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TOPIC: Oral approval for children

Oral approval for children 2 years 6 months ago #1369

  • CJ
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Hi,
I'm wondering about the approval of the orals in children. I know there have been trials , I was hoping my son who is 15 would get into a Harvoni trial recently, but evidently it was only for kids overseas, not here in Australia.

I am trying to get an appointment to speak to Dr Freeman about any advise he could give.

My son is GT 1a & had the virus since birth.
He's often so tired & gets sick a lot.

Does anyone know if trials have ended?
Any results?
Wonder when approval will be?

They should be approved for kids, my son's been offered the old Interferon + Ribas, but I wont put him through that.
That tx is a night mare, I went through it 4 times, terrible stuff.

Good luck to all,
Cindi x
J the young dragon slayer is:
HepC 1a since birth
Male aged 15
VL 2000000
Started Twinvir/ 10-11-15-then Sof/led.
NO sides so far !
after one week VL : 37
after 4 wks VL : UND !
EOT 2/2/16 UND.!
4 wks. post tx results....pending....
7/3/16 VL result : 4 week post tx: SVR !
12 weeks SVR !
24 wks SVR yeeaa!!
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Oral approval for children 2 years 6 months ago #1379

  • pat1
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Hi Cj
I hope you are able to access treatment for you and your son.
Best wishes
gt 1a VL 6m
F2/3 FibroScan - 9KPa in 2011 and 7KPa in 2015
sof/dac 10 December for 12 weeks
pre tx alt 85 ast 51
4 wk alt 34 ast 31 UND <35
8 wk alt 29 ast 32 UND <15
12wk alt 25 ast 25 EOT 3.3.16
SVR24 UND KPa5.3 F0 in normal range
I am well
.forever grateful to fixhepc
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Oral approval for children 2 years 6 months ago #1381

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Thanks :)
I should add that I am now hep clear after my 4th tx, luckily.

But I desperately want to find a way to access the Generics for my son, he's like an adult , as tall as one & weighs more than me !
I guess I was hoping James may drop in & give his opinion.

But I imagine he's run off his feet.

it's just I feel so guilty that my boy was born with the virus.
I went through so many IVF treatments to finally have him, he's so precious to me.

I would do anything to help him.
My miracle boy!

Very grateful for James Freeman for doing what he does, I realise he is a very rare human being, very special.
Not many specialists seem to care as much as him.

xo
J the young dragon slayer is:
HepC 1a since birth
Male aged 15
VL 2000000
Started Twinvir/ 10-11-15-then Sof/led.
NO sides so far !
after one week VL : 37
after 4 wks VL : UND !
EOT 2/2/16 UND.!
4 wks. post tx results....pending....
7/3/16 VL result : 4 week post tx: SVR !
12 weeks SVR !
24 wks SVR yeeaa!!
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Oral approval for children 2 years 6 months ago #1382

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Hi Cindy
I understand, I have 3 sons
X
gt 1a VL 6m
F2/3 FibroScan - 9KPa in 2011 and 7KPa in 2015
sof/dac 10 December for 12 weeks
pre tx alt 85 ast 51
4 wk alt 34 ast 31 UND <35
8 wk alt 29 ast 32 UND <15
12wk alt 25 ast 25 EOT 3.3.16
SVR24 UND KPa5.3 F0 in normal range
I am well
.forever grateful to fixhepc
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Oral approval for children 2 years 6 months ago #1385

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Ah yes, you must understand.
Thank you for caring :)
x
J the young dragon slayer is:
HepC 1a since birth
Male aged 15
VL 2000000
Started Twinvir/ 10-11-15-then Sof/led.
NO sides so far !
after one week VL : 37
after 4 wks VL : UND !
EOT 2/2/16 UND.!
4 wks. post tx results....pending....
7/3/16 VL result : 4 week post tx: SVR !
12 weeks SVR !
24 wks SVR yeeaa!!
The administrator has disabled public write access.

Oral approval for children 2 years 6 months ago #1405

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You won't find an official answer, and the trials in children are phase 2 and not scheduled for completion until August 2017.

clinicaltrials.gov/ct2/show/NCT02249182

So let's resort to the logic of first principles.

Children are different in three primary ways (physiologically)
  1. They are growing both physically and mentally
  2. They may not have all the metabolic pathways for drug breakdown seen in adults
  3. They are a different weight

He's old enough that most of his bits are fully formed but some - cartilage in bones allowing them to grow, and his brain are not - it's possible these medications could do stuff here - ?

You can observe that for many common medications there are < 12 yo doses and then Adult doses - tick

If your son is full sized then we need not have concerns that the tablet size is too big for his body - tick

So if you weigh up the risks of treatment they are real, and to a degree unknown.

Then you look at the impact of Hep C and the risks of having it - they are real, substantial and well known.

To my logic the risk of treatment are small, the risks of not treatment are large, so the risk:benefit stacks up on the treatment side.

He's around the age of Gillick competence which is where the child is deemed capable of consent (usual situation an underage girl seeking either contraception or a termination).

On that basis if he wants to do it, and you are assessing a significant impact treatment is not unreasonable.

There is nothing magical that suddenly happens on a child's 18th birthday that says yesterday treatment was dangerous, but today it's safe. It is an arbitrary line in the sand and an adult sized 15 year old should tolerate an adult dose of medication fine and have a risk profile similar to an adult.

I would certainly be thinking along your lines if faced with the same dilemma.
YMMV
Last Edit: 2 years 6 months ago by DrJames.
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Oral approval for children 2 years 6 months ago #1422

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Can't tell you how much I appreciate your reply.
So grateful. I imagine you're so busy, I wonder if you ever sleep?!

I so agree. My son is almost 16 and weighs 72 kg and tall.
So as big as he'll ever be I think.

Thank you :)

Cindi x
J the young dragon slayer is:
HepC 1a since birth
Male aged 15
VL 2000000
Started Twinvir/ 10-11-15-then Sof/led.
NO sides so far !
after one week VL : 37
after 4 wks VL : UND !
EOT 2/2/16 UND.!
4 wks. post tx results....pending....
7/3/16 VL result : 4 week post tx: SVR !
12 weeks SVR !
24 wks SVR yeeaa!!
The administrator has disabled public write access.

Oral approval for children 2 years 6 months ago #1444

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You are welcome. As a doctor I would have no difficulty in supporting a decision to treat.

If it was my son I would treat them if they wanted to.

If, in the worst case, it went badly I would find solace in knowing we tried.

While we know these drugs have risks they are far safer than Interferon/Ribavirin and they have been used. In "UpToDate"

www.uptodate.com/contents/hepatitis-c-vi...nfection-in-children

We can read that PEG Interferon/Ribavirin is approved for use in children.

To me that's like saying amputation is approved for the treatment of gangrene in children but I can't give you antibiotics because they are too new and only approved in adults.

Personally I would take a punt on the antibiotics and leave the amputation to the annals of history....
YMMV
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Oral approval for children 2 years 6 months ago #1447

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Hi Cindi,
My little girl has been infected at birth too. I have exactly the same feeling of guild. I'm waiting for the results of the trials too and as soon as they establish the right doses for the youngest group, I will be looking to start treating her. She is only 3 years old and seems fit and healthy but she does complain of tummy discomfort and gets tired a lot quicker then other children.
Virus not detected from 14.10.2015
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Oral approval for children 2 years 6 months ago #1469

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Hi Nadia,
I feel your pain, it's not a good feeling.
My Doctor said only 5% pass on the virus to the baby.
Did you have a caesarean? I did.
Are you still hep positive?
Love Cindi x
J the young dragon slayer is:
HepC 1a since birth
Male aged 15
VL 2000000
Started Twinvir/ 10-11-15-then Sof/led.
NO sides so far !
after one week VL : 37
after 4 wks VL : UND !
EOT 2/2/16 UND.!
4 wks. post tx results....pending....
7/3/16 VL result : 4 week post tx: SVR !
12 weeks SVR !
24 wks SVR yeeaa!!
The administrator has disabled public write access.

Oral approval for children 2 years 6 months ago #1471

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Hi Dr.Freeman
But if it failed, would he have developed resistance? this really worries me.
What then....?
Thanks,
Cindi
J the young dragon slayer is:
HepC 1a since birth
Male aged 15
VL 2000000
Started Twinvir/ 10-11-15-then Sof/led.
NO sides so far !
after one week VL : 37
after 4 wks VL : UND !
EOT 2/2/16 UND.!
4 wks. post tx results....pending....
7/3/16 VL result : 4 week post tx: SVR !
12 weeks SVR !
24 wks SVR yeeaa!!
The administrator has disabled public write access.

Oral approval for children 2 years 6 months ago #1472

  • Nadia
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Hi Cindi,
I had a natural birth but with some complications. My viral load was sky high I guess. I didn't know about it at that time.
I'm on my 3rd week of treatment and looks like I'm responding well. Once the safe doses have been established for the youngest group, I hope our remarkable doctor James would organise a trial for us.
Virus not detected from 14.10.2015
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Oral approval for children 2 years 6 months ago #1491

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HI Nadia

That is so sad! But unfortunately a small percentage receive from childbirth. I always worry about my own children shit I didn't know until they were older, so I often think back about all my bleeds when the kids were helping me renovate etc.My 3 girls are all adults now and I've told them that they should bet tested. Typical answer is, dad I've had every sort of test surely they would pick it up - No sweety, get tested, chances are slim but hey. I would die to know that I'd passed it on. Hugs Nadia oo
Geno 1b F2/3 snce early 80s. Treated in 2008_9 for 63 weeks on INF/Riba. Commence Sof/Dac on 6 October 2015 and completed 18 weeks of tx. UND at 4-6 weeks, UND at EOT, SVR 2, SVR 6 and SVR 12 on 6 May 2016.
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Oral approval for children 2 years 6 months ago #1495

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It's a shame they don't just make it normal to test everyone.
I bet there's heaps of people out there hep positive & don't know it.
Especially the baby Boomers.
I hope you can talk your children into getting tested, but I know it's hard telling kids to do anything, they usually think they know best !!
Hope they're ok.
x
J the young dragon slayer is:
HepC 1a since birth
Male aged 15
VL 2000000
Started Twinvir/ 10-11-15-then Sof/led.
NO sides so far !
after one week VL : 37
after 4 wks VL : UND !
EOT 2/2/16 UND.!
4 wks. post tx results....pending....
7/3/16 VL result : 4 week post tx: SVR !
12 weeks SVR !
24 wks SVR yeeaa!!
The administrator has disabled public write access.
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