8 year old Partial Responder

Hi
I’m brand new on here but am hoping you can help.  I adopted my son from foster care when he was a baby and later learned that he had Hep C, genotype 1.  He is 8 years old now.  Last year, his biopsy indicated that he had mild scarring and inflammation, although it looked about the same as when he was 2.  Even so, he started  PegIntron and Ribavirin treatments in October, 2009.  Here is what happened:

October, 2009 – 285,000 (start)
December, 2009 – 231,000 (week 4)
Jan, Feb – around 200,000 (week 8)
March, 2010 – 150,000 (week 12)
April, 2010 – 40,000 (week 16)
May, 2010 – 4,000 (week 20)
June –  500 (week 24)
July -  700 (week 28)

His doctor said that if his viral count went up at all, she would stop the treatment.  So, she just informed us that she is stopping.  We are, however, allowed to use up the 3 week supply we have left.  I feel like he could still hit 0 and why can’t we give it until 48 weeks, like originally planned.  She said that he will not be able to sustain the 0 and will relapse.  Do you think we should fight to keep going if he hits 0 in the next couple weeks or do you think we should wait several years for the new drugs to be approved for children?  He has had no side effects, but I’m told that children do tolerate these drugs much better than adults.  He hasn’t grown and its hard to keep weight on him, so it still is affecting his little body.  It just feels like we are so close and we don't want to give up now.
Thanks,
Sue

[meakea]

Personally, I would not give him any more meds at all - I would not continue to give him the meds that are left.  The doc is correct that statistics show that those who don't respond better than your son has don't have much of a chance at all of being successful with treatment.  There are better meds coming out in the next year or so and, personally, I would at least wait for the better stuff.  But, that's just my opinion and I am not a doctor.

[mcksu02]

Thank you.  His doc said that the meds that are coming out soon will take at least 3 more years to be approved for children.

[Marcia2202]

I agree with meakea.

I would not want to expose my child with more of these meds, when he hardly responded. I think in this case he is called a non responder, as he never hit UND.

Usually treatment (genotypes 1 and 4) is discontinued, if you are not UND (undetected) by week 24.

Giving him a few more shots and taking more riba is not going to do anything, except expose him to more of these drugs.

I would wait for the new drugs, he will have much better chance to beat this.

My heart reaches out to you and your family.

Marcia

[Trinity4]

The interferon did not work effectively with his immune system to suppress the virus.  Your doctor is correct by stating 48 weeks or antiviral therapy would not produce SVR.
He is unlikely to achieve SVR even with extending treatment to 72 weeks because he still had a viral load at 28 weeks.  In my opinion continuing treatment would only subject to these powerful drug needlessly.

I was a slow responder, did 72 weeks of treatment and relapsed.  I'm waiting for the protease inhibitors which will hopefully become part of the standard of care sometime next year.  The odds of achieving SVR with the addition of the PI's  are roughly 70 percent.  Those are very good odds.

Best of luck to you both.
Trinity

[Bill1954]

Hi, and welcome to the discussion group.

We hear from very few pediatric patients in here; sorry to hear of your son’s illness, but it’s wonderful that you are taking such good care of him, and obviously love him so much.

I can’t see any reason to give him one more day of the drugs at this point; further treatment has only dismal chances of a successful endpoint.

I would seriously consider waiting to see what happens with the upcoming protease inhibitor class of drugs on the horizon; I’d bet he’d benefit greatly from them.

Here is a guide of current HCV treatments in various stages of development:

http://www.hcvdrugs.com/

The two closest to approval are ‘Telaprevir’ and ‘Boceprevir’; both are in late phase trial and Telaprevir seems poised for approval and subsequent market release as early as 2011. Both will be used initially in conjunction with the current interferon/ribavirin, but will increase efficacy, and in some cases might reduce treatment duration. This will reduce exposure to the interferon as well.

Good luck to you all—

Bill

[meakea]

Okay...I didn't take into account that children might not fall into the category of getting the new meds when they first come out.  But still, since he has "mild" scarring/inflammation that hasn't progressed in the past 6 years, I would think that monitoring him until the new meds are approved for children would be prudent.  

I know it's hard for you to think of having put him through 28 weeks of treatment and then stopping without finishing but, since his VL is still there, I still believe the doc is right.  I've been through treatment and it's not kind to the body or mind...which is easily forgiven if treatment is successful but it doesn't appear that treatment is going to work for your son.  I am sorry about that.

[can-do-man]

This doctor?? should have stoped this at week 12 when he didn't even have a one log drop. Wishing the best for your son and you.

[meakea]

I agree with you on this.  Unfortunately, I'm finding from reading other Hep C forums that a very common frame of mind lately seems to be to just keep going with treatment as if the goal is to simply get to undetectable and then everything is okay.  There seems to be a lot of docs forgetting that getting to undetectable is only a small part of the battle.

To mcksu02...  Keep your son on a healthy diet with regular exercise and be mindful of any type of medications (both over the counter and prescription) the might be liver sensitive.  Always discuss these things with your doctor.  Take heart in the fact that many of us have had Hep C for many, many years (and I could go on with the manys).  You might consider getting a second opinion for your son with another hepatologist.  Many of us here have found that not all doctors are equal and it has served many of us well to switch doctors.

[spectda]

If his disease continues to progress slowly he may be able to wait until they can treat him without ribaviran and interferon. It's probably 5-8 years away before they have reached that point. just a guess on time, but I think it's a reasonable one.

I don't know a lot about how quickly the disease generally progresses in children. With adults it is usually very slow, often 20-40 years before serious damage occurs. Many people after 40 years have no or minimal damage.

I wish you and your son the best. This must be very difficult for you.

- Dave

[can-do-man]

From meakea..........."You might consider getting a second opinion for your son with another hepatologist.  Many of us here have found that not all doctors are equal and it has served many of us well to switch doctors."

Very good advice from meakea.

[mcksu02]

We really like his doctor.  She has alot of experience and, up until my son, had a 100% cure rate with the many children she has treated.  We take him to one of the top childrens hospitals in the country.  She originally told us about the 12 week mark, but then had another child that responded very late, so maybe that it why she kept going.  In any case, we (my husband and I) didn't have all our facts right.  Up until a couple days ago, we thought 0 meant he was cured, and we thought he would get to 0, so we're still trying to digest and accept this.  My husband and I were just talking about how silly it is that we are so emotional about throwing away the meds.  We just had so much faith in those little bottles.  I don't know how to sit back and wait, and just do nothing for him.  Mom's aren't very good at just doing nothing. Thanks very much for all your replies - very, very helpful.  

[meakea]

As a mom who helped a son through cancer treatments, I know exactly where you are coming from...I understand.  

[spectda]

" Up until a couple days ago, we thought 0 meant he was cured, and we thought he would get to 0, so we're still trying to digest and accept this."

There is no test that is able to detect HCV to 0 so we never know until we have a sustained viral response that we are actually cured.  

[Cory255]

I think that's correct, there is no test to detect zero.  

[portann]

Hi Sue,

It's easy to confuse getting to zero as victory but now you know it's not.

Your doc sure didn't follow conventional markers, like being undetected at week 12 and doing 48 weeks or being undetected by week 24 and doing 72 weeks.

I understand your doctor has specialized knowledge concerning pediatric hepatology (which is more uncharted) but at this point, I strongly think you and your husband should take a deep breath, pull back and hold off. This just ain't working, as much as we all wish it had. It's heartbreaking, I know.

Although I don't have a crystal ball, I agree with Spectda that maybe both riba and interferon will be relics down the road.

You probably know that riba was delayed (2003?) in treating children, who were doing monotheraoy after adults were doing current SOC. My guess is the same thing will happen with the new STAT-C's.

Lalapple (also a member here) was nineteen when she treated (successfully) and had had HCV since birth, with either zero or stage one liver damage.  I think Mea has a similar story - infection since birth, little damage and then clinical cure. I had it for over forty years and also had almost zero damage. All cured and we sure didn't rush into things.

As for your son's lack of growth, it could be the meds: "Growth retardation can also occur, mainly due to gastrointestinal disorders linked to interferon alfa-2b (loss of appetite, nausea and vomiting, diarrhoea). Catch-up growth appears to occur during the six months after treatment cessation." http://www.ncbi.nlm.nih.gov/pubmed/17458046

Such a tough road to travel for you all. Best wishes.

Susan

[portann]

oh, and the guys are right, there's no test to check to zero...

[nygirl7]

We really like his doctor.  She has alot of experience and, up until my son, had a 100% cure rate with the many children she has treated.  "

I'm sorry but if your doctor lead you to believe that getting to "zero" (undetectible is the best we can call it and the best test only goes down to test to the "2" IUs...would mean cured then as much as you like the doctor - they aren't very good at all.  He should have been stopped at week 12 - these medications have their own set of dangers about them and since he is young and healthy it would be prudent to be careful of what they can do themselves and not expose him to them.

Is this a general practitioner or a heptologist that you were going to?  Many doctors don't know everything that is going on with hep because they aren't specialists.....although they think they are.

I'm so sorry for what you are going through.  Please let this doctor know what you have learned and advise them not to let people think "zero" is cured because it just isn't in any way and no one should be confused about that.

Best of luck.

[mcksu02]

NYgirl7, our doctor is a gastroenterologist.  Should we be going to a heptologist?

[spectda]

A hepatologist is best, but I don't think it would have changed the outcome. What I think might have happened is that they would have stopped treatment much earlier as many have suggested should have been done. At this point I don't think it will change anything except to get a second opinion and have a connection for the future.

I would also question a doctor saying that they have had 100% success with hcv patients. That makes me believe they have perhaps not treated a lot of people for hcv. Since we really don't know your doctor or her qualifications, perhaps our opinions are misguided and she is really is the expert.

Good luck, being a parent I can only imagine how difficult it's been.

[copyman]

If it was my child I would be taking them to a Hepatologist.

I'm certain a Hepatologist would not have "anyone", adult or child continue treatment beyond 12 weeks with just a one log drop. Of course this is only if they have minimal liver damage.

Best of luck

[portann]

"Current guidelines recommend children be treated for hepatitis C virus (HCV) using the same principles applied in adults. There are however few published studies which assess the efficacy and safety of HCV therapy in children."

"There were insufficient data to assess the applicability of the week 12 stop rule (stopping therapy at week 12 if there is less than a 2 log drop in HCV RNA) ...."

"Conclusions/Significance"

"Current guidelines for the treatment of HCV in children are based on limited data. Further research is needed to define the optimal therapy for HCV in children."


http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0011542

[Trish77]

Portann:  You could take that in a couple of ways.  That perhaps children should be treated with greater concern as to the efficacy and safety of HCV therapy would be my take on it.  When I read that article, it seemed to indicate that the literature they studied was inconsistent and completely lacking in sufficient information to draw any conclusions of any kind, let alone the 12 week rule as it applies to adults and their only conclusion really was that further study is warranted.

mcksu02:  I would agree with can-do-man and wonder why he wasn't taken off of treatment at 12 weeks.  An adult would have been, why not a child in particular when there is no evidence to back up continuing past that time for a child.  No need to expose the child past 12 weeks when there isn't even a 2 log drop.  I don't understand the doctor's logic in getting to 0 as being the goal rather than a specific response by well known marker points established in adults in the absence of any different treatment protocols established for children.

I'd also be skeptical of anyone who claims a 100% cure rate when cure rates themselves are not 100% and for Genotype 1, the most prevalent Genotype in North America, cure rates statistically are just under 50%, Genotype 2 and 3 somewhere in the 80 % range.  I hope she's basing her cure rate on the 6 month post treatment test showing undetectable for the virus rather than how many she gets to 0%. over the course of treatment.

I would definitely consult with a hepatologist for a child rather than a gastroenterologist.  A doctor can be sincere but also be sincerely wrong and I would definitely go for a second opinion.  Have seen more than one person on here with a doctor who claims to have treated many Hep C patients but has also not kept up on current treatment methodologies and continues to treat using incorrect protocols.  A second opinion with a hepatologist would be useful, I think.

As for doing nothing, you can do something, it's just a something that makes the most sense, yes?  Your child hasn't been delivered a death sentence at all, it's to regroup and determine what makes sense now that you know more than you did before about treatment for HCV.  If you want to do something for your child, then focus on a good diet and a healthy lifestyle, perhaps investigate some of the supplements that adults take to manage their HCV when treatment isn't possible - either because it's failed or because they have other conditions that would put them at risk if they treated - and see if that might be okay for your child.

I would also say take this time to read up on all the studies you can on what is known about treatment for children with HCV and disease progression - what I've read so far seems to indicate that it's very slow - and any information on extra-hepatic illnesses in children - there may not be much information but I'd search it out.   The better informed you are, the better choices you'll make.    A quick search turned up this for starters - a bit older but I'm sure you'll find more:

http://www.natap.org/2005/HCV/102105_02.htm

"Conclusions.
Children with CHC were symptom free and had a morphologically mild liver disease. Interferon therapy may be effective for patients infected with HCV genotypes other than genotype 1, whereas lower response rates are expected for HCV genotype 1infected children. The real impact of therapy on long-term outcome remains to be established."

Good luck with this.

Trish

[Marcia2202]

Yes, I believe that you should definitely go to a hepatologist. And I would try to find one who is very familiar with treating hep C patients. It would even be more preferable if he has experience with children.

Wishing you all the best.

marcia

[mcksu02]

Found out our doctor is a pediatric gastroenterologist and also qualified in pediatric hepatology/transplant hepatology. She is the Department Head at one of the top children’s hospitals and has a lot of experience.  I always believe a 2nd opinion is worthwhile, but I also really believe that we chose a good doctor.

The “getting to zero” statement that I made was “my language.”   My husband confirmed that the doctor always used the term “responding,” so I apologize for my rudimentary knowledge of clinical terms.  

Our doctor did tell us about the first 12 weeks being so important to the outcome, however, she had some success stories with children that were not “typical”.  It is also our understanding that it is much more prevalent for children to reach SVR than adults. Children also tolerate the treatment so much better than adults.  Our doctor said that we could expect only very mild side effects, if any, in kids and this was true (we didn’t see any, except his appetite wasn’t what it used to be).  All his blood tests came back with normal blood counts and TSH levels.  He did really well on the drugs, which also made the decision to continue easier.

I would just like to throw this out there, as the devil’s advocate, for a friendly little debate:  
Isn’t it just possible that our doctor knew what she was doing and that children respond differently than adults?  I know what the studies say (although I don’t think our exact treatment has even been around that long for children).  I guess that I tend to trust a doctor who has successfully treated many children first hand over these studies on the internet.  It’s hard to find parents who have young children with Hep C, but so far, I’ve only heard success stories from them.  I don’t feel that our doctor was lying when she said that my son is the first one she hasn’t been cured (meaning SVR for at least 6 months).  She did tell us, right from the start, that statistics say 40-45% will reach SVR, but that has not been HER experience with the children she has treated.  

Also, I’m happy that new treatments will soon be approved – for Adults – but who knows how safe they will be.  At 24 weeks, my son’s doctor felt that based on what she had seen in pediatric cases, he still had a very slight chance of SVR.  A very slight chance, with a tested drug, seems safer than starting all over in a couple years and adding another drug to the mix.  In the long run, that’s exposing him to a lot more drugs than the few extra months we went this time around.  I guess, though, you’d have to believe that he had a slight chance by continuing, and I don't think any of you do.

When we picked up our son from foster care as a baby, he was bruised all over and had broken legs, a severely abused preemie addicted to heroin.  I can’t begin to tell you how many miracles this kid has already pulled in his lifetime.  I guess we’ve just heard too many statistics and studies in the past 8 years that turned out to be dead wrong!!!  We’re stopping the medicine – we’re not unrealistic – it didn’t work -  but I’ll never stop questioning these statistics that everyone quotes.  I’m actually glad we found a doctor who goes with her gut and her hands-on experience in the field.  She held onto hope because of a few cases that beat the statistics.  We held on and agreed to continue because we believe in miracles and don’t think of our son as a statistic.  I don’t have any regrets or feel the need to look for a new doctor as many of you have suggested, but we sure have gained a lot of information here and I thank you.

[spectda]

It sounds to me like you have a good doctor, finding one who treats children is and has her qualifications is not easy. The drugs that will first be available in about a year are telaprevir first and then most likely boceprevir. the success rate for genotype 1 when these drugs are added is about 75-80%. The side effects are not a lot more sever then the drugs he was taking already.

There has been an explosion in drug development  in the past few years for HCV and I have my suspicion that your son will get cured before this damages his liver too much.

Your son is very lucky to have such loving parents. I wish you and your son the best. This forum has a lot of great information about treatment and HCV, I would keep asking questions here and let us know how you are doing.

Take Care - Dave

[spectda]

the typed words don't come out the way I intended since I am on treatment. Hopefully you understood my message regardless.

- Dave

[Bill1954]

I think spectda’s message above was clear and succinct. I’d like to add a link to the new HCV meds now in various stages of development:

http://www.hcvdrugs.com/

My very best to your family—

--Bill

[portann]

Thank you for sharing that information. You have contributed a lot to my own very limited view of pediatric HCV.

I had no idea that children may experience few, if any, side effects on tx. Thank goodness, if true.

I know your doc is highly educated and trained but I think it's worthwhile to seek out a second opinion from another highly educated and trained pediatric hepatologist. Can't hurt to meet. It may provide a chance to hear a different perspective, given that opinions in this narrow field may vary quite a bit. And he may be more involved in what's coming down the pipeline. ( I suggest a different hospital, though, as sometimes one doc won't contradict another if they work together.)

I have one other comment but it's a bit complicated, so I have to think of how to put it and don't have time just now.  

In a nutshell, though (and I don't mean to be rude), where's the fire?

HCV has been around for thousands of years, unidentified, and it's not a death sentence for most. Had he been born when you were, noone would have ever known he had it and he may have lived his whole life none the worse for wear.

Did you ever consider waiting until he's old enough to have a say in the matter, as a young adult, and when the protocol would likely be vastly improved?

We have one member here, Isobella, whose daughter got HCV at birth and now she's a young adult who I believe is going to treat soon. It would be good to hear from Izzy about this.

Best wishes and thanks for broadening my knowledge.

Susan

[mcksu02]

Thanks again for all your kind comments.  I want to answer portann’s question “where’s the fire?” and I do not at all think you’re rude for asking.  There is no fire.  I know that.  It doesn’t have to be cured today and I do believe that he will be cured some day.  There are, however, a few reasons why it would be nice to cure it now and one reason is the social aspect of being a child with Hep C.  I feel that in our small town there is still very much a fear of our child playing with yours.  Kids fall a lot and kids bleed alot, esp. rough and tough boys.  His friends do not know he has Hepatitus (hepatitis) C and that is because I strongly feel like their parents would discriminate.  When it comes to someone’s child possibly being infected by my child, most parents just don’t want to chance it.

My husband coaches his baseball team and we have playdates at our house.  Not an inconvenience at all, but it would be nice if he could have a normal childhood.  I also worry very much about his teenage years, relationships and the possible experimentation with alcohol and how it will affect his liver if he does.  He’s a happy boy and, except for during the treatment, we don’t focus on his disease but he does say often that “he just wishes he was like the other kids.”  I guess every parent just wants their kid to fit in.  It would be nice to get rid of this sooner, rather than later.  The shots and hospital visits have been very hard for him - scary for an 8 year old.  I'd like it to be over and not put him through it again.  Also, I try not to think of the worst case scenario, but it is a death sentence for many people – I know one of them. There is always the fear that he could be one.  

[portann]

For sure I hear you.....so much stigma and we never know when it will pop up.....

Best to you,

Susan

[Trish77]

Thanks for your gracious response, particularly in light of some very forthright direct comments made.  Your doctor's credentials certainly sound impressive and certainly treatment for children is not something that comes up here very often.  It's a very worthwhile opportunity for all of us to be able to learn more about this via this discussion.  

I'm sorry that your son is the one to break your doctor's winning streak and I have to confess I still have a hard time believing that one, that every patient of hers has SVR'd and would like to know if she bases that on the usual 6 months post end of treatment Undetectable result.  I'm sure she does, simply asking.  I'm also intrigued to know where her stats come from, that children SVR at a higher rate than adults.  The link I gave you actually notes that children who are Genotype 1 had a 23% SVR rate which is much lower, not much higher, than adults.  Now, that study is 2005 so it's older and perhaps the older drugs but I did spend a bit of time reading and I haven't found anything yet that indicates that children SVR at a higher rate than an adult but rather at rates comparable to an adult.  I'd very much like to see what your doctor bases her findings on, unless it's her own practice only?  It would, again, be useful information.  

I know it must seem audacious of me to question someone with such incredible credentials, it's just that some things are defying a bit of logic and what's known but that doesn't make it incorrect.  Just pressing for more information really.  i'm always up for a friendly debate so I wanted to respond to your devil's advocate comments:

"I would just like to throw this out there, as the devil’s advocate, for a friendly little debate:  
Isn’t it just possible that our doctor knew what she was doing and that children respond differently than adults?  I know what the studies say (although I don’t think our exact treatment has even been around that long for children).  I guess that I tend to trust a doctor who has successfully treated many children first hand over these studies on the internet. "

I'd say yes, it's possible your doctor knew what she was doing and that children respond differently than adults.  Therefore, I'd like to know on what data she bases that on and is it published anywhere?  It's considered irresponsible to take an adult past 12 weeks of treatment without a 2 log drop so to do that to a child would seem even more of a risk.  So it would be interesting to know more about this.  Hopefully she's also publishing studies and research findings if she's that experienced in pediatric care of children with HCV.   That would be useful information.  

A comment on "studies on the Internet".  You say that as if somehow them being on the internet makes them less credible.  However, they were studies done by people with the same kinds of credentials as your doctor and in research facilities and teaching hospitals who had to follow strict protocols and have published their findings for many others to examine.  The fact that we now have the Internet for these studies to be read doesn't make them any less credible.   Taking a study from a printed book and posting it verbatim on the internet doesn't change the validity of that study one bit.

Having said that, statistics and studies are guidelines and help medical professionals and ourselves make decisions but occasionally there are situations where you decide to push the boundaries a bit and step outside the box.  Fascinated somewhat to know more about what your doctor is doing in the field of pediatric care of kids with HCV.

To find a doctor you have such faith in is important and parents have their own gut instincts about such things so I leave that to your own judgment on what is best for your child and your family.  He's lucky to have you as parents.  I wish you well as you go forward.

Trish

[mcksu02]

Wow, its been difficult to hear such skepticism on this board when my husband and I made our decision to treat our 8 year old based on many of the facts that are disputed.  Like the 100% success rate that our doctor has with children, using the newest treatment which, by the way, was only approved for children in December, 2008.  Our decision to treat was also based on the fact that children do not suffer from many, if any, side effects.  Our son breezed through the treatment without missing a day of school for sickness and so did all the children we knew, but I feel like I’m being called a liar with statements like “that’s great, if true.”  Also, the data that our doctor gave us that shows that children do not follow the typical course, sometimes achieving a response later and having an easier time reaching SVR was a major factor in our decision.  

Trish, I never read any data or studies before starting the treatment.  I did, however, see a 10 year old little girl going in for a liver transplant with end stage liver disease.  I also saw a little boy respond at 23 weeks and sustain.  I also sat in a waiting room every month with many parents who were told that their child had a 1 percent chance of getting Hep C from them. So, whether it is on the internet or in book, I just believe that statistics and studies do not allow for the millions of exceptions out there.

My husband talked to our doctor 2 nights ago after reading the advice that was given here.  She was well aware of the statistics and data out there, but said again that from her experience, children are unpredictable and do not follow the same course as adults.  She had to provide data in order to get my son’s extended treatment approved by the Hospital and by the insurance company.  She won an appeal, after submitting her data, when the insurance company first turned her down. I would think that you’d be calling me for her number instead of insisting this is untrue.  

Anyway, I’m not here to argue with people.  My husband and I have spent a lot of time arguing with people this past year, while trying to advocate for our son.  I’ll give you just one example:   I hear that adults get prefilled syringes or epi pens.  Because there are so few children with Hep C, the pharmaceutical company does not make them for kids – we receive powder and saline and mix up and measure our own dosage here.  We had to fight with the pharmacy to stop sending it on ice, like your doseage.  The powder can chrystalize if its put on ice and compromise the treatment.  Do you know how long we had to fight about this because the pharmacy was told “it needs to be kept cold – that’s what it says.”  The nurses said it too – keep it cold – that’s what they say.  We had to go directly to a knowledgeable person at the pharmaceutical company when we had questions about the treatment for kids.

My original question was “should I use up the 3 week supply we have left?”  All of you replied, unanimously, with a NO.  The doctor said, in our conversations this week, “it won’t hurt to go 3 more weeks, but if he responds, don’t expect him to sustain at this point.”  So, I have one last question for you.  Who has a better chance of being eligible for clinical trials in the future – the Partial Responder or the Relapse Responder, or doesn’t it matter?  My son's records say he is a Partial Reponder right now.

[nygirl7]

Here is a point that confuses me.  If all children respond to treatment at 100% success rate, why is your son an abberation? Will she still continue to state to patients that she has a 100% rate?

There really is no such thing as a partial responder - either you do or you don't.  He did not relapse as he never got to SVR in the first place. He's not even a viral breakthrough because he never got to UND. That makes him a non-responder unfortunately but truthfully.

So to answer your question no it doens't matter. Hopefully the new drugs will be approved for children soon (and adults too) and then he will certainly succeed!!!!!!!!!!!!!!!!!

I'm so sorry you have been great advocates for your son but at this point after week 24 the chance of success is relatively zero, so again why give him the poisons that cause all sorts of autoimmune diseases and things when they wont achieve SVR?

[mcksu02]

All children DO NOT respond to treatment 100%.  I never said that.  My doctor's track record with using the latest treatment, approved a year and 1/2 ago for children, was 100% success until my son.  She informed me that she has a second child who will most likely not respond.  Partial Responder is what his records say.  I've been able to find alot of info on Partial Responders so apparently this category exists.  If we use up the 3 remaining weeks of medicine and he responds, but does not sustain, he will be a relapser.  He could respond in the next 3 weeks since he has gone from 250,000 to 500 in a the past couple months.  Just trying to think ahead.

[mcksu02]

I read this sentence more than once on the internet, which is what prompted my question:

Partial Responder: A partial responder is someone who experiences at least a 2-log decrease in hepatitis C viral load during HCV treatment. Partial responders are more likely to respond to re-treatment than non-responders or null responders.

[Trinity4]

Do what you think is best.  There are NO doctors here and certainly no pediatric patients.  Debate can be helpful but when it comes to an eight year treatment options change and so does the perspective.  You don't have to answer to anyone except your doctor and yourself.  If it were my child I would feel obligated to do everything in my power to make sure they had the best possible chance at a cure.  I know your family has struggled over the last year and I hope you find some peace of mind.  Your son will attain SVR at some point in his life,  that I am certain of.

I wish you only the best going forward.

Trinity

[can-do-man]

Like trin said, no doctors here. You came you asked and people went out of their way to try and help............. Good luck going forward

[meakea]

I am so touched by the number of children you have encountered, during your trips to the doc with your son, who have Hep C.  Even though "statistics" say that parents have only a 1% chance of passing it to their children, it has to be extremely hard when that 1% ends up being "you" (not you but you in general) and even harder to accept especially when it's your child.  I have a cyber friend that I met on another Hep C forum and she found out that she has Hep C about two years ago.  She insisted that her 16 yo daughter get tested and, unfortunately, her daughter was one of the 1% who did get it from her and, to make it worse, her daughter was already at late stage 3/early stage 4 liver damage.  So, yes, I understand where you are coming from in not putting too much stock in the statistics when it comes to you and your son's personal situation especially when you have a doctor that you have become very comfortable with.  Each situation is different with adult Hep C so I can image that pediatric Hep C is even more uncertain.

You and your doctor know best for your son.  Please don't be offended by any of our responses.  You posted for our thoughts and we all gave our honest responses.  Unfortunately, we are basing our responses on our own personal experiences and what we have learned with our own treatment experiences and everything we've read over the past many years about Hep C.  I admit that pediatric Hep C is not something I have read anything about.

I feel like I'm one of those statistic oddities too.  I believe I got Hep C 55 years ago from a blood transfusion when I was 2 days old.  What's the odds of having Hep C for 53 years (I found out about it when I was 53) and being fortunate enough to have "only" stage 1 liver at that point AND that I didn't pass it on to any of my children or spouse?  Hep C is unpredictable all the way around.

Please keep us posted about your son.  I wish him the best and I think you are a wonderful mom.

[EricAgain]

I am sorry to hear about your troubles. Bless you for adopting this abused child. You and your husband are doing all the right things regarding your son’s chronic HCV infection. Based on what you told us, I think your doctor is doing a good job. However, it would be worthwhile to consult with a hepatologist who has treated hundreds of patients with interferon and ribavirin and has experience treating patients with the new direct acting anti-viral drugs (in clinical trials).

Your son is a partial responder to interferon and ribavirin and may benefit from treatment that adds one of these newer drugs as triple-therapy. I have been communicating with a number of hepatologists who completed clinical trials with Telaprevir and Boceprevir. I would be happy to help you find a top-notch hepatologist near you. My database includes 30 hepatologists and does not cover every major city, so I cannot guarantee anything. My contact information will be in your inbox.

The right doctor will tell you up front that s/he will work closely with your current gastroenterologist. Your gastroenterologist should not be the least bit concerned that you are getting a second opinion. Good doctors are comfortable collaborating with other specialists.

Sincerely, . . . Eric

PS: Every patient is different. While liver disease progresses slowly in most HCV patients, this is not always the case – even for children. The following URL contains a discussion on hepatitis C in children that sheds more light on this.

http://www.nejm.org/doi/full/10.1056/NEJM200001273420414

[portann]

I think what we all have in common is how it pulls on our collective heart strings because a child is at the center of this discussion.

No matter what opinions we express here (and we are very opinionated, which is what I love), we care a lot about the frustrating situation you find yourself in.

You have gone to such lengths for so long to make this work and now what you have is uncertainty, instead of UND.

I'm not sure what to make of this very up-to-date study about pediatric hepatology, so I hope you'll at least have a look at it. It doesn't support some of what your doc said but as we know, it  sometimes takes a doc to think outside of the box and she may be one:

From Expert Review of Gastroenterology and Hepatology
Treatment of Hepatitis C in children
Paloma Jara; Loreto Hierro
03/02/2010; Expert Rev Gastroenterol Hepatol. 2010;4(1):51-61. © 2010 Expert Reviews

Here's a quote:

"There are different approaches to the treatment of children with chronic hepatitis C.[42] The main characteristic of chronic hepatitis C is its persistence over time with slow progression to fibrosis. Severe disease is rare in children, and therefore follow-up without treatment until adult life is a valid option for most pediatric patients. Treatment during childhood does not achieve increased rates of response compared with adult patients and adverse effects are frequent and, even in some cases, may be severe. Conversely, treatment may be justified, since it allows definitive resolution in a subgroup of patients. Quality of life is not affected in children with HCV infection, but parents are worried about the outcome and perceive the difficulties of social life, even when there is a negligible risk of horizontal transmission.[43,44] "

http://www.medscape.com/viewarticle/717069_7


The article is very long, in ten parts, and summarizes several pediatric trials world-wide. I didn't see anything in it to suggest that continuing without at least a two log drop at week twelve is worthwhile. Since your son started with a viral load of 285, 000 and at week twelve had a viral load of 150, 000 (far from a two log drop to 2850), I'm puzzled and would at least seek an opinion from another pediatric specialist.

As for stigmatization, his HCV should be disclosed on a need-to-know basis. Often (maybe always?) any child who is 'different' is stigmatized by others but with your guidance, I'm sure he'll be able to successfully navigate his future.

And think of how many kids he plays with, who have various 'stigmas' of their own that you don't know about.

Bigotry is a fact of life and I feel confident that parents as dedicated as yourselves will provide him the tools to deal with whatever comes his way.

Best wishes,

Susan

[EricAgain]

Regarding: "So, I have one last question for you. Who has a better chance of being eligible for clinical trials in the future – the Partial Responder or the Relapse Responder, or doesn’t it matter? My son's records say he is a Partial Responder right now."

If you decide to continue treating there are three possible outcomes regarding viral response.
1) Partial responder (already there)
2) Relapser
3) Sustained viral response (SVR)

Clinical trials in the past have typically begun with treatment naive individuals exclusively. I have not seen a clinical trial that accepted treatment experienced relapsers, but excluded partial responders (for example). So the likely answer is "it doesn't matter".

Based on trading emails with fifteen clinical researchers, I know that some of these physicians are talking to Vertex and Schering about additional studies for Telaprevir and Boceprevir after FDA approval. From their emails it appeared (to me) that cohorts such as the HIV coinfected, incipient decompensated, HCC pre transplant, and fibrotic post transplant groups are being discussed. It may be awhile before we see clinical trials in pediatric patients. This is only my opinion. These priorities are based on risks versus benefits.

The more likely options for your son would be to wait for FDA approval of triple therapy (single-DAA + SOC) in 2011 or multi-DAA therapy (perhaps in 2015). That would place his earliest opportunity for direct acting anti-viral therapy between ages 9 and 13. Even then, it might be prudent to wait. It is encouraging to know that your son’s biopsy score has been stable over the last 5 years. His chances for a cure are very good. In the unlikely event that his biopsy score worsens after 2011, the option of treating OFF LABEL with a single-DAA plus SOC is there. This should only be done by a suitably experienced liver specialist.

Best wishes, . . . Eric

SOC stands for the current “Standard of Care” - pegylated interferon and ribavirin.

[nygirl7]

"Treatment during childhood does not achieve increased rates of response compared with adult patients and adverse effects are frequent and, even in some cases, may be severe. "

See this is the assumption we were all working under.  It confuses me that your doctor would have better luck with child patients and I am wondering if perhaps she has added something special into the "new" drugs that were just approved for children - did she add something into the cocktail that might benefit others?

Good luck with everything.  I hope that you realize that we have tried to help and give you an honest set of opinions here.  Since he did not have a 2log drop by week 12 and also that he did not get to UND by week 24 which is the standard cut off point for contiuning those are the sad facts that we have based our opinions on.  What does partial mean really when the only goal is to get to undetecible using an extremely sensitive test and then to achieve SVR? Nothing.

Hopefully again, they will approve the new treatments soon and make them available to children soon after.

[nygirl7]

PS Techincally he is what would be called a "non-responder" as he did not achieve viral clearance by the end of treatment.  Using this term might help you skip confusion in the future with any trial doctors that you might have to deal with.  The idea of partial responder isn't really a technical term that would be used in this arena.

Saying partial responder just sounds like whitewashing the whole thing.  I'm sorry but lying to you isn't going to help anything and we do hope that you can get him to SVR next time.

[EricAgain]

Partial responder is a term that is commonly used in clinical trials

CAMBRIDGE, Mass., Oct 28, 2009 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that treatment with telaprevir-based regimens in Study 107 resulted in high sustained viral response (SVR) rates in treatment-failure patients infected with hepatitis C virus (HCV). Interim results from 94 patients in Study 107 showed that 90% of prior treatment relapsers (n=29) and 55% of prior treatment partial responders (n=29) achieved an SVR after treatment with 24-week or 48-week telaprevir-based regimens, and 57% of prior treatment null responders (n=28) achieved an SVR after treatment with a 48-week telaprevir-based regimen.  

I found different definitions in various presentations and papers done over the last four years.

Less often, in older documents:
Partial Responder: Two log decrease in HCV RNA but still HCV RNA positive at week 24

More often, in recent documents:
Partial Responder: ≥ 2 log10 reduction in HCV RNA at Week 12, but not achieving HCV RNA undetectable at end of treatment.
Null Responder: <2 log10 reduction in HCV RNA at Wk 12 on a PEG-IFN/RBV regimen

Vertex and the FDA adhere to the newer definitions. By these definitions your child would be a null responder, and not a partial responder as I incorrectly wrote in my previous reply. These categories (relapsers, partial responders, null responders) could be important. Poor response to interferon may increase the likelihood of DAA drug resistance. Doctors do not know if SOC null responders and partial responders will have different outcomes regarding resistant HCV variants and their impact on subsequent DAA therapy is unknown.

Back to the issue at hand - there was universal agreement to follow your doctor’s advice to stop treatment.

From the PegIntron package insert:
“Pediatrics (3-17 years of age): It is recommended that patients receiving PegIntron/REBETOL combination (excluding those with HCV Genotype 2 and 3) be discontinued from therapy at 12 weeks if their treatment Week 12 HCV-RNA dropped <2 log10 compared to pretreatment or at 24 weeks if they have detectable HCV-RNA at treatment Week 24.”

Nygirl, Trish, and spectda were very concerned that your physician claimed, “100% cure rate with the many children she has treated”. It is hard to believe that this doctor treated very many genotype 1 children. From the PegIntron package insert: “38 of 72 genotype 1 children (52.8%) achieved SVR.” Three out of four chronic-HCV patients in the U.S. are genotype 1.
    
Also from the PegIntron package insert regarding Pediatrics:
“Severely inhibited growth velocity (<3rd percentile) was observed in 70% of the subjects while on treatment. Of the subjects experiencing severely inhibited growth, 20% had continued inhibited growth velocity (<3rd percentile) after 6 months of follow-up.” Susan (portann) brought this up earlier.

For all these reasons, you should seek a second opinion from a doctor who has a lot of experience treating patients with interferon. Please heed the caveats by can-do-man and trinity, “there are no doctors here”. That said, there are many caring, knowledgeable people on this forum and it is good to get their unvarnished viewpoints. Without a doubt we are all deeply moved and troubled about HCV in a child – especially one who was abused as an infant. He is very, very lucky to have been adopted by such determined and loving parents. He has a lot going for him.

. . . Eric

[portann]

Hi Eric,

How kewl.

TY.

Susan

[Trish77]

Thank you.  There is no way that a pharmaceutical company is going to publish such information unless they are compelled to and ongoing results that prove these things to be true would compel a drug company to report them.  It's good solid information and also begs the question where the studies are that support it because, again, the pharmaceutical company would not put that out there unless the data exists that would compel them to.  

msksu02:  It seems almost a sin to respond to you in this way, to give you a friendly debate despite you asking for one  - there is no doubt that you care very much about your son and that you want the best for him.  So do we.  Therefore, you'll not get candy-coating or backpatting here at the expense of sharing what knowledge and experiences we have.  You asked for feedback and you got it.  I'm sorry that it was upsetting to you to get feedback you were not expecting.  We are not in the habit here of telling people what they want to hear but rather what we feel they must know so that they can make appropriate decisions for themselves.  

You asked for a friendly debate and you got that as well.  I'm sorry if not taking your doctor 100% at face value because you do is upsetting to you.  You are amongst people who are busy with acquainting themselves with research and studies and advocating for our own health in an active way with our treatment teams.  You didn't read any studies or research ahead of time and you chose to put your faith completely in your own doctor's hands.  Many people choose this approach.  However, you seem to dismiss studies as not being worth consideration.  I have to ask you .. when your doctor lobbied to extend treatment to your son, what evidence did she rely on and what evidence did she present to back up her treatment approach?  Did she say "I just know in my gut?"  I'm sure she pulled out data and presented it and it would be useful and helpful if you were able to post information on HCV treatment of children, particularly that which your doctor relies on, which seems to fly in the face of everything that has been found and posted on this topic in this thread so far.  You also mention a protocol for children that was published in 2008 and it would be extremely helpful if you could post a link that references it for the benefit of others who may come along asking the same questions as you - or be quietly lurking yet reading as some prefer to do - and simply because there are many of us here would like to be current and informed and ensure we are giving out the right information.  

As for myself, without reading studies and data and discussing things on this forum so that the folks here could share what THEY know and what their experiences are - what a great resource this place is - I would not have been able to advocate nearly as well for myself throughout my own treatment on the clinical trial I was in.  There were a number of times that I advocated for a particular approach, always based on studies and data.  I would argue with the nurse and to her credit, she would finally say "I'll let you talk to the doctor about that" and the first time, she was surprised to see him agree with my point and allow me my request.  She got used to that... and by the time my treatment was done, despite the trial ending prematurely for me at 34 weeks, I managed to get to SVR and the nurse said that more things were tried with me than with anyone on the trial at my treatment centre. I am both pleased and sad with that.  Pleased that I was able to be an effective advocate for my own care and sad that others who did not have the same knowledge may not have done so well as a result and I am sad for that.  Incidentally, I did not have pre-filled syringes, I had vials and syringes and drew my own dosages.  While most have pre-filled, not all do.

I haven't seen a single thing that backs up extending a child past 12 weeks of treatment if there is not a two-log drop.  While we don't get many parents of treating children in here, the posts here do come up in search engines and there may be other parents of treating children to come along.  Any information you can present will be helpful.  It is very true and a good reminder that there are no doctors here.  Just people sharing experiences and information.   What tends to happen is that people present whatever information or experiences they have and it is then, of course, up to the person themselves to sift through it all and come to their own decision.  We are always looking for more information, current information, valid information.  If you have anything to post, please share it.

As for your son's null response to treatment - there are various reasons that are known for a poor response to interferon or combination treatment.  That has been discussed a number of times in threads on this forum.  One of the most common discussions is around insulin resistance and it might be worth looking into that, particularly if you have had ANY concerns about your son having diabetes of any kind.  That is only one possibility.

Again, I wish you the best with your son.  No doubt he has good parents who care about him immensely and I wish you wisdom as you sort out what your next steps in his care should be.

Trish

[Trish77]

I also wanted to say...there is certainly something to be said for a parent's gut instincts. I had a lovely pediatrician when my children were small and he would tell me what appeared to be the issue with my child and then would ask me "What do YOU think?" and he put some stock into the observations and experience of the parent with their own child.  I also valued those educators in my children's lives who would not dismiss my concerns or opinions by telling me to leave everything in their hands as they were the learned ones..I did have a couple of those but not many.  The others understood the value of parents and educators being a team.  

So...your point is also taken that while studies and data give us a great foundation .. there are times you have to go with your gut.  There are also simply other times when you make the best decision you can at the time and go with it and hindsight then teaches us we were correct or what we can do differently next time.  I dismissed some of the warnings on neutropenia for the trial I went on and took a risk with it .. deciding that it was a good calculated risk at the dosages we'd be on, etc etc etc.  And in the end, that is precisely what the trial was pulled on, too many adverse effects impacting our immune systems and white counts until it became dangerous and the trial ended prematurely across the board for all participants.

Anyway...enough blather from me.  I simply wanted to also acknowledge your assertion that sometimes you go with what you think is right, regardless of what a study may show.  Good luck as you go forward.

Trish

[Isobella]

I read this earlier this morning and have had you on my mind all day.  The first thing that struck me was in the early part of this thread you said something along the lines of...it's hard to sit back and do nothing when it's your kid.  (sorry if I misquote, but I think that's the gist of what you were saying).

As a mother of a child born with HCV, I can totally relate.  But maybe look at it this way....for us, while my daughter (20 years old) is waiting for the new drugs to come out, we are busy maintaining a healthy liver.  Everyday the choices she makes regarding diet and excercise involve liver health.  In the long run, it makes for a healthier lifestyle all the way around.  

Before being diagnosed, every year she would have bouts of exhaustion, low grade fevers and feeling weak.  We now know. that's when her body was just pooped and make she makes sure not to get so worn down.  We try to give her immune system all the help we can.  Since being diagnosed in 2008, she has not had any of those bouts at all---because she is maintaining a healthy lifestyle.

As far as alcohol goes, she's not legal yet, but her 21st birthday is right around the corner.  She is not a drinker anyway and has no big plans to go crazy on that day.  As of now, we keep an eye on her LFTs and VL, so all things considered, I'm not too concerned.

When she was in middle school and high school playing sports we were unaware she had the virus.  Looking back, there was not one time in all those years of soccer, volleyball, swimming, and softball where she had blood to blood contact with another player.  Had she been a boy playing full contact football or in wrestling, that may have been another story, but there are many, many sports out there where the risk of coming into contact with blood are slim to nothing. Maybe steer him in the direction of lesser contact sports and that will help ease your worries in that matter.

Since we were diagnosed, we are very aware of our blood.  We both carry first aid kits with us with bandaids and she even has gloves.  I have always been aware of "avenues of entry" as far as broken skin, so if a kid had come over to play when she was younger, I would have slapped bandaids over any boo-boos that were uncovered.

As far as other parents, quite frankly, I don't see where it is any of their business.Of course, we all handle how we disclose differently, but in our case, we have not disclosed to anyone but a few family members.  I feel like we would face the discrimination you mentioned as well.  WIth your son being so young, I can relate to the fears of "what if".....like he cuts his finger at a friends house or something when you are not around.  

My babe lives on her own and has roommates, she keeps all her personal hygeine items in her room so on one else can use them.  As you son gets older and understands his condition better, it will be easier for you. You can start training him well now about standard precautions to maintain.  You do it on his level...for instance, kinda jokingly, we were calling our blood bugger juice when we were first diagnosed.  As in "keep your buggers to yourself".  

As far as trials go, that route was fine for me.  I was in a Vertex trial and had 12 weeks of Telaprevir and 48 weeks of tx and am currently 1 year post SVR.  But I would not consider a trial for my daughter.  I don't want her to be a guinnea pig like I was.  I would want full control of her treatment and access to all the rescue drugs she needs to complete therapy.  But had something been available that met those criteria...I may have considered.  Really hard to say...I want control--it's my baby, lol!!

For the record, she is a Geno 1a, VL 7500, 1/1.  

I just wanted to chime in, even though I'm late to the thread.  But mother to mother....I want you to know that your son can have  a totally normal childhood.  So, to tie it all back to the beginning of my long winded post....you're not going to be sitting around doing nothing.  You are going to get the best education possible on this virus and you will learn everything about all the new treatments and you will be raising a beautiful, liver loving young man in the process.  You are going to advocate for him and continue to love him and guide him through this.  Part of that includes finding the best care possible...sounds like you're on that one already.  Your son will be blessed to have you fighting for him =)

We're all here to help with advice and friendship.  

All the best to your and your family,

Isobella

[portann]

I really appreciated your input on this one, Izzy.

TY.

Susan

[Isobella]

Thanks, Susan =)

[silentlamb]

You might try getting him into some of the pedi clinical trials that are going on for the PI's. That's about the only thing I can think of.  Good luck!!

[nygirl7]

More often, in recent documents:
Partial Responder: ≥ 2 log10 reduction in HCV RNA at Week 12, but not achieving HCV RNA undetectable at end of treatment.
Null Responder: <2 log10 reduction in HCV RNA at Wk 12 on a PEG-IFN/RBV regimen


He did not even nearly have a two log drop. But really it's all semantics anyway.