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Post Info TOPIC: Merck Receives Breakthrough Therapy Designation for MK-5172/MK-8742


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Merck Receives Breakthrough Therapy Designation for MK-5172/MK-8742
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Hi SusiQ, your trial co-ordinator sounds like she`s very helpful, and she did well getting you on this Merck trial. It sounds very promising from the information that`s been published so far.

Looks like it`s going well for you anyway, and your blood levels are stable which is good.  Best of luck with your 8 week results, keep us updated!



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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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I am awaiting the reviews that will be presented in Wash DC on the weekend of Nov !st.  My coordinator will be attending the conference, 

I still feel great and go in for my 8 week blood work on Nov 6th--changed from 5th as my coordinator won't be back from DC.

I had local blood work done this week.  My red count is still 11.1--not continuing to drop.  My platelets are high 100's, I think.  Dr. is mailing a copy of the labs to me. They didn't do a viral load.  There are a number of folks with Hep C locally, but the Dr s don't seem interested in my info.  They ship us out to gastros 50 miles away who treated me like as a stubborn old lady when I told them I would not take interferon. I have not been back to them. I will not drive 50 miles and pay $50 to be dismissed.  Finding a clinical trial around here is a definite do-it-yourself project. I originally applied for Gilead trial, but was refused after free biopsy showed cirrhosis.  Cheryl (at the study center) kept looking for a trial for me and called when the Merck trial came up. She did the screening at midnight as there were few slots available nationwide and she wanted her group to be in first.  We got our slots--thanks to her.    

Cheryl said she can finally discuss my trial with me after the conference when Merck publically releases the info. She is excited about the conference as the center does trials for several drug companies and she stays informed.  They did the earlier Merck trial last Spring.  I am sure it did well or Merck would not have received Breakthrough Designation. 

So far--so good--just hope I remain UND.

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



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More hope for those ahead, thanks for the time, energy and the post.smile



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Don't sweat the small stuff, it will only give you hair loss.



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Merck Receives Breakthrough Therapy Designation for MK-5172/MK-8742

This is one of the fast rising new HCV drug combos that will likely be the next most studied 2nd generation DAA that has high resistants to mutations. The MK-1572 is made up of  NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor.

Interesting that this was revealed three days before the FDA review of Sofosbuvir and Simeprevir.

Yes another very sharp sword to battle the dragon with, pretty soon he won't stand a chance if we learn to use the sword correctly.

Matt

The designation of MK-5172/MK-8742 as a Breakthrough Therapy for chronic hepatitis C is an important milestone for Merck, said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. There remains significant unmet medical need in hepatitis C, and we are looking forward to working with the FDA to advance this program as quickly as we can to bring this investigational combination to HCV specialists and their patients. 

According to the FDA, the designation of an investigational drug as a Breakthrough Therapy is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. 



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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Thanks Matt, I was going to post it this morning!  Excellent news, in the same week that the FDA are meeting to review Simeprevir and Sofosbuvir.  Although concerns have been noted about the rashes and sunburn that Simeprivir can cause in some cases.

http://www.npr.org/templates/story/story.php?storyId=239678497&ft=1&f=

I`m moving this thread to the `HCV News` section so it doesn`t get buried here in the `General Discussion` area.  This is an important step forward in the search for the most effective 2nd generation future drug combo.



__________________

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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Hi Matt,

I saw this myself and shouted Hooray! At last the most mutation-resistant anti-protease and NS5A blocker have been given a Breakthrough designation.

The results of the Phase 2B Trials will be announced in early November, then hopefully the Phase 3 Trials can start immediately. This will be the combo for the failed antiprotease patients, as MK-5172 is active against all known mutations from Incivek and Victrelis. Again, I repeat, why were Merck so slow to act? Cheers.

 

 

 http://www.news-medical.net/news/20131023/FDA-grants-Breakthrough-Therapy-designation-to-MK-5172MK-8742-for-chronic-HCV-infection.aspx

 



-- Edited by mallani on Wednesday 23rd of October 2013 08:36:40 AM

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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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