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Post Info TOPIC: Abby's - Pan 8 week Glec/Pib


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Abby's - Pan 8 week Glec/Pib
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Hi angel,

Nice you are getting to the bottom of the funding quest.

Yes, 16 weeks IS the current guideline ... see this ( https://www.hcvguidelines.org/treatment-experienced/gt1/ns5a ) specifically to compare drugs suggested for you, cure rates, course lengths.

Above link is only a partial excerpt (pertaining to retreatment of GT1's) from the much larger guidelines (entire guidelines will be found in the Knowledge section), and within the guidelines are good resources about RAV's and many other interesting topics.

Nice you have met Norwegian Waffle on her thread and will have a buddy with whom to compare notes.

Maybe you should have your very own thread too? Just a thought. Nice to have a select place of your own to land and re-land as you travel through various on-going aspects of your journey to treatment. This thread actually just started out, in it's intent, merely being a kind of "historical review" of Mavyret and it's evolutionary coming into being on the market. Doesn't really do your good research on solving the difficulties of how you are arriving to re-treatment, justice. smile C.

 



-- Edited by Canuck on Monday 4th of December 2017 05:02:40 AM

__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)



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Looks like abbvie runs the same program gilead runs to give out free meds if your income is less than 100,000 a year... the first gentlemen I spoke with when I received the insurance denial letter from a company affiliated ith abbvie (Proceed) gave me the wrong information therefore I spent a lot of time on trying to obtain information that was useless!! He gave me the name of three places to apply for grants. Well, grants only pay if you have some of your insurance paying but honestly no one seems to know that.  After speding hours on hold with PAN, I finally was given the correct information when I called Abbvie back.  They will file another claim for meds through Marketplace which will of course be denied.  Then the doctor has to fill out some information and send them the prescription, his information and my tax return to verify income.  Then I have to apply for Medicaid (what a waste of time, in no way would I be eligible)  Applying for Medicaid in itself will be a handful and I probably won't get a denial letter for weeks.... The good news is that eventually I will get the meds. Obviously I will not be expecting anything quickly...

Somehow people need to be advised of what to do if their insurance won't pay for the meds... I even contacted the Hep.mag and they were not helpful.... I will see how this all pans out and if it doesn't work out, well, I will take generics... At this point I am not sure about anything...

Actually for a relapse the meds are taken for 16 weeks....

LOL (in my dreams)  connie/angelseven



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62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.



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hi, thanks for your response!!  Actually I don't want to take vosevi due to the horrible headaches I had with harvoni!!!  I have not had another fibroscan and I don't plan to, I doubt the doctor will ask for it.  I will find out more about this PAN grant when I can talk to the pharmacy that will be handling my meds.  At this point the doctors office does not know what pharmacy they will be using, they have several options.

thanks for your interest!!

 

connie



__________________

62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.



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Hey angel,

Nice to see you back and busy "on it". With interest I will go look at the new lab link you and Tig have just entered.

On another thread, I know (prior) you said you had a fairly complete set of labs done not that long ago?, was about 8 months ago?, but ya, what Tig said, I too would be interested to know what your newest (just done) labs results are. So, with a fibroscan score of .5?, about a couple years ago? (in sig line), have you since then had another fibroscan?, and/or have any of your old or newest labs included a "Fibro-Test" or other like blood method fibrosis-assessing tests?? I'm not sure which tests you used, but note you did summarize your Fscore (in sig line) as being F1-2? Forgive me if you have already provided this info elsewhere, but some of your communications have been over quite a few differing threads and I loose track.

I hope you are successful with the new doc and in getting the double 5A/3/4A Maviret (or any drug regime appropriate for you), sounds like you are on a roll thus far, good access to good lab prices and a hopeful way to afford accessing Maviret. Please do let us know what is transpiring as you continue on. I am so pleased you are so ardently pursuing treatment.

Of course I have no familiarity/frame of reference/experience with the co-pay and the "pan" grant thing you refer to - so i can not offer any info on that, other than those good links to various drug companies Tig has kept updated on the site.

What ever happened to the explorations you were considering regarding the triple 5A/5B/3/4A Vosevi. Did you ever find any financial assistance to Vosevi via those links/contacts? As a treatment experienced, you, if anyone, should especially be qualified to more easily get access to a triple.

Good work you are doing! biggrin C.



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)



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Wow, 1000.00 for viral load, that is highway robbery for sure!!!!  It is such an amazing resource... i was shocked !!!!!



__________________

62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.

Tig


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Hi Connie,

I added the link HERE in the Knowledge section. I reviewed the services and am amazed by the retail prices for tests. If we have to pay for them, these actually seem affordable. I have paid over a $1000, just for a viral load! I‘m looking forward to hearing more positive reviews. A service like this could really benefit all of us! Keep us informed about their services as you go forward. Good find, thanks!  smile



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Tig

62 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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Tig, thanks for your response,  I hope you can place a link for the Link2labs site somewhere on this site, I could not believe their low prices, especially for texas!!.... The gentlemen that runs it, Wayne Gossley, is very knowledgeable about hep c and he actually has worked with the gastro guy I will be going to next Friday who is supposedly excellent and I am thankful I do not have to go down to the medical center!!!  I will keep you updated!!

Wayne was thinking about closing the site at one point so I told him I would try to get the word out there also.  It was so easy, I paid online, went to quest and was out in about 5 mintues, no question about billing or anything!!!

hugs,  connie



__________________

62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.

Tig


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Hi Connie,

I like the sound of all that! I would like to think that the grant would cover treatment in general. They’re aware of the reason for it, so I hope they considered that very important item. Of course the only way to know what they’re offering is a face to face. Write down any questions before you talk to them. I would forget things all the time. It’s a plus that you are an established patient, too. 

Those lab prices are unreal! It’s nice to see the prices come down in some labs and services. A little competition is good. It keeps them on their toes. I’m going to look at that. It takes networking to stay on top of these different services. Let us know your LFTs and VL. It’s nice to know what your baseline is. Then we watch it dive into normalcy, together! This is good news and is progressing all the time. Keep on them!

It‘s your time!  



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Tig

62 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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Hello all!!  Now I am hoping to get Mavyret ... I have dr appointment on Friday and was approved for a pan grant but I have no idea how that works exactly... my grant was for 7200.00 plus the copay coupon... I have tried to get them on the phone, finally I  got a person after holding for 1 hour but she did not really answer my question which was "do they keep approving the grant monthly"?  I mean what if the funding runs out halfway through the treatment??  If isto much of a hassle I will just wait for the generic version which should be available in 10 months or so.  My marketplace insurance doesn't cover any portion of the meds... really doesn't cover much of anything other thank giving me a discounted doctor's visit

I did find a great resource which is Link2labs... I got all my needed bloodwork for 52.00 including viral load test (which is free the first time)  After that the viral load is around 70 to 90.00... amazing. The manager did tell me that Texas has really good prices... I think they are in about 39 states.

If anyone knows exactly how pan works, please let me know!!

 

Peace, connie (angelseven)



__________________

62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.



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ah the magic of Tig - my hero. biggrin How you do that!



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)

Tig


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"hm, wish I could meld this other thread ... About ABT-493/530"

You mean like this?    smile  You know you could have that power, if.... wink



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Tig

62 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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hm, wish I could meld this other thread ... About ABT-493/530 ... (an older glec/pib thread, from over in Knowledge Base) to be at the bottom of this one, and re-title the whole thing to show it all in better historical timeline sequence!... with new title something like ... About AbbVie's "Maviret", Glec/Pib, formerly ABT-493/530 ...

Oh well, I will just add this now (below) to this thread instead:

 

HelioIN THE JOURNALS -November 20, 2017

Mavyret effective for HCV genotypes 1, 4 in DAA-experienced patients

Poordad F, et al. Hepatol. 2017;doi:10.1002/hep.29671.  

"Patients that have virologic failure with NS5A inhibitor-containing regimens commonly develop resistance-associated substitutions that decrease the efficacy of subsequent retreatment," Fred Poordad, MD,from the University of Texas Health, and colleagues wrote. "Effective retreatment of patients who have had virologic failure on NS5A inhibitor-containing regimens has been challenging, and retreatment options for this population are currently limited."

In part two of the MAGELLAN-1 study, researchers enrolled 91 patients with HCV, including patients with cirrhosis, who had prior treatment with a NS3/4A protease and/or NS5A inhibitor-based DAA regimen.

Patients had genotype 1 (n = 87) or 4 (n = 4) and were mostly men (70%) and white (76%). The researchers randomly assigned patients to receive either 12 weeks (n = 44) or 16 weeks (n =47) of Mavyret (glecaprevir/pibrentasvir, AbbVie).

Thirty-nine patients in the 12-week arm (89%; 95% CI, 76-95) and 43 patients in the 16-week arm (91%; 95% CI, 80-97) achieved SVR. The researchers observed one on-treatment virologic failure and four relapses in the 12-week arm and four on-treatment virologic failures in the 16-week arm.

All patients whose prior DAA treatment included only NS3/4A protease inhibitors achieved SVR. Patients whose prior treatment included only NS5A inhibitors had SVR rates of 88% in the 12-week arm (95% CI, 64-97) and 94% in the 16-week arm (95% CI, 74-99).

Patients who had prior treatment with both NS3/4A and NS5A inhibitors had the lowest SVR rates in both the 12-week (79%; 95% CI, 52-92) and 16-week arms (81%; 95% CI, 57-93). Three of six patients with prior experience with both inhibitor classes who did not achieve SVR and experienced on-treatment virologic failure.

Most adverse events were mild (65%), and no patient discontinued treatment due to adverse events. The most common adverse event was headache in both the 12-week (14%) and 16-week arms (23%). The researchers did not correlate any of the three serious adverse events to the treatment drug. - by Talitha Bennett

 



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)



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A glec/pib (Maviret) update for Canadians:

(I can't find my old, "older" gossipy research about glec/pib from when it was still called ABT-493/ABT-530 and was still in the last stages of pre-market, so I'll just stick this recent announcement onto this thread).

So, re: this announcement below ... Ya, ya, I know, depending on what Province you live in and after you get through all the haggling medical services plan fine-print, this "approval"" does not necessairly mean that you or I (anytime soon) will get Maviret, but it IS "technically", now, "on the books". Good news (in theory), but in practise ... well, we'll hope and see how soon it will truly be readily available to all Canadians.

Health Canada approves Maviret for pangenotypic chronic HCV - August 17, 2017 - Helio

Health Canada approved AbbVie's Maviret for treating adults with chronic hepatitis C for all genotypes, according to a press release. Maviret is designated for patients without cirrhosis and who are new to treatment.

"With the approval of Maviret, we are proud to bring the hope of a new cure to people living with hepatitis C in Canada, reflecting AbbVie's dedication to addressing critical unmet needs for patients," Stéphane Lassignardie, general manager of AbbVie Canada, said in the release. "Maviret is designed to deliver a virologic cure for most HCV patients including those with specific treatment challenges. AbbVie will continue to work with local health authorities and stakeholders across Canada to get our treatment to as many patients as possible."

Maviret (glecaprevir/pibrentasvir, AbbVie) is also approved for patients with compensated cirrhosis, severe chronic kidney disease, those with genotype 1 who were not previously cured with certain direct-acting antiviral treatment, and those with genotype 3 chronic HCV.

Canadian patients prescribed Maviret may also enroll in AbbVie Care, AbbVie's patient support program designed to provide services such as reimbursement assistance, education and ongoing disease management support.

Reference: www.abbvie.ca

 

 



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)

Tig


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About ABT-493/530
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High rates of success with latest Abbvie offerings! In the final stages.

 

"- 95 percent of patients infected with genotype 3 (GT3) chronic hepatitis C virus (HCV), without cirrhosis and who are new to treatment, achieved SVR(12) with 8 weeks of treatment(1) 

- Together with previously reported data, these study results support the potential of G/P as an 8-week treatment for the majority of people living with HCV across all genotypes 

- GT3 is the second most common genotype worldwide and the most challenging to treat(2),(3); limited treatment options exist for newly diagnosed patients"

Eight Weeks Geno 3's?

***************

- New data demonstrated high SVR(12) rates across compensated cirrhotic patients with genotype 1, 2, 4, 5 or 6 chronic hepatitis C virus (HCV) infection with 12 weeks of treatment(1)
- No patients discontinued treatment due to adverse events in the Phase 3 EXPEDITION-1 study(1)
- Study results add to body of data for G/P in patients with compensated cirrhosis across all genotypes

99% SVR rates Glec/Pib w/o Ribavirin



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Tig

62 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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Tig


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Abby's - Pan 8 week Glec/Pib
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Outstanding!! Another sword with which to slay ye old Dragon!! Thanks Canuck, excellent news.

A little info:

GlecnPib



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Tig

62 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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News about Abby's Pan 8 week Glec (NS3/4A) and Pib (NS5A). No SOF. Especially intersting for those with compromized renal function, TN/TE/cirrhotics. They are stiving for shorter treatment times for these Pans. smile

FDA grants priority review for AbbVie's pan-genotypic HCV regimen  - February 3, 2017

 

The FDA has accepted AbbVie's New Drug Application for glecaprevir/pibrentasvir and granted it priority review, the company announced.

Glecaprevir/pibrentasvir is an investigational regimen under evaluation as a possible 8-week cure for non-cirrhotic patients with all major genotypes of hepatitis C virus infection who have not received prior treatment, according to a press release.

The regimen combines two antiviral agents - 300 mg of glecaprevir, an NS3/4A protease inhibitor, and 120 mg of pibrentasvir, an NS5A inhibitor - that are administered once daily in three oral tablets.

Data from eight registrational studies involving more than 2,300 patients from 27 countries support the NDA, which AbbVie submitted in December. These studies evaluated all major HCV genotypes, treatment-experienced and -naive patients, those with and without cirrhosis, those who were not cured with a previous direct-acting antiviral containing regimen, and those with treatment challenges like severe chronic kidney disease.

"We will continue to work closely with the agency as they review our New Drug Application and we remain committed to bringing a new cure to patients with chronic hepatitis C," Michael Severino, MD, executive vice president of research and development and chief scientific officer at AbbVie, said in the press release.

The FDA designates priority review status to drugs that show potential for significantly improving the safety and effectiveness of the treatment of a serious disease.

 



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)



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RE: About ABT-493/530
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Another FDA announcement about ABT-493/530 (GLEC/PIB) - as one type of a "rescue regime" for particular types of GT1 relpasers, and, may also be of benefit for those with renal impairment:

FDA grants breakthrough designation to regimen for patients who fail DAA therapy - September 30, 2016

The FDA has granted breakthrough therapy designation to AbbVie's investigational regimen for patients with hepatitis C virus infection who failed previous direct-acting antiviral therapy, the manufacturer announced.

The pangenotypic regimen - ABT-493 (glecaprevir, AbbVie) and ABT-530 (pibrentasvir, AbbVie) - is for patients with HCV genotype 1 who failed treatment with DAAs, including treatment with an NS5A inhibitor and/or protease inhibitor, according to a press release. The designation is indicative of clinical results from the phase 2 MAGELLAN-1 clinical study.

"The FDA's Breakthrough Therapy Designation is an important step in our effort to bring our pan-genotypic regimen to market, which we are also investigating as an 8-week path to virologic cure for the majority of patients," Michael Severino, MD, executive vice president, research and development and chief scientific officer, at AbbVie, said in the release.

In the MAGELLAN-1 study, which was presented in April at the International Liver Congress, results from the regimen showed sustained virologic response rates around 90% in a cohort of treatment-experienced patients, including those with resistance-associated variants. Of this cohort, half had failed therapy on an NS5A drug, and 84% had failed on a protease inhibitor.

The regimen consists of the two drugs dosed once daily as three oral tablets, according to the release.

Phase 3 clinical data on this regimen will be presented at an upcoming scientific conference, according to AbbVie.

 

Disclosure: Severino is employed by AbbVie.



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)



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Glec/Pib - by another name - AbbVie - ABT-493/530
 
ABT-493 = Glecaprevir (a NS3/4A), and ABT-530 = Pibrentasvir (a NS5A). 
Touted pan for GT 1-6. 
The links below are just general info out there about glec/pib.
Are they still amassing trial data, or, is it in use on any market?
Like sof/vel, being used as a triplet with either riba and (perhaps soon) vox, glec/pib is also being touted for use as a triplet using riba.
 
One notable attribute in glec/pib use, is for those with renal impairment, who are avoiding sof? - we had one fellow come on this site who had an uncommon reduction in his sof dose which I believe was a sparing precaution due to his renal status?
 

International Liver Congress 2016: Glecaprevir/pibrentasvir will pose ...

 

www.datamonitorhealthcare.com Research Wire
 
Apr 28, 2016 - Glecaprevir/pibrentasvir (ABT-493/ABT-530; AbbVie) is forecast to gain US approval in September 2017 and will pose a major threat to Gilead's ...
 

Glecaprevir/pibrentasvir - AdisInsight

adisinsight.springer.com/drugs/800044162
 
Jul 21, 2016 - AbbVie is developing a fixed-dose combination of glecaprevir and pibrentasvir for the treatment of hepatitis C virus (HCV) infections.
 
 
 

Cokiera EU Withdrawal Signals Abbvie Betting On Glecaprevir/Pibrentasvir

 

Executive Summary

By pulling its EU marketing authorization application for Hep C therapy Cokiera, AbbVie seems resigned the antiviral can't adequately compete there against Gilead's Harvoni and Merck's Zepatier and that the company will instead await arrival of its more potent, lower priced Glecaprevir/pibrentasvir combo next year.



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)

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