Link to a study by Dr. Jensen, et al?

[prettydamscared]

Hi,

My doctor mentioned to me yesterday a study by Jensen & colleagues regarding probability of svr in 1a/1b patients treating for 24 weeks with 4 week rvr.  Apparently, there are some studies that suggest 24 weeks of treatment is sufficient to attain svr in some 1a/1b patients. I've googled it and do not seem to be able to find a link.  Is anybody familiar with this study or similiar studies or have any links?

Thanks much,  Char

[chcnme]

Hi Char.  I remember reading something about this a while back.  Could this be what you are talking about?  All I could find was a press release.

TITLED:   Shorter Course of PEG-INTRON(R) and REBETOL(R) Combination Therapy Approved in European Union for Certain Hepatitis C Patients With Genotype 1 and Low Viral Load

SOURCE:   http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/10-05-2005/0004160280&EDATE=


And....here's another link

http://schering-plough.se/press/47_SHORTER_COURSE_OF_PEGINTRON_AND_REBETOL_COMBINATION_THERAPY_APPROVED_IN_EUROPEAN_UNION_FOR_CERTAIN_HEPATITIS_C_PATIENTS_WITH_GENOTYPE_1_AND_LOW_VIRAL_LOAD


I'm glad to see the board is back up and running!  

[Kalio1]

Im still trying to find the actual study for you, here is an article that references the Jensen study and also has a lot of good info. So you are thinking of shorterning tx? I'd be really careful doing that. You have been through so much I want you to have the best shot at SVR!!

Hope you are hanging in there!

http://www.projectsinknowledge.com/Init/G/1745/

[ala carte]

I did 24 weeks.  I posted about it on 12/17--the title is 1a, 24 wk tx, und 6 mos. post. In a post to jim on that thread I mentioned an abstract from the aasld 2006 conference that also discusses it.  I did it based on the Jensen study and another the name of which I can't remember.  Both done in europe.  I have some links at home I can send you tonight.  It is risky--some of the predictors for a good result that I remember are:  genotype 1b, female, <600,000 iu/mg viral load, low fibrosis score, age less than 40 or 45.  The links may have more info.

[prettydamscared]

I just read the thread from 12/17...it's very interesting.  I need to go the the studies that you mentioned and read the abstracts and I'm definitely going to do that.  So, it seems that the European initiative to treat some 1A patients for 24 weeks is based primarily on two studies only?

Congratulations to you for taking the risk and it's success! Good luck to your husband as well.  Mine also finished treating mid October and goes for 3 mo. pct mid January, but unlike you and your hubby, he has a different genotype.  

If you think of it and do have the links to those studies at home, I'd appreciate them.  I spent some time yesterday looking for the actual studies and just couldn't seem to find them.  I know they're out there but if you do have them, it would save me some time.

Thank you. Char

[prettydamscared]

Hi,

I definitely agree with you about tailoring treatment to an individual, but since I'm in the study, I have to take that into consideration as well.  I appreciate having the opportunity to participate in the study and would like to be compliant as far as staying in the group that I'm assigned to.  However, I do need to factor in my own stats and the fact that we don't have too much info to go on at this point.  My doc is a wonderful resourse as well.  I value his opinion but feel that on some level he would agree with me that while the study is extremely important, study participants have to consider their health and safety first and foremost.

[prettydamscared]

BTW, I wasn't addressing that disclaimer to you in particular.  I just wanted to get it said as I seem to have ruffled some feathers at vertex with some of my posts.

[NYgirl]

Depends on a LOT of information (going 24) like being UND by 4 things like that. If you factor in the other studies and all using YOUR information - you can see what YOU specifically have to do.

I'm a BIG believer in tailoring individual treatment using all info. Not one for all you know?

[prettydamscared]

Thank you for those two sites.  I briefly read through one of them and it is referencing the European study which may be the one my doctor referred to.  I need to thorougly read through them all.  Thanks for replaying

Char

[prettydamscared]

Thanks for that site.  I just read it, need to go back and re-read it.  I'm not sure if this is the study that my doc was referring too.  It's not that I'm considering a shorter course of therapy.  I'm in the study and get unblinded in a week or two.  I could be in the study group that treats 1A patients for 24 weeks only.  I agree with you about being careful. I stopped the vertex at 10 weeks, as opposed to 12 and did take the prednisone for 3 weeks. Irregardless, it's scary to think of stopping at 24 weeks for 1A's no matter what and I did have a 10M baseline viral load which doesn't seem to fit the criteria in these studies. I really need to keep reading.  

Thanks again for the study and if you do find another one, I'd love to see it.

DISCLAIMER:  I don't mean to imply that which study group I end up in isn't of utmost importance to me.  I absolutely feel a responsibility to the study, however, must make decisions factoring in what is best for me as well, as I think most thinking, rational people would.

[Kalio1]

I agree with you, your criteria does not all fit for stopping early. If it turns out you are in the 24 week arm, will they then let you continue tx until week 48 or do you have to find another doctor and treat with him for the oher 24 weeks?
Seems to me you are trying to avoid relapsing OR having to treat longer than a year. You are smart to think this through beforehand I think.
I see your dilemma. Let's hope you are in the 48 week one!

[prettydamscared]

Thanks for your comments.  If I'm in the 24 week group & I decide to continue treatment, I would have to withdrawal from the study, however there's no reason my doctor couldn't continue to treat me...it just wouldn't be through the study.  Preliminarily, I would feel more comfortable treating for 48 weeks, but I have to be much more familiar with the studies and talk it over extensively with my doctor before I make that decision.

Char

[Kalio1]

The tough thing is even with all the facts and factors, it is still a crapshoot! It's sure hard on us. Good luck with your decision and I hope you and your loved ones have a mighty fine Holiday season!

[jmjm530]

If I remember correctly, you're in the Vertex trial? If so, you're comparing apples to oranges, or let's say those not taking VX-950 to those who do. Also, not sure what week you became non-detectible, but from what I've been reading, the VX-950 group are actually responding faster in many cases than 4 weeks. The other thing is that if you do continue to treat longer you will of course have to get drugs from outside the trial as well as disqualify from you from trial data. Not sure if you had to sign anything, but if you don't officially disclose an  extension (assuming you extend beyond 24 weeks) to your trial doctors you could then be potentially skewing the trial SVR data erroneously which could adversly affect future patients who take VX-950. So, in other words, if you're going to break protocol, you really should at some point let your trial doctors know exactly what you're doing. Personally, I would be very happy to be in the 24-week Arm of the VX-950 trial, assuming I got a rapid viral response -- and my thinking would be (assuming I got the 48 week arm) maybe I'll stop at 24 weeks -- but that's me.

All the best,


-- Jim

[ala carte]

Hi.  Here's the links I found on my home computer.  The Zeuzem study is not a link, but it is the study name.  I couldn't find anything about Jensen, but the name is so familiar I'm sure I've run across it somewhere.

I'm not sure these have any relevance to you because of the vertex, but it sounds like you have a very good doc and he would know. I didn't check the other links posted, so I hope these aren't repeats.  The first has some good graphics about the predictors for svr.  


http://www.natap.org/2005/AASLD/aasld_54.htm

S Zeuzem and others. Efficacy of 24 weeks treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C infected with genotype 1 and low pretreatment viremia. Journal of Hepatology 44(1): 97-103. January 2006.

http://www.hcvadvocate.org/news/reports/AASLD_2005/11%2015%20treatment%20-4.htm#Treat_4_2

http://www.hivandhepatitis.com/hep_c/news/2005/ad/100705_a.html

http://www.hcvadvocate.org/news/reports/AASLD_2006/Abstracts/Tuesday%20clinical%20trials%20and%20therapeutic.htm#CTrials_1124