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Any Knowledge on the Lambda Studies

Does any one know anything about the Lambda (I think that is the way it is spelled) studies that are taking place now.  Last May I was scheduled to be in a study at the University of Utah but I was disqualified because they did not want any one who had suffered depression.  I'm just curious.  I remember reading a lot about it, and recently I have heard nothing.  Just curious.

Thanks,
Debbie
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1372757 tn?1305916571
I have been in the Lambda study for 21 weeks. I took my 21 injection today. 3 more to go. I am G2 S2. Have been UD since week 12. All of my blood tests have been very positive. The lowest my HGB has been is 14.3. Very few side effects, more from the ribaviron than the Lambda. I know I am receiving the Lambda by a blood test result that is typical of the IL29 and not typical of Alpha 2a.

There is a possibility you are receiving the Interferon Alpha 2a. Have they told you if you were receiving the IL29? They told me no one would know for sure until everyone in the study is completed. A total of aprox 18 months from June 1, 2010.

I hope things get better for you and you next treatment will be less painful.
Helpful - 0
408795 tn?1324935675
Unfortunate that you had to drop from the trial as I hit that same brick wall and had to quit my trial as well for similar but different reasons a couple of years ago .   I was under the impression that the Lambda form of interferon was less toxic and therefore less side effects.   So is Lambda interferon less toxic or not?  Anyone else on a Lambda clinical trial?
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Avatar universal
I usually don't do much posting in forums.  I felt like my experience might be valuable.  I just dropped out of the IL-29 (lambda) study.  I became so anemic that I could not continue my life as usual and meet my responsibilities.  I also experience very deep fatigue, bone and joint pain and insomnia.  My Hemoglobin count went down to 10.0 and they were going to reduce the meds the week I dropped out.  My viral load over 12 weeks went from 3.5 million to 160.  I was treatment naive, and I have Geno 1 and have been infected for over 40 years.  I have very mild liver disease.  I felt that I just could not go on for another 9 months with little more than a 50/50 chance of a sustained viral response.  It was a difficult decision, but one my trial doctors, my own doctor and my general practitioner all agreed on.  At least in the clinical trial, there is no medication or treatment for the anemia.  I went to an acupuncturist, and that REALLY helped.  Good luck to anyone on IL-29.  
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1451042 tn?1285095983
My husband will start week 15 (injection 16) on the Phase 2b study in a couple of days, started week 0 on June 9. We feel certain he is getting the lambda IFN due to the relatively mild side effects as CoStudy has reported. He also experiences a good bit of fatigue, irritability, and low motivation, but also seems to do better once he gets going on something. There was one point, I think around week 8, that he said the IFN felt like a completely different medicine than before - even wondered if somehow he had gotten Pegasys by mistake. (I found it interesting that this occurred immediately after him talking with a man who had gone through SOC twice several years ago, and then he seemed to be experiencing the side effects the other guy told him he had - severe headache, extreme fatigue, severe muscle and joint pain - wondered if it was at all psychosomatic.) The RN told us a couple of weeks later that another patient had reported a particularly tough week at the same time in their treatment. Some weeks are better than others for him/us.

As I posted in another thread we don't have the HCV RNA data but the fact that he has been confirmed to continue in the study apparently means UND. He is mildly anemic but not of concern, they say. No labs have indicated dose reduction. He is genotype 1, stage 0-1, and mostly asymptomatic other than a pattern of elevated liver enzymes over time, even after stopping drinking alcohol, that made his PCP look closer for the reason - that doctor may have saved his life diagnosing the HCV.
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Avatar universal
I wish you the best on this treatment.  It sounds great that you doing so well and not experiencing the onerous sides of SOC.  

Keep us posted on this treatment.  I do have everything crossed for your success, which sound real promising at this point.

Debbie
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Avatar universal
The Lambda sounds great, unfortunately it won't hit the market for those looking to treat next year with the new PIs.  Oh well.
Judy
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Avatar universal
I am really interested in Lambda interferon.  Roll on the trials of this drug using non-responders to alpha interferon.

It is commonly understood that it is the riba which caused the anemia, not the interferon.  Are you sure that your study docs are saying that Pegasys causes anemia?  Even if it is the mix of riba with Lambda that does not drop the HGB and WBC, that is an extremely interesting result and any more info that you have on it would be welcome.  The absence of those particularly horrible side effects would be bliss compared with current SOC.

Thanks for posting and I hope you will let us know how it goes.  Fingers crossed for SVR for you,

dointime
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1372757 tn?1305916571
I am currently in the Phase IIB part of the Lambda study. I started June 14 and took my 9th injection on Monday. I can definitely say I am getting the Lambda and not the Pegasys due to the lack of side effects and the blood test results. The study Drs that I am with does not know which patients are getting which drug. The side effects of the Lambda are minimal. I am fatigued at times and a little cranky at times and a lack of motivation most of the time but once I start doing something I get energized and feel great. It’s just getting started that’s hard. I don’t know how much of that is from the Ribo though. The biggest draw back is I will not know my viral load until after week 12.  I am Geno 2a Stage 2 Grade 2-3. I assume I have had Hep c for 20 or more years with no symptoms.

One of the interesting things they are finding out is the Lambda does not produce the drop in HGB and WBC that Pegasys does My HGB started at 15.8 g/dL and was at 14.7 g/dL last week. My WBC started at 7.02 x10/3 /ul and was 6.52 last week. This is very interesting as there is no threat of anemia present. If you want to know more blood test results let me know and I will provide them. I feel very fortunate to have the opportunity to be in this study.  I just hope it produces the result I am looking for. 4 more weeks to HCVRNA results.
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Avatar universal
Susan, thanks for this information.  I think it is probably too early to tell when and if this medication will ever hit the market.  It hasn't gotten the splashy news and high hopes that the PIs have generated.

Thanks,
Deb
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Avatar universal
This may be what you're looking for:

ZymoGenetics Initiates PEG-Interferon Lambda Phase 2b Clinical Trial in Hepatitis C in Collaboration with Bristol-Myers Squibb

Dose-dependent effects on viral load seen in Phase 2a Development of novel interferon continues on schedule

Seattle -- June 2, 2010 -- ZymoGenetics, Inc. (NASDAQ:ZGEN) today announced the initiation of the second part of a Phase 2 clinical trial with PEG-Interferon lambda (IL-29) and ribavirin in treatment-naive patients with chronic hepatitis C virus (HCV) infection. ZymoGenetics is developing the investigational compound PEG-Interferon lambda in collaboration with Bristol-Myers Squibb Company (NYSE:BMY).

"We've moved forward into part B of our Phase 2 study of PEG-Interferon lambda in hepatitis C," said Eleanor L. Ramos, MD, Senior Vice President and Chief Medical Officer of ZymoGenetics. "In part B, we expect to generate a substantial body of data to inform the design of Phase 3 studies, which will assess the potential role of PEG-Interferon lambda in addressing the unmet medical need for a safer, more effective treatment for hepatitis C."

The Phase 2 EMERGE study is an international, randomized multi-center clinical trial. The Phase 2a open label portion continues and is exploring a range of four doses. Based on antiviral effects after four weeks of treatment and accumulated safety data, doses were selected for the second part of the study (Phase 2b). A status report with top-line interim results from the Phase 2a clinical trial was disclosed by ZymoGenetics on May 4, 2010. The companies selected the three highest doses of PEG-Interferon lambda for inclusion in Phase 2b, namely 120 mcg, 180 mcg and 240 mcg.

The Phase 2b study will enroll approximately 600 patients with genotypes 1-4 chronic HCV infection. The study will assess the safety and antiviral efficacy of the three specified doses of PEG-Interferon lambda compared to Pegasys. Each cohort of approximately 150 patients will include at least 100 genotype 1 patients. Weekly subcutaneous doses of PEG-Interferon lambda or Pegasys will be administered for 48 weeks in genotype 1 or 4 patients and for 24 weeks in genotype 2 or 3 patients. All patients will also receive daily ribavirin. The primary endpoint of the trial is the proportion of patients who achieve undetectable levels of HCV RNA after 12 weeks of therapy (complete Early Virological Response). Sustained virological response (SVR), defined as undetectable levels of HCV RNA 24 weeks after treatment, will also be assessed.

PEG-Interferon lambda

PEG-Interferon lambda (IL-29) is a novel interferon in development for hepatitis C. PEG-Interferon lambda is a member of the Type III lambda interferon family, which includes IL-28A, IL-28B and IL-29 (also known as interferon lambda 2, 3, and 1, respectively). Type III interferons signal through a different receptor than type I interferons, such as interferon alpha. The native human interferon lambda proteins are generated by the immune system in response to viral infection. A Phase 1b clinical trial was conducted in patients with relapsed HCV, in which PEG-Interferon lambda was administered over four weeks in combination with ribavirin.

http://www.hivandhepatitis.com/hep_c/news/2010/0608_2010_b.html
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Here's an abstract from the 2008 AASLD Liver Conference:

Interim Results from a Phase 1b Dose-Escalation Study of 4 Weeks of PEG-Interferon Lambda (PEG-rIL-29) Treatment in Subjects with Hepatitis C Virus (HCV) Genotype 1 with Prior Virologic Response and Relapse to Peginterferon Alfa and Ribavirin.  E. J. Lawitz; A. Zaman; A. J. Muir; M. L. Shiffman; B. Yoffe; T. Zhang; S. Souza; D. F. Hausman View Pres.

http://www.aasld.org/Pages/Default.aspx

_______________________________________

It's also published online at Wiley but $$$:

http://onlinelibrary.wiley.com/doi/10.1002/hep.23743/full

Susan
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