Merck 5172-068 Clinical Trial 12 weeks > EOT

[mac790]

Hello All,  Instead of a verbose update, I will add this cut and paste I just received yesterday from the one of the clinical trial coordinators @ HUP:

Hi Chet,
            
GOOD NEWS! Your post-treatment Week 12 results came back and your virus remained undetected, so you are effectively virus free! Still important to complete the final Week 24 followup, as there is a minute chance of the virus returning, but for now, everything looks great!

   Myself, I will not believe it until I receive a TND viral titer on the one year anniversary of my tx inception. That will be August, 2015. It has been a long road, but compared to other health matters I have to deal with, this clinical trial was absolutely a joy to participate in. The drugs, MK-5172 and MK-8742 now have names: Grazoprevir, and  Elbasvir. The pill was a large brown oval, containing 100 mg. of Grazoprevir and 50 mg. of Elbasvir. If you like, you can read more about them @: http://www.healio.com/hepatology/hepatitis-c/news/online/%7B1538869e-14ce-46a8-9214-3b575b69bc48%7D/c-worthy-grazoprevirelbasvir-regimen-yielded-high-svr-rates-in-patients-with-hcv-genotype-1
Curiously, the null responders to any INF based regimens, and with cirrhosis, did the best of all of the various sub groups. The SVR status of persons who fall into that category looks to be >95%. Merck was a little late to the game with these drugs, but with their basically negligible side efx and almost 100% efficiacy, they are sure to give Harvoni a run for its' money. Harvoni may be active against more GTs, I'm not certain. I was GT 1a, and in 8 days of therapy dropped from a viral titer of 585,000+ IU/ml to 396 IU/ml. In Europe, they are beginning to use much shorter times to determine if you will eventually attain a SVR, and the tx duration is being lowered in trials as we speak. I feel a bit guilty posting my success actually. I know there are some folks who will read this and feel despondent, because they can not afford Gilead's obscene prices, or don't live close to major university teaching hospitals where these trials are mostly conducted. Best of luck to you all, and especially to the friends I made along the way. mac790

[GP7852]

Thanks Sue
I knew that you would know what was going on with these new meds.I was sitting here wondering if I nshould call the nurse and see if I should try and get those injections but after reading what you said I am just going to see how my 2nd bloodwork turns out.If I do get rejected for both their Merck and Giliad trials I will go see my doc about trying my insurance for these meds when they are approved.I just hate the waiting,I can deal with the leg cramps but the itching is starting to challenge my sanity.

[SurfsideGal]

Glen, the nurse is misinformed but that is ok. We know the Merck drugs will be available very soon. In fact there is a Merck conference call set up for February 1 to discuss patient assistance and that has never happened before FDA approval so I think they are in line for a late January approval. Glen, I think you were likely going for Procrit (epoetin alfa) injections. They raise the hemoglobin, not the platelets. You become anemic when the hemoglobin drops. When platelets drop it is called thrombocytopenia. There is a drug called promacta that has approval to be used in HCV patients but it is not used often and I am not sure why. You would need to ask the doctor if rescue drugs like promacta and procrit and allowed in the study.

Dim, thanks for your explanation on buying these drugs out of the USA. I now know a bit more about it. I think it would definitely be an option for someone who has run out options for getting the drugs made here. Best wishes to you on that SVR. It's awesome and a surreal feeling after living with this disease for decades with no response from prior treatments. I want everyone to experience being hep C free and if we can access the drugs, that will happen.

[Dim37]

Hi Sue. I am not sure if they sell API's to individuals ,what i am saying is that the drugs are not hidden in a secret laboratory any more, they are available on the market in this form. Last August I found out about daclatasvir being available  in China . At first i thought it was a joke .At that time  I was dreaming about three bottles of Harvoni witch cost about 55000 in Europe . Anyway after two months of hesitation I contacted the company called Mesochem . In 5 days time I had the meds delivered with all the paperwork .99% purity . Today I am starting week 12 . I am not celebrating yet but I have a feeling God willing I will SVR . I am sure that this guys that created this byers club in Australia will soon find a route for people like Glen to be able to get grazoprevir . What I am trying to say is that there is a light in the end of the tunnel .  Soon people will start getting cured by millions all over the world . Gilead knew that this would  happen so they put wile they could this astronomical prices to get asap the most of the profit .  

[GP7852]

Sue
I trust you more than anybody.This nurse yesterday told me the drugs in the trial were probably 2 years away from being fda approved.I know after talking with you that she is way off but it still alarmed me that she would say that.I just wanted to check out every option available to me as far as online purchasing.

[GP7852]

Thanks for that info Dim
I am writing it down and if I get excluded I now have another option.They make it so hard to try and fix yourself.

[GP7852]

Hi Sue
I was thinking of the times when I became anemic from the peg and ribo and my doc would send me to the cancer clinic for injections to raise my platelets.I could ask them for 1 more chance with the bloodwork and get a script for the injections before I went back up there.That would surely put me over the limit as long as my doctors office cooperates.

[SurfsideGal]

Glen, with all due respect to Dim, who is trying hard to help you, you have options here before you have to go the route of buying on line which is not the safest way to do things. If your lab work does not come back as we hope, it won't be long until the drugs are available through Merck.

Dim, I didn't realize these drugs were available on line. But it scares me. In the late 90's an uninsured friend I adored, bought Infergen and ribavirin on line and ended up on the transplant list. The drugs were analyzed and they were not what they were promised to be. Unfortunately she died of liver failure long before she would have otherwise. Those drugs killed her with their impurities on top of a sick liver. Glen, hang in a bit longer before you take a chance on an unknown, please.

[Dim37]

Hello Glen . I am sory for your misfortune that keeps going on . I did a little search on the Internet and I  found  5 companies that produce grazoprevir and elbasvir in an API form witch is the active ingredient .
Basically that is the medicine, the rest are additives like glucose to make the pill taste better .  Two  companies are in China . Personally I prefer the Chinese because they love selling and they make things easy if you want to by.The other two companies are Indian and another oe is American witch probably supplies Merck  . Also  is stil around the sof+dac  24 weeks option . This one is very easy and cheap to get now . You don't have to beg the big companies to accept you . You can take your health in your hands . Just google grazoprevir China . As I said before things are getting easier . Best of luck.

[SurfsideGal]

These meds are not available on line. As you said they are not FDA approved yet.

Did the doc tell you when he will have your results? I bet if you call them today and tell them you are very anxious, they will have them already. A CBC and complete metabolic panel only takes 24 hours to be reported, in my experience.

[GP7852]

Congrats Chet
I was supposed to be in the same trial by Merck.grazoprevir,elbasvir for 16 weeks with ribo or 24 weeks without.I had to redo my bloodwork cause my platelets were too low.If they didn't go up I am going to be removed from this trial.Are these meds available for purchase online?I know they are not fda approved yet but I would buy them if they were available.

[Livelife777]

Hi there Chet
Have to say Congragulations ......thus far.
Mayo Clinic is also on the side of a 24 week cure as well.
Recently did pass the 24 week inspection and was given a "Thumbs Up"
Must say, your def in the drivers seat but 24 does create a huge sigh.
So very happy for you and hope the trend continues.
Be well
....Kim