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Author Topic: AbbVie’s Experimental Hepatitis C Treatment Performs Well as Retreatment  (Read 8744 times)

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Offline Hep Editors

  • Member
  • Posts: 784
    • Hep Mag
AbbVie’s investigational glecaprevir/pibrentasvir, known as G/P, cured very high rates in a recent trial of those with genotype 1 of hepatitis C virus (HCV) who had failed a previous cure attempt.
 
AbbVie applied for U.S. Food and Drug Administration (FDA) approval of G/P in December 2016. The FDA recent granted the regimen priority review.

For more information...
https://www.hepmag.com/article/abbvies-experimental-hepatitis-c-treatment-performs-retreatment

Offline elias

  • Member
  • Posts: 285
Re: AbbVie’s Experimental Hepatitis C Treatment Performs Well as Retreatment
« Reply #1 on: February 16, 2017, 04:54:51 pm »
Some write-ups indicate Abbvie's salvage treatment is for all genotypes. (See: Surveyor II studies).

And suggest Abbvie's applied for fast-track approval for all genotypes. Others mention only GT1.Is this fast track being done one genotype at a time or for all?

Would you be able to clarify this?
« Last Edit: February 16, 2017, 05:10:27 pm by elias »
Contracted HCV ~age 12
Diagnosed: September 2016 GT2b
F3 by Fibrosure: 0.66
Necroinflammat activity: A3 0.76
================
VL Sep. 12, 2016: 1.44 million/ Log: 6.157
AST:71/ ALT:114   Sept. 1, 2016 Before treatment
==================
4 week after beginning  Epclusa:
Viral Load: UNDETECTED
AST 17/ALT 11
===============
Began Epclusa:  October 22, 2016
End of Treatment [EOT]: January 13. 2017
====================
EOT+4 Weeks: UNDETECTED
====================
SVR 12 April14-HCV Not Detected

Offline Gaj

  • Member
  • Posts: 172
  • Optimist
Re: AbbVie’s Experimental Hepatitis C Treatment Performs Well as Retreatment
« Reply #2 on: February 17, 2017, 06:47:39 pm »
That press release seems to focus on GT1 (probably because it is largest group) but below is another that indicates that the priority review covers GT1-6.

https://news.abbvie.com/news/us-fda-grants-priority-review-to-abbvie-for-its-investigational-regimen-glecaprevirpibrentasvir-gp-for-treatment-chronic-hepatitis-c-in-all-major-genotypes-gt1-6.htm
Male - 61 years
Genotype 3a (since 1978?)
Diagnosed 2012
Treated 2013 PEG/Riba/Dac (Relapsed)
F4 - HCC#1 Resected 06/15 - #2 RFAblated 11/15
11/18/15 Commenced Generic Tx - Sof/Dac/Riba (24wks)
Pre Tx = ALT: 270  AST: 209  ALB: 31
05/05/16 = ALT: 34  AST: 32  ALB: 40  VL: Undetected (EOT)
06/16/16 = Relapsed
06/23/16 = ALT: 92  AST: 59  ALB: 40  VL: 290,770
01/12/17 3rd Tx - Zepatier + Sofosbuvir (16wks)
05/03/17 EOT und
06/22/17 SVR7 und
07/27/17 SVR12 UND!
10/26/17 SVR24 UND & Cured!!!

Offline elias

  • Member
  • Posts: 285
Re: AbbVie’s Experimental Hepatitis C Treatment Performs Well as Retreatment
« Reply #3 on: February 17, 2017, 08:12:37 pm »
Thanks Gaj:


However,
I think that GT 1-6 FDA priority review you linked to is not for those who had failed previous DAA treatment. Seems this one for all GTs is for treatment naive:

Quote
G/P is an investigational, pan-genotypic regimen that is being evaluated as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment, who make up the majority of HCV patients. AbbVie is also studying G/P in patients with specific treatment challenges, such as genotype 3, patients who were not cured with previous DAA treatment and those with CKD, including patients on dialysis.

The above statement does indicate Abbvie is studying that. And from what I've seen, those had done remarkably well with Gle/Pib. But I'm still unclear if retreatment for GT2 and GT3 for those who failed is up for priority review as well. Seems a bit ambiguous to me.
« Last Edit: February 17, 2017, 08:19:44 pm by elias »
Contracted HCV ~age 12
Diagnosed: September 2016 GT2b
F3 by Fibrosure: 0.66
Necroinflammat activity: A3 0.76
================
VL Sep. 12, 2016: 1.44 million/ Log: 6.157
AST:71/ ALT:114   Sept. 1, 2016 Before treatment
==================
4 week after beginning  Epclusa:
Viral Load: UNDETECTED
AST 17/ALT 11
===============
Began Epclusa:  October 22, 2016
End of Treatment [EOT]: January 13. 2017
====================
EOT+4 Weeks: UNDETECTED
====================
SVR 12 April14-HCV Not Detected

Offline Gaj

  • Member
  • Posts: 172
  • Optimist
Re: AbbVie’s Experimental Hepatitis C Treatment Performs Well as Retreatment
« Reply #4 on: February 17, 2017, 10:23:20 pm »
Hi Elias,

My understanding is that in cases like this, priority reviews are just a speeding up of the standard process by throwing more FDA resources at it so that it occurs in six months rather than the usual ten or more.

They cover safety, efficacy, etc.....and minimum use requirements so in this case 8 weeks for tx naive patients, all genotypes. The 8 week minimum probably helped to trigger the priority and is also a good news story for Abbvie which is why they emphasise it in press releases. I doubt either FDA or Abbvie would want to go through multiple approvals if they can avoid it.

Once approval of the medication occurs it is to the discretion of doctors how they treat more complicated cases unless the FDA makes exclusions. Eg Epclusa which was approved last June is also available for those requiring retreatment.




Male - 61 years
Genotype 3a (since 1978?)
Diagnosed 2012
Treated 2013 PEG/Riba/Dac (Relapsed)
F4 - HCC#1 Resected 06/15 - #2 RFAblated 11/15
11/18/15 Commenced Generic Tx - Sof/Dac/Riba (24wks)
Pre Tx = ALT: 270  AST: 209  ALB: 31
05/05/16 = ALT: 34  AST: 32  ALB: 40  VL: Undetected (EOT)
06/16/16 = Relapsed
06/23/16 = ALT: 92  AST: 59  ALB: 40  VL: 290,770
01/12/17 3rd Tx - Zepatier + Sofosbuvir (16wks)
05/03/17 EOT und
06/22/17 SVR7 und
07/27/17 SVR12 UND!
10/26/17 SVR24 UND & Cured!!!

Offline BillT

  • Member
  • Posts: 573
Re: AbbVie’s Experimental Hepatitis C Treatment Performs Well as Retreatment
« Reply #5 on: February 18, 2017, 07:51:40 pm »
It's amazing to me how quickly these tx are progressing.It's almost come to the point that if you fail one one there's another that will work.We've come a long way in just a few years.
Contracted 1973 Military
Diagnosed 1980
Pegintron treatment 2004 unsucessful
Genotype 1b
FibroScan 10 (F2)
Start Viekira 10.17.2015

AST 40 ALT 69
VL 440k
10.31.2015/Week 2 Labs : AST 14/ALT 17
No VL done
10.14.2015/Week 4 labs : AST 14/ALT 14
VL UNDETECTED!!!
12.11.2015/Week 8 Labs : AST 12/ALT 13
No VL done
01.05.2016/EOT labs : AST 15/ALT 13
VL UNDETECTED!!!

12 WEEK SRV:UN-BLOODY DETECTABLE !!!!!!!!

24 WEEK SVR:UNDETECTABLE!!!! Thank You God.

Fibroscan 6Mo. Post Treatment 7.15.2016-5.3(F1)

Offline elias

  • Member
  • Posts: 285
Re: AbbVie’s Experimental Hepatitis C Treatment Performs Well as Retreatment
« Reply #6 on: February 18, 2017, 08:12:56 pm »
Gaj wrote:

Quote
Once approval of the medication occurs it is to the discretion of doctors how they treat more complicated cases unless the FDA makes exclusions. Eg Epclusa which was approved last June is also available for those requiring retreatment.

Probably so. Once approved its up to prescribing physician to decide. The reason I raise this point is that "off label" use might just give insurance a reason to deny coverage.

BillT wrote:

Quote
It's amazing to me how quickly these tx are progressing.It's almost come to the point that if you fail one one there's another that will work.We've come a long way in just a few years.

It is truly amazing. And I've read researchers say that in theory just about every case of HCV can now be cured by one regimen or another. It is therefore heartbreaking to learn of patients needing to jump through hoops to access this. Or even worse not get it in a timely way. Hopefully, now that Abbvie is putting out some powerful regimen at about same time Gilead is applying for its Sof/Vel/Vox triplet, the competition might drive drug costs down somewhat

Contracted HCV ~age 12
Diagnosed: September 2016 GT2b
F3 by Fibrosure: 0.66
Necroinflammat activity: A3 0.76
================
VL Sep. 12, 2016: 1.44 million/ Log: 6.157
AST:71/ ALT:114   Sept. 1, 2016 Before treatment
==================
4 week after beginning  Epclusa:
Viral Load: UNDETECTED
AST 17/ALT 11
===============
Began Epclusa:  October 22, 2016
End of Treatment [EOT]: January 13. 2017
====================
EOT+4 Weeks: UNDETECTED
====================
SVR 12 April14-HCV Not Detected

Offline dragonslayer

  • Member
  • Posts: 873
Re: AbbVie’s Experimental Hepatitis C Treatment Performs Well as Retreatment
« Reply #7 on: February 23, 2017, 09:44:38 am »
It's amazing to me how quickly these tx are progressing.It's almost come to the point that if you fail one one there's another that will work.We've come a long way in just a few years.

There's gold in them thar hills.
Paul

DX 2008
Started Harvoni 11/26/14 for 8 wks
Completed 8 wks Harvoni 01/20/15
EOT RNA Quant result:  Detected 29
7.5 wk post tx: Detected < LLOQ(12)
11 wk post tx: UNDETECTED SVR12
24 wk post tx: UNDETECTED SVR24; AST 26; ALT 22; ALP 73
48 wk post tx: UNDETECTED SVR48; AST 18; ALT 18; ALP 70
GT 1a
vl 2.4mil
2008 bpx: Stage&Grade 0
2013 bpx: Stage&Grade: 0-1
IL28B: TT
likely infected early '70s

 


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