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29837 tn?1414538248

New Approach for Treatment

As some of you know, I've been trying to get a "compassionate use" approval through both the FDA and Vertex for the VX-950 protease inhibitor. The road has been long, going back and forth with the FDA as to exactly how to fill out the paperwork, with the doctor finally sending all the paperwork to the FDA tomorrow. He will also contact Vertex once the FDA gives their approval. I will post the results.

My Gastro has a plan, and I would like to know if anyone else has heard of or has tried this approach:

When I finally get the VX-950 (or something else), he first wants to double dose me with Pegasys and raise the Riba to 15mg daily from 12mg. His train of thought is that if and when we bring the viral count down enough, then we introduce the protease inhibitor.

This seems like a enigmatic move to me, but he has given it a lot of thought. Now, I would like to get your thoughts on this type of approach. Naturally, he said it was up to me. He also said that if I don't drop the viral load soon after the double dosing, he would go back to standard dosing and the protease inhibitor. He plans blood work every two weeks to be sure I'm not being killed. In case you don’t know, I’m a four time non-responder.

What do you tink?

29 Responses
751342 tn?1534363621
I'm thinking you don't have anything to lose with this approach. I have heard that higher doses of Riba can up the viral load drop. I'm currently on a study, and depending on my last results, the 12 week, I may be adding a protease inhibitor and another drug that helps with the uptake of the protease inhibitor. I will do 12 weeks of these 2 in addition to Peg/Riba, then go back to SOC for the duration of what will end up being 60 weeks if my math is correct. What my study is doing sounds very similar to what he's suggesting, except that I have had weight-based Riba for the past 12 weeks. You will be on a higher dose, and will probably have some brutal sides. If your doc is checking your blood every 2 weeks, you should be OK. I get mine drawn once a month and while they will get a phone call on the weekend if my platelets drop, they could conceivably drop earlier rather than later in the month. I could be anemic for 3 weeks without knowing. Good luck with this, it sounds like a valid plan to me.
789911 tn?1368640383
How do you go about getting a compassionate use approval by the FDA?  
9648 tn?1290094807
I'm on the boceprevir trial. We did that 4 week lead-in of SOC which was supposed to give us a boost--just standard dosing. My experience with that was thus:

Day 1  1,320,000
Week 2  940,000
Week 4  629,000
Week 6   <25

Can you see where I started using the PI?

If you've treated several times and haven't cleared, I don't see what it is going to do for you to crank things up that high. It's really the PI you are counting on to make it all work. I think the pre-dosing makes sense but double-pre-dosing seems excessive to me. Just my opinion.  
Avatar universal
I don't think it is necessary. The PI added to SOC will knock it down within the first week without all this extra stuff. Why jepordize the TX with double dosing, etc
408795 tn?1324939275
Amazing!  I'm glad to hear that you got the ball rolling on the fda and compassionate use idea.  I hope you get something that works for you.  The idea the doctor has sounds like a good idea.  I think he just wants to make sure that it works for you which is what everyone wants.  I think you know how much you can take since you were almost od'd before on the infergen or something, right?  Anyways, go for what you know as you are definitely a a hard to tx type of person.  I wish they would get to the point in research so they can tell which subtype is the most difficult to tx and break it down so we heppers will have more info to go on.  Anyways, just thinking out loud.  good luck to you and I'll be following your progress
233616 tn?1312790796
well I'm totally rooting for you to get this compassionate use...

although I wish you could share your doctors reasoning with us. I know you said he though about it a lot...but I'm concerned for several reasons.

1. We know the teleprevir works better than the riba, so the only advantage to preloading anything is to get to UND quicker and have a better outcome especially if the length of teleprevir is to be limited to 6 month tx this might make sense.

2. However, you still are treating for the 4th time, and I have no idea at what stage/grade
My question to your doc is how likely is this to overload your liver. We know that the higher the Riba the more the chance of kidney fibrosis and or failure, and doubling INF is dangerous as well as brutal at any stage but especially in later stages. It seems a lot of doctors are doing this now, or else desparate patients are doing it on their own, but it would make more sense to me if you were say to preload with some alinia, and not OD the Riba, nor rather than to double your INF...as this can also lower VL significantly but with no where remotely close to the deliterious side effects.

3. Is the doc trying to make sure you succeed even if it costs you your liver or kidneys?
I only ask this because I ALSO wanted very much to double my meds until I tried briefly, and also read that 1 in 5 with Higher Riba dosing lost a kidney...between that and the DD of INF over one week...it cured me.  Of course, it's your body, and you may react differently....but most of the people who have DD'd have later said they wish they hadn't...at least from what I've read.

4. I think that DD should require a weekly CBC etc.  It takes time for neupo or epo to work...and the sooner you catch a tank the better...plus, you are likely to tank before you even get to the Vertex drug...how does that effect tx when the telprevir is hardest on the WBC of anything....I'm just saying...this might be a genius reasoning, or something that will blow up in your liver, not his...so I would want him to define his reasoning and see the studies where predosing did make a distinct difference.

5. Also, Vertex may have some guidelines even for compassionate use, just as they would for SOC...those guidelines might include being removed from tx should platelets fall below acceptable levels. I'd want to know what those guidelines were up front, and be careful not to tank myself in the first month of PI tx if it were me.
Hoping not to discourage you here magnum, just wanting to make sure you and your doc have thouroughly discussed all this and that he is aware of the inherent risks as you should also be.

6. Also the final thought that comes to mind is that "compassion use" may mean that your insurance company may look at the whole tx as off label...in which case how likely are you to get rescue drugs such as epo/neupo. I'd want this answered as well.

7. My prayers are with you, that you get the permission, and also that God grant your doctor superior wisdom and a real concern for you as his patient.

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