus in their blood.  If you are a carrier (?) of the Hepatitis B or C virus the virus may become active while you use Xeljanz"

I probably used the wrong word in my initial post. I'm sorry.
I am wondering if they don't really know and are are just covering their A__
One thing it does say is it is not good for the liver.

Thank you again for all of your posts.
Helpful - 0
317787 tn?1473358451
Hi I am sorry, I hope no one minded that I posted this, it was in People magazine with a warning and it scared me.  Here is a description

http://www.drugs.com/xeljanz.html

I am really confused and did not mean to confuse any one else, just wanted to share this information
Helpful - 0
1815939 tn?1377991799
"but I gotta say-  if a med is known to reactivate ANY virus... I'm doing without! "
-----------------------------

I have to agree, I would also be inclined to avoid any drugs that reactivate any virus. Of course, I might re-evaluate that thought if the drug was all there was to treat a disease, for instance, if I developed some form of cancer. I would have to weigh the pros and cons.
Helpful - 0
1815939 tn?1377991799
"Their website www.xeljanz.com has a very vague warning for people that carry the hep B or C virus in their blood saying it can cause activation (not reactivation) of the virus. Not sure what that means or how it relates to SVR or cured HCV. Also, if you carry the virus in your blood it is already active. This definitely needs some clarification! "
---------------------------------------

I think they are covering their butts.

People who screened positive for Hep B or Hep C were excluded from their trials. So they have no data on it. I think they are covering their butts by warning that it is a possibility, especially since they know the drug lowers the immune system.

Their website says this:
"What are other possible side effects of XELJANZ?"
"XELJANZ may cause serious side effects including hepatitis B or C activation infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use XELJANZ."

But that warning is not based on their studies (because no studies containing people with Hep B or Hep C were done) and, if people who were Hep B and Hep C positive were excluded from their trials, then they are just putting forth a possibility. Plus, Hep B and Hep C are different, Hep B being a DNA virus and Hep C being an RNA virus. Thus, Hep B could become reactivated.

The other thing is, I have noticed that various authors use various definitions for the term Hep C reactivation. To some, reactivation means that the virus was present to begin with but that it increased a certain amount. To others (the majority), reactivation means that the person was UND/SVR and then the virus was again present after chemotherapy or after having attained SVR. For instance, look at the following article from the Journal of Hepatology. They define viral reactivation as 1log10 IU/ml increase of HCV viral load following chemotherapy.

Acute exacerbation and reactivation of chronic hepatitis C virus infection in cancer patients

"Background & Aims
Data on acute exacerbation and reactivation of chronic hepatitis C virus (HCV) infection following chemotherapy are very limited. We sought to characterize the episodes of acute exacerbation and viral reactivation of HCV infection in cancer patients.
Methods
The medical records of HCV-infected patients seen at our institution (2008–2009) were analyzed retrospectively. Acute exacerbation was defined as greater than 3-fold increase in serum level of alanine aminotransferase, and viral reactivation as 1log10 IU/ml increase of HCV viral load following chemotherapy.
Results
Acute exacerbation occurred in 33 (11%) of 308 patients with proven HCV infection. Patients with acute exacerbation more often had underlying hematological malignancies (73% vs. 29%; p<0.001) and lymphopenia (6% vs. 0%; p=0.01) than patients without it. In multivariate analysis, underlying hematological malignancies (p=0.02; odds ratio, 3.2; 95% confidence interval, 1.2–8.7) and use of rituximab (p=0.004; odds ratio, 4.2; 95% confidence interval, 1.6–10.9) were associated with acute exacerbation. Patients with acute exacerbation received higher median cumulative dose of rituximab than those without exacerbation. Discontinuation of chemotherapy due to liver dysfunction was more common in patients with acute exacerbation than in patients without it (45% vs. 11%; p<0.001). Eight (36%) of 22 patients with known pre- and post-chemotherapy viral load had viral reactivation.
Conclusions
Acute exacerbation and reactivation of chronic HCV infection occur often after chemotherapy. Liver dysfunction can lead to discontinuation of potentially life-saving chemotherapy in nearly one-half of the patients with exacerbation of HCV infection."

So the patients in this analysis were never clear of the virus, even before chemo.

http://www.journal-of-hepatology.eu/article/S0168-8278%2812%2900607-1/abstract
Helpful - 0
Avatar universal
Here is an excerpt that touches on the discussion- from 2006!


Nov 14, 2006
To: Hepatitis ResearcherBlank
Context relevant research seems quite, well, relevant to the issues at hand.  Thanks again for this invaluable input.

What clinical followup, if any, would you recommend for patients who have been categorized as attaining SVR, especially those for whom further biopsies (to r/o HCV RNA in liver tissue) are highly unlikely?

You have mentioned some research of OTC immune stimulants at AGI.  Did any look especially promising to you?  What about lactoferrin, which a poster mentioned today?  Others?   Any thoughts on maintaining strong immune response post-treatment, especially when treatment has triggered chronic autoimmune conditions of various sorts?

Blank Reply

Hepatitis ResearcherBlank

Nov 14, 2006
To: revenire
Well that is all part of what is discussed here. So the durability question of SVR probably depends on
a) how crippled the remnants are ( remember the importance of riba to overmutate)    see above:

" a sign that the remaining virus at least does not replicate at any substantial rate. In other words its replication efficiency - if any - is very low, since the residual virus found in the liver is not so ultralow as the plasma virion level. That part is good news and probably  partly causes the stability of SVR"

b) How well the memory immune supression works. This will depend in turn on the general functionality of the immune system, the extent it has focused on the virus, the extent to which ( because of all the mutations in that remnant trash virus) the viral residuals still display relevant epitopes ( class I 10aa on the liver cells, class II ( 20 aa length viral breakdown peptides) through macrophages and dendritics that uptake and digest viral material from dying cells and otherwise. It might also paradoxically depend on the very quantity of that residual to keep it on constant alert, as we see this all the time in HBV. Supress the virus too much with antivirals - immune system looses interest - no more antiviral - no suffcient memory cells around - virus comes back real high- now a new flare hits. This seem to be also sometimes the case with HCV after treatment stops. ( Thats when post tx the ALTs go really high - same scenario.}

Nov 14, 2006
To: Revenire
See all these mechanistic ideas basically serve the purpose to get a feel for the size of the problem. What matters most are the facts - the bottom line and so far so good. But with chemo or immunsupressive antirheumatic therapy the relapsers will likely increase and prophylaxis will be needed. New drugs coming up will hopefully do that.
Blank Reply
Helpful - 0
Avatar universal
http://www.medhelp.org/posts/Hepatitis-C/A-few-questions-for-hepatitisresearcher-re-occult/show/95275

I found a good link where Hepatitisresearcher addresses reactivation. You need to dig around but if you are familiar with the science you will pick it up a lot faster than I.(Still working on it, but wanted to share)
I sure wish he was still posting.
Helpful - 0
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