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317787 tn?1473358451

HCV UND - SVR NEW INFO

Hi all I found this article and thought it was so interesting and it gives hope to those who may still be detectable on tx.  There is so much new information coming out all the time it is difficult to keep up.  I hope this helps someone.
Dee


New Hepatitis C Treatments and Viral Load Results: Clearing Up Confusion
By Lucinda K. Porter, RN on March 23, 2015 1:39 PM | 12 Comments
HepCvirus.JPG

New hepatitis C medications are changing lives, saving lives, and bringing hope. However, there is some confusion about viral load testing used during hepatitis C treatment. I am aware of this confusion because I am repeatedly asked two questions.

Question One:

"What does this test mean?" This question is accompanied with test results such as:

HCV Viral Load (Log IU/mL)   <1.18 NOT DETECTED

Answer: This is the very best news.

Undetectable means that hepatitis C is gone, and presumably all gone. The confusion over this test is because viral load tests don't measure down to zero. Further, viral load tests vary. For instance, the Abbott RealTime HCV assay (assay is a fancy word for a test that determines and measure the ingredients of something) measures down to 12 IU/mL in a 0.5 mL sample of blood. This means that if you have 12 IU/ml of hepatitis C (HCV RNA) in your blood, the test will detect it and count it. If you have less than 12, the test might not see it, and if it does, it won't be able to count it. .

Each test has its own detection range, some lower than others. The main thing is this:

    "Not detected" = negative for hepatitis C
    "Detected" or an actual number of how much HCV RNA you have = positive for hepatitis C

If you are concerned that you may have some residual HCV swimming around in your body, hoping to set up shop in your liver, rest assured, as this is quite unlikely. Hep C replicates a trillion times a day, so "not detected" might as well be zero. It is extremely unlikely that a small amount of HCV will remain alive in your body without having replicated to much higher amounts. In fact, viral load tends to replicate at much higher numbers when treatment fails.

Question Two:

I am on treatment with Harvoni. My pre-treatment viral load was X million. My week 4 (or week 8 or week 12) viral load came back detectable. I am devastated. Should I be?

Answer: No.

In the old days, back when treatment was long and used interferon, there were clear milestones that helped us know what our chances were of permanently clearing hepatitis C. Ignore all of that. New research funded the NIH Clinical Center showed that low levels of HCV RNA at the end of treatment are not predictive of treatment response among patients with hepatitis C virus treated with interferon-free regimens. (Clinical Infectious Diseases, March 2, 2015) In fact, low levels of HCV RNA detected at the end of treatment, and even post-therapy, do not signify treatment failure.

Here is a bit more information. Sidharthan and colleagues enrolled 114 subjects with chronic HCV/genotype 1 and no prior treatment. Six patients with detectable viral load at the end of treatment achieved a sustained virologic response (SVR12). You can read more about it: Utility of Hepatitis C Viral Load Monitoring on Directly Acting Antiviral Therapy - S Sreetha Sidharthan, et al.

The bottom line is that a detectable viral load at the end of treatment DOES NOT mean that treatment failed when using Harvoni-based treatment.

Important:

    Don't despair if you have detectable virus during or at the end of HCV treatment.
    Be sure your doctor doesn't stop treatment just because you have detectable HCV RNA. The HCV guidelines recommend viral load testing after 4 weeks of therapy and at 12 weeks following treatment completion.  If quantitative HCV viral load is detectable at week 4 of treatment, repeat viral load testing at treatment week 6. If viral load has increased by greater than 10-fold on repeat testing at week 6 (or thereafter), then discontinuation of HCV treatment is recommended. There are no other recommendations to stop or extend therapy based on viral load results.

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Best Answer
1961140 tn?1450738712
Hey, I too obsessed about the diffference between the viral titer result listing first showing "< 15IU/ml", then changing to "TND". This is the acronym some lab in KY Merck used for "totally non detectable". What was the difference, I asked? I never got a consensus answer to that question, so I finally let it go. Since week 5 of tx, I was "TND". I began tx 8-05-14, and my next titer will be drawn on 4-14. The Director of Hepatology wrote me a letter, quoting the relapse rate for persons who were TND 12 weeks post tx as "less than 1%". He feels I am in the clear, I would rather wait to see the result of this upcoming titer. I think the trend of shortening tx periods has become the new holy grail, now that they know how to eradicate it, the race is on to do it faster than the other drug mfr. Hang in there all you GT3s, yours will just be the last one to take a permanent vacation.     mac
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Avatar universal
Very interesting article.  I hope those heppers whose Drs cut them off at 8 weeks because not UND will show this article to those same Drs.

Praying that, by now, they ARE UND and on the way to SVR, but having evidence to back up a claim for continued tx for what I consider that critical extra 4 weeks is excellent!

On to SVR, All!

Pat
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Avatar universal
VERY INFORMATIVE  THANKS
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4896357 tn?1360670904
Nice! More proof that there is more collective data here than most doctors know!
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Avatar universal
Dee thanks for always looking out for this "Community". Great article!
......Kim
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317787 tn?1473358451
You guys are so great!  Thank you!  I saw this, thought about people being detected at 8 weeks hoped this would help them

Dee
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317787 tn?1473358451
Along the lines of information. I just saw the first commercial from the CDC re HCV.  It is the Know More HCV Campaign.  It said that people born between 1945 and 1965 are FIVE TIME'S more likely to have HCV.  They are now saying there are more than 4M in US with HCV.  3 out of 4 infected were born during those 20 years.  I hope people get the word. 75% of people infected don't know.
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317787 tn?1473358451
Thanks so much, I thought it was interesting, Dee
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Avatar universal
Great article, Dee. Lucinda is amazing. Thanks for posting it.
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Avatar universal
" I hope those heppers whose Drs cut them off at 8 weeks because not UND will show this article to those same Drs"

Are you referring to patients who were prescribed and started 12 or more weeks of the new drugs then having their tx stopped at week 8 if VL detected? Except for a 10 fold increase in VL.  

Where there any members who posted that this happened to them? If so what did they do?

I know there are member here with GT1 VL under 6M who started 8 week tx. and are trying to get 4 more weeks.  This article wouldn't support that in my opinion.

Helpful - 0
1689583 tn?1387752394
I am on the 8 week tx did a viral load at 3 weeks was 108 doing another viral load Tuesday that will be week 4 for me my doctor told me I will be fine and will need the additional 4 weeks my pre tx viral load was 2million so it dropped from that to 108 Does this make sense?
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1689583 tn?1387752394
Corredition doctor said won't need the additional 4 weeks.
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1689583 tn?1387752394
Darn phone.... Can't type today, sorry folks.
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Avatar universal
It's 2 week VL. 2000000 to 108.   I believe you will be undetected or maybe det un 12 at 4 weeks and will achieve SVR.    In my opinion some posts by some members although well intentioned may cause unnecessary worrying for others and that "may be unhealthy"

I was in a similar boat last year when I started tx GT2. Cirrhosis SOV/RBV 12 weeks and had read 16 weeks might be better.  I mentioned it once or twice and expressed a little concern but concentrated on tx. and didn't worry about it
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1689583 tn?1387752394
I am optimistic I shall achieve svr and so is my doctor.I will see what the viral load is by the end of next week. Thanks.
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Avatar universal
I was directing it mainly at the 2 or 3 who posted that because they were not undetected they were terminating tx. I believe those posts were in Dec or Jan but could be wrong.

Also, my intent toward those who were given an 8 week tx protocol, to try for 12 weeks, if they felt uncomfortable w/8 weeks tx.  I haven't seen anything from the AASLD saying that 8 weeks was the accepted protocol, even on Harvoni, even thought we have people who are clearing in 8 weeks.

Am I wrong?  Has AASLD changed their recommendations for SOC for Harvoni?

If so, please correct me, and point me to the info.  I do not want to give out incorrect info.

Thanks

pat
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Avatar universal
It is acceptable with *  ..." identified lower relapse rates in patients receiving 8 weeks of ledipasvir/sofosbuvir who had baseline HCV RNA levels below 6 million IU/mL (2%; 2 of 123), and was the same for patients with similar baseline HCV RNA levels who received 12 weeks (2%; 2 of 131). This analysis was not controlled and thus substantially limits the generalizability of this approach to clinical practice. Shortening treatment to less than 12 weeks should be done with caution and performed at the discretion of the practitioner"

AASLD/IDSA/IAS–USA. HCV testing and linkage to care. Recommendations for testing, managing, and treating hepatitis C.

http://www.hcvguidelines.org/full-report/initial-treatment-hcv-infection
Accessed April 11,  2015

Note it is possible that some health professionals and or insurance may have access to more current data than what is officially reviewed and or published.
Helpful - 0
1689583 tn?1387752394
I read that report and forwarded it to my doctor on Friday it appears the 1a's as I am should consider the 12 weeks and the 1a's and 1a's fair better. They mention caution should be taken when prescribing 8 weeks, so I shall see after next week viral load to see if we will push for the 12 weeks. I am tx naive gt 1a F2 viral load 2million. Who knows?
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1689583 tn?1387752394
Typo 1a's fair better.... Darn
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1689583 tn?1387752394
1b....for the third time.
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Avatar universal
Genotype 1b treatment-naive patients
There is no measurable difference demonstrated to date in treatment response to ledipasvir/sofosbuvir for HCV genotype 1 subtypes, thus the supporting evidence remains the same as for HCV genotype 1a–infected patients (see Genotype 1)

AASLD/IDSA/IAS–USA. HCV testing and linkage to care. Recommendations for testing, managing, and treating hepatitis C.

http://www.hcvguidelines.org/full-report/initial-treatment-hcv-infection
Accessed April 11,  2015

Best wishes
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Avatar universal
Thanks!  I appreciate the update----now, if I can just remember that there IS a time so I can look it up!  : -)

Pat
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1689583 tn?1387752394
I must have misread then I thought there was a difference good to know I have to reread the article.
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1689583 tn?1387752394
I see the date is April the article from I was reading was in January 2015
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