I could not find anything that presented documented evidence of Hep B or Hep C reactivation. People with Hep B and Hep C were not included in clinical trials, so if there was any documented reactivation, it must have happened after the trials were completed (which was not that long ago). Still, I could not find any documented cases. I suspect that some articles and/or programs are erroneously including Hep B and Hep C reactivation as a side effect mainly because the drug can reactivate shingles and some other diseases. Therefore they are including reactivation of Hep B and C as possibilities (even though there is no proof.....that I could find).
Also, there have been cases of Hep B (a DNA virus) reactivation with some cancer treatments. However, Hep C is an RNA virus and, to my knowledge, this difference is why Hep B (a DNA virus) can be reactivated and Hep C (an RNA virus) is not reactivated.
Viral Reactivation
"Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were observed in clinical studies with XELJANZ. The impact of XELJANZ on chronic viral hepatitis reactivation is unknown. Patients who screened positive for hepatitis B or C were excluded from clinical trials"
5 WARNINGS AND PRECAUTIONS
5.1 Serious Infections
"Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in rheumatoid arthritis patients receiving XELJANZ. The most common serious infections reported with XELJANZ included pneumonia, cellulitis, herpes zoster and urinary tract infection [see Adverse Reactions (6.1)]. Among opportunistic infections, tuberculosis and other mycobacterial infections, cryptococcus, esophageal candidiasis, pneumocystosis, multiderma tomal herpes zoster, cytomegalovirus, and BK virus were reported with XELJANZ."
"Malignancy and Lymphoproliferative Disorder
Gastrointestinal Perforations
Laboratory Parameter Problems
Hepatic Impairment
Problem with Vaccinations"
http://labeling.pfizer.com/ShowLabeling.aspx?id=959
Wow, Dee this flies in the face of what I thought I knew. I thought if the virus was gone it was *gone*, that is no longer in the body so how can it be reactivated??
Very disturbing.
I am anxious to hear form the scientists on this forum.
Please tell us it ain't so...
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