MK5172-068 Clinical Trial Update

[mac790]

Hello Everyone,  The viral titer results came back from my December 26, 2014 blood draw. The result is still "TND" or totally not detectable. This lab Merck uses has the most sensitive test I've read about, their lower limit for harboring a "not clinically significant" level of viral particles is 15IU/ml. I was at 17IU/ml after only 18 days on the meds, from a pre tx level of 585,000+IU/ml. Merck has a sure winner on its hands it would appear. I'm not certain it is effective on all GTs, in fact I just found out the name it will be marketed under: "Grazoprevir". The last portions of the names of these new generation HCV drugs are so similar, I would suspect their methods of action are also very similar. Whatever the case, they have finally unlocked the secret to killing this SOB of a virus. I see Gilead may lose a legal fight in India, and have to allow Sovaldi to made in a generic form, for 1/10th the cost here in the USA. I wonder how many trips to India will all of the sudden come about if Gilead loses this legal battle? They are touting it as a "24 week, 90%+ SVR producing, well tolerated single pill per day therapy, effective for all GTs". I sure hope so, then some generic Sovaldi can finally be available for those who could not afford it, or were not lucky enough to find a local clinical trial. Two more viral titers ( 3 months from now, then 9 months) for me, and if I am still TND, I will be considered to have achieved  a Sustained Viral Response. I truly hope any of you that have not been afforded access to these new gen HCV meds get your chance, and get it soon. The cure is here, just keep on banging away until you can get your tx. Maybe I should not be dispensing advice sounding as though I am "cured", but after four viral titers showing no viral particles, I think I've got a good shot @ SVR. I will remain cautiously optimistic, until August 5, 2015. That will be one year since I started tx, which only lasted 12 weeks. No RBV and of course no INF, just one big brown pill per day. I'll keep the updates coming, and the very best of luck to all of you.   mac

[susan400]

Had I been undetected at my 12 wk post treatment blood draw, my doctor had wanted me to also have a 6 mon. post treatment viral load, too.  Since, I relapsed on the 12 wk, it was unnecessary to do a 6 mon. post TX.  Since, mac790 was in a clinical trial and also using a different medication than Sovaldi or Harvoni, the specifications may be different.  That 12 wk post TX recommendation may not be the case on all TX's.  Susan400

[Ekkiemom]

Oops
Take care and Peace
Deb :)

[Ekkiemom]

Hi 14!  That is just awesome news to hear! Keep up the fight and stay strong and victory will be yours

[Stronglady14]

I took my last pill jan 22nd and was told I am considered cured at the 9 month test , That the 12 wk is too soon. So I think there changing from the 12 wk . I was undetected at wk  (und/15)4 by week 9 I had no detection at all. Zero sign of virus.

[Ekkiemom]

TND= totally not detected which means Mac had NO viral copies, NO partial replicating bodies, no deteriorated virus left. As he explained not one antibody left in his body blood/body.  Really great news for him!
Best
Deb

[AugustineMama]

Congrats on the UND. I had one test that was LabCorp Hepatitis C Virus (HCV), Quantitative, PCR, NGI QuantaSureT

The NGI QuantaSureT assay has a quantitative range of 2-2,000,000 IU/mL or 5-5,000,000 copies/mL. It actually goes beyond the 15

[mac790]

I guess I should read the whole post before replying, yes?   It was one large oval brown pill per day. With or w/o food, any time of day, just keep the dosages as close to 24 hours apart as possible. I had to record the doage time on an electronic pad, that sent the data to HUP wirelessly.

[mac790]

Hi, This is just the tech speak used by this particular lab, PPD in KY. Their limit for being virus free is <15IU/ml    mac

[mac790]

Sorry- about the sfx. I had absolutely none, zero, zip, nada.    mac

[mac790]

Hi, Actually Merck said 6 months > EOT with no detectable viral particles = SVR. I'm going to wait a bit longer before declaring victory.    mac

[mac790]

Hi,  GT= 1a    mac

[flyinlynn]

Hi found this

http://www.gilead.com/news/press-releases/2014/10/us-food-and-drug-administration-approves-gileads-harvoni-ledipasvirsofosbuvir-the-first-oncedaily-single-tablet-regimen-for-the-treatment-of-genotype-1-chronic-hepatitis-c

"Patients who achieve SVR12 are considered cured of HCV."

There are a variety of opinions out there on the subject. My hepatologist the director of the liver center considers SVR 12 cured but still wants to check at 24 just to be sure as 24 weeks was the standard for so many years.

[Livelife777]

Mac your the man!
Congrats my friend.
Wonderful news!!!!!
.....Kim

[Stronglady14]

I just finished my meds Jan 22nd and they told me I will be considered cured at the 6 month mark. They said 12 weeks is too soon.

[patra_]

Congratulations on SVR 12!!m

I agree with you and your Dr, whoever, I will be glad of SVR12, but want to,see that SVR24.

Pat

[keepingOnkeepingOn]

I never heard of totally undetectable. It's just Undetectable isn't it?. Second what meds are you doing? One Brown Pill?

[AWorriedMom]

Cure is 12 weeks after treatment ends.

[JubalMcClaws]

Congratulations on the SVR12!   So if I read this right, CURED is declared 9 months post treatment correct? Also, What were the reported side effects and did you experience any? Best to you  JM

[Mattsmom218]

Oh, one more question. What is your genotype?

[Mattsmom218]

This is AWESOME news!!!! so so happy for you. I am on SOL/RIBA for GT2 and have my 4 week BW this Friday. Praying for the same results. God Bless you and may you have continued good health!!