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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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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
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
I must have misread then I thought there was a difference good to know I have to reread the article.
Thanks! I appreciate the update----now, if I can just remember that there IS a time so I can look it up! : -)
Pat
Pat
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
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
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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