Aa
big decision to make
So I finally found that I am genotype 1, after months of retesting. Went for my 1st liver biopsy on Monday. Now waiting for the results. I have a chance to do a study trial with all oral drugs with a group of hepatologists at a hospital. It worries me that these drugs are not FDA approved and have never been used all together on humans before. Or I can do a study with the approved drugs with the same specialists. The all oral drugs they say have less side effects and its possibile to treats in 12 weeks. The approved drugs are longer and more side effects. The plus is that my treatment would all be free. Every visit, test, all drugs. But I would have to drive an hour to this hospital at least once a week. What would u do?
The Dr is encouraging me to treat soon
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Never a bad idea,however" with what" is important. The current approved meds have approx. 70 -80% chance of success and possibly for 24 weeks.
Not to discourage you from a trial ,however always keep in mind they are experiments you donate yourself for so the drug comapnies can gather data on their new meds and the SVR rates are still an unknown.
Having said that ,there has been some excellent results early on with these trials ,but still lots of data to be compiled.
Again...do lots of reasearch and ask questions,and you could still consider waitng some (until a bit more is known),if it turns out you have "no " damage.
Will
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Never a bad idea,however" with what" is important. The current approved meds have approx. 70 -80% chance of success and possibly for 24 weeks.
Not to discourage you from a trial ,however always keep in mind they are experiments you donate yourself for so the drug comapnies can gather data on their new meds and the SVR rates are still an unknown.
Having said that ,there has been some excellent results early on with these trials ,but still lots of data to be compiled.
Again...do lots of reasearch and ask questions,and you could still consider waitng some (until a bit more is known),if it turns out you have "no " damage.
Will
There are several unknowns here. I am curious as to why your doctor is encouraging you to treat "soon". Perhaps he has some inkling that you have a disease process going on which requires more immediate action be taken? Many people with low fibrosis scores are being advised to wait for more benign therapies to hit the market before they treat.
I do have to correct something you wrote. The FDA approves all drugs before they are given to human beings. Some drugs are approved for investigational use only but there are strict guidelines and protocols for all drugs. This is why not everyone is accepted into every trial at every stage. You are not a total guinea pig. There has been considerable work in the labs, with human analogs and in early (Phase I) trials. All studies have to be approved not only by the FDA but also by Institutional Review Boards who ensure that subjects are treated ethically and appropriately. Further, in the HepC trials now, people have a good idea of what works and so you will probably not find a true placebo. If a placebo is used for a time, you will likely be given a chance to treat with the study drug and then often with SOC if you fail. This has not always been the case as I am sure you will hear from others in the forum.
I was informed today that there haven't been breakthroughs in my study which is still in early stages but the same site does do studies with the triple now on the market and there are breakthroughs and relapses in that treatment. Studies are being planned to treat people who are failing the triple treatment. Bottom line on this is that there is often an opportunity to do another treatment with other classes of drugs though the wait may be long. If you do consider a study, you will want to do your own little research on the drugs involved and whatever you can glean from prior studies.
As far as participation in a trial; from what I understand, many more people would rather face potentially severe and debilitating side effects than to put up with the inconveniences and unknowing of a trial. If you know yourself that you can neither wait nor tolerate two weeks of leave time from work and whatever else they request of you, it is best to go to the standard protocol. But it is a good idea to also do that with eyes wide open. You may find that you will reach a point that you are unable to work when treating with the triple therapy. Hopefully, you will also plan for that possibility.
I do have to correct something you wrote. The FDA approves all drugs before they are given to human beings. Some drugs are approved for investigational use only but there are strict guidelines and protocols for all drugs. This is why not everyone is accepted into every trial at every stage. You are not a total guinea pig. There has been considerable work in the labs, with human analogs and in early (Phase I) trials. All studies have to be approved not only by the FDA but also by Institutional Review Boards who ensure that subjects are treated ethically and appropriately. Further, in the HepC trials now, people have a good idea of what works and so you will probably not find a true placebo. If a placebo is used for a time, you will likely be given a chance to treat with the study drug and then often with SOC if you fail. This has not always been the case as I am sure you will hear from others in the forum.
I was informed today that there haven't been breakthroughs in my study which is still in early stages but the same site does do studies with the triple now on the market and there are breakthroughs and relapses in that treatment. Studies are being planned to treat people who are failing the triple treatment. Bottom line on this is that there is often an opportunity to do another treatment with other classes of drugs though the wait may be long. If you do consider a study, you will want to do your own little research on the drugs involved and whatever you can glean from prior studies.
As far as participation in a trial; from what I understand, many more people would rather face potentially severe and debilitating side effects than to put up with the inconveniences and unknowing of a trial. If you know yourself that you can neither wait nor tolerate two weeks of leave time from work and whatever else they request of you, it is best to go to the standard protocol. But it is a good idea to also do that with eyes wide open. You may find that you will reach a point that you are unable to work when treating with the triple therapy. Hopefully, you will also plan for that possibility.
I don't have the papers with me, but when I get home, I will check and let u know. The Dr is encouraging me to treat soon. He says I'm young and should just do the treatment and move on. The main problem with the all oral trial is that u have to report to the study Dr every day for the first 14 days. That's just impossible with my job. So I'm leaning more to the regular interferon/RIBA study. You only have to report in once a week for that one. Lots to think about. Want to make the right choice. This Dr is head of the whole hepatologist dept and I'm sure,I will be in good hands.
Hi Summer. Nice to see you again and glad you finally got the Geno type established. Did they finally decide to send it to a more advanced lab?
I would agree with nygirl on waiting until you have the results of your bx. before you decide what to do as far as tx. goes. If you have "no" or "minimal damage "(fibrosis) you may want to consider waiting until even more meds are approved . it still seems like it could be a few years out though .
If you have moderate or advanced damaged your doctor would probably suggest treating currently .
As far as a trial ..there are pros and cons to this and doing lots of research is important.
As sue asks what trial have you been offered ?
Good luck on the bx. results..
Will
I would agree with nygirl on waiting until you have the results of your bx. before you decide what to do as far as tx. goes. If you have "no" or "minimal damage "(fibrosis) you may want to consider waiting until even more meds are approved . it still seems like it could be a few years out though .
If you have moderate or advanced damaged your doctor would probably suggest treating currently .
As far as a trial ..there are pros and cons to this and doing lots of research is important.
As sue asks what trial have you been offered ?
Good luck on the bx. results..
Will
I'd wait to find out the results of my biopsy and determine if I had time to wait and see if the all orals have a chance or not. At Phase 1 nobody really knows if UND is SVR or not. If you have time to wait why not wait till there is data in to give you something to go by? Otherwise you are flying blind on that.
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