Posted 12/21/2013 1:08 AM (GMT 0)
This is what else we learned today.
Mike is assigned to Trial: GS-US-337-0123, Cohort B, Group 4.
Here it is: http://www.clinicaltrials.gov/ct2/show/NCT01938430?term=US+337-0123&rank=1
YOU can cut and paste it into your browser..only Mae knows the magical way to make that a hot link...she told me but I'm not smart enough to have understood. Or too tired.
Sofosbuvir, Lepasvir, and Ribivirin (no Interferon in this study).
They are looking at both 12 and 24 week groups which will be assigned randomly. He has not been chosen for part of the study yet. This means he is in a group who is post transplant with rapid return of the virus.
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They took a bunch of blood today, did an EKG, reviewed the consent forms, had the Research Center Chief, Dr. Shiff of the Shiff Center, examine him and give him a big pep talk:
- Most reach SVR quickly.
-Few fall out of the study from the sides.
-Though there are side effects, they will treat aggressively so he can keep going.
-With the rapid loss of Hep C copies, he should feel "better," not worse, during treatment when his viral load drops rapidly, even with side effects.
-If the Riba drops his red cells too much, they will reduce the Riba....woo hoo. He starts at 1000 mg a day.
-He is confident Mike will be CURED. Yes, Dr. Shiff used that word.
-Though the lab results will be collated for the research and not reported forward patient by patient, he will learn about his own viral load and labs each time.
He goes for labs every 2 weeks for a while and then every month.
He can resign from the study if he needs to for any reason without penalty.
They will follow him for several months after and he agreed to be followed for several years (several extra years sounds good to him).
He agreed to join a collateral study that looks at genes for clues as to why some folks are responders and others non-responders. That will be interesting to watch. We will not know anything about how that turns out until you see it in the journals....he will not learn if he has the genes that are not treatable.
The pills cost $1500 APIECE...you do the math -- for 3 months or 6 months. He is SOOO lucky to have this opportunity.
We asked what % chance there is at this point that he'd be OUT. Dr. Shiff said that they'd been following Mike for awhile (huh????) and had prescreened him pretty carefully and that something really bad would have to happen to NOT include him at this point.
Okay, so now I'm crying again a little...but that's just me.
Like the day we learned he had been listed for transplant, or got THE CALL...this is BIG for us. To think after all this time that there is actually a CURE at hand is another amazing miracle.
Thanks for listening to an old woman count her blessings.
Hugs,
.