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Null responder needs advice.
I am a null responder with early cirrhosis- liver function so far is quite good. Have been waiting patiently for telaprevir approval and just received devastating news from my consultant that for people like me telaprevir is very disappointing- only 14% chance of SVR ( based on data released at EASL 2011).
This very depressing news was given alongside warnings about viral resistance and potential exclusion from other trials further down the line because of failure with a protease inhibitor (if I do fail).
My consultant was talking about quad therapy like the Roche trial now in phase 2 and believes quad therapy is the future treatment of choice for null responders. The Roche phase 3 quad therapy trial won't come around until the end of 2012. I can't wait that long, but nor do I want to be excluded from more promising treatments that are on the horizon.
I feel utterly stuck and damned either way- any advice or alternative ways of viewing this situation would be really welcome.
I now have to try to glean information from those who know and also keep watching how other people choose to deal with these difficult decisions and try to make some sort of informed choice. Can anyone lend a hand as I can't think straight now !
Hope everyone's well.
Thanks
Paul.
This very depressing news was given alongside warnings about viral resistance and potential exclusion from other trials further down the line because of failure with a protease inhibitor (if I do fail).
My consultant was talking about quad therapy like the Roche trial now in phase 2 and believes quad therapy is the future treatment of choice for null responders. The Roche phase 3 quad therapy trial won't come around until the end of 2012. I can't wait that long, but nor do I want to be excluded from more promising treatments that are on the horizon.
I feel utterly stuck and damned either way- any advice or alternative ways of viewing this situation would be really welcome.
I now have to try to glean information from those who know and also keep watching how other people choose to deal with these difficult decisions and try to make some sort of informed choice. Can anyone lend a hand as I can't think straight now !
Hope everyone's well.
Thanks
Paul.
Best Answer
Thanks Susie good to know there are other people too, will keep you posted of course,
.Going to see a specialist on 14th June so will mail you if anything noteworthy.
Cheers
.Going to see a specialist on 14th June so will mail you if anything noteworthy.
Cheers
Thanks. My viral load didn't go down 2log over a twelve week period, think it was only about just over 1log drop.
Hope I can get more responses so I can build some clarity as this is driving me a bit nuts, there doesn't seem to be any end to waiting.
Cheers guys
Hope I can get more responses so I can build some clarity as this is driving me a bit nuts, there doesn't seem to be any end to waiting.
Cheers guys
Hi Paul, I am in exactly your position. I am a previous null responder (1.9 log drop at 12 weeks) and I have had cirrhosis (well compensated) since my first biopsy in 1992. My NP is a previous Hepatitis C Clinical Trial Research Nurse with a large practice in NJ, and she thinks I ought to try the telaprevir. She does not believe it will necessarily keep me out of future trials and she said that resistance isn't much of a problem for genotype 1b's. Even if you are geno 1a, the resistance seems to go away after a while.. There is no way to know all of the specifics about a person in a trial and why they did or did not SVR. She recently attended a talk by Dr. Eugene Schiff, at UMiami, and he said he has had some good luck with his previous null responders with late stage disease. I think I am going to take her advice and try. Lets keep each other in the loop regarding anything we may find out.
How null is null ? ie what did your VL drop look like?
Your consultant's take sounds on target. Quad tx will definitely be the best option for nulls - the equivalent of what triple is for relapsers. End of 2012 for start of phase III quad trials sounds unduly pessimistic however. BMS appears to be moving forward more aggressively than Roche (who is raking in tons of cash on Pegasys sales and presumably in no hurry to see that dry up). Scouring all upcoming trials (BMS/Gilead/Pharmasset) is a good idea. If you can't wait further, supplementing with what's currently available (high dose RBV, Alinia/NTZ, IV-SIL, SAMe) might improve your ifn response and thus your odds with triple. Best wishes.
Your consultant's take sounds on target. Quad tx will definitely be the best option for nulls - the equivalent of what triple is for relapsers. End of 2012 for start of phase III quad trials sounds unduly pessimistic however. BMS appears to be moving forward more aggressively than Roche (who is raking in tons of cash on Pegasys sales and presumably in no hurry to see that dry up). Scouring all upcoming trials (BMS/Gilead/Pharmasset) is a good idea. If you can't wait further, supplementing with what's currently available (high dose RBV, Alinia/NTZ, IV-SIL, SAMe) might improve your ifn response and thus your odds with triple. Best wishes.
Don't give up, hang in there. I don't have much knowledge to share on Tela/Boce, but hopefully someone more knowledgeable will pop in and give you their perspective.
What I will say, though, is that my husband was diagnosed with 'borderline' compensated cirrhosis in 2007 (liver function NOT quite 'good'), but has stayed stable for 4 years, so with early cirrhosis and good liver function your prospects of getting to 2012 are excellent, imho. And remember, statistics are only that: my husband was given less than 20% chance of success with SOC, and he got to undetected; so even if it is 14% chance, you might be one of that 14 in 100. Just a couple of thoughts -- keep calm and keep thinking it through! Good luck with it all. ~eureka
What I will say, though, is that my husband was diagnosed with 'borderline' compensated cirrhosis in 2007 (liver function NOT quite 'good'), but has stayed stable for 4 years, so with early cirrhosis and good liver function your prospects of getting to 2012 are excellent, imho. And remember, statistics are only that: my husband was given less than 20% chance of success with SOC, and he got to undetected; so even if it is 14% chance, you might be one of that 14 in 100. Just a couple of thoughts -- keep calm and keep thinking it through! Good luck with it all. ~eureka
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-- PIs (protease inhibitors like Boceprevir and Telaprevir) are not the only game in town. There are all sorts of other drugs now in trials. One of the more promising (to my mind) is Globeimmune's GI-5005 immunogen, which has recently reported some trial success with null responders (see the news articles at Globeimmune-dot-com), and also particularly with people who have the IL28B T/T genotype.
-- Have you tried to find out why you are a null responder? Knowing the cause of a condition is the first step in dealing with it. Cause and effect is the basis of all knowledge, and knowledge is power.
-- Trying to get rid of the virus is only half the fight. The other half is keeping up your liver function. There are things you yourself can do for that. Some are: diet, exercise, and alternative meds (silibin, PPC, ALA, Vitamin E, SAMe, Lactoferrin, etc., and especially the immune system boosters). Believe it or not, some of them do work.
Maybe you know all this stuff. If so, I apologize for wasting your time. However, I'm a firm believer in self-help. It keeps you from slipping into a dependence syndrome. Taking action is one of the best medicines around.
Good luck.
Mike