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Tx stop criterion set for week 7

Apr 15, 2009 - 0 comments
Tags:

stop trreatment

,

non-responder

,

slow responder



Today I had my next appointment with my doc. I've used the past week to assess my situation carefully. The facts:

- I have genotype 1
- Since two years ago (when I got infected), my liver went to stage 3 fibrosis (based on one fibroscan in September 2008)
- My chance of success was only 30% at the start of treatment (due to my co-infection of HIV)
- I started treatement with a high VL of 13.8 million
- My drop in VL at week 4 turned out to be a disappointing 0.23 log
- According to the protocol, failing to reach a 2 log drop at 4 weeks translates into drop in expected success of treatment downto 10%
- Also according to protocol, continuation of treatement is to be decided by the VL test at week 12. If the drop in VL is less than 2 log from baseline, chance of success is less than 5%. Hence, treatement would be discontinued.
- At week 8 there's an additional VL test.

If the VL test at 8 weeks is again a disappointment, I don't see the use of continuing upto week 12. Especially, since there are so many promising new drugs on the horizon (like R7128, SCH 900518, VX 950, and especially BI 201335). I expect these to hit the market in 2 years time. And perhaps, being co-infected, I can participate in trials aimed at co-infected patients earlier.

On top of that, I have a vacation planned between week 8 and week 12. (This was already fixed before I knew I would start treatment, trust me, I would have planned otherwise if I had known!). Hence, I additionally proposed to do the next VL test not at 8 weeks but at 7 weeks. Then IF I stop treatement, it would allow me to stop before I leave,

Of course, she was reluctant to give in to my request. After all, she prefers to stick to the protocol, and decide at week 12. But luckily, she also saw the logic of my reasoning. Regarding my next VL test (at the proposed 7th week) I confronted my her with the question what result she would regard to be "hopeless". She said that a 2 log drop from baseline would be hopefull enough to continue, but a drop of less than 1 log would surely be hopeless.

So the deal is:
- I'm allowed to be tested one week earlier than supposed to for my next VL.
- If the drop of that test turns out less than 1 log, I quit immediately. (It remains to be seen what we'll do if it's a little over 1 -- but still far from 2 -- but I'll see then)

I'll get the result the day I leave for my trip, in two weeks exactly from now. That's promising to be an exciting day!

At least it's clear what will happen, and that I am not going to stay on treatement the full 12 weeks if my chances remain hopeless.

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