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Avatar universal

Baraclude (entecavir) - What are the risks?

My father is diagnosed as undergoing early cirrhosis and chance of getting liver cancer is very very high.

He's a 65 year old male with hepatitis B diagnosed about 20 years ago. Been experiencing Low blood platelet counts for the past two years from 90++(x10^9/L)in Dec 2005 to 85 (x10^9/L) in Dec 2006. And raised Liver enzyme AST(SGOT): 52 U/L & ALT(SGPT): 87 U/L

Doctor has prescribed 'Baraclude 0.5mg - 1 tablet daily' for 3 months before he will see the doctor again. However, we are told to fax him the blood test results (1. HBs Ag, 2. HBs Ab, 3. Hbe Ag, 4. Hbe Ab, 5. Total Bilirubin, 6. SGPT (ALT) 7.AFP) once a month for these 3 months.

Question:
1) The leaflet of 'Baraclude' warns that 'Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals.
How high of this could happen to my father and anyway to prevent it?

Also understand that this drug is new, 2)Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy,including entecavir. hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
since 2005? Is there such a need to take such a risk by taking this medication? Any other alternatives?

Would appreciate some opinions as we didn't get to discuss this with the doctor and we are sti
18 Responses
Avatar universal
MEDICAL PROFESSIONAL
Baraclude is currently the anti HBV antiviral that has the lowest rate of resistance and  the highest antiviral power.
While it should be used more for fist line therapy it is typically not in the US, because of its cost.

Where are you located? Your doc did the right thing to start your father with the Baraclude. But ideally it should be combined with Tenofovir, if treatment will be for indefinite times, to prevent resistance with the highest possible probability. Tenofovir (Viread) will be approved for HBV in about a year and 1/2 and will be the new star HBV antiviral then, but is currently available worldwide for HIV so it can be prescribed off label for HBV.

But what is the viral load of HBV? Before treatment started?! This is important information. e antigen status is important.
HBV is many different diseases. This looks like it is advanced. Was or will there be a biopsy? Upper endoscopy? Spleen size?

Dont worry about the warning label. It is standard for all the nucleoside analogues.

And the warning re the danger of discontinuing/flares is simply a reflection of the fact that this disease will need permanent treatment, particularly in case of advanced liver damage.
If your father will treat his HBV hepatitis properly his liver will get better soon and he might be able to reverse the cirrhotic status.

Avatar universal
I am on Baraclude, taking it for one month, I am eAg-, basal core mutant. VL was  246,000,000. First week of taking the medication, I had a real nasty headache, and was not able to sleep at all. Felt very agitated. Gradually got better, now I feel fatigue when I take it. But it is ok so far.

Hopefully this thing works. But then again no matter what drug they give us there is no end point with these current treatments.
217229 tn?1192766004
Is this in the same class type of drug as interferon?

I mean - do they do the same thing? Or is this just a "keep it at bay" medicine?

Not a cure?

Meki
(I'm learning more about HEPB --- I think I'm ok - have had the HEPB immunizations - but I like to learn.)
217229 tn?1192766004
So - if you have the HEPB vaccine - you're ok - but if you don't and you get it --- then you're SOL?

217229 tn?1192766004
And if that is true --- why can't they just use the HEPB Vaccine on those who have it?
Avatar universal
Baraclude (Entecavir) is an antiviral. So it keeps it at bay I hope it works. But as far as cure god only knows when. I hear maybe 10 + years away. There is really nothing effective out there at this point for HBV.
217229 tn?1192766004
(I know - probably a stupid question -- but I really don't know the answer to that one.)
Avatar universal
Yeah if you are vaccinated you are OK. I wish I knew that. I didn't even know before all this that there is Hepatitis B.

Why they don't use vaccine? Becasue it's too late. HBV integrates into host(liver) cells DNA there no medicine can reach it so far. So once you are infected and your body did not clear the virus. You are stuck. Most people however like 80-90% of adults clear the virus on their own, unless they get infected with a mutant virus that will stay chronic. Some people don't completely clear the virus and become carriers and can have the virus reappear years later. So in many ways chronic HBV can be like HIV where in HIV everything shuts down in HBV it is just the liver.

Hopefully there will be more effective treatments available soon.
217229 tn?1192766004
Thank you for that information. I didn't know.

Meki
Ps. Hopefully there will be a cure for HEPC and HEPB --A and D... Soon!
Avatar universal
Thank you. And hopefully in US they stop denying people health insurance if you have chronic Hepatitis
Avatar universal
I just started Baraclude 2.5 weeks ago- no side effects whatsoever.  I am chronic- infected as a child, but didnt know it. I was vaccinated at age 17 without being tested, just diagnosed a year ago at age 29- but the so called specialist I saw at that time said since my liver functions are fine and my viral load is so low ( lest than 5K copies), i didnt need treatment or to stop drinking- so long as i didn't binge drink- WRONG !  

Got a new specialist this May and she scanned my liver- which was fatty- then biopsy- which was scary- traumatic, etc.  No scarring, but some "inflamation"- but i really think its cause i was a super heavy weekend  drinker- the kind of girl at the party that blacked out and a also drank 3-4 nights a week  at work related cocktail parties and happy hours - usually 2-4 glasses of wine or bubbly.  

So now Im on Baraclude but it took a long time for my insurance to clear and I was on travel for part of the summer so I just started taking it.  Its pretty easy- tiny pill- no side effects...

I have to admit I've had a few drinks- 2-3 glasses of wine- 3 times since taking it- which i sore i wouldnt do... I'm working on it quitting.

Any suggestions? Also, what does precore mutation mean?

181575 tn?1250202386
Suggestion? Yes.  Take care of your liver and stop drinking now.  Not next week, not tomorrow, but now.

Studies have found that men with unmonitored HepB had a 40% chance of developing liver cancer.  Women 15%.  These studies were done many years ago in Asia where many have HepB.  Now the doctors are saying that one of the reason is that Asian men drink and smoke more than woman.  Makes sense to me.

You also have to understand that when alcohol enters your body, the hepB virus actually don't like that.  It hurts them.  What do they do? they reproduce more to compensate.  So alcohol is killing your liver cell and the many many more virus are invading your healthy liver cells.  Not a good thing.  

Lastly, when alcohol and the HepB virus kills off liver cells, your liver cells regenerate right.  HepB is a DNA virus, it messes around with your liver's DNA, and it could affect your liver's DNA instructions for repair and regeneration control over time.  Although this is low risk, it could also lead to cancer.  That is why cancer could occur without cirrhosis.  Keep the need for repair and regeneration low.

Drinking is one of the variables you could control, so stop drinking.  I love to drink too, but I haven't touch a drop of alcohol since being diagnosed.  I like alcohol but decide I like my liver more.

Precore mutation is a permanent (natural) mutation of your HepB virus genome.  It's a active disease and long term treatment should be considered.

Tkae good care and good luck to you.    
Avatar universal
Thank you.  I will do my best to quit.  I appreciate your very thorough response.
Avatar universal
the baraclude is long term treatment- my dr says i could be on it for years...
181575 tn?1250202386
your doctor is right. Based on your post, I assume you have what's call an e-antigen negative chronic HepB.  It's a active disease where long term treatment is recommended to supress the viral count for the above stated reasons.  If you stop, the viral count will likely go back up.  You may need to take it until the virus develop resistance.  Hopefully before that happens, new treatment would be available.
Avatar universal
Thank you so much steven for sharing your info.   I cant tell you how scary this has been for me to realize after being vaccinated that I have had this disease virtually all my life- and will have to deal with it all my life.  One more question:  if the virus develops resistance, then what?  Move on to the next drug?  And after that?   Also, what if I switch jobs?  Could I be denied health insurance cause now i have a documented pre existing condition?  This is what scares me__ i dont want to be chained to my current job for fear of losing good health insurance.....
181575 tn?1250202386
If you take care of your liver, your prognosis is still good even with treatment.  But treatment definately helps in my opinion.

The resistance profile for Baraclude is excellent.  Less than 1 % shows resistance after 4 years of use.  There are newer (hopefully better) meds coming along.  You would like need to change or add meds in the future.  And hopefully there will be new meds without resistance soon.  Can't predict the future, just do best to take care of things now.  Re: you insurance question, yes, it's a dilemma.  Someone else on this forum wrote that he couldn't use his insurance from new employer until after he waits a year for pre-exisiting conditions.  On this issue, I don't have enough experience to give a suggestion.  Hopefully, you have a good employer that won't put you through that.  Good luck.
Avatar universal
Thanks again for the great info.  I saw your response to Yoki-- you really are doing folks a good service on this board.  Thank you for that. I am west african born as well, and I feel for those back there who don't have access to good care and meds- the disease is also pretty prevalent in Africa-- not as much as Asia, but still prevalent. oki and I are lucky we are here- not there....
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