All Oral Trials Question

For those of you doing the all oral trials.....any idea when the trial phases will end?.....any idea how long the process takes to get these drugs to the patients not in the study?  Even though I know some drugs take years to get FDA approval.......some of the oral trial drugs have been fast tracked, so I wondered if that shaves off years or what?  I am about to start triple therapy with VIC soon but a family member brought the new drugs to my attention, so I wanted to pass it through to the forum.  Did a little research and found this article:

http://viralmatters.blogspot.com/2011/07/medivirtibotecs-hcv-protease-inhibitor.html

[curiouslady1]

The study that people have been referring to lately (a 2a study) is not finished recruiting yet.  Once it is active and no longer recruiting, the last participant enrolled can hypothetically be in the study as much as 96 weeks before it ends (if the last person is on rescue tx for 48 weeks and then is followed for another 48 weeks).  I cannot imagine the FDA moving on a drug that is still being researched at the 2a level.  However, opportunities exist to enter trials at the Phase 3 level where entry criteria is not as stringent.  Willy can correct me if I am wrong.  

[orphanedhawk]

Thanks for sharing.
Hopefully these new meds w/o interferon will prove successful.

[dixiechicdana]

My Doctor said that if I didn't make it with the triple therapy, it would be about 2 years for the oral drug without interferon to come out. said it was very promising.

[Willy50]

I believe the Vertex phase 2a trials started in 2006. The drug Just was approved; that took about 5 years to get from 2a to approval.

Many of these non interferon trials are 2a trials.  I believe it will be more than 2 years.
2014 or 15 is a good guess at an approved combination.  

Obviously, there will be many trials as that day approaches, but I'm not aware of one yet that is in phase 2b.

best,
willy

[dixiechicdana]

I don't know. My Dr is lead heptologist at Mayo Clinic rochester. He told me last time how long this one would be and he was dead on. He is really good at keeping on top of the mix.

[curiouslady1]

The study that people have been referring to lately (a 2a study) is not finished recruiting yet.  Once it is active and no longer recruiting, the last participant enrolled can hypothetically be in the study as much as 96 weeks before it ends (if the last person is on rescue tx for 48 weeks and then is followed for another 48 weeks).  I cannot imagine the FDA moving on a drug that is still being researched at the 2a level.  However, opportunities exist to enter trials at the Phase 3 level where entry criteria is not as stringent.  Willy can correct me if I am wrong.  

[Vannh9]

I also had become familiar with the oral only drugs and when I went to the doctor yesterday I asked him about all options, but especially the oral only. He indicated that while there are many new options coming and many new studies coming that formal FDA approval dor oral ONLY would probobaly be 4 plus years. Not sure how accurate his info is, but he did mention a couple of other studies that don't require meds 3x a day as I am concerned about the 60 g fat.

Good Luck!

Vann

[beeblessed]

Thanks for your input everyone!  I almost wish they wouldn't tell us about the possibility of better therapy, considering the side effects involved right now.  Frustrating not knowing whether to go right or left on this one.  I do have to say....my doc did have me wait to treat until FDA approval for Teleprevir and Boceprevir, because she thought the odds were better.  So she didn't just thrust me into SOC tx.  The idea of future all orals, with minimal to no sides is awesome but it just depends on how soon they will be available.

[curiouslady1]

There is no such thing as an easy life.  The back up for the all oral is interferon and ribaviron.  If you fail or look like you are failing, you get to take FOUR drugs instead of three.  Yipeee!