Criteria for participation in a clinical trial vary from trial to trial. It depends on many factors, but one of the most important is the health of your liver. Do you know what stage of liver damage you have, and when was your last liver biopsy? What was your response to prior treatment (partial? null? breakthrough? relapse?) Are you followed by a hepatologist, and, if so, how frequently?
You can check: www.clinicaltrials.gov, and place in your search criteria in the boxes. There is an article in my journals that you can read that contains information about things to consider if you are thinking about a trial.
My husband is in the same boat as you. He is G1a, failed SOC (partial responder), failed Consensus Interferon + RBV (partial responder) and failed triple tx with Incivek (partial responder). He has Cirrhosis, but his liver is still compensated. There are currently no trials in our area for which he would qualify, but some may be coming up this year. We are looking for trials and waiting for new meds. He is followed every 6 months by his hepatologist to be screened for decompensation and liver cancer.
thanks a lot !!! First tx SOC non responder, the same VL when I started.
2nd tx SOC null responder at week 24, 3logs at week 4, but no UND after and started to go up at week 8, so suspended. I'm followed by the same hepatologist every 6 month, he said that I'm a null responder for BOC. Cirrhosis compensated at the moment, hope not to get worse. I checked clinicaltrials but there is nothing yet for TVR or BOC experienced patients.
I hope good news for everybody
Wow, if I'm reading your previous results correctly, you must either have a very resistant virus or your body responds really poorly to Interferon or both. Hopefully some of the real knowledgeable folks regarding treatments will post replies to your questions too. My husband is a partial responder to all of his previous treatments (had the two log drop to SOC and Consensus, but did not get to UND by week 12 either time; got to UND by week 8 of triple tx w/ Inc, but then had a viral breakthrough by week 20 or so). He is considered to be a "tough to treat" patient in that either his virus is quite resistant or his body does not respond well enough to Interferon or both. If your VL never dropped with your 1st SOC, and then dropped 3 logs but no UND with 2nd SOC, and then never made it to UND with triple tx w/Boc and then went back up, you must be in that category of very difficult to treat. So, if I'm understanding correctly, you have Cirrhosis, but your liver is compensated, right? So far as I know, there are few or no trials for which you would qualify at this time. That is because you are in a difficult to treat group and you have Cirrhosis, and most of the drug companies are just completing phase 2 and 3 trials now and will be starting trials with Cirrhotics later.
Another forum member posted this trial: http://www.clinicaltrials.gov/ct2/show/study/NCT01466790?term=7977+TMC&rank=1&show_locs=Y#locn, so you can look this over. It is a phase II trial, so you will need to consider carefully whether or not the benefits outweigh the risks. However, it is an open, unmasked trial with a goal of intervention.
How often are you being followed by your hepatologist? You should probably be seen every 6 months to be screened for liver cancer and to make sure that your liver is still compensated. Also, hopefully you are familiar with all of the liver friendly advice to keep your liver compensated. If you become decompensated, you will be less likely be able to participate in a trial or treat your Hep C in the future.
Keep in touch.
Thanks for your aswer.At the 2nd tx with SOC, my VLdropped, but less than 1 log. I'm exactly as you sad, both. Viral resitence after BOC when VL dropped for >3 log but went up at week8 and poor sensibility to ifn. For sure I'm one of difficult to treat. I'm 61 years old, my hopes are vanishing, I think I have to to wait, keeping my liver compensated. I'm followed every 6 month. My best for your husband and hope for better news.
Yes, that's exactly what you have to do, wait, eat a liver friendly diet, maintain an ideal body/mass index, have a healthy lifestyle, don't take any iron, don't take any supplements or medications unless your hepatologist prescribes them or OKs them, see your hepatologist every 6 months and follow all of his/her recommendations, ask him/her to notify you of any trials that might be beneficial to you, check www.clinicaltrials.gov frequently, keep your liver compensated, and wait for either a trial or new meds. Check this forum frequently too for info about trials and treatments for "treatment experienced, compensated Cirrhotics, prior partial responders."
Hopefully hope for you is right around the corner. By 2014 we should have a effective 1 drug treatment using the protease inhibitors. Recent advances have been made using a one pill per day treatment with the goal to be 12 weeks of treatment time. This was the entire reason that the triple tests were conducted so that the efficacy of protease inhibitors can be shown. It has been and now because the enormous number of people who have been diagnosed with HCV and the potential money to pharm companies being billions they have sped up the development of RNA specific treatments that eliminate the issue with genotype resistance. The new treatments wipe out the virus (so to speak) no matter which genotype you have. Most of this research is derived from the same techniques being used to develop HIV meds. Although the virus is different the techniques and research to find a "magic protease inhibitor" that causes fewer side effects and quicker response time is similar.
thanks a lot ! Hope that one pill treatment will be as soon as possible available for all of us. I'll be content even with more pills if necessary, just to be the right one before I get too old to be treated. For now I just wait and continue my normal healthy lifestyle. It's so comfortable to find such a nice and helpful forum with people like you all.
Could please post the info to these 1 pill treatments you are speaking of because I am unaware of any 1 pill a day treatments without interferon and ribavirin in any trials at this time, unless they are all oral treatments which actually involve more than one pill a day
The folks in Europe are about 2 to 3 years ahead of us. I agued with the people at the University including nurses that should know that side effects from some of these combination treatments can cause horrible skin lesions (which I experienced) the only way I found out about some of these side effects was from the European results. They all ready went over the fiscal cliff long ago and actually work for a living in that part of the world. They actually have people that believe in climate change and science too! Maybe someday we in this country can get around to solving problems rather then creating them...
To my knowledge, GS7977 is a nucleotide, not a protease inhibitor. I believe Gilead hopes to apply for GS7977 to be approved in combination with other drugs such as Interferon and/or Ribavirin to treat Hep C. Approval can take many months and may or may not happen. Gilead is doing trials with it's own NS5A inhibitor, GS5885, but that drug is only in phase 2 trials (and one phase 3 trial with treatment naives) will not to my knowledge be submitted for approval next year.
The next treatment for compensated Cirrhotics who have failed triple therapies with the protease inhibitors Incivek or Victrellis will likely by GS7977 (Sofosbuvir) combined with Interferon and Ribavirin.
As a PS to my post above: Of course, it won't be long after GS7977 (sofosbuvir) is approved in combination with RBV and IFN for Cirrhotics with G1a, that sofosbuvir will likely be submitted for approval in combination with GS5885 and probably combined with RBV as well (based on the combinations of drugs that are in current or upcoming trials). I don't see a 1 pill once daily treatment for 12 weeks in the very near future though.
we can dream can't we? since I did respond to the 3 drug cocktail rapidly and completely I can't wait till I get to do it again! But thanks for correcting me since that post I have "straightened" myself out with all these new scenarios for treatment--didn't know there were so many strategies for attacking this virus.
Maybe they should run the odds to a single drug cure on the Las Vegas sports boards -- then 50% of the money could go to research. According to some sources the new taxes on the health care industry will cut research spending by 5 to 10 % just what we don't need
There are probably about 55 trials either recently completed, currently active, or recruiting with various GS drugs for Hep C treatment. For each of the drugs that you listed above there are various combinations in trial and various arms of each trial.
GS7977 is in various trials combined with TM435, w/RBV, alone, for pre-transplants only, for G1s only, w/IFN, for treatment naives only, w/SOC, etc.
GS5885 is in various trials combined with GS9451 + RBV, w/IFN, w IFN+RBV, and w/GS7977, etc.
GS6624 is in various trials for both HIV and/or HCV participants with fibrosis
GS9190 is in various trials w/IFN, w/RBV, w/GS5885, w/GS5885+RBV, w/GS5885+IFN
GS9256 is in various trials w/GS9190, +IFN, +RBV
GS9451 is in various trials alone, w/IFN + RBV, w/GS5885 + RBV, w/IFN + RBV
GS 9620 is currently in one trial for treatment naive only
GS9669 is currently in one trial alone
Someone else on the forum may have more experience than I do regarding trials, (I have no experience other than reading), but I believe when the drug companies are completing all of their trials they test the drugs in various combinations and with various populations to see what works and what doesn't work and what works best with the least adverse effects. As they move through the various phases of their trials, they discontinue testing combinations that are not successful or have too many adverse effects. They continue testing with combinations that are successful. They present all of this trial data when they submit various drugs or various combinations for approval.
We are fortunate that there are people who are willing to participate in trials at so many levels so that drugs can move forward through the trial phases in order to even be submitted for approval. Without those willing participants, there wouldn't have been Incivek or Victrellis approved to successfully treat so many people in the past 1 1/2 years.
The risks are high for trial participants, especially when the drugs are only in phase 1 or phase 2 trials, if the results are masked, or if the potential for developing resistance to a particular drug or a type of drug is high. Participation and potential failure may affect one's ability to participate in a future trial or to treat with a future approved drug.
In my humble opinion, when drugs reach phase 3 or phase 4 trials, the likelihood is higher for successful intervention. Additionally, if the results are open and if there is no risk for resistance, it seems like a good idea to look into the trial, especially if there are no approved treatment options available.
Anyone participating in a trial should consider it very carefully first.
There are many factors to consider and much depends on individual variables such as genotype, stage of liver damage, etc.
Personally, I think if a phase 3 or phase 4 trial came up with GS7977 for G1a's with Cirrhosis, my husband would probably try to enroll if his hepatologist thought it would be a good idea, primarily because at his stage of liver damage and his age there is a risk to waiting for new treatments to be approved.
I asked my hepa about re-treatment with a DAA after a failure with a DAA. She said that this was a pretty new subject and there is concern about creating drug resistant variants which could get back out into the public causing bigger problems so for now it is not reccomended, but there will be trials at some point.
I like your attitude of concentrating on being kind to your liver, body, and mind until things are sorted out.
For me that means proper:
DIET - everything you put in your body goes through your liver even if it is not metabolized there
EXERCISE - I was skeptical of this because many times you don't seem to have the energy to do it, but since I have been doing it the last three years, I almost feel normal on some days!
ATTITUDE - whatever that works for you to improve your outlook on life and helps you realize that you need to live your life just for today. Learn from the past but realize you can't go back and change things. Plan for tomorrow but that is the only real power you have over it. That you woke up today is a blessing and a gift not to be squandered. Because it is a gift, it is called the present! For me this means prayer, meditation, serenity in accepting the things I cannot change, and the courage to change the things I can...
I appreciate the research and education being on this thread people: thank you for providing the knowledge.
There are so many new meds being researched, for the Treatment of Hep C, so I just keep reading about it all, and letting it sink in, and then more review, and more reading, and this is good stuff :)
There is a lot on this site about trials with Gilead Science's 7977. In fact there is an entire thread dedicated to it. Go there and ask how to apply to get on a trail. All I have read is the treatment is spectacular. Average treatment appears to be 7977 with Ribavirin for 12 weeks.
Actually, the point I was trying to make to rodian, who like my husband, is G1, has compensated Cirrhosis, is about 60, and has failed treatment with a triple tx with a protease inhibitor, is that there are currently very few trials with GS7977 that are accepting people in that category of hard to treat (G1) and with Cirrhosis. If you look at the inclusion criteria of most of the current trials with GS7977, rodian and my husband would be excluded. As I mentioned above, another forum member posted this trial: http://www.clinicaltrials.gov/ct2/show/study/NCT01466790?term=7977+TMC&rank=1&show_locs=Y#locn, which is accepting Cirrhotics. Later in my posts in this thread I wanted to address einsteinus' post about a 1 pill (GS7977) once daily treatment for 12 weeks that she said would be approved in 2014. The lists of trials currently running or recruiting do not indicate that a 1 pill (GS7977) once daily treatment for 12 weeks will be approved in the near future.
Doofus_jones, since rodian, and my husband, have Cirrhosis, they would not be eligible for the GS7977 trials that other members of this forum are currently on.
Again, rodian, the best thing to do is to see your hepatologist every 6 months or as often as he/she says, be screened for HCC and decompensation, live a liver friendly life (and I agree with Big_Daddy59 this includes positive attitude along with diet and exercise), watch for possible trials for treatment experienced, non-responder to protease inhibitors, G1s with Cirrhosis, but consider them carefully with your hepatologist before applying/enrolling. Trials are experimental in nature, even if their goal is intervention, and with Cirrhosis, one must be careful to avoid the risk of an experimental (or even an approved but very difficult) treatment which might cause one's liver to decompensate. Treatment becomes more difficult as we age and also as liver damage progresses.
You have made no errors! Few of us have to to sift through the rapidly changing, immense amount of info on the Internet If anything there is only the possibility that perhaps like you me you may be a bit naive when the Protease Inhibitors were "fast tracked"
The article on that one pill treatment indicates, "plans to start a combination study of two drugs in a single pill to treat hepatitis C by the end of the year, putting it on track to request U.S. regulatory approval"
If the combination is effective, the company could apply for regulatory approval in the middle of 2014, Bischofberger said.
"Starting a combination study"
"Could be apply for regulatory approval"
I am in no way trying to rain on your parade I am merely saying I have seen projections for the initial dates change more time than I care to remember. In fact, off hand I do not think I have ever seen many adhere to the time frame outlined in the initial announcement.
Let us hope that is not the case here since this one is Ribavarin free!!
Double thanks or the link since I was unaware of this♫
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