Interferon Lambda clinical trials??

[chiahsun]

Are there any people who are enrolled in this trial?  From the research I have done this interferon is more potent than interferon alpha in reducing viral load but without all the nasty side effects such as flu like symptom, neutropenia, and depression etc....

[CoStudy]

Yes I ate everything in site. NYgirl suggested I try ice cream. Dairy Cream has become one of my everyday stops. I sure I would have lost more weight if not for ice cream.

[Susan_1a_CC]

Really good to hear of your positive experience.  It seems that the Lambda could save us all a lot of pain if it continues to result in SVR.

I hope to know soon if I'm in the study and I appreciate that I can contact you with questions if needed.  One question - you said that you were hungry all the time but lost 5 lbs.  Were you able to eat?

[CoStudy]

I have felt more or less normal all the way through. Fatigue on occasion, irritable on occasion, and a few cold like symptoms 3 days after injection sometimes. I would take an Advil cold and sinus and it would go away. And some of the normal things ie.. rash, lost 5 lbs, hungry all the time, couldn't sleep a couple times. Some of it was probably the riba. Now that I am almost done I look back and think that wasn’t bad and it went really fast. I pray it works and this new interferon will be available for everyone some day.

[dointime]

Hi CoStudy,
Great you checked in.  It sounds like all good news for you.  When you say you have had few sides, does that mean you have felt more or less normal all the way through?  No fatigue?  No mental freakiness?  The idea of being able to function normally while on tx would be nothing short of miraculous to me.

Fingers crossed for SVR for you,
dointime  

[CoStudy]

I have been in the Lambda study for 6 months. I took my 23 injection Monday. I have One (1) injection left.  I have had very fer sx. Send me a not with your questions and I will try to answer them. I have ben UD since week 12.

[Susan_1a_CC]

I finish the screening tests this week for the study and, if I get in, you can bet I'll post about it here.

[dointime]

Thanks for this info fretboard.  I note that the IL28 investigation was done with peginterferon alpha.  I believe it is the hope that people who are non responders with the alpha might respond with the lambda, but there are no study results yet to tell us if that is the case or not.

There are also no results yet to tell us if the lambda might be more effective overall than the alpha, but your study Susan sounds very promising.  Even less side effects would be wonderful.  It would be great if you could post info here about this study as so little is known about the lambda.  All the best and high hopes for your SVR with it,

dointime          

[Susan_1a_CC]

Hi,

I haven't heard that the IL28 test refers to the success of lambda interferon tx. What I can tell you is that, there are two other studies going on with the lambda and I was told that all the participants (at the facility I am going to) (mixed genotypes) except one were SVR at twelve weeks.  The one person who wasn't was being given a really low dose.  

[fretboard]

I checked Pubmed and this came right up so I hope it helps.  

Hepatology. 2010 Aug 20. [Epub ahead of print]
IL28B genotype is associated with differential expression of intrahepatic interferon-stimulated genes in patients with chronic hepatitis C.

Urban TJ, Thompson AJ, Bradrick SS, Fellay J, Schuppan D, Cronin KD, Hong L, McKenzie A, Patel K, Shianna KV, McHutchison JG, Goldstein DB, Afdhal N.

Center for Human Genome Variation, Duke University Medical Center, Durham, NC.
Abstract

Genetic variation in the IL28B (interleukin 28B; interferon lambda 3) region has been associated with sustained virological response (SVR) rates in patients with chronic hepatitis C (CHC) who were treated with peginterferon-α and ribavirin. We hypothesized that IL28B polymorphism is associated with intrahepatic expression of interferon-stimulated genes (ISGs), known to influence treatment outcome. IL28B genotyping (rs12979860) and whole-genome RNA expression were performed using liver biopsies from 61 North American patients with CHC. After correction for multiple testing (false discovery rate < 0.10), 164 transcripts were found to be differentially expressed by IL28B-type. The interferon signaling pathway was the most enriched canonical pathway differentially expressed by IL28B-type (P < 10(-5)), with most genes showing higher expression in livers of individuals carrying the poor-response IL28B-type. In 25 patients for which treatment response data were available, IL28B-type was associated with SVR (P = 0.0054). ISG expression was also associated with SVR; however, this was not independent of IL28B-type. Analysis of miR-122 expression in liver biopsies showed reduced miR-122 levels associated with poorer treatment outcome, independently of IL28B-type. No association was observed between IL28B-type and levels of liver IL28B or IL28A messenger RNA expression. IL28B protein sequence variants associated with rs12979860 were therefore investigated in vitro: no differences in ISG induction or inhibition of HCV replication were observed in Huh7.5 cells. Conclusion: The good response IL28B variant was strongly associated with lower level ISG expression. The results suggest that IL28B genotype may explain the relationship between hepatic ISG expression and HCV treatment outcome, and this is independent of miR-122 expression. IL28B-type was not associated with intrahepatic IL28B messenger RNA expression in vivo. Further investigation of the precise molecular mechanism(s) by which IL28B genetic variation influences HCV outcomes is warranted. (HEPATOLOGY 2010).

[dointime]

Does the IL28 test apply to results for interferon lambda?  I've only ever heard of it used to predict results for interferon alpha.  Any info you have on this would be great.

dointime

[Susan_1a_CC]

No, never been tx'd before.  First MD I saw wanted to do 72 weeks but at that time I had no reason to believe that I had greater than a 30% chance of SVR so I didn't go for it.  Now, I know my ILP-28 suggests that I'd actually have an 80% of SVR but I'm hoping for fewer side effects with the lambda.  

Will know soon if I am in the study - hopefully after next weeks bx - and I start a thread.

[fretboard]

Well I'd like to hear about your journey but you should prolly start a new thread to fill us in.  Good luck on getting in the trial, have you tx'ed before?

[Susan_1a_CC]

I know that your post is older but I've just joined this forum and wanted to respond as I am almost through the screening process for a trial of 24 wks of lambda interferon along with riba.  I'd be happy to post my experience (and if there's a particular thread for that would someone let me know please.)  I can tell you that there are two other studies with the lambda going on and the research nurse has suggested to me that no one is having severe side effects.  We shall see...

Susan

[fretboard]

I never heard of this new inteferon, good info.  I don't know anyone who is on this trial and the information says that they're barely on phase I trials and still recruiting in the US.  They have had other trials in India or SouthEast Asia with promising results.  Top link is about the lambda inteferon and the other two are just information.  good find


http://www.natap.org/2009/HCV/011309_01.htm  

http://clinicaltrials.gov/ct2/show/NCT00565539

http://www.lambda-cro.com/