Viral load is less than 43 at week 4

[SteveWonder]

Hi all,

I got my blood work back and my viral load is less than 43 at week 4. I'm genotype 1a and am on the three drug program with Incivik. The positive viral load means I'll be going the 48 weeks instead of 24 weeks. This past week I've gotten a bad case of brain fog and exhaustion. My (HGB) red blood cell count is down to 10 from 11 last week and my TSH is a bit high at 5.63.

Fortuanately work and home life is good. I'd like to shake this brain fog and concentrate on getting rid of the remaining 43 hepC viruses 

[DougV]

Good luck to you.  Sudden drop in hgb is going to cause some fatigue.  Sorry to hear you get the 48 week routine.  Life does improve for most after Incivek is stopped.

Lot of people seem to be having false positives these days, before doing 48 weeks you might ask about a retest.

Doug

[SteveWonder]

Thanks Doug. It doesn't hurt to ask. I'll send an email to my doctor.

[Jazzdenova]

As Willy told me the test only goes down to 43I argued for and got them to change to the 24 weeks. You pretty much cleaned it all out.

[willy]

That seems to be the called for test, but I believe that the line in the sand is clear at 4 & 12 weeks= 24 weeks total SOC

If detected, even if it is not quantifiable.... the recommended is 48 weeks.  Keep in mind that there are many many vials of blood in a persons total some of blood in ones system (not to mention some that could reside in tissue)  It doesn't take but a few virons to repopulate an infection.

The issue is that one is positive, even though it is very low.  That signals that both the PI, the SOC and the innate immune response have not been able to eliminate the virus.....yet.  What probably, almost certainly what remains are somewhat hardier, more resistant virii.

I think it's a good idea to see if you can retest any remaining blood from the positive draw.  Lacking that another PCR.  Depending upon the doctor and the test used I believe that some doctors have misread/misinterpreted the results.  Make sure that they are clear on whether you are positive or not, get a hard copy of the result, and knowing that the results are based upon an amplification process ask about getting a subsequent PCR.

There are some doctors who are very familiar with the drugs, the PCR's and the interpretation of results.  I've seen some that are less so and sometimes the results fall short of making such a critical test crystal clear;  detected or undetected.

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http://www.ncbi.nlm.nih.gov/pubmed/22095516

Hepatology. 2011 Nov 16. doi: 10.1002/hep.24791. [Epub ahead of print]
Clinical relevance of detectable but not quantifiable hepatitis C virus RNA during boceprevir or telaprevir treatment.
Harrington PR, Zeng W, Naeger LK.
Source

Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993. Patrick.Harrington@fda.hhs.gov.
Abstract

Boceprevir- and telaprevir-based treatments for chronic hepatitis C virus (HCV) infection use specific response-guided therapy (RGT) guidelines. Eligibility for shortened treatment duration is based on achieving Undetectable HCV RNA early during treatment. It is unclear whether a detected HCV RNA level that is below the assay lower limit of quantitation (Detectable/BLOQ) is comparable to an Undetectable HCV RNA level, particularly regarding RGT decision making.

We analyzed data from boceprevir and telaprevir clinical trials to obtain a comprehensive understanding of the frequency and clinical relevance of Detectable/BLOQ HCV RNA measurements. In Phase 3 trials P05216 (boceprevir), C216 (telaprevir) and 108 (telaprevir), Detectable/BLOQ levels were reported for approximately 10-20% of all on-treatment HCV RNA measurements. In P05216 and C216, subjects with Detectable/BLOQ HCV RNA, on average, had a reduced sustained virologic response (SVR) rate compared to subjects with Undetectable HCV RNA at the same on-treatment timepoint.

At key RGT timepoints (Week 8 for boceprevir, Week 4 for telaprevir), subjects with Detectable/BLOQ HCV RNA had an approximately 20% lower SVR rate compared to subjects with Undetectable HCV RNA, and this difference widened for later on-treatment time points. A similar trend was observed for Study 108, but the differences in SVR rates were more modest, which may be explained by a higher frequency of reported Detectable/BLOQ results. Analyses of Phase 2 boceprevir and telaprevir trials indicated subjects with Detectable/BLOQ HCV RNA at RGT timepoints benefited from extended treatment duration.

CONCLUSIONS: During boceprevir- and telaprevir-based treatment, subjects with Detectable/BLOQ HCV RNA had a reduced virologic response compared to subjects with Undetectable HCV RNA. Eligibility for shortened treatment duration should be based on patients achieving Undetectable HCV RNA at RGT decision timepoints. (HEPATOLOGY 2011.).

Copyright © 2011 American Association for the Study of Liver Diseases.
PMID:
    22095516  [PubMed - as supplied by publisher]

=========================
http://pi.vrtx.com/files/uspi_telaprevir.pdf
(see section 2.1 -willy)

For the purpose of assessing response-guided therapy eligibility at weeks 4 and 12 (see Table 1), an “undetectable” HCV-RNA result is required; a confirmed “detectable but below limit of quantification” HCV-RNA result should not be considered equivalent to an “undetectable” HCV-RNA result [see
Laboratory Tests (5.6)].

[SteveWonder]

the doctor said a retest wasn't warrented. doesn't hurt to ask but at this point I'd rather error on the side of caution. 48 weeks it'll be be. i got a hard copy of the result. the nurse gave it to me last Friday. Orignally she said I was undetected. I gave her a high five. She re-read the result and sure enough it is detected. Like willy said they had to do a secondonary test as the viral load was low. I guess it isn't surprisely low. The nurse gave me a chart showing the actions taken according to viral loads. If my count had been above 1000 they would have terminated treatment. So a drop from 2.3 million to < 43 is dramatic but apparently not surprising.

How the heck to get rid of the remaining 43 virals?

I'm feeling a lot better since my last post. The Anemia simply knocked me out completely. The doctor reduced my Ribovirin from 1200 to 1000 on Friday and this morning I started to feel a change. I called in sick Monday.

[willy]

Steve, I wonder....are you or have you been taking Vit D?  It has been in a few studies and seems to improve viral response.  Coffee seems to also be implicated in better response.  I've seen pot smoking linked to better SVR rates; it seems to improve dosing compliance.  I think it helps people not notice how bad they feel at times.   

There have been a few studies which suggest that milk thistle may help.  there was a recent one which said it was no good at all but .....IMHO.... it was a rather flawed study.  My belief is that if one buys the best it may help.  The issue is that MT is poorly absorbed.  there are some brands (such as from Liver Support) which have been formulated to improve absorbtion; they claim 10X.  (who knows?)  There were several IV MT trials which showed it to have antiviral properties, and they were able to prove ( I believe) that it was a mild polymerase inhibitor.  For me..... if I was taking a protease inhibitor (incivek) + a polymerase inhibitor (the MT) plus SOC, I would expect a better result than just the triple therapy.  Anyway......

Just a few things to thinkj about.  Sometimes a little bit here and a little bit there can make a difference; just look at the difference a few virii in your viral load ends up making.

In any case..... press on and gods speed.

willy