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Avatar universal

When can I stop Baraclude treatment?

I am female, 28 y.o. I have known being the carrier for about 10 years (probably since birth).
I first started treatment since Jan 08, due to very high load of DNA (almost 600m copies) and high AST, ALT (200, 600 respectively). Echographie abdominale shows Liver were functioning well (all following tests showed same result).
As prescribed by doctor, I have been using Baraclude since. After 6 months treatment (Jul 08), ALT, AST were back in normal range. Virus count dropped to less than 30K copies . Anti-Hbe tested Pos. I was told that the treatment objectives were achieved but advised to continue with the medicine to bring back DNA to lower level.
6 months later (1 year after treatment), my DNA test was done again and showed the undetectable level of the virus (<500copies/ml). I expected then the treatment might be able to stop. However I was advised to continue to taking the medicine being afraid that the resistance to the medicine might develop if I stop using. I have since continued the treatment and all follow-up check-up shows very good result.
Most recently, test in Dec 2009 shows AST 16.2, AKT 11.2. HbeAg Neg. Non-detectable virus count (<500copies/ml).
It looks like it is advisable for me to use Baraclude for life, which is although not too much a problem on the finance aspect, but is extremely inconvinient for other aspects of life. This is because I would like to use contraceptive pills for birth control but it is advisable that anyone taking treatment for Hep B shouldn't use pills.
My questions are therefore, in my case, when can I stop Baraclude? My second question followed, if I have to continue w the medicine, what are the options I can use for birth control (beside usage of condom everytime, which is not a prefered choice)?
Thank you very much for helping with my case.
337 Responses
Avatar universal
you should have monitored hbsag quantity and its decline, so an expert liver specialist can understand if you have achieved immune control or if hbsag is the same as before therapy or even higher

check also our alinia post and developments

when you make hbeab antibody you should have some immune control but at the moment it is not possible to know if it is enough or if you will relapse.you might use hbsag and see if it increases and start immediately if so (hbsag increases before hbvdna and all other tests) but you cannot be 100% sure you don't develop resistance

Avatar universal
Thank you very much for your prompt reply.
Regarding HbsAg, as of Dec 2007 (before treatment), it was Pos S/co: 3793.
2 years later in Dec 2009, HbsAg It is Pos S/co: 4251.

More on HBeAg, before treatment Dec 2007, it was Pos S/co=371.2. 6months into treatment (July 08), HbeAg Neg S/co=0.748. Latest Dec 2009, HbeAg eg S/co=0.092.

Can you tell more of my case in this? Also, do you have experience/advices regarding birth control issue for female carrier.

Avatar universal
Now you are seroconverted .. HbeAg+ to -ve and your HBV DNA is undetectable .which is the expected treatment ouctcome for Hbeag+ patients... .  take your doctor advice on continuing the treatment..... generally if seroconverted with HBV DNA is undetectable, ALT/AST normal .. you can stop treatment after 6 months(observation is needed off the tratment period)... but you still need to monitor you ALT/AST and HBV DNA tests...

One more Question:
when your ALT/AST are high(before your treatment) did u feel any symptoms(abdormimal discomfort/yellow urine)? Now you ALT/AST is very low and ywhich means you are asymptomatic (mostly)
Avatar universal
Thanks for your opinion. However it seems like my doctor's concern was that if I stopped the treatment and if relapse happens, my respond to Baraclude my lose its effectiveness in 2nd round of treatment. I am not sure if anyone has been in similar case? How long will it normally take to the next relapse? If so, how is the reaction to the same medicine (Baraclude)?
As in my case, based on the definition of seroconversion you guided, I have reached that stage for over a year by now. I don't like this situation of continueing taking the medicine without any end. But at same time I don't want to face the risk that the medicine will not respond effectively should a relapse happens. Please advise.

Regarding symptoms during the time that my ALT/AST were high, basically I didnt feel any abdormimal discomfort. Cant recall any changes in urine color then. But I do remember my body temperature was hotter than average person. I had nose-bleeding once. There were also acnes behind the back then (now they are gone). Also, it seems like it was easier for me to get cough/cold (which was on-going for like a-month). Taking medicine for my cough then may actually accelerate the ALT/AST in the liver too. After my ALT/AST back to normal range, all those bad symptoms are gone. Thanks goodness.
Avatar universal
stay on baraclude, hbe ag is still present and overall virus has increased because hbs ag has increased, relapse is almost certain since there is no immune control (in that case you would have had hbsag decline), entecavir is perfectly safe with almost no sides, resistance is 1% at 6 years (i am on entecavir too)

if you like you can combo with alinia and see if hbsag declines, check also your vitamin D level, i had many cold/flu problems due to severe deficency which is present in almost all hepatitis patients.

since good news from replicor as a final cure to seroconvert to hbsab stay on entecavir until replicor drug is available, it takes 12weeks to make hbsab antibodies and other 12 weeks to gain immune control and stop therpy with high hbvdna, i guess hbvdna und can even gain immune control in shorter time
Avatar universal
Thanks for your info.
I will stay on Baraclude for now and will follow the hbsag more closely from now.
It is a bit more complicated though as I am female and Baraclude is not advisable to use during pregnancy or breastfeeding the baby. Though it is not an immediate issue for me now but I would like to know in advance. Please share any experiences/advices regarding this matter.
Thanks.
Avatar universal
Hi Stefano and everyone,
Further question on my situation. Regarding the HbsAg amount, I think the test that I had on were qualitative and therefore not reflective on the quantity.
Tested Dec 07  Pos S/co=3793, July 2009  Pos S/co-4400 and Dec 2009 Pos S/co-4251.
Stefano, do you know what is the quantitative test that I can specifically request? I doubt if it is even available in where I live, which is a developing country in Asia.
Putting HbsAg amount aside, I had achieved seroconversion for almost 2 years by now (since July 2008), should I ask my doctor to allow me to stop medicine for a few months and closely monitor my HBV DNA count on monthly basis to assess whether relapse is likely?
to provide further background, 8 months into treatment due to my travelling, my medicine intake stopped for some 3 weeks and my doctor were very unpleased about it. However the result of AST and ALT after the break were still in normal range. Unfortunately immediate measure of HBV DNA were  not done. 3 months later another test showed DNA undetectable (this was Dec 2008).
My problem is that I am not convinced that "life-time" treatment is the recommended choice given my effective respond to the medicine (serocoversion after 6 months of treatment, and undectable level of virus after 1 year), and also there is no indication of virus replication if the antiviral treatment stops. Do I make sense?
Thanks for reading.
Avatar universal

at last conference in vienna end of april they finally declared that there is no stop point for treatment on nucs, only hbsag decline and cccdna decline might say if you can safely stop.

entecavir and tenofovir seroconversion to hbeab has almost no meaning and most reverse to hbe positive active hbv when they stop treatment, only interferon seroconversion can have a meaning because it actually lowers hbsag/cccdna

to stop treatment you can start interferon for about 6months this will mount an immine response so when you stop etv you will have no mutation or active disease for sometime.
unfortunately many have hbv reactivation after interferon too but it requires some years and has no resistance

another try is to start nitazoxanide, generic nizonide500 or nitarid and after 6 months stop entecavir and keep only nitazoxanide.this drug is free of sides, cheap, and leads to hbsag seroconversion in the highest percenatege compared to other drugs.it has no reistance

hbsag quantity is made by abbott architet with diluition for hbsag higher than 250iu/ml.many wrote me from china and other parts of asia with this assay result, i guess you just need a big hospital specilized on hbv, assay is nothing special.

in vienna they gave a level less than 500iu/ml for 100% inactive carriers and of course they have an immune response to reach this level so i'd suggest stop etv only if you find this level of hbsag or switch slowly to nitazoxanide

s/co unit has nothing to do with quantity, only s/n with 1:1000 diluition or iu/ml can quantitate hbsag
Avatar universal
Your information is indeed very valuable.
I actually come across this article just now. You might have read it before.
http://www.touchgastroenterology.com/articles/hepatitis-b-treatment-how-avoid-long-term-drug-cocktails?page=0,3
Quoted: "In contrast to their HBeAg-positive counterparts, the treatment endpoint for patients with HBeAg-negative disease is unknown. Although the loss of HBsAG is a very rare occurrence, seroconversion to anti-HBs has been purported as an acceptable end-point in these patients. Because of this ambiguity with respect to treatment end-point, and the fact that HBeAg-negative patients are more susceptible to relapse with one year of therapy cessation, it is recommended that patients undergo long-term therapy of which the optimal duration is unknown. Importantly, relapses are a common occurrence, even in patients who exhibit persistently undetectable serum HBV DNA by PCR assays." I think this means the same with what you have been saying?
Question, in case you've known of this:
- In case if I am already in "inactive" stage, what is the pros & cons of continueing the treatment w baraclude? I assume that the antivirus is not of any help at all at "inactive" period.
- It is obvious that I will have to stop the treatment before getting pregnant, during pregnancy and during breast-feasting, in total at least 2 years. What is the risk of my relapse during this two year-break? Since the body is more vulnerable during pregnancy, I am worried that the risk for a flare during this period would be quite high? What are my options should the relapse happen? What can I do to prepare to prevent it from happening? I know you might haven't looked at it since you are not female. Just in case you can help.
I will check in nearby facility to see where I can get that quantitative test on my HbsAg.
Thank you.
Avatar universal

the problem is hbvdna is not a good test to understand evelution of hbv infection and gain of immune control, only cccdna is a good tool but in the past it was possible to measure it by biopsy only.

now there are two ways to measure cccdna:
1 research only, blood test of cccdna though lymphocytes
2 available in every uptodate lab, hbsg quantity in iu/ml

you gain immune control after hbsag is <500iu/ml in 100% cases, in some cases (i don't remember percentage even hbsag<1000iu/ml), at the same time hbvdna<2000iu/ml or und and normal alt/ast.

this is data without antiviral but such low hbsag means you have some immune control because there is another research on hbsag quantity that says: hbsag is used by virus to suppress immune response against the virus, the level of hbsag reflects the degree of immune suppression

so to stop antiviral you might check these levels and start again if you see hbsag increasing since it is the first to increase before hbvdna and alt/ast.although keep in mind there is no data after you stop antivirals, all this data is about levels achieved naturally to predict seroconversion chances or best therapy, not to see who is safe to stop antivirals, we are just assuming that

anyway i do suggest to keep antiviral because cccdna will keep lowering slowly by the time, hbsag seroconversion should happen between 10-15 years if you have a continous slow decrease
antother way which i do strongly suggest is try nitazoxanide (alinia) combo like our gruop and me is doing and see if hbsag decrease or gets negative by 1-2 years or once you see it decreases you can stop etv and switch to nitazoxanide monotherpay.

alinia is safe enough on pregnancy although no drug is the best or switch to tenofovir which has more data than etv on pregnancy.

another way is 6 months interferon which lowers hbsag and makes you gain some immune control, there is research that confirms you can stop antiviral after interferon combo or slow staggering until interferon mono, once you stop interferon relapse is very slow usually

- In case if I am already in "inactive" stage, what is the pros & cons of continueing the treatment w baraclude?
it will continue to decrease cccdna and hbsag, although you should have a check at baseline and then check during therapy, some have steady hbsag and no decrease

I assume that the antivirus is not of any help at all at "inactive" period.
it depends on hbsag if steady you don't improve but you don't get worse too, you prevent any liver damage although virus cannot be eradicated because cccdna is stable inside the cells

- It is obvious that I will have to stop the treatment before getting pregnant, during pregnancy and during breast-feasting, in total at least 2 years. What is the risk of my relapse during this two year-break?
i'd check if alinia is safe during breastfeeding and try that or try interferon and then stop for 2 years any therapy

Since the body is more vulnerable during pregnancy, I am worried that the risk for a flare during this period would be quite high?
sorry i don't know about this, what was your condition before therapy?after you stop by interferon you should have a stronger immune responce than before starting etv

What are my options should the relapse happen? What can I do to prepare to prevent it from happening?
alinia or tdf continuos therapy during pregnancy is the only chance to be 100% sure virus stays hbvdna und or keep etv

I know you might haven't looked at it since you are not female. Just in case you can help.
did you check with a very uptodate liver specialist, what is his opinion?

Avatar universal
Thank you very much. That is quite a lot of new info for me to do further research on.
Haven't checked with my specialist yet. Will consult him more in next visit and let you know. Normally he is so busy and ppl are in a huge queue to get to see him and each visit average 5 -10 mins. That is the practice in where I live. No phone consultation either... So I have to do all research independently... You have told me much more info that he did.
Really appreciate it...
1024307 tn?1291998486
Hello everyone. Getting into the spirit of Christmas yet?:) I have a one question regarding HBeAg-. Maybe it has been answered before,maybe I had missed it. Could you please explain to me how does one know if his/her HBeAg- is an effect of seroconversion or wirus mutation. I don't get this HBeAg issue. Thank you for your patience.
P.s. Stefano,you are doing wonderful job on this forum. Thank you for sharing your knowledge.:)
Avatar universal
virus mutants are present both for hbeag positive and hbeag negative, both for active carriers or inactive so the only test to know about mutants are:

bcp/precore tests, there are many types commercial or research settings

polimerase mutations tests, these ones have nothing to do with hbeag and are different mutants but i'll make both tests

if you like i will check the names of my tests method but since it is a research center i don t know if they used the commercial ones on me
1024307 tn?1291998486
O no Stefano,don't trouble yourself. I'm unable to access those tests here in Canada,anyways.But thank you kindly. So you're saying that the only way to check if HBeAg- is the result of seroconversion or not is by doing bcp/precore tests? Thank you again.
Avatar universal

maybe you have a wrong thought from hbv specialists from 2000-2005 period, you are looking for the hbeag seroconversion to put your immune response into inactive carrier?

if so that type of seroconversion has nothing to do with the mutants and it is achived very rarely on antivirals, only immune modulators like interferon can have that result.

since that type of seroconversion is not correlated to hbv virus but only to yor immune system there is only one test that can reflect that status and it is hbsag quantity.it reflects the number of infected cells and since only immune system can lower it it also reflects a sustaned immune response
so you might know for sure if hbsag gets down to 500iu/ml and hbvdna stays below 2000iu/ml without drugs

the chances this happen by Nucs like entecavir or tenofovir is very very low and only after a decade of use, this point can be achived by interferon+entecavir or tenofovir and/or nitazoxanide

another very good test would be cccdna quantity by biopsy but this is only in research centers which in italy are normal hospitals in US and canada i don t think that research centers are hospitals which apply these tests and drugs to patients

in italy we have this very good thing about research and cure to patients which are at the same level, they can be directly applied, this is very very good for cancer because there is no point in waiting 5-10years t get the cures, they must reach patients immediately when needed
1024307 tn?1291998486
Stefano,you are very lucky to live in such a medically advanced country. I won't even mention how beautiful.:)
My question was related to my lack of knowledge. And only for my interest. I'm trying to understand if my husband's negative HBeAg is the results of a seroconversion sometimes in the past (on it's own) or the presents of a mutant. We won't be able to check as we don't have easily accessible research centers but I would like to understand more about his illness. Thank you again for your patience.
Avatar universal
anyway ask for hbsag quantification it is now 3 years it is presented in conferences and has become routine so they have to buy the new machines to do it, another member in canada found fibroscan and is checking for hbsag quantification, i will let you know in the board if he finds it

unless he makes 1 or 2 years of interferon alone or combined hbe seroconversion is useless and as soon as he stops antivirals hbe returns slowly positive.

etv and tnf do not cure hbv but only stops liver damage, during this antiviral therapy liver usually gets more infected so while liver repairs damage it is actually worst in terms of hbv infection and hbsag stays the same or rises
Avatar universal
when hbsag goes down the cells are clearing from virus, all other tests are useless to see how infection is going

hbvdna is only for checking the effect of antivirals but it is totally useless to see if infrction is clearing or getting worst
1024307 tn?1291998486
"etv and tnf do not cure hbv but only stops liver damage, during this antiviral therapy liver usually gets more infected so while liver repairs damage it is actually worst in terms of hbv infection and hbsag stays the same or rises"

This make me very sad. He's on tnf. It's been over a year now. His HBV DNA is undetectable. Which I know means not much. His hbsag has not been checked. Ever. He will not go on interferon therapy. I finished my therapy a year ago (HCV). He saw what I went through and swore never to go. Even thou mine wasn't too too bad. Maybe that's just an excuse,I don't now. But I do know that he will not go. He has a medium damage to his liver (S3). He is male ,over 40. It worries me. I hope you're right. I hope they purchase new medical equipment soon. Maybe then with the new tests and results-he will change his mind. Take care Stefano. Thank you again.
Avatar universal
don t worry in terms of health he is perfectly ok like me reversing all the liver damage, the presence of hbv in the liver cells makes no damage itself, it is only dangerous if one stops therapy with all these liver cells infected with the cccdna because they will restart producing hbv and immune system kill them making a mess of the poor liver.
so a slong as he keeps taking tnf he will be alright, plus we do know that also hbsag and ccdna go down after about 10 years of hbvdna und in many patients

it is just wrong to think we are clearing the infected liver cells, but i do believe that we will have good results from ntz and from the new interferon lambda which has only mild sides.by the way could you clear hcv complitely or are you still in the window period checking hcv rna und?
1024307 tn?1291998486
I've won the war.:) I'm virus C free.:) I have what's called SVR,which means und after 6 mos after finishing 48 weeks of treatment.
Thank you Stefano,you are a treasure. :)
I will keep reading and learning everything that you and other post. Like most of the people on this forum I learn about HBV from you and others. My doctor doesn't have time and patience (?) to explain everything. Unfortunately he seems slightly annoyed when we ask him questions. All the best-April.
Avatar universal
I am 27 years old and I got HepB therapy for a year by taking Baraclude, Previous 3 months test show ALT=33 and AST=32 and the virus load is 68257 copies/ml.

Im still taking Baraclude after that until I found out today that Im pregnant for 6 weeks now, I don't know should I continue taking Baraclude or stop eat for a year after having the baby. But Im afraid I might resistance with Baraclude and the virus will tun to very high and it could affect my liver.

Please give suggestion as soon as you can because I am very stress at the moment, whether it affect the baby if I still keep continue Baraclude.

All the best!
Avatar universal
the virus load is 68257 copies/ml.

if this is the result after one year baraclude is not working, make baraclude+tenofovir for about 2 months and then slowly discontinue etv

should I continue taking Baraclude or stop eat for a year after having the baby
tenofovir is better for pregnancy and you cannot stop drugs otherwise there is a risk to infect the baby dispite vaccine

the antivirals cannot be stopped due to the fact that they just stop replication while the liver cells keep being infected and sometimes get more infected too so that when you stop immune system will kill them by very high alt dangerous flares
if hbvdna is so high after one year you are already resistant to etv or it doesn t work, tenofofvir will, just remember to check creatinine during tenofovir and after pregnancy add ntz
Avatar universal
THank you all for this quite convenient and serious blog about HB.
I`m spanish. 35y/o patient chronic HBV positive. I ve been with pegiltaed beta interpheron for one year and that therapy failed completely. Nowadays I am under treatment with entecavir.
Before therapy these were my analyses:
ALT 126
HBAg >125000
HBV-DNA 8.8log10
HBe 1787

After 4 months with entecavir therapy I have this new results:

ALT 146
HBAg 10877
HBV-DNA 4.01log10
HBe 357

My doctor told me that the tratment is being effective and it is sure it will work in all aspects. My doctos ir normaly quite depressive in the sense that he never smiles and I feel like always I am having really bad news. However in this ocassion he looked quite happy for me. What do you think about these results? could I consider a future free of HBV?
Many thanks

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