Viral Loads In Clinical Trial Report

[mac790]

Hello All, It has been a while since I posted, simply because due to paperwork difficulties the viral load test results were delayed. I finally received them, for those who don't reognize the post's title/name: I was lucky enough to be accepted into a clinical trial at a major NE USA medical center conducting Phase III clinical trials of a new combination therapy drug from Merck. I began tx on 8 Aug 5, 2014, with a viral titer of 585,000+. After 7 pills, the load was 396. After Week 2 (14 pills ,one a day in the AM) it was undetectable.To be precise, this lab's cut off for detectable/undetectable is <15 IU/ml. My Week 2 load was 17 IU/ml, but marked with a note "clinically not significant". Perhaps Hecotor or others know for certain, but I suspect that there is a certain margin of error in counting the copies spawned by the virus, perhaps how quickly they spin down the samples and perofrm the test effects the result. In my experience, "clinically insignificant" means it does not constitue any meaningful difference. Week 4, a total of 27 pills actually, the load was "<15 IU/ml". If I was not "technically" undetectable at @Week 2, I certainly was at Week 4. I am only on the meds for a total of 12 weeks, it could have been for 16 weeks, but for the roll of the dice. These drugs are so new that there is no data stating that those who are treated for 16 weeks attain/sustain an SVR more frequently than those treated for 12 weeks. This is Phase III of the trial, it is not due to conclude until June 2015. I am Stage 5, and have had this unwelcome guest in my body for almost 30 years now. Given all that, from 585,000 IU?ml+ viral copies down to <15 IU/ml after 27 pills is nothing short of miraculous. I failed miserably the "Pegasys/"Copegus" combination therapy in 2009, of PEG-INF ALPHA-2A and RBV. I was terminated after 3 months after not attaining the necessary "log 2" drop in viral load. I fully realize that things could change from day to day, week to week, ad infinitum. I wonder what will happen when I stop the tx, and if I will retain a permanent SVR. Only time has the answer to that. I go into this depth of detail to try to explain why I am always advocating that people who do not require immediate tx NOT bankrupt themselves, and search for clinical trials for one of the many  new generation txs for HCV/CHC that are in Stage II and III of testing. Also, I post all this detail to explain why I advocate, if medical conditions warrant, that people who are not fortunate enough to find a local clinical trial wait as long as possible to get treated. If you MUST pay for it, please avail yourselves of all of the financial assistance programs extant. In the following years, Merck, AbbeVie, Gilead and others no doubt will have practically identical versions of these new, 97%+ SVR rate meds, (regardless of cirrhosis,BTW) on the market. This competiton, plus the pressure put on the companies from the public's clamor via Medicare and private medical insurers for these miracle drugs, will have to force the prices down. To all those recenlty diagnosed, your future is gleaming with hope. This breed of meds may have come along too late for some our brethren, unfortunately. I can envision the day, 10 years from now, when you simply check into a clinic or hospital for an overnight stay, you undergo an infusion lasting a few hours, and obserevd for 24 hours. You are then released, totally virus free. I really believe we will get there, and possibly even sooner than 10 years from now. They have broken the genetic code of the HCV, and figured out a way to kill it completely ( well, 97%+ of the time as of today) without major side effects from the medications. Very encouraging indeed, yes? If anyone has any detailed questions about being in a clinical trial, or my experiences in particular, please do not hesitate to post to the forum or drop me a line directly. I will help wherever I can. To all of you, in tx or not, best wishes. Finally, for those who find themselves in a dark place right now, please try to find hope in the knowledge great things are coming, and quite soon.   mac790

[mac790]

Penn, I can't say, I'm not an MD nor virologist. I've been fortunate enough to avoid it, as I understand herpes is an annoyance at worst, there is no lethality attached to it. The HCV can lead to liver cancer in as many as 20% of cases, and there are over 3 million Americans alone infected with this pernicious, furtive, and up until now, very hard to eradicate virus. The >3 million Americans suffering with what could turn out to be a lethal disease is a great motivating factor for Big Pharma to crack the genetic code and find a cure. Even a vaccine is in the works. Just a jaded opinion from a 30 year host of this stinking virus, but maybe, if my luck holds, on the verge of eradicating it.   Mac

[penn1023]

Why can't they do this for herpes virus, epstein barr, cytomegalovirus, etc?

[Livelife777]

Congrats on getting into this trial and hoping you experience a positive result.
Also find it encouraging what the future has in store for us regarding all illnesses.  Would be interested to hear how Tx progresses.
May you achieve SVR
Be well
....Kim

[mac790]

Hi saltavar, Very sorry to hear about your unfortunate turn of events. As mentioned by searching both sites I mentioned in my overly verbose post, you might find a trial near you for one of the many new 97%+ success rate medications. Merck will want $84,000 for 12 weeks of this med I am using, which is unfathomable to me. We can only hope competition and public pressure will force the prices down. Good luck with your next attempt at getting access to a drug that provides you with a SVR.  Mac

[mac790]

Dee, Hi. If you go to clinicaltrials.gov, search for the NDC# NCT02105701. That will give you all the info on it, and let you search if there is a similar trial near you, if you were interested.   Mac

[mac790]

Hello Hector, Sorry for the error in spelling your name. The trial is described in length @ healio.com, just search under "C-WORTHy" from the "EASL 2014" confrences. The drugs are from Merck, the designations on my consent form are : MK-5172, and MK-8742
Clinicaltrials.gov ID# NCT02105701
I do know the MK-8742 is a NS5A replication complex inhibitor, and the MK-5172 is a NS3/4A protease inhibitor. The study arms open were 12 weeks, 16 weeks, then the same periods with RBV as well. I drew the one pill a day, w/o RBV 12 week tx arm. Of course, it is easy to assume if 12 weeks is good, 16 weeks is better. As they will not even conclude the tx part of the trial until June of 2015, then have to analyze the data, this assumption is pure speculation. BTW Hector, I do enjoy your replies, most informative. A note worth mentioning I think is this study was open ONLY to patients that failed to attain the necessary log 2 drop after 3 months in Roche's combination Pegasys/Copegus therapy. So, failing that regimen in 2009 may well turn out to be a blessing in disguise. Only if my SVR holds for let us say, 12 months, will I hoist the flag of victory. As we all know, this is one furtive, hard to eradicate virus. Take Care Hector,   Mac

[saltavar]

After recently failing 8 weeks of tx with oly/sov I want to thank you for your post! It made my day!!

[Dee1956]

Hello, this is very encouraging, I am so happy for you!
Thank you so much for posting this positive information.  It will give people hope.  97% is really good.  Does this trial have a name?  Sorry if you mentioned and I over looked :)
Take Care
Dee

[HectorSF]

Are you in the Merck C-EDGE Phase III clinical study with MK-5172 and MK-8742 trial?

Hector