IL28b test

[Boobert]

I went to visit my GI today and brought up the IL28B test to him and he wasn't very up to date on the test. I explained what I knew of it and he had heard of it, anyway he went ahead and ordered the test. I left his office and went downstairs to Quest labs and after waiting awile I was informed they had no knowledge of the test and that I would have to go to a hospital or another lab. My question is before I pursue this can anybody give me any info on this test, I am a geno4 is this test for any type and will my insurance cover it. I have a ppo with blue shield. Any info would be greatly appreciated.

[Boobert]

Not yet, getting ready. Bali suggested Alinia to you, talk to your doc about it mine okayed it already. I'm going in for another Biopsy in a couple weeks and then I will decide when to treat. last BX 2007 Stage 0-1 grade 1. This will be my third BX. I was DX in 2002 probably had it since 1985-86. Keep me informed on your treating.

Bob

[zako7]

Are you treating now? If yes, please can you tell me your combination of drugs and the progress of your treatment. I am just curious regarding my up coming treatment and will like to know the general result of the drugs out there since geno 4 are few.

[Boobert]

This post is 8 months old. I had the teast done back in march and came back a CT. It is not just for type 1.

[desrt]

http://www.natap.org/2010/HCV/062810_05.htm

[desrt]

The IL28B test also plays a role in tx decisions for genos 2 and 3 - especially those who are still detecible at week 4.

http://www.natap.org/2011/HCV/021611_02.htm

[HectorSF]

Note: The IL28B test is only for genotype 1, as Bill stated.

Quest "AccuType® IL28B"
CPT code(s)*: 83891, 83898, 83896 x2, 83912
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Monday, April 18, 2011

Quest Diagnostics Launches Hepatitis C Virus Therapy Test Based on IL28B Gene Variants

AccuType® IL28B test now available to physicians and for clinical trials research
MADISON, N.J., April 18, 2011 /PRNewswire/ -- Quest Diagnostics Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced the availability of its AccuType® IL28B test for aiding in the prediction of patient response to peginterferon alpha-based therapy for hepatitis C virus (HCV) infection.

Quest Diagnostics is now offering the test to physicians and other healthcare providers in the U.S. and to pharmaceutical companies for use in clinical trials research.
The test was developed through a global non-exclusive license agreement under which Schering Corporation, a Merck affiliate, licensed certain patent rights claiming Interleukin (IL) 28B genetic markers to Quest Diagnostics. These genetic markers have been shown to provide an indicator of potential response to peginterferon alpha-based therapy for HCV. Additional terms were not disclosed.

"Our AccuType IL28B test will give physicians greater insights for treating individual patients infected with the most common form of HCV using standard antiviral therapies," said Rick L. Pesano, M.D., Ph.D., medical director, infectious diseases, Quest Diagnostics. "AccuType IL28B testing will also help physicians consider alternative therapies, which in the future may include HCV protease inhibitors."
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AccuType® IL28B
Test Highlight

Clinical Use

    Predict response to pegylated interferon-α/ribavirin therapy in patients with genotype 1 hepatitis C virus infection

Clinical Background

Chronic hepatitis C virus (HCV) infection affects approximately 4.1 million people in the United States and is the leading cause of cirrhosis, liver cancer, and liver transplantation.1 The recommended HCV treatment, pegylated interferon-α plus ribavirin, is expensive, poorly tolerated, and ineffective in some people.2 Prediction of treatment response may help clinicians determine an appropriate treatment strategy.2,3

Both viral and host factors influence the treatment response. For example, HCV genotype is an important viral determinant of response: patients infected with type 1 or 4 have lower sustained virological response (SVR) rates than those infected with type 2 or 3.4 Host factors influencing treatment response include age, gender, ethnicity, and genetic polymorphisms.4,5 For example, European-Americans have higher SVR rates than African-Americans.3,5 Half of this difference is caused by the single nucleotide polymorphism (SNP) IL28B rs12979860.5 This SNP has 3 possible genotypes: CC, CT, and TT. The CC genotype is associated with better rapid virological response (RVR) and SVR rates than are the CT or TT genotypes.3-5 A favorable IL28B genotype improves the treatment response considerably in individuals infected with unfavorable HCV genotypes (1 or 4).3 Individuals infected with HCV genotype 2 or 3 tend to have relatively strong responses irrespective of host factors; a favorable IL28B genotype has less effect in these patients.3 Preliminary studies of HCV-infected liver transplant patients also suggest that the CC (vs CT/TT) genotype in either or in both donor and recipient correlates with higher SVR rates in the recipient.6

The AccuType IL28B test determines the rs12979860 genotype to help predict therapeutic response in HCV-infected patients who are being considered for treatment with pegylated interferon-α/ribavirin.

Method

A real-time PCR allelic discrimination assay is performed on extracted DNA, using fluorescent probes specific for the C and T alleles of the rs12979860 SNP. The SNP genotype (CC, CT, or TT) is reported.

CPT code(s)*: 83891, 83898, 83896 x2, 83912
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I had mine performed by Mayo Labs Laboratories, 200 First Street, SW, Rochester, MN 55905.

Take care!
Hector

[Bali05]

"He is planning to add PI to my treatment "

Which PI  ? there is no approved PI for Geno 4 .available.

[zako7]

I am geno 4 too. I think the test is for geno 1. To increase your odds of clearing the virus you have to convince your doctor to up your doses of the 2 drugs even if you are TT or to add the third drug like the PI or Alinia. Remember no 2 individuals are the same. It's good to learn from forums like this but that should not replace the advice of
your doctors. Make sure you don't push things too far to suggest to your doctor you know how
to treat this virus better than he does.
I will start treatment in December . I asked my doctor about the test and he said I don't have any need for that. He is planning to add PI to my treatment and up the doses of RIBA and peg and I am still going to sit down with him to finalize the treatment plan. I think biopsy test should be more
important to you than this test at this time. This is just my opinion.

[zako7]

I am geno 4 too. I think the test is for geno 1. To increase your odds of clearing the virus you have to convince your doctor to up your doses of the 2 drugs even if you are TT or to add the third drug like the PI or Alinia. Remember no 2 individuals are the same. It's good to learn from forums like this but that should not replace the advice of
your doctors. Make sure you don't push things too far to suggest to your doctor you know how
to treat this virus better than he does.
I will start treatment in December . I asked my doctor about the test and he said I don't have any need for that. He is planning to add PI to my treatment and up the doses of RIBA and peg and I am still going to sit down with him to finalize the treatment plan. I think biopsy test should be more
important to you than this test at this time. This is just my opinion.

[zako7]

I am geno 4 too. I think the test is for geno 1. To increase your odds of clearing the virus you have to convince your doctor to up your doses of the 2 drugs even if you are TT or to add the third drug like the PI or Alinia. Remember no 2 individuals are the same. It's good to learn from forums like this but that should not replace the advice of
your doctors. Make sure you don't push things too far to suggest to your doctor you know how
to treat this virus better than he does.
I will start treatment in December . I asked my doctor about the test and he said I don't have any need for that. He is planning to add PI to my treatment and up the doses of RIBA and peg and I am still going to sit down with him to finalize the treatment plan. I think biopsy test should be more
important to you than this test at this time. This is just my opinion.

[bestcorp]

please tell me the sequence of primers that are used for SNP rs12979860 detection by allele specific PCR.

[pjhep80]

my insurance paid, united healthcare, and yes it is labcorp

[Bali05]

Sometimes you get more info on geno4 in Europe. The only geno4 Telapevir study C210 was done in Ireland for example.

Here is a study from Austria including geno 4 response looking at IL28b.

Poster Presentations
Session Title: Category 12. IL28b POLYMORPHISM
Presentation Date: Apr 17, 2010

IMPACT OF IL28B-GENOTYPE ON TREATMENT OUTCOME OF AUSTRIAN PATIENTS WITH CHRONIC HEPATITIS C
A. Stättermayer*, K. Rutter, S. Beinhardt, T.M. Scherzer, K. Zinober, P. Steindl-Munda, H. Hofer, P. Ferenci
Internal Medicine III, Gastroenterology & Hepatology, Medical University of Vienna, Vienna, Austria. *albertfriedrich.***@****



Background and aim: A genome wide association screening in patients participating in the IDEAL trial revealed a SNP in the IL28B-gene which predicted outcome of antiviral treatment in chronic hepatitis C patients with genotype (GT) 1 (Ge D et al., Nature Gen 2009).
The aim of this study was to investigate the role of this polymorphism on virological response in treatment-naïve Austrian patients participating in published randomized controlled trials (GT1: J.Hep 2006, GT 2/3: Hepatology 2008, GT 1/4:Gastroenterology 2009).
Methods: DNA was obtained from 524 patients. The rs12979860 region of the IL28B-gene was investigated by StepOnePlus Real time PCR System (Applied Biosystems, Foster City, USA). All patients were treated with 180µg Peginterferon-alfa2a (Pegasys®, Roche Basel) and depending of the study protocol with 400 or 800mg (GT 2/3) or 1000-1200mg (GT1/4) ribavirin/d (Copegus®, Roche Basel). Treatment duration was 24 weeks for GT 2/3 and 24-72 weeks for GT 1/4. At time of writing this abstract data of 364 patients were available.
Results: The presence of a T-allele in rs12979860 is associated with poor outcome of interferon/ribavirin therapy in GT 1 (SVR: 85% vs. 44%; p< 0.001) and GT 4 patients (SVR: 88% vs. 31%; p< 0.001) but has no impact on outcome in GT 2/3 patients (79% vs. 74%; p=0.095). C/C-genotype was also associated with higher rate of rapid virological response (RVR) in all patients irrespective of HCV-genotype.
GT1(n=222): C/C:n=79(36%), RVR: 40%, SVR: 85%; T/C:n=114(51%), RVR: 13%, SVR: 45%; T/T:n=29(13%), RVR: 4%, SVR: 41%
GT2/3(n=108): C/C:n=47(44%), RVR: 85%, SVR: 79%; T/C:n=51(47%), RVR: 53%, SVR: 78%; T/T:n=10(9%), RVR: 50%, SVR: 50%
GT4(n=34): C/C:n=8(24%), RVR: 89%, SVR: 88%; T/C:n=22(64%), RVR: 10%, SVR: 32%; T/T:n=4(12%), RVR: 0%, SVR: 25%
Conclusion: This study reconfirms the previously reported findings in US patients with chronic hepatitis C genotype 1 in a European population, and extends the observation to patients with genotypes 2/3 and 4. The C/C-genotype is associated with higher on treatment response rates to peginterferon/ribavirin and with higher SVR in patients with genotypes 1 and 4. Determination of the rs12979860 genotype may be a useful parameter for future treatment protocols.

[meakea]

Boobert, I'm glad you pursued this and found a lab near you so you can get the test.  It's very easy for people to just stop when their doc doesn't know much about certain issues.  You didn't stop...GOOD FOR YOU!!

[EyesofBlue55]

Blue Cross/Blue Shield paid for my test.

[Boobert]

That's what I wanted to hear Bali. Thanks again to all!!!!

[Bali05]

and through in some Alinia for good luck......

[Bali05]

Yes it is, G1 & G4
Actually the TT for geno4 is worse than for geno1.
If I had to start again knowing I have CT or TT I would
try and get a higher INF dose to start with and  in addition to Pre/High dose Riba.
But that is just me....

[Boobert]

I just am not certain this is going to benefit a G4. Almost home buddy good for you.

[Bali05]

What for ?
I am 3/4 thru tx and when I started it was not available yet.

[Boobert]

Thank you guys, the people on this forum are amazing. I found a Labcorp about 4 miles from me and actually made an appointment online                                                    
Trinity I appreciate your research big time, I'm still going to go ahead and have the test being a Geno4. We'll see if insurance covers it anyway.That's why I asked Bali if he had taken the test, he's also a 4.Thank you all.

[Trinity4]

Use:  Genome-wide association studies have identified a single nucleotide polymorphism (SNP) (rs12979860) upstream of the IL28B gene, which is associated with higher sustained viral response rates to pegylated interferon/ribavirin therapy in HCV genotype 1-infected individuals. The CC genotype, as compared to either the CT or TT genotypes, has been associated with an approximately twofold to threefold greater rate of sustained viral response in hepatitis C virus genotype 1 chronically-infected individuals treated with combination pegylated interferon/ribavirin therapy.1 Similar sustained viral response associations across various racial groups including European Americans (95% CI 1.8-2.3), African Americans (95% CI 1.9-4.7), and Hispanics (95% CI 1.4-3.2) have been observed.1 The CC genotype has also been associated with a threefold increase in rate of spontaneous clearance of HCV.2 Allele frequencies for the rs12979860 C allele vary across racial and ethnic groups. The rs12979860 C variant is most frequently present in individuals from East Asia (allele frequency >0.9) and least common in individuals of African origin (allele frequency 0.2-0.5).2 In a recent US-based study, the favorable CC genotype was observed in 37% of Caucasians, 29% of Hispanics, and 14% of African Americans tested.3

Limitations:  IL28B genotype is only one of many factors that can influence response rates to pegylated interferon/ribavirin therapy in HCV genotype 1 infection and should be interpreted in the context of other clinical factors. The mechanism by which the IL28B genotype mediates pegylated interferon/ribavirin treatment response in HCV genotype 1 is not yet understood and is the subject of intense research. The impact of the IL28B polymorphism on response rates in HCV genotypes other than genotype 1 is still being investigated.

Methodology:  Real-time polymerase chain reaction (PCR) with allele-specific TaqMan® probes is used to detect a single nucleotide polymorphism (SNP) (rs12979860 C/T) on chromosome 19q13. The rs12979860 SNP maps 3 kilobases upstream of the IL28B gene (OMIM 607402), which encodes the type III interferon-λ3. No other polymorphisms are detected by this assay.

[Boobert]

Hey Bali have you had one?

[Trinity4]

I believe Labcorp offers this test and the people who have posted their test results also said their insurance paid for it.

Interleukin 28B (IL28B) Polymorphism (rs12979860)

Test Number: 480630