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Post Info TOPIC: Most recent ALERT regarding HCV and HBV


Guru

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RE: Most recent ALERT regarding HCV and HBV
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Yes, it needs to be watched and as per my 2016 year post, I am hoping I am not one of the statistics but I am being as positive about it as possible. I will get my LFT's done next week or shortly after when I have been off Crestor for a few weeks. If they are starting to return to normal I will breathe a sigh of relief but anything else and I will not be happy.

My timeline in starting those new meds and my liver acting up is consistent with statistics so I am holding onto that for now.

 

SF



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65 yo, GT1A, , Cirrhosis, F-Scan F4 33.5, TX Naive Harvoni 12 wks

SOT 2/9/16 / ALT 187 AST 114 VL 2.3M.    POSTS

EOT 5/2/16  ALT 35/ AST/25  platlets 126 C/B VL UND

EOT +12 7/26/16  ALT 25 /AST 22/ ALP 83  platlets 129 C/B VL UND

EOT + 24 10/18/16 ALT 27/ AST 20/ ALP 71 platlets 153 C UND

 * SVR *

Tig


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Some continuing alerts regarding HBV-R (reactivation) associated to DAA's following HCV Tx. The incidence remains low, but has to be a part of the overall monitoring and consideration for coinfected people. Good to know they are addressing these issues.

HBV-R Natap

Core Protein Allosteric Modifiers (CpAMs)

 



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Tig

63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 6+ years!

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Guru

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Here's a tidbit ... "The patients who developed HBV reactivation were heterogeneous in terms of HCV genotype. These patients were also heterogeneous in terms of baseline HBV disease, fitting into three general categories of patients: those with detectable HBV viral load (n=7), those with positive HBsAg and undetectable HBV viral load (n=4), and those with negative HBsAg and undetectable HBV viral load (n=3). For the remaining 10 patients, HBsAg status was either not known or baseline HBV could not be interpreted."...

This happens - (the above statement about "could not be interpreted") - the first-tier of common superficial baseline HBV assessment data can be mis-interpreted, (now, it IS RARE) but it can completely miss and not reveal an "occult" B. Occult B is rare (ever wondered why!!) haha  So, "occult" B people, have been and can continue to be left out of the equation!! This has always been my big bone of contention!- they have only been warranting and doing further B PCR's based on surface and core antigen/antibody testing, or, (if you are lucky) at best, if the results show up at odds/inconclusive!! Until they start spending the big money to do B PCR's on all types- there are more than 3 divisions in my book - (acute/active, chronic, spontaneously resolved, and the people who are uninterpreted/inconclusive, and, those who show neg but could be occult)!!, how can they say they have screened you to know where you are with B! Common tests can show you to be neg (NOT chronic), and ARE most often very reliable, but, it IS "possible" for a miniscule percentage of the population who are unknown occults, because regular testing misses them, are virtually an undiagnosed B, until confirmed by B PCR! They don't call it "occult" for nothing! For my wish list ... I believe, at minimum, anyone who has had a case of spontaneously resolved HBV, or shows inconclusive testing interpretations should automatically have a B PCR. They should really just go ahead and do B PCR's on everyone who is C pos! Oh what the hay, how 'bout we just do frequent B and C PCR's, on everybody, period!! hee hee 

A very good OLD study was done showing the limitations of the interpretation of standard baseline B assessments, and as far as I know that study data still stands well today - they determined B PCR is the only way to know for sure if you are an occult B, as rare as being occult may be.

See my same beef over in " About contracting HBV and HCV at the same time "  (I'll move this rant over there too!) confuse  C.



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HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)



Guru

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It is important to note that in most cases reactivation took place withing 4 to 8 weeks after SOT.

http://www.healio.com/hepatology/hepatitis-c/news/online/%7B82d71b85-989d-4226-99c5-878595449a3c%7D/fda-issues-boxed-warning-for-hbv-recurrence-from-certain-daas

I am posting this so the friends who have compleated treatment and on to SVR are not alarmed.

 

JimmyK

 



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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If people re-activate, isn't it treatable Hep B? I remember reading there was one drug on the market used, and they're working on a permanent cure for it. But, what does that drug actually do, put it dormant, and it comes back, or just reduces the virus? I'm a little curious now, you and Canuck probably know as much as the doctors now!



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Genotype: 3b

VL.�over 15, 000 000

Failed TX 2014: Interferon/Riba.

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Guru

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Thank you for posting this!

It is true that many of us are well aware of this and I as well as Canuk fall into this category. Actually all through my HVC treatment, I had B Viral loads done every four weeks and at EOT plus EOT+12. They will not do it later this month as my LFT's under normal circumstances would tell if it possibly reactivated. I will get my EOT+24 C however. Why? because I want it.

 

SF



__________________

65 yo, GT1A, , Cirrhosis, F-Scan F4 33.5, TX Naive Harvoni 12 wks

SOT 2/9/16 / ALT 187 AST 114 VL 2.3M.    POSTS

EOT 5/2/16  ALT 35/ AST/25  platlets 126 C/B VL UND

EOT +12 7/26/16  ALT 25 /AST 22/ ALP 83  platlets 129 C/B VL UND

EOT + 24 10/18/16 ALT 27/ AST 20/ ALP 71 platlets 153 C UND

 * SVR *



Member

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Thanks for your responses. This news re HepB reactivation is news to us here in Australia. Well for me and my friend anyway. Thanks. When I get back onto a laptop or pc i will respond properly. Its too laborious on a phone.

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Guru

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Hi again Binalovina!

I met you over in your first thread where you were speaking about "cryoglobulinemia" concerns.

Glad to see you back again .... but I hate to burst your bubble though, below, where you said in this thread .... "I hate to be the bearer of bad news" - the HBV reactivation topic is an old one around here, and there are other announcements and thread content on this site about how this small risk has already been studied in depth, that guidelines are in place for it, as well as this late news you found - on "labeling". Some of us have been reading excellent studies on this B reactivation topic, many good ones can be found between 2005 and now. Not really anything "new" scary, just scary.

I assume you have been tested for A, B, C and HIV?

Boy you sure found some scary possibilities to think about. I found what REALLY scared me the most, of all possibilities, was the stark reality of my situ, packing HCV for so long, the ravages it had done to me, was doing to be, and could do to me, untreated. It is especially not a good scenario, being a GT3, and packing it for over 40 years (like me). I am SO glad I am undetected now, and my ALT is normal. I just hope I got treated in time. 

Search around the threads here and you will find info and conversations about testing for A, and B, and C, and HIV, prior to treating C (it's pretty well a standard). Just like if you search around the topics and threads you will find out more about cryo.

Were you going to tell us a bit more about yourself and your concerns with the cryo thing (over in your first cryo thread) - we struck up a conversation over there yesterday, and some of us were left feeling concerned for you, about how maybe your fear, or not getting enough info, will prevent you from treating your HCV! Were you going to let us know (over in the cryo thread) your thinking, or your doc's thinking, regarding the questions we were asking you?? 

I am still wondering what you are thinking about getting your HCV treated, and what drugs your doc suggested to you. 

I'll keep checking back on the cryo thread for you. smile 

 



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)



Guru

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No worries, the link works.

The warning on the label is something many of us have been aware of and for the most part co infected folks are also aware. SF comes to mind.

The FDA does stuff like this to remind folks of how important The Government is.

A good Doctor knows and explains the risks as well as actively monitors the Patient.

"FDA identified 24 cases of HBV reactivation reported to FDA and from the published literature in HCV/HBV co-infected patients treated with DAAs between 22 November 2013 and 18 July 2016."

I would assume more folks walking in a crosswalk were killed in the same time period but alas, there is no warning on the little button to get the green light at the corner. wink

 

JimmyK

 



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



Member

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Sorry I was trying to repost the link properly. I added a sentence at the end of the link and was trying to eliminate it. I didn't. Basically it says the new drugs can reactivate Hep B. So FDA had to place a warning on the packaging.

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http://www.hepatitiscentral.com/news/fda-now-requires-boxed-warning-on-hcv-drugs-harvoni-sovaldi-daklinza-and-more/?eml=special161005 Sorry to the bearer of bad news.

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