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Post Info TOPIC: Merck is in town.


Guru

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RE: Merck is in town.
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Malcolm, thank for watching Benitec.  All I get on it over here in USA is the goop on the Internet . 

RC 

 

 



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 M-68, 3 Treatments)( SOF-RIBA 2014)(SOF-RIBA-PEG 2016)(HCC 2016) (LIVER TRANSPLANT 8-2017)(VOSEVI-RIBA 2017)   SVR-12. 3-13-18   



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Well, it is about time for Merck approval.  I have been UND for 2 years, 5 months now and declared SVR July 2014.  I got the Merck trial arm of 18 weeks with ribavirin in my clinical trial--Had cirrhosis and was 79 back then. Have had no serious side issues then or now.  Just seems the pills caused some stomach problems now and then.  But I really had few problems with my HepC either. Maybe because I stopped drinking, etc 50 years ago when I was told I had some sort of liver damage.  I was already 31 by then so had some years back in the 1960's to do plenty of experimenting--especially in Los Angeles, where I lived then.  About time to go in for another round of tests from Merck--so far--so good.  Very, very grateful that Merck accepted me into their trial.

SuziQ     



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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR



Guru

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Oh oh, it looks like I appear to be the first on the train here.

I really hope Malcolm gets a good night sleep down there and wakes up saying "On second thought..." no

JimmyK

 



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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Robert,

Benitec are moving VERY slowly. The TT-034 Trials are all in the USA and to date, only 7 patients have been dosed in the Phase I-IIa Trials.

I understand they are awaiting FDA approval to do further Phase II-III Trials. The correct dose is still uncertain. I get updates, so I'll post anything of importance. Cheers.



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Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm



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This is still in the recruitment phase. Looks like the end of this year. It is an 8 week formula. 1 pill. For 1a and 1b. 



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60 yrs. Geno1b 2001. 9mil. VL. �Failed Post Riba/Peg tx. 2006 46 weeks. Diagnosed 1A 2015(?) F3 fibr. 225k VL. Vikera/Riba 12 weeks 3/20/2015. "Undetected" start to finish. Undetected 1yr post tx.



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Merck is indeed too slow. Gilead already made a ROI+profit from purchasing Pharmaasset's golden (kinda stolen) PSI-7977.

Any results from trials with MK-3682 yet?

best



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GT 3 dg. 08-2012 / FibroScan: 5 kPa F1 / FibroTest: F0-1 A1 / SoC TX: PegInt 120mcg+Riba 1000mg UND from w8 relapse EOT+4w
01-2016 Sof+Dac+Riba UND from w8, SVR24!




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Merck is in NJ near me. Lately you could hear them sobbing as you drove by. They are the ones that formulated and produced that nasty "Interferon".  I am happy now that my neighbor has produced a much welcomed drug to kill more Dragon's.  Good Bye Interferon!!!!! Hello Zepatier. At bargin basement prices, comming to a pharmacy near you. Now it's me who can sit back and watch Big Pharma scramble instead of me! I love it. On to my SVR24 next month. (I am late so it will be a SVR34) Doc's really overwelmed with patients! It will be interesting to see another force or army on this form, so we can compare it to our other 2 drug makers.

PS, Zepatier uses Riba with or without based on amino acid levels. 95% cure rates.  Mmmm.



__________________

60 yrs. Geno1b 2001. 9mil. VL. �Failed Post Riba/Peg tx. 2006 46 weeks. Diagnosed 1A 2015(?) F3 fibr. 225k VL. Vikera/Riba 12 weeks 3/20/2015. "Undetected" start to finish. Undetected 1yr post tx.



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Malcolm,  How's that little Aussie  Company   "Benetec" doing??    They are working on a one time infusion, may even prevent re-infection??   Any news from down under on this company?  RC



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 M-68, 3 Treatments)( SOF-RIBA 2014)(SOF-RIBA-PEG 2016)(HCC 2016) (LIVER TRANSPLANT 8-2017)(VOSEVI-RIBA 2017)   SVR-12. 3-13-18   



Guru

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I'm still waiting for MK-3682. This is Merck's new nucleoside NS-5B blocker, said to be better than Sovaldi. The Trials are taking forever.

Man, Merck are slow.



__________________

Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm

Tig


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The article I just read said Merck's banking on the larger number of GT 1-4's vs pan genotypic approach to take market share away from Gilead. They're hoping to cash in on the tide moving to Zelpatisvir for 1-4, simply because of price. Velpatasvir if not released at a more affordable price, Gilead will lose to generics and lower, as effective treatments. At least that's what some of "them" are saying. Your block might be sitting just fine! The insurance carriers are going to flock to that here in the States. At least it seems very possible to me. We'll see....



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Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Guru

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I'm disappointed. I have a large block of Merck shares and was hoping for better.

Unfortunately, Elbasvir is the weak link in Zepatier. As pre-treatment RAV testing should be performed, Z. is unlikely to challenge Gilead.

RAV's at the NS-5A domain continue to be the issue. These may be pre-existing or due to a prior treatment failure. It appears that increasing the treatment length to 16 weeks, and adding Ribavirin, will increase the SVR rate. Geno 1b's do best.

It appears that Sovaldi is required in any treatment regime, to achieve the best possible chance of SVR.

Also, I thought this was to be pan-genotype. Why are Geno 2 and 3 patient not included?



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Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm



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Competition rules and it's always great to hear there are more weapons to fight this virus.

Thank you for the information Bubble.

 

 



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65 yo, GT1A, , Cirrhosis, F-Scan F4 33.5, TX Naive Harvoni 12 wks

SOT 2/9/16 / ALT 187 AST 114 VL 2.3M.    POSTS

EOT 5/2/16  ALT 35/ AST/25  platlets 126 C/B VL UND

EOT +12 7/26/16  ALT 25 /AST 22/ ALP 83  platlets 129 C/B VL UND

EOT + 24 10/18/16 ALT 27/ AST 20/ ALP 71 platlets 153 C UND

 * SVR *



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Yes, certainly exciting on a couple of fronts:

1) Another weapon available to those with Genotypes 1 & 4

2) More competition thus should tend to push prices down across the board.

Hopefully we see this scenario with pan-genotype DAA's as well, sometime in the not too distant future.

Fortunately, market fluctuations tend to happen at a very rapid rate so puts a lot of pressure on those like Gilead to respond to that competition. (It sure would be great to see them have to back down from that $1000/pill price tag).

 

Dave

 p.s. Thanks for the news Bubble!



-- Edited by Linuxter on Friday 29th of January 2016 08:58:38 PM

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63yy,HCV,2b,F3-A1, Sof/Riba,12wks Tx   SOT: 1/20/16, HCV-RNA 9,816,581, ALT 56, Hb 14.6

4wk: HCV-RNA <15 Detected, ALT 15, AST 17, Hb 13.6 EOT: 4/12/16, ALT 18 , Hb 12.9176a2f85d05d9c965eafe199f2ba9ba5.jpg SVR Achieved 7/8/16

 

Tig


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Nice to see another weapon in our arsenal of new drugs. The rates of success are equivalent with the other new DAA's and treatment lengths, 12 or 16 weeks, depend on treatment experience and fibrosis. Looks promising and the treatment cost will definitely impact treatment consideration. I'll add the new information regarding their new PAP to our forum information.

Keeping an eye on GILD.... smile



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Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Guru

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Thanks Bubble, yes this is Merck`s `Zepatier` (elbasvir + grazoprevir), and here`s the full details..

Zepatier FDA approval

Interesting! 



__________________

Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 



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We have #3 in the Hep C market today. Merck has been FDA approved for Geno 1 and 4. And it is cheaper than Harvoni and Abb-Vie.  Only $53,000. Gilead's stock has dropped at this hour by 3%.



__________________

60 yrs. Geno1b 2001. 9mil. VL. �Failed Post Riba/Peg tx. 2006 46 weeks. Diagnosed 1A 2015(?) F3 fibr. 225k VL. Vikera/Riba 12 weeks 3/20/2015. "Undetected" start to finish. Undetected 1yr post tx.

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