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Avatar universal

Labcorp Test for PI Resistance/Mutations Available Now

Might have already been posted but I missed it, if so. Guess this news release went out in July. Having been exposed to Boceprevir for 9 weeks, I have been torn about retreating with Telaprevir, in spite of Doc eager to have me do so. Like the IL28 test, this will be a great tool for anyone exposed to PI or worried about taking on the extra sx without decent odds of responding, if they cannot wait for the next batch of drugs to be approved. Basic info for your doc:

Dear Health Care Provider,

LabCorp and Monogram Biosciences are pleased to announce the launch of HCV GenoSure® NS3/4A, a
protease inhibitor drug resistance assay for the clinical management of patients with hepatitis C.  

HCV GenoSure NS3/4A provides a comprehensive sequence-based analysis of a patient’s hepatitis C virus
to assess drug resistance (or susceptibility) to the NS3/4A protease inhibitors, boceprevir1 and telaprevir2. It
also includes a detailed understanding of the viral population for the entire region of the non-structural
proteins NS3 and NS4A for hepatitis C virus genotypes 1a or 1b.

Other assay features include
• Highly reproducible for patient specimens with viral loads > 2000 IU/mL
• Sensitive to detect mixtures of wild-type and drug-resistant viruses when present at levels as low as 10%
of the total population
• Uses Monogram’s HCV genotypic rules-based algorithm to provide a result of “sensitive,” “resistant,” or
“resistance possible” for each protease inhibitor. The algorithm is reviewed and updated regularly.
• Includes HCV genotype (subtype) assignment for the NS3/4A region, providing information that may be
important for long-term drug treatment strategy and drug resistance assay interpretation.
• A turnaround time of approximately 7 to 10 days

HCV GenoSure NS3/4A can be ordered using Monogram test number C5000 (LabCorp test number 550540).

LabCorp and Monogram have applied their expertise in HIV drug resistance to the newly approved, direct-
acting antiviral agents for hepatitis C. In clinical studies of boceprevir and telaprevir, a significant portion of
patients who did not achieve sustained viral response (SVR) were found to have treatment-emergent
mutations.1,2  HCV GenoSure NS3/4A can help identify which patients have developed resistance to these
protease inhibitors.

If you have questions or would like additional information regarding HCV GenoSure NS3/4A, please
contact your local Monogram or LabCorp representative or call Monogram Client Services at 800-777-0177.


Charles M. Walworth, MD
Senior Director, Global Medical Affairs & Education
8 Responses
789911 tn?1368636783
everything HCV treatment is moving so fast!  Amazing!
1130586 tn?1316266292
FF, Really sorry to hear your story ....

A couple questions first .. What kind of doctor is this .. GI, GP, Hep C specialist ? Why did you stop at 9 weeks ?

"Current data suggest that for patients receiving
BOC, therapy should be stopped at week 12 if the
viral level is >100 IU/mL or >10-15 IU/mL at
treatment week 24"

The resistance issue with these PI's is real and .. it is definitely Not Recommended to start one right after the other .. Boce more than Tela seems to have "resistant" strains that remain for a longer time period after stopping before reverting to "wild" type ..

If your doctor is recommending this ... you might want to consult with a different specialist, sorry to say your doc is not up to date and what he is suggesting is risky and not current protocol ..

Take a look under updated 2011 Practice Guidelines at AASLD , or goggle Boce resistance , there is enough data to warrant caution with these drugs  ...



Hope the data helps ... Regards

Avatar universal
Doc is hepatologist, head of transplant at major teaching hospital so it is difficult to disagree with him, even when I know I am right! At last visit (April) I had to mention the Zeuzem Barcelona info on cirrhotic response to the PIs, told him where to find it. He jotted down my comments ; )

He is an awesome doc, I just don't think he had the time to worry about treatment with a second PI when they hadn't even started doing triple therapy at that time. I was to schedule an appointment in Sept to start and just couldn't do it, even though he may have been enlightened over the summer. I am sure he will write the order for this test. I want to see on paper what my mutational analysis looks like, but also what my potential response to PI looks like.

I was in Sprint 2, fall of 2008, had almost a 5 log drop on SOC lead in at 4 weeks and 1 log after Bocep was added. Remained detectable <25 weeks 8, 10 and 12. So stopping rule would have had me going to week 24. It will be three years since last blue pill was swallowed, so a good amount of time has passed.

I threw in the towel Feb. 13, 2009, week 13 when they called with 12 week results, overwhelmed by sx and little support from trial docs. Based on labs, I figured I must have been getting placebo since almost everyone in trials here was clearing left and right. And they were going to kick me out if my nausea hadn't lifted by week 14 visit. So I quit before they fired me. Debilitating nausea almost the whole time.

Obviously I know my response to the PI was not great, but if this test reveals that it could add even a little oomph (and that I have no mutations) I would go for it. I now know that working may not be possible and can plan accordingly, get my vitamin D on, etc. Pretty unlikely that I will be adding Telaprevir, but you never know. I am just thrilled that this test is available since trial did not give much info other than what arm you were in.

I think this could be a valuable test for a few other peeps on the board, Susan400 comes to mind. Also I think there are people that are very sick (that also have a history of severe sx) that just don't want to add the third  drug without reasonable odds. Like the IL28b, this will give you an idea of what the PI may or may not do for your genetic makeup.

I will post what doc says about ordering the test, what insurance says about paying for it, and what my results are.

Thanks for your interest and comments.


419309 tn?1326503291
Nice to see you posting, and definitely valuable information for those who were courageous enough to sign onto trials and received little info after the fact.  At least this will help avail those who still have to pursue treatment after PI exposure additional information to make better informed decisions... hopefully the more individualized, the better the success rates.  Best of luck with this! ~eureka
789911 tn?1368636783
yeah, so sorry about your results but sounds lke you have a good start on a new attack.  Please let us know more about this test as you find out.  
1130586 tn?1316266292
FF, sounds like you know what's needed to try again , and that you will do it from an informed position !

Glad to hear you are "dialed in" to Dr. Zeuzem's studies and LabCorps NS3 resistance test ; ) I hope more folks become aware of it .. not many are at this time ...

I hope the best results for you & look forward to your update ..

Cheers, Aaron
223152 tn?1346978371
This is great knowledge to share and will help a lot of people who fear they developed PI resistance. I had not hear that LabCorp had developed the test yet.

thanks for posting, foo, and hope you can get the test.  I will be very interested to see your results.

Avatar universal
Great info foo, thanks for posting.

I too would be extremely interested in how you get on with the test and with the conclusions and the decisions that come out of it for you.

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