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Just finished TX ?... 12wk post tx UND maybe as good as 24wk to predict...
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Just finished TX ?... 12wk post tx UND maybe as good as 24wk to predict SVR

Some of us that just finished tx might find this study from the 2008 liver meeting very interesting.

Can someone please explain to me if I am correct in my understanding of this study,
does the 4 wk post eot UND pcr = 96% svr rate in this study ?

What I get out of this study is, if you get a UND, TMA VL test, 4wks after end of tx, you have a 96% chance of SVR ...pretty good odds  
At 12 wks after tx, in this study, UND, TMA VL test, was a 100% chance of SVR.

http://aasld2008.abstractcentral.com/planner?NEXT_PAGE=ITINERARY_ABS_DET_POP&SESSION_ABSTRACT_ID=332272&ABSTRACT_ID=504907&SESSION_ID=35383&PROGRAM_ID=2214

AASLD 2008 Annual Meeting
ID#  1253
Nov 03 8:00 AM - 5:30 PM
Q07. HCV: Treatment

Assessment of serum HCV RNA at week 12 post-treatment is as relevant as week 24 to predict SVR in patients with chronic hepatitis C treated with Pegylated interferon plus ribavirin
M. Martinot-Peignoux1; M. Ripault2; S. Maylin1; L. Leclere1; N. Boyer2; P. Marcellin2, 1
1. INSERM U773 -CRB3, HOPITAL BEAUJON, Clichy, 92110, France.
2. Service d'Hépatologie, HOPITAL BEAUJON, Clichy, 92110, France.


Sustained Virologic response (SVR), in patients with chronic hepatitis C treated with pegylated interferon alpha (PEG-IFN) + ribavirin (RBV) is defined by undetectable serum HCV RNA at the end of the 24 weeks post-treatment follow-up period. Once achieved SVR is durable.
The aim of our study was to evaluate if 12 weeks post-treatment serum HCV RNA assessment could be as relevant as 24 weeks to identify patients with SVR.
Methods: 137 patients, consecutively treated with standard of care regimens of PEG-IFN alpha 2b + RBV, with an end of treatment response were included in the study. Serum HCV RNA was measured at 12 weeks and 24 weeks, after treatment cessation. A subset group of patients was analyzed 4 weeks after treatment cessation. SVR was defined as undetectable serum HCV RNA at the end of the 24 weeks post-treatment follow-up. Virologic relapse (VR) was defined as reappearance of detectable HCV RNA during the 24 weeks post-treatment follow-up. Serum HCV RNA was measured with the VERSANTR HCV RNA Qualitative Assay (TMA) (Siemmens). We evaluated the positive predictive value (PPV) of an undetectable serum HCV RNA to identify patients with SVR at week 4 and week 12 post-treatment follow-up.
Results. At the end of the 24 weeks-post treatment follow-up 108/137 (79%) of the patients demonstrated a SVR and 29/137 (21%) patients demonstrated a VR. At week 12 post-treatment follow-up serum HCV RNA was undetectable in 108 patients, all were SVR: PPV for SVR was 100%; 100 patients had normal serum alanine aminotransferase (ALT) level 97 were SVR: PPV for SVR was 97% (CI: 95%-99%). In the patients with VR viral load was: 6.56±0.59 and 6.11± 0.59 log copies/ml (ns) at baseline and at week 12 post-treatment, respectively. At week 4 post-treatment follow-up serum HCV RNA measurements were available for 60 patients (11 VR and 49 SVR), serum HCV RNA was undetectable in 51/60 patients, the PPV for SVR was 96% (CI 93.3%-98.7%).
Conclusions. Our results show that the assessment of serum HCV RNA at week 12 post-treatment follow-up (PPV 100% is as effective as week 24 to predict SVR). This result emphasizes that post-treatment follow-up to identify patients with SVR or VR could be shortened to 12 weeks.

Abstract Central® (patent pending). © ScholarOne, Inc., 2008.




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8 Comments Post a Comment
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547836_tn?1302836432
i'm not good with statistics but:

"End of Treatment Response (EOT):
A negative HCV RNA (viral load) once treatment has been
completed. This measurement is highly predictive of achieving
an SVR.
Sustained Virological Response (SVR):
SVR24: Continued lack of detectable serum HCV RNA 24
weeks after the completion of treatment. In on-going clinical
trials when a person achieves an SVR24 there is more than
a 99% chance that the virus has been eliminated from the
body.
SVR12: Continued lack of detetable serum HCV RNA 12
weeks after the completion of treatment. This response term
is being evaluated to see if measuring HCV RNA 12 weeks after
treatment has been completed is comparable to measuring
HCV RNA after 24 weeks (SVR24) with regard to achieving
an SVR."

can find more on this page:
http://hcvadvocate.org/hepatitis/factsheets_pdf/treatment%20response%20terms_08.pdf
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Avatar_m_tn
If you check the dates, the study posted by Apache probably trumps the Advocate fact sheet. In other words, SVR 12 is the same as SVR 24. in other words, if you're a virus undetectable 12 weeks post treatment, you can consider yourself SVR. The caveat might be if your stage four. I do remember one study that stated the correlation in stage fours between SVR 12 and SVR 24 was around 90%. So that means, even if your stage for, SVR 12 is extremely encouraging. While no studies I can point to, I've read and heard that if you are undetectable 30 days after stopping the treatment drugs, and then your chance of SVR is around 90%. All all this,, points to the fact, that in the vast maturity of cases, if the viruses can a comeback after treatment, it comes back pretty soon.

-- Jim
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Avatar_f_tn
I read that too. When I was UND at 6 weeks post, I was really excited. I guess I was in the other 10%. So other things need to be factored in. Such as length of time on tx, compliance, whether in the early stages of tx, there were any dose reductions, at what week you went und.
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92903_tn?1309908311
"The caveat might be if your stage four. "

My recollection, back when I had a vested interest and I researched stage four relapse a lot, was that by SVR 12 I felt odds were overwhelmingly in my favor. Even at SVR 4, I felt was looking pretty cool. But then I've always looked pretty cool. Huh, Ladies?    
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179856_tn?1333550962
Goof you know how we feel about YOU - if only alas you were not already snatched up and taken otherwise WAR would break out on this forum for REAL!  :)

Even if 12 is as good as 24 ----- try telling that to somebody having their one/two/three year test LOL it really makes no difference you're still going to be just as nervous as that first test.  At least that is how I felt.

The more time you have behind you the better it just feels mentally, true or not but the fact is once you are really UND you are done....it only makes sense that if it were to come back you would see it in the first month most oftentimes. That test is the big mammajamma in my opinion.

How many people have we known who have actually relapsed after the 4 week post? I'm just curious.
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186344_tn?1278268245
Ejoli, Myown and this husband of a wife who wrote in are 3 I can think of straight off. It does happen.
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Avatar_m_tn
....shoot even I think you look good, Goof. ;)
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Avatar_m_tn
G3
UND at 4weeks
Middle of week 10 right now
Total weeks: 24
Beginning viral count: 2,266,000
Age: 33
Born with HEP
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