Aa
Aa
A
A
A
Close
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.

Leave a comment
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
35 Responses
Sort by: Helpful Oldest Newest
Avatar universal
And just keep on Keeping on!

SVR for all - however the meds get us there!
Helpful - 0
317787 tn?1473358451
(From Lucinda Porters RN post above)

    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.
Helpful - 0
317787 tn?1473358451
Hi I was trying to give hope to people who did not get to UND early.  Sorry if this scared anyone.  That definitely was not my intention.
Helpful - 0
317787 tn?1473358451
Bumping up for HepCnme
Helpful - 0
Avatar universal
Dee:   Thanks for the comment.  I totally agree!  : -) Pat
Helpful - 0
317787 tn?1473358451
Sorry so late to respond, this article reminded me of Fred who's doctor stopped tx at 8 weeks.  I think it is so important to find a doctor who has real time experience with tx.  It is so frustrating to treat in the first place, then to be cut off is heartbreaking.
Thanks
Helpful - 0
317787 tn?1473358451
bumping up for others to see
Helpful - 0
1689583 tn?1387752394
It is the same document I read it states caution should be taken when prescribing 8 weeks. That was my concern. I am sure I will be ok seeing I am below 6 million the relapse was 2% if I remember correctly.
Helpful - 0
Avatar universal
I got a similar typing problem on my LG G2  April 11, 21015 ??   couldn't even imagine that far in the future.
Helpful - 0
Avatar universal
It isn't an article, it's a living document that can be updated at anytime. The important thing is to revisit before acting on any recommendations.
Helpful - 0
Avatar universal
How to cite and request permissions www.hcvguidelines.org:
The website as a whole:
AASLD/IDSA/IAS–USA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Accessed April 11, 2015

http://www.hcvguidelines.org/news/how-cite-and-permissions   Accessed April 11, 2015

For clarification April 24, 2014 in the example,that represents the date that page was updated.  When citing you use date you accessed the website (page).

On the home page
This website is constantly being updated. Please remember to always refresh your page.

in the box
"NOTICE: Guidance for hepatitis C treatment in adults is changing constantly with the advent of new therapies and other developments. A static version of this guidance, such as printouts of this website material, booklets, slides, and other materials, may be outdated by the time you read this. We urge you to review this guidance on this website (www.hcvguidelines.org) for the latest recommendations."

The information at hcvguidelines.org is copyrighted and for fair use brief quotes can be used if properly cited,

Any extensive copying of text and re-posting must get permission.
Request Permissions
We’ve partnered with Copyright Clearance Center to make it easy for you to request permissions to reuse [Publisher] content.

I try not to quote hcvguidelines.org material without revisiting site as I did today to be sure it hasn't been updated since my last visit.  When I use April 11, 21015 that tells everyone that I checked today to verify the info I quoted
Helpful - 0
1689583 tn?1387752394
I see the date is April the article from I was reading was in January 2015
Helpful - 0
1689583 tn?1387752394
I must have misread then I thought there was a difference good to know I have to reread the article.
Helpful - 0
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
Helpful - 0
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
Helpful - 0
1689583 tn?1387752394
1b....for the third time.
Helpful - 0
1689583 tn?1387752394
Typo 1a's fair better.... Darn
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?
Helpful - 0
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
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
Helpful - 0
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.
Helpful - 0
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
Helpful - 0
1689583 tn?1387752394
Darn phone.... Can't type today, sorry folks.
Helpful - 0
1689583 tn?1387752394
Corredition doctor said won't need the additional 4 weeks.
Helpful - 0
2
Have an Answer?

You are reading content posted in the Hepatitis C Community

Top Hepatitis Answerers
317787 tn?1473358451
DC
683231 tn?1467323017
Auburn, WA
Learn About Top Answerers
Didn't find the answer you were looking for?
Ask a question
Answer a few simple questions about your Hep C treatment journey.

Those who qualify may receive up to $100 for their time.
Explore More In Our Hep C Learning Center
image description
Learn about this treatable virus.
image description
Getting tested for this viral infection.
image description
3 key steps to getting on treatment.
image description
4 steps to getting on therapy.
image description
What you need to know about Hep C drugs.
image description
How the drugs might affect you.
image description
These tips may up your chances of a cure.
Popular Resources
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
Can I get HIV from surfaces, like toilet seats?