New medication for Hep C study for the CURE

[Joycie1950]

Hi everyone.
I've been invited to join in a double-blind study for two new meds for a "CURE" for Hep.C. And of course, a placebo.
Maybe someone in this community has already been in the previous study groups. This will be the Phase III. The medicines are called "Asunaprevir" (ASV). The 2nd one is "Daclatasir" (DCV). These are the Dual Therapy drugs.
I won't be on Ribavin or Peginterferon for this study.
The docs claim that there are no side effects with these two drugs.

Does anyone have any advice for me?
Is there anything I need to ask the docs before I start the meds?
Thanks,
Joyce

[buslanejane]

Hi, You were lucky! I have genotype 3a and am in a phase 11 trial I'm pretty sure it is with the Pharmasset7977+ Ribavirin, peg interferon(a) + Ribavirin trial. halfway through Gilead bought out pharmasset. Anyway I had a fibroscan and found out that I have cirrhosis. I was not lucky enough to be chosen by a computer that I would take the new trial drug and got the standard treatment. I tolerated it not too bad, except for insane rash and itch on my legs and until near the end where I feel the ribavirin made me feel ill more so than the interferon. It took between the 8wk and 12wk visit for the virus to be undetectable and my liver function tests got worse. I have put on weight and am bloated and a week after treatment stopped my liver ached so badly, I just knew the virus had returned with a vengeance-and it had.
It's been 5 mths since then and I am still waiting for the 7977 and ribavirin to start, but what makes me mad is the first treatment, I should not have been on as it has really made my liver worse and I just hope my liver can handle the next treatment, even though 7977 has no side effects, the ribavirin is what worries me. What annoys me the most and I feel people should be aware of is that the trial doctors and nurses, really don't care if you have cirrhosis and you are making your liver worse by the standard treatment and they still tried to tell me I had a 60% chance of being cured, which is ridiculous. The other 2 people that had standard treatment with me are cured and the other 5 that got the new drug 3 have been cured. The 2 that aren't only 1 had cirrhosis. I am the only poor sod that got the standard and has cirrhosis. I'm just angry as a liver doctor would have not recommended me going on interferon with cirrhotic liver. I just hope the new drug works and I can try and repair my liver somewhat, as at 44 this month and a daughter that's 17 next month, I am not ready to check out just yet. Glad it worked out for you and I hope it works out for me too. Just wish I had of got the new treatment to start with. Peace, Jane.

[Puppyluvur]

Thoughts please! I'm considering Abbot Trials phase 3. I was reading some of the posts about being careful with trials. I came across cheesegrater's post where he/ she said ASV (protease inhibitor ) & DVC( n55a inhibitor) combined showed dismall results in 1a. Could you explain?

[dmgt86]

I got my results today, HIV1&2  Antigen/Antibody            Negative.
Hepatitis B (HBsAg) screen Negative.
Hepatitis C antibodies Negative.

I was so nervous when he was reading  the results out that when he told me I was Negative i shouted out "YESSSSSS" in total relief,I now have a little better understanding of what ur all going through.
All the best for you all and thanx for the advice.

[UKgirl55]

I wish people knew what they were talking about before they say such negative comments. This is why I rarely come to this site, but on occasion I do and then I have to respond. The reason you've been offered this trial is because you're a geno 1b. The combination of these two drugs have been VERY successful for geno 1b's. You'll do really well on this trial....I have no doubt! Congrats for getting in the trial and lucky you being a 1b :-)

[maybe368]

You do not Svr until 6 months after end of treatment. You are probably undetected viral load. My doctor told me that they may lower the svr time to 3 months after end of treatment, but as of yet they have not done this. I have 6 more days of riba and I will be at end of treatment. Have been und since week 4 and hope to svr in 6 months and a week...good luck...Mark

[johno222]

My docter told me before going on tripple therapy thathe wouldnt go on it knowing what he did .I remember he said to wait as therewould be new drugs out coming soon with allot less side effects .Those in the know know .I have just finished 12 weeks on incevek .was told im SRv but will have to be on Ribivirin and peg for anothe 9 months .I would not personally reccomend for anyone to go on this stuff .Think very carefully and read as much as you can .

[Joycie1950]

Hi,
Thanks for your response.
This is the Phase 3 clinical trial.
I found out yesterday that they changed my status or protocol, whatever. I will be in a sub-group that is open. I will be on Asunaprevir (ASV) 100 mg. twice a day taken orally and Declatasvir (DSV) 60mg. tablet once a day.
I'm praying that there will be no bad side effects.
I've decided if I notice any discomfort, I'll stop the trial.

[Joycie1950]

Hi...Thanks for your input. I will ask the research coordinator I'll be working with the questions you put forward. I do know its a double-blind study. And that if I'm on the placebo after the first 12 weeks, I will be receiving the asunaprevir & declatasvir for another 12 weeks in a separate research study for 24 weeks total. If I'm not responding well to (ASV) and the (DCV)  and I am in the null or partial responder group or in the tx naive group, I have the opportunity to take those 2 drugs plus peg interferon and ribaviron.
I know I won't tolerate that and I won't do it.
I don't feel sick and my doc said that my liver wasn't that scarred after they did the biopsy.
The docs know I am not willing to do the peg interferon/ribairon.
I've been slim most of my adult life and obesity is not an issue.
I've had this disease since the mid-1970's. I don't have Hep B or any other diseases.
I have HepC, Genotype 1b.
What else should I ask???

[dmgt86]

Thanx iv arranged it but surely if id had it it woulda showed on my liver function test in 2010 if i had it then?
Which if i do have it means i did then,a friend of mine got diagnosed a year ago and said theres a new treatment out thats 90% successful and he has now got rid of it.Any1 here heard of that?

[Noku77]

Thank you. Is all I am going to do.
Regards
n

[orphanedhawk]

Currently the only cure available to most people is interferon based.
Here in the US, people with genotype 1 are using interferon, ribavirin and a third med, either boceprivir or teleprivir.
Statistically this is the best chance for genotype 1 to achieve a cure.

However, there are new meds, with far less side effects, currently doing well in trials here in the US and no doubt, abroad as well.
Some people are choosing to wait until the new meds are available to do treatment however we do not know how long that will be.

You need to talk to your doctor, preferably a hepatologist, a liver specialist, or other doctor experienced in treating the virus, to learn what is available to you in your country.

[Noku77]

Hello evryone! What might be the best cure for 1b genotype?
regards
e

[rivll]

I was in a study with pharmasset before they sold to Gilead.
I was given psi 938 and a placebo. Though I was undetected within the first two weeks, they halted the study after the 4th week because many people had sky rocketing liver enzymes as a result of psi938. I did not.
Part of my contract with my study was that I would have the rollover option-absolutely essential if you do this study.
The promise was that if the original meds did not work for any reason, I would be given the meds that had been proven most effective. It turned out to be what is now GS 7977 and Ribavirin.
I had a hard time with the riba, I suspect because I was already really sick with cirrhosis. Anyway it seems to have worked. I have been undetected and remain so 16 weeks after treatment. I feel better every day.
The Dr. told me if I relapsed they would keep working with me.
I couldn't do interferon. I always knew would not have been able to tolerate it and took a huge risk which turned out well for me.
I advise you to think carefully before refusing this option. It may not be for you but don't dismiss it w/o further inquiry and make sure they have the rollover option.
I wish you al the best, whatever you choose.

[hrsepwrguy]

"im afraid i have it and afraid to be tested HELP please thanx.
PS im in no way scared etc so dont sugarcoat it thanx"

The only way to know for sure is to get tested

[dmgt86]

Im curious if anyone hear before they were diagnosed with HCV had put on a serious amount of weight?
Id like to know please to ease my curiosity thanx.
I last had a liver function test in Feb 2010 and was told it was fine but now someone i know has it and im afraid i have it and afraid to be tested HELP please thanx.
PS im in no way scared etc so dont sugarcoat it thanx

[Cheesegrater]

ASV is a protease inhibitor, DCV is an NS5a inhibitor,
Be warned...
These two compounds in combination have shown dismal results with genotype 1a HCV.

[Xhrles]

These are Bristol Meyers Squibb drugs and there is info on them. The NS5 drug was trialed with Gild7977 and was 100% effective. The Asunaprivir is BMY's replacement for 7977 since Gild will not do a further trial. There should be trial info on the BMY website.  Good Luck

[rambleon40]

"The docs claim that there are no side effects with these two drugs."

You think?  that truly made me chuckle!  :-)  

[Advocate1955]

I agree with Dee.  It is important to do some research on the trial to make sure that the likelihood that it will benefit you is high.  The purpose of the trial can vary, sometimes it's for treatment/intervention, and sometimes it's not.  If treatment/intervention isn't the goal, then you may not benefit.  If you received the placebo, would you then be treated afterward?  Sometimes the results are open and sometimes their blinded.  If the results are blinded, it may take years before you find out exactly which drugs you received, which may prevent your ability to treat with an approved drug in the future.
I have some info posted in my journals about the need to research trials carefully before deciding.  This article was posted by specda, another member of this forum.  Here is the link to my journal:
http://www.medhelp.org/user_journals/show/332520/Clinical-Trials-and-Medical-Research-in-Hep-C
Advocate1955

[Dee1956]

Hi, do you know what level this study is?  I did a level 2 study, thinking the objective was to make me well.  It wasn't, it was to help the drug company decide if the drug was safe enough to go on to a level 3.  They couldn't and it caused me some problems.
If I were in your position I don't know if I would want to go on a study where I might receive a placebo.  If there is nothing else and you have a lot of damage I could see where you would want to do this.  I am sorry that I don't know anything about this medication.  I wish I had known what I did not know back when I trusted a doctor to put me on a study.  I should have done more research
Have you already done a tx? Do you know the level of damage you have right now?  
I wish you all the best.
Dee