Hepatitis Forums
Hepatitis C Main Forums => Hepatitis C Research News & Studies => Topic started by: Hep Editors on February 16, 2017, 03:13:01 pm
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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
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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?
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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
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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:
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.
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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.
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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.
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Gaj wrote:
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:
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
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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.