mac790: EOT was today

[mac790]

Hello Friends, Well, I was not extended to 16 weeks of my clinical trial tx. This trial, run @ HUP in Philadelphia, has no exotic name such as ION, SAPPHIRE, TURQUOISE, etc...  Its' designation is simply MK5172-068. A 1 pill per day regimen, each tablet containing 100 mg of an NS3/4A protease inhibitor and 50 mg. of an NS5A replication complex inhibitor. Some arms of the study run for 12 weeks, some 16 weeks, with and w/o RBV. I drew the 12 week w/o RBV arm. I have read in other trials with drugs which now have names, the addition of RBV ( in the vast majority of cases) was clinically insignificant. I know of no data that confirms that 16 weeks of this Phase III trial comination tx from Merck yields clinically significant higher percentaghes of a lasting SVR than 12 weeks of tx. The trial coordinators have assured me there is no difference in the groups they have been able to follow thus far. This trial is about 50% complete, unfortunately if you live in the area and wanted to possibly participate, they filled the 400 open slots quite quickly, I would imagine there was at least 1 prior group of a similar number of people completing this trial before my group was screened and chosen. These meds are so new, Merck has not yet announced names for them yet, but my guess is that the names will both end with the letters "vir". The fact it is lagging behind meds like Sovaldi and Harvoni gives me hope they are an improvement, but I can not back that up in any way. Merck has invested billions in this particular duo of meds, so wouldn't think they would want to finally bring to the market an inferior product. I was very lucky to get this treatment, I dropped from a VL of 585,000+ to ND in 15 days. With a significant amount of cirrhosis however, only time will tell if I remain ND, and hopefully see some improvement in liver function. My last VL titer from 10-17-14 was ND, as it has been since August 20. I hope I have given at least one person a look into the process of clinical trials, and encouraged them to grab a slot in any Phase III ( meaning no placebos, excellent response rates, and obviously no horrific side effects in Phase I and II of the trial),  sponsored by a major pharmaceutical mfr., and conducted by a fully accredited teaching hospital like HUP. I wish continued good luck to all who have already achieved SVR, and to those who have not, please keep fighting. Keep checking the "https://clinicaltrials.gov" website, and if prescribed one of these new generation miraculous drugs such as Harvoni, look for financial assistance from the drug maker and conncect to other financial support via the Patient Assistance Network, "https://www.panfoundation.org". Keep bringing the fight to this miserable, insidious, miscreant scourge, and hopefully in 10 years time there will be no more HCV. That is the world I hope to live to see, I have seen too many people I know become statistics to this !@#$%^& of a virus. I'll be in touch from time to time, helping where I can and providing the periodic update.  T.I.A.F.C.,   mac790

[Livelife777]

Good morning Chet...For whatever reason I truly believe that you know in your soul if the Tx has worked.  Each case is so individually wrapped in its own uniqueness, that a broad sweep of the brush may not have entitled you
a greater likelyhood of SVR.  Hopefully your own immune system will kill this virus along with these promising breakthrough meds.
Only time will tell.
Wishing you the best!
....Kim

[simon4271]

greetings mac790 I also tried to extend my trial  treatment from 12 weeks to 24 but was told no from gilead .
I am almost finish solvadi ledipasvir 12 weeks .
Undetected at 8 weeks .
As I have cirrhosis I am hopeful but fearful at the same time .
By the way this treatment is harvoni is great I feel so much better
I bounce out of bed in the morning , 3 months ago I was in slow motion and foggy .
Good luck my friend

[simon4271]

greetings I also tried to extend my trial  treatment from 12 weeks to 24 but was told no from gilead .
I am almost finish solvadi ledipasvir 12 weeks .
Undetected at 8 weeks .
As I have cirrhosis I am hopeful but fearful at the same time .
By the way this treatment is harvoni is great I feel so much better
I bounce out of bed in the morning , 3 months ago I was in slow motion and foggy .
Good luck my friend

[Ekkiemom]

Hi Chet....well the good news is that you are UND and for that I'm so happy for you. The drop in VL in just 15 days is great! I know you were hoping for the extension and you're pretty disappointed. Look at it this way, you may not ever need another treatment, how great would that be right!  You will see that HCV free world we all will sooner than we think. Don't be a stranger! Will be praying for you, as always
Peace and good Karma
Deb

[patra_]

I know you were really hoping for the extension.  I was hoping for it for you.  Obviously, either you will not need anything else (truly my prayer, now), OR there is something else coming down the pike for you.

Thanks for the update, and keep on keeping on.  We will all be at SVR soon and very soon.  Pat